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Barclays Official

California

Code of
Regulations

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Title 17. Public Health

Complete Title

Vol. 22

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•

TITLE 17. PUBLIC HEALTH

NOMENCLATURE CROSS-REFERENCE

(NOTE: Effective April 1 , 1 990, the Office of Administrative Law authorized the renaming of the
hierarchical headings used within the Titles of the California Code of Regulations. Until the agen-
cies implement these changes in their regulations, use the following Cross-Reference Table for
the new organizational headings used in this Title.)

OLD HIERARCHY REVISED HIERARCHY

Part Division

Chapter Chapter

Subchapter Subchapter

Group Group

Subgroup Subgroup

Article Article

Part Subarticle

Section Section

Title 17

Public Health

Title Table of Contents

Title 17. Public Health

Table of Contents

Division 1.

Chapter 1 .
Subchapter 1.

Subchapter 2.

Article 1.

Subchapter 3.

Group 1.

Group 2.

Subgroup 2

Group 3.
Group 4.

Group 5.
Subchapter 4.
Article 1.

Article 2.

Article 3.

Article 4.

Subchapter 5.

Chapter 2.
Subchapter 1.
Group 1.

Article 1.
Article 2.
Article 3.

Page

State Department of Health

Services i

Administration i

State Department of

Health Services i

Hospital Districts l

Liability Loans i

Hospital Inspection i

Clinics and Dispensaries 2

Health Facilities 2

Requirements for Outpatient

Clinics 2

Nonprofit Hospitals 2

Establishments for Handicapped
Persons 2

Public Medical Institutions 2

Records and Statistics 2

Access to the Records in the

Office of the State

Registrar and in the

Offices of Local

Registrars 2

Late Registration of Births

and Deaths 3

Birth Certificates of

Deceased Persons 3

Definitions of Live Birth

and Fetal Death 3

Home Health Agency

Licensing Requirements 4

Laboratories 4

Service Laboratories 4

Production and Distribution of
Biologies 4

Licenses 4

Exemptions 4

Inspection and Records 4

Page

Article 4. Storage 5

Article 5. Containers and Labeling 5

Article 6. Advertising 5

Article 7. Samples 5

Article 8. Vaccine Culture ?

Article 9. Preparation and Distribution

of Whole Blood (Human) 3

Article 10. Preparation and Distribution

of Normal Human Plasma 8

Article 1 1 . Preparation of Other Blood

Derivatives 8

Article 12. Transportation of Etiologic

Agents 9

Article 1 3. Research Projects 9

Group 2. Clinical Laboratory

Regulations 9

Article 1 . Definitions 9

Article 1.5. Licensure of Clinical

Laboratory Personnel 19

Article 2. Training 20.10

Article 2.3. Clinical Laboratory

Supervisors 20.13

Article 2.5. Confinuing Education 20.1?

Article 2.8. CLIA Certification/State

Licensure 22

Article 3. License 22

Article 4. Personnel Report 22.1

Article 5. Issuance of License 22.1

Article 5.2. Test Kits Approved for Over-
the-Counter Sale to the
Public by the United States
Food and Drug
Administration 22.3

Article 5.3. Blood Electrolyte Analysis
by Respiratory Care
Practitioners 22.4

Article 5.5. Use of Poini-of-Carc

Laboratory Testing Devices

by Registered Nurses 22.4

Page i

Title Table of Contents BARCLAYS CALIFORNIA

Page

Article 5.6. Moderately Complex
Laboratory Testing by
Licensed Psychiatric
Technicians. Licensed
Vocational Nurses, Licensed
Midwives, Certified Nurse
Assistants, and Certified
Home Health Aides 22.4(a)

Article 6. Laboratory Reports 22.4(a)

Article 7. Cytotechnology 22.4(b)

Article 8. Enforcement 22.5

Group 3. County and Municipal

Laboratories 22. 1 1

Article 1 . Official Public Health
Laboratory Service
Required 22.11

Group 4. Tests for Syphilis Under the

Premarital and Prenatal Laws 23

Article 1 . Serologic Tests 23

Group 5. Care of Laboratory Animals 24

Article 1. Definitions 24

Article 2. Certification Requirements 25

Article 3. Minimum Standards 25

Article 4. Filing of Complaint 26

Group 5.5. Methadone Drug Analysis

Laboratories 26

Article 1 . Application 26

Article 2. Definitions 26

Article 3. Requirements for Methadone

Drug Analysis Laboratories 26

Article 4. Licensing Procedures 27

Article 5. Substances Approved for
Analysis, Requirements for
Collection and Handling of
Samples 27

Article 6. Methods of Analysis and

Standards of Performance 28

Article 7. Inspections, Quality
Control, Proficiency
Testing 28

Article 8. Records 29

Group 6. Water Laboratories 29

Group 7. Human Tissue Preservation 29

Article 1. Approval 29

Group 8. Forensic Alcohol Analysis and

Breath Alcohol Analysis 30

Article 1 . General 30

CODE OF REGULATIONS Title 17

Page

Article 2. Requirements for Forensic

Alcohol Laboratories 30

Article 3. Licensing Procedures 31

Article 4. Training of Personnel 32

Article 5. Collection and Handling of

Samples 32

Article 6. Methods of Forensic Alcohol

Analysis 33

Article 7. Requirements for Breath

Alcohol Analysis 34

Article 8. Records 35

Group 9. HIV Antibody Testing 35

Article 1 . Approval of Laboratories 35

Chapter 3. Local Health Service 36

Subchapter 1 . Standards for State Aid
for Local Health
Administration 36

Article 1 . Organization 36

Article 2. Program 37

Article 3. Personnel 38

Article 4. Finance 40

Subchapter 2. Standards for State Aid
for Comprehensive
Environmental Agencies 41

Article 1 . Definitions 41

Article 2. Agency Personnel and

Facilities 41

Article 3. Organization 41

Article 4. Program 42

Subchapter 3. Standards for Maintaining

County Health Services 42

Article 1 . Application 42

Article 2. Definitions 43

Article 3. County Health Services

Multi-Year Plan and Budget 46

Article 4. Allocations, Agreement,

Disbursement, Reporting and
Recoupment Procedures 47

Article 5. Public Hearing Procedures 50

Article 6. County Medical Services

Program 50

Chapter 3.1. Indian Health 51

Article 1. Definitions 51

Article 2. Indian Health Policy Panel 52

Article 3. Assistance to Indian Health

Programs 52

Article 4. Standards of Service 53

Page ii

(7-25-2008)

Title 17

Public Health

Page

Joint Regulations for Article 3.

Handicapped Children 59

Interagency Article 4.

Responsibilities for Subchapter 5.

Providing Services to Group 1

Handicapped Children 59

Article 1.

Preventive Medical Service 59

Reportable Diseases and Group 2.

Conditions 59 Subchapter 6.

Reporting 59

General Instructions 66

„ -r- TA- T Subchapter?.

Specific Diseases and

Conditions 67 Subchapter 8.

Reporting of Human

Immunodeficiency Virus

(HIV) Infection 76.2

1 . Definitions 76.2

4. Reporting Requirements 76.4

Approval Procedures for

Canine Rabies Vaccines 76.6 Article 1 .

Adult Health 76.8 Article 2.

Disorders Characterized Article 3.

by Lapses of

Consciousness 76.8

Definitions 76.8

Reporting 76.8 Article 4.

Services for Physically Article 5

Handicapped Children 76.8

Minimum Standards for the Care Subchapter 8.1.

of Physically Handicapped

Children for Local Subchapter 8.2.

Communities in California 76.8

General 76.8

Immunization Adverse Subchapter 9.

Reaction Fund 76.9

Podiatrist and Family Group 3.

Practice Physician Article 1

S^^^^^^^ ''-^ Article2.

Genetically Handicapped

Persons Program 76.10 Article 3

Registration as School Article 4

Audiometrists 77

General 77 Group 5.

The Infant Botulism

Treatment and Prevention Article 1 .

P^^g^^"^ '^-^ Article3.

Definitions 78.1

Distribution of Botulism Article 4.

Immune GlobuUn 78.1

Title Table of Contents

Page

Reporting Requirements for
Hospitals Receiving BIG 78.1

Fees 78.1

Public Health Nursing 79

Issuance of Public Health

Nursing Certificates 79

Trained Attendants 79

Tuberculosis Hospitals

and Sanatoria Receiving

State Subsidy 79

Venereal Diseases 79

Immunization Against

Poliomyelitis,

Diphtheria, Pertussis,

Tetanus, Measles

(Rubeola), Rubella,

Haemophilus Influenzae

Type B (Hib), Mumps, and

Hepatitis B 79

Definitions 79

Required Immunizations 80

Admission to School, Child

Care Center, Day Nursery,

Nursery School, Family Day

Care Home, or Development

Center 82

Exclusion 85

Records As Evidence of
Immunization 86

Immunization Against

Measles (Rubeola) 87

Immunization Against

Diphtheria, Tetanus, and

Pertussis 87

Testing for Heritable

Disorders 87

Newborn Screening Program 87

Definitions 87

Testing and Follow-Up

Program Requirements 89

Sickle Cell Programs 92

Newborn Screening

Participation Fee 93

Prenatal (Multiple Marker)

Testing Program 94

Definitions 94

Testing and Follow Up

Program Requirements 94.2

Prenatal Screening Fee

Collection 94.3

Chapter 3.5.
Subchapter 1 .

Chapter 4.
Subchapter 1 .

Article 1.
Article 2.
Article 3.

Article 3.5.

Subarticle
Subarticle
Article 4.

Subchapter 2.
Subchapter 2.5.

Article 1.

Article 2.

Subchapter 3.

Group 1.

Article 1.
Article 2.

Article 3.

Article 4.

Group 2.

Article 1.
Subchapter 4.

Article 1.
Article 2.

Page iii

Title Table of Contents BARCLAYS CALIFORNIA

Page

Subchapter 10. Tuberculosis Screening of
Employees and Volunteers
in Private, Parochial
and Nursery Schools 94.4

Article 1 . Definitions 94.4

Article 2. Records as Evidence of

Compliance 94.4

Subchapter 1 1 . First Aid and

Cardiopulmonary

Resuscitation Training

Standards for Public

Safety Personnel 94.4

Article 1. General 94.4

Article 2. Definitions 94.4

Article 3. Training Standards 94.4

Article 4. Designated Agencies 95

Subchapter 12. Ambulance Personnel 95

Subchapter 13. Child Health and

Disability Prevention

Program 95

Article 1 . Definitions 95

Article 2. Program Administration 97

Article 3. Eligibility for Services and

Reimbursement 99

Article 4. Required Services 100

Article 5. Providers of Health

Screening and Evaluation

Services 104

Article 6. Claiming for Services 105

Article 7. Records, Reporting and

Confidentiality 106

Subchapter 14. Stop Tobacco Access to

Kids Enforcement (STAKE)

Act Program 107

Chapter 5. Sanitation (Environmental) 108.1

Subchapter 1. Engineering (Sanitary) 108.1

Group 1. Domestic Water Supplies

Quahty and Monitoring 108.1

Group 1.1. Waterworks Standards 108.1

Group 2. Certification of Water

Treatment Facihty Operators 108.1

Article 1. General 108.1

Article 2. Responsibility of Water

Supplier 108.1

Articles. Responsibility of Operators 108.1

Article 4. Issuance of Certificates 108.1

Article 5. Types of Certification 108.2

CODE OF REGULATIONS Title 17

Page

Article 6. Certification Issuance,

Renewal, Suspension and
Revocation 108.2

Article 7. Examination 108.3

Article 8. Fees 108.3

Group 3. Drain Wells 108.4

Article 1 . Drain Wells 108.4

Group 4. Drinking Water Supplies 109

Article 1 . General 109

Article 2. Protection of Water System 11 0

Article 3. Protection of Public Water
System at Service
Connection 112

Article 4. Protection of Potable Water

System Within Premises 112

Article 5. Domestic Water Supply

Reservoirs 112

Article 1 1 . Delegation of Authority

Pursuant to Section 4025 of
the Health and Safety Code
(Permits for Small Water
Systems) 113

Article 12. Production and Distribution

of Bottled Water 113

Group 5. Sanitary Control of Shellfish 113

Article 1 . Shellfish Certificates 1 13

Article 2. Safety of Shellfish and

Health of Employees 114

Article 3. Records 114

Article 4. Shellfish Beds 114

Article 5. Plants and Operations 114

Group 6. Pubhc Swimming Pools 116

Group 7. Bottled Water and Water

Vending Machines 116

Article 1 . Water Bottler and Water

Vendor Responsibilities 116

Article 2. Definitions 116

Article 3. Water Quality 116

Article 4. Good Manufacturing

Practices 116

Article 5. Out-of-State Bottler or

Distributor 117

Article 6. Licenses and Fees 117

Group 8. Sanitary Inspections 118

Article 1. Sale of Rat Exterminators 118

Article 2. Capture, Holding, Shipment

and Sale of Wild Rodents 118

Group 9. Registered Sanitarians GTP 119

Page iv

(7-25-2008)

Title 17

Public Health

Page

Internship Program 119

Approval of Educational

Institutions 1 19

Registration Procedures 119

Minimum Educational and
Experience Qualifications
for Admission to the
Examination for Registered
Sanitarians 119

Application Procedures for
Sanitarian Registration 120

Sanitation, Healthfulness and
Safety of Ocean Water-Contact
Sports Areas 120

Intent of Regulations 120

Definitions 120

Sanitation 120

Healthfulness 120

Safety 121

Sanitation of Public Beaches 121

Intent of Regulations 121

Definitions and Exemptions 121

Day Use Beaches 122

Beaches Allowing Overnight
Camping 122.1

Food Crop Growing and

Harvesting Sanitation 123

Intent of Regulations 123

Definitions 123

Toilet Facilities 123

Servicing of Units 123

Supplies 124

Handwashing Facilities 124

Waste Wash Water Disposal 124

Reclaimed Waste Water 124

Regulations for

Implementation of the

California Environmental

Quality Act of 1970 124

Foods and Drugs 124

Rules and Regulations 124

Definitions 125

Drugs and Devices

Regulations 125

Food Regulations 132

Food Additives Regulations 134

Title Table of Contents

Page

Foods Under Agricultural

Code Regulations 1 34

Poultry Meat and Poultry

Products 1 34

Raw Milk and Raw Milk

Products 134.1

Horse Meat Regulations 1.34.1

Cold Storage Regulations 134.1

Low Acid Frozen Foods in

Hermetically Sealed

Containers, Regulations 1.34.1

Bakery Sanitary Regulations ... 1.34.1

Local Enforcement of the

Sherman Food, Drug and

Cosmetic Law As It Relates

to Retail Food

Establishments 135

Food Sanitation Regulations 136

Cannery Inspection

Regulations 138

Olive Oil Regulations 152

Mobile Food Preparation

Units 152

Commissaries Servicing
Mobile Food Preparation
Units 155

Requirements for the Sale of

Imitation Hamburger in

Restaurants 155

Requirements for Roadside

Stands, Food Establishments

Open to the Outside Air,

and Retail Dairies 155

Ventilation Standards for

Retail Food Establishments 156

Raw Oysters 156

Frozen Food Locker

Regulations 156.3

Hazardous Substances

Regulations 157

Definitions and Standards 157

Food Standards 157

Flour and Cereal

Products 157

Corn Flour and Related

Products 157

Rice and Related

Products 157

Bakery and Bakery

Products 157

Article 1.
Article 2.

Article 3.
Article 4.

Article 5.
Group 10.

Article 1.
Article 2.
Article 3.
Article 4.
Article 5.
Group 10.1.
Article 1.
Article 2.
Article 3.
Article 4.

Group 11.

Article 1.
Article 2.
Article 3.
Article 4.
Article 5.
Article 6.
Article 7.
Group 12.
Subchapter 1.5.

Subchapter 2.
Group 1.
Article 1.
Article 2.

Article 3.
Article 3.1.

Article 3.5.

Article 3.6.

Article 3.7.

Article 4.
Article 5.
Article 5.5.

Article 6.
Article 6.1.

Article 7.
Article 8.

Article 9.
Article 10.

Article 10.1.
Article 10.2.
Article 10.3.

Article 10.4.

Article 10.5.
Article 11.

Article 12.

Group 2.
Article 13.
Subarticle

Subarticle

Page V

Title Table of Contents BARCLAYS CALIFORNIA

Page

Subarticle 4. Alimentary Pastes 157

Subarticle 1. Canned Vegetables 158

Subarticle 2. Canned Vegetable Other
Than Those Specifically
Regulated 158

Subarticle 3. Canned Tomatoes 158

Subarticle 4. Tomato Products 158

Subarticle 5. Tomato Products, Mold

Filament Tolerance 158

Subarticle 1 . Canned Fruit 158

Subarticle 2. Fruit Preserves and

Jellies 158

Subarticle 3. Fruit Butters 158

Subarticle 3.5. Citrus Products 158

Subarticle 4. Carbonated Beverages 158

Subarticle 1. Dressings for Salads 159

Subarticle 1 . Canned Shrimp 159

Subarticle 2. Canned Oysters 159

Subarticle 3. Raw Oysters 159

Subarticle 4. Sea Food Cocktails 159

Subarticle 5. Canned Tuna Fish 159

Subarticle 1 . Extracts 160

Subarticle 2. Flavors 160

Subarticle 3. Labeling 160

Subarticle 1. Olives, Ripe, Sold in

Bulk 161

Subarticle 2. Canned Whole and Pitted

Ripe Ohves 161

Article 13.1. Actionable Defect Levels for

Processed Foods 163

Article 14. Wine Standiu-ds and

Prohibited Practices 163

Article 15. Distilled Spirits Standards 164

Article 16. Processed Pet Food

Regulations 165

Subchapter 3. Vector Control 167

Group 1 . Standards Governing State Aid
to Local Mosquito Control
Agencies 167

Group 2. Standards Governing

Certification of Local Vector

Control Agency Personnel 167

Article 1 . Definitions 167

Article 2. Certification Examinafion 168

Article 3. Condnuing Educafion 170

CODE OF REGULATIONS Title 17

Page

Subchapter 3.1. Implementation of the
Emergency Mosquito
Abatement Funding Act of
1983 170

Article 1. General Provisions 170

Article 2. Conditions Governing
Expenditure of the
Emergency Mosquito
Abatement Trust Account or
Fund 171

Article 3. Criteria for Determining If
a Local Agency Has
Established Adequate
Emergency Mosquito
Abatement Procedures 171

Subchapter 3.2. Importation of Wild

Animals 171

Article 1. General 171

Arficle 2. Import Permits 171

Article 3. Quarantine Facilities and

Operating Standards 174

Article 4. Quaranfine Provisions 174.1

Article 5. Quarantine Records 174.2

Article 6. Quaranfine Reporting 174.2

Article 7. Cooperation with Other

Governmental Agencies 174.2

Article 8. Excepfions 174.2

Subchapter 4. Radiation 175

Group 1 . General 175

Arficle 1 . Definifions 175

Article 2. Exemptions and Enforcement .... 176

Group 1.5. Registration of Sources of

Radiation 176

Article 1. Registration Procedure 176

Article 2. Exclusions from

Registrafion 177

Article 3. Records 177

Arficle 4. Fees 177

Group 2. Licensing of Radioactive

Materials 178

Article 1. General 178

Arficle 2. Definifions 179

Article 3. Exemptions 179

Article 4. Licenses 1 80

Article 5. Transfer of Material 1 86

Arficle 6. Enforcement 186

Article 7. Reciprocal Recognition of

Licenses 186

Article 8. License Fees 186.1

•

Page vi

(7-25-2008)

Title 17

Public Health
Page

Schedules 187

Standards for Protection

Against Radiation 191

General 191

Notices, Instructions, and

Reports to Workers;

Inspections and

Investigations 192

Surveys and Tests 195

Records and Notification 196.1

Special Requirements for the
Use of X-Ray in the Healing

Arts 197

Requirements for the Use of

X-Ray in Mammography 202.1

Special Requirements for the

Use of Radioactive Material

in the Healing Arts 203

Special Requirements for
Radiographic Operations in
Industrial Radiography 203

Radiation Safety

Requirements for Well

Logging Operations 208.8

Transportation of Radioactive
Material 214

Requirements for
Transportation of
Radioactive Material 214

Participation by Local Health
Departments 215

Local Health Departments 215

Radiologic Technology 233

Administration 233

Definitions 233

Special Permits 233

Requirements for Continuing
Education Performance, and
Renewal of Certificates and
Permits 234

Display of Certificates and

Permits 234

Deadlines 234

Change of Name and Address 235

Fees 235

Authorization to X-Ray

Technicians to Perform

Digital Radiography 235

Title Table of Contents

Page

Training of Students of

Radiologic Technology 236

General 236

Radiologic Technology

Schools 236

Radiologic Technologist
Fluoroscopy Permit Schools 237

Limited Permit X-Ray

Technician Schools 238

On-the-Job Training for X-

Ray Technicians 239

Notification 239

Disciplinary Action 239

Additional School
Requirements and
Recordkeeping 240

Certificates for Radiologic
Technologists and Permits for
Limited Permit X-Ray
Technicians 240

Certification of

Technologists 240

Permits for Limited Permit X-

Ray Technicians 240

Use of Fluoroscopy Equipment

by Radiologic Technologists 240.1

Radiologic Technologist
Fluoroscopy Permits 240.1

Use of Mammography Equipment

by Radiologic Technologists 240.2

Mammographic Technology
Certificates 240.2

Certification of Licentiates 240.2

Licentiate Certificates and

Permits 240.2

Requirements for Land Disposal

of Radioactive Waste 240.2(a)

Applicable Federal

Regulations 240.2(a)

General 240.2(a)

Proprietary Documents 240.2(a)

Selection of License

Designee 240.2(a)

Forfeiture of Performance

Bond 240.2(b)

Fees 240.2(b)

Financial Assurances 240.2(b)

Rate Review and Approval

Process 240.2(c)

Article 9.
Group 3.

Article 1.
Article 2.

Article 3.
Article 3.1.
Article 4.

Article 4.5.
Article 5.

Article 6.

Article 7.

Group 4.
Article 1.

Group 5.

Article 1.
Subchapter 4.5.
Group 1.
Article 1.
Article 2.
Article 3.

Article 4.

Article 5.
Article 6.
Article 7.
Article 8.

Group 2.

Article 1.
Article 2.

Article 3.

Article 4.

Article 5.

Article 6.
Article 7.
Article 8.

Group 3.

Article 1.

Article 2.
Group 4.

Article 1.
Group 4.5.

Article 1.

Group 5.
Article 1.

Group 7.

Article 1.

Article 2.
Article 3.
Article 4.

Article 5.

Article 6.
Article 7.
Article 8.

Page vii

Title Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

Subchapter 4.6. Nuclear Medicine

Technology 240.2(c)

Article 1 . Definitions 240.2(c)

Article 2. Certification of Nuclear

Medicine Technologists 240.3

Article 3. Administration 240.4

Article 4. Exemptions and

Enforcement 240.5

Subchapter 5. Air Sanitation 241

Article 1 . Standards for Ambient Air

Quality 241

Subchapter 6. Organized Camps 242

Article 1 . General 242

Article 2. Utilities 243

Article 3. Housing 243

Article 4. Food Service Facilities and

Operations 244

Article 4. 1 . Food Service Facilities and
Operations at Intermittent
Short-Term Organized Camps
[Repealed] 244

Article 5. Solid Waste 244

Article 6. Vector Control 244

Article 7. Swimming and Bathing 245

Article 8. Supervision 245

Subchapter 7. Wiping Rags 246

Article 1 . Definitions 246

Article 2. Minimum Standards for

Sanitizing 246

Subchapter 8. Drinking Utensils and Ice

Buckets 246

Article 1 . Definitions 246

Article 2. Washing, Sanitizing, and
Handling of Drinking
Utensils and Ice Buckets in
Hotels, Motels, and Other
Public Places 246.1

Chapter 6. Lead Poisoning Prevention

Programs 247

Article 1. Definitions 247

Article 2. Fees 248.2

Article 3. Exemption from Fees 248.3

Article 4. Application to Reassess Fee 248.4

Chapter 7. Health Facilities Planning 248.4

Chapter 7.5. Eminent Domain Procedures for

Nonprofit Hospitals 248.4

Page

Chapter 7.7.

Fire Protection Loans

. . . 248.4

Chapter 8.

Accreditation, Certification and
Work Practices for Lead-Based

Paint and Lead Hazards

... ''48 4

Article 1.

Definitions

... 248.4

Article 2.

Eligibility Requirements for
Accreditation and Course

Approval

.. 248.14

Article 3.

Core Instruction

.. ''48.16

Article 4.

Lead-Related Construction
Inspection and Assessment

Course

.. 248.16

Article 5.

Lead-Related Construction
Supervision and Project

Monitoring Course

.. 248.17

Article 6.

Lead-Related Construction
Sampling Technician

Course

248.18(a)

Article 7.

Lead-Related Construction

Work Course

248.18(a)

Article 8.

Lead-Related Construction
Supplemental Supervision
and Project Monitoring

Course

248.18(b)

Article 9.

Lead-Related Construction
Certified Industrial

Hygienist Course

248.18(c)

Article 10

Continuing Education

248.18(d)

Article 11.

Application Requirements and

Procedures for Training

Provider Accreditation,

Renewal, or Course

Approval

248.18(d)

Article 12.

Suspension or Revocation of
Accreditation, Provisional
Accreditation, or DHS

Course Approval

248.18(g)

Article 13.

Eligibility Requirements and
Application Procedures for
Certification or Interim

Certification

248.18(g)

Article 14.

Suspension or Revocation of
Certification or Interim

Certification

248.18(k)

Article 15.

Enforcement

.248.18(1)

Article 16.

Work Practice Standards

.248.18(1)

Chapter 9.

Screening for Childhood Lead

Poisoning

. 248.18(n)

Article 1 .

Definitions

. 248.18(n)

Article 2.

Standard of Care on

Screening for Childhood
Lead Poisoning

248.18(0)

Page viii

(7-25-

Title 17

Public Health

Page

Occupational Lead Poisoning Article 1 .

Prevention Program 248.1 8(0) Article 2

Definitions 248.1 8(0) Article 3

Waivers of the Occupational Subchapter 8.

Lead Poisoning Fee 248.l8(p)

Applicable Industries 248.19

Health and Welfare Agency —
Department of Developmental
Services Regulations 249 Article 1

General Provisions 249 Article 2.

Monthly Parental Fee 249

Article 3.
General 249

Definitions 249

Administrative Provisions 250 Article 4.

Determination of Ability to

Pay 250 Subchapter 9.

Determining Required Levels Article 1 .

of Payment 251

,5. Family Cost Article 2.

Participation 252 Article 3.

General 252

Definitions 252 Article 4.

Administrative Provisions 252.1 Article 5.

Assessment of the Family Chapter 2.

Cost Participation 252.1 Subchapter 1.

Department of Article 1

Developmental Services — .

Conflict of Interest ^^^^*^ ^•

Code 252.2

T, 1 r /- J .■ Subchapter 2.

Rules tor Conductmg ^

Research 252.3

_^ ^. . . Article 1.

Deimitions 252.3

Article 2
Rules for the Conduct of

Research 253 Subchapter 3.

Clients' Rights 257

Article 1.
Purpose and Definitions 257

Article 2.
Rights of Persons with

Developmental Disabilities 258

Article 3.
Notification of Rights 259

Denial of Rights 259 Subchapter 4.

Complaint Procedure 261

Clients' Rights Advocate 261 Article 1.

Service Provider Article 2.

Accountability 261 Subchapter 5.

General Provisions 261 Article 1 .

Fiscal Audit Appeals 267 Article 2.

Title Table of Contents

Page

General 267

Administrative Review 269

Formal Hearing 270

Peer Review of Behavior

Modification

Interventions That Cause

Pain or Trauma, and

Electroconvulsive

Therapy 274

General Provisions 274

Review by Qualified

Professional 275

Review of Behavior

Modification Treatment

Plans 275

Electroconvulsive Therapy

(ECT) 276

Fair Hearings 277

General Provisions and

Definitions 277

Adequate Notice 278

Procedures for Fair

Hearings 278

Miscellaneous Provisions 278

Mediation 278.1

Early Intervention Services 278.1

General Provisions 278.1

Definitions 278.1

Eligibility for California's

Early Start Program 278.3

Program and Service

Components 278.4

Child Find & Referral 278.4

Evaluation and Assessment 278.5

Individualized Family

Service Plan 278.6

General 278.6

Content and Procedures for

thelFSP 278.6

Transfer and Transition

Procedures 278.9

Service Coordination and

Interagency Agreements 278.11

Service Coordination 278.11

Interagency Agreements 278.11

Procedural Safeguards 278.12

Notice and Consent 278.12

Access Rights 278.13

Chapter 1 1 .

Article 1.
Article 2.

Article 3.
Division 2.

Chapter 1.
Subchapter 2
Article 1.
Article 2.
Article 3.
Article 4.

Article 5.

Subchapter 2

Article 1.
Article 2.
Article 3.
Article 4.

Subchapter 3

Subchapter 4

Article 1.
Article 2.

Subchapter 5
Article 1.
Article 2.

Article 3.
Article 4.
Article 5.
Article 6.
Subchapter 6

Article 1.
Subchapter 7

Page ix

Title Table of Contents BARCLAYS CALIFORNIA

Page

Articles. Complaint Process 278.14

Article 4. Mediation and Due Process

Procedures 278.16

Articles. Surrogate Parents 278.17

Chapter 3. Community Services 278.17

Subchapter 1. General 278.17

Article 1 . Definitions 278.17

Article 2. Eligibility 278.18

Subchapter 2. Vendorization 278.18

Article 1. Definitions 278.18

Article 2. Vendorization Process 279

Article 3. Vendor Numbers and Service

Codes 282.9

Article 4. Vendor Compliance and

Prohibitions 282.20

Article 5. Vendorization Appeal 282.21

Subchapter 3. Regional Center

Administrative Practices

and Procedures 282.23

Article 1 . Regional Center Conflict of
Interest Standards and
Procedures 282.23

Subchapter 3.5. Regional Center Budget

Deficit Controls 282.26

Article 1. Definitions 282.26

Article 2. Service Authorization and

Review 282.26

Article 3. Plans of Action 282.27

Article 4. Service Standards 283

Subchapter 4. Residential Services and
Quality Assurance
Regulations 284

Article 1 . Definitions 284

Article 2. General Requirements 286

Article 3. Program Design 288

Article 4. Consumer Placement and

Relocation 289

Article 5. Consumer Services 291

Article 6. Welfare and Institutions

Code Section 4695.2 Direct

Care Staff Training

Regulations 292

Article 7. Personnel 292.3

Article 8. Monitoring and Evaluation 292.5

Article 9. Corrective Action Plans and

Sanctions 292.8

Article 10. Records Maintenance 292.8(b)

CODE OF REGULATIONS Title 17

Page

Article 11. Facility Appeals Process . . . 292.8(b)(2)

Subchapter 4. 1 . Family Home Agency (FHA)

Regulations 292.8(b)(3)

Article 1. Definitions 292.8(b)(3)

Article 2. Competitive

Procurement 292.8(b)(4)

Article 3. Contract and

Vendorization 292.8(d)

Article 4. Program Design 292.8(d)

Article 5. Criminal Record

Clearance 292.8(e)

Article 6. The FHA 292.8(f)

Article 7. The Family Home 292.8(g)

Article 8. Referral for Service 292.8(h)

Article 9. Consumer Funds and

Property 292.8(h)

Article 10. Health-Related Services 292.8(i)

Article 11. Abuse and Special Incident

Reporting 292.8(i)

Article 12. Termination of Residency 292.8(j)

Article 13. Monitoring and Sanctions 292. 8(j)

Article 14. Appeals 292.8(k)

Subchapter 4.2. Intermediate Care
Facility (ICF);
Intermediate Care
Facility/Developmentally
Disabled (ICF/DD);
Intermediate Care
Facility/Developmentally
Disabled-Habilitative
(ICF/DD-H); Intermediate
Care Facility/

Developmentally Disabled-
Nursing (ICF/DD-N);
Skilled Nursing Facility
(SNF) Monitoring
Requirements 292.8(n)

Article 1 . Definitions 292.8(n)

Article 2. Monitoring 292.8(n)

Subchapter 5. Standards for

Nonresidential Services 292.8(o)

Article 1. Definitions 292.8(o)

Article 2. Standards for All Community-
Based Day Programs 292. 8(p)

Article 3. Additional Standards for

Adult Day Programs 292.13

Article 4. Additional Standards for
Infant Development
Programs 292.16

Article 5. Standards for In-Home

Respite Services Agencies 292.18

Page X

(7-25-20

Title 17

Public Health

Page

Ratesetting Procedures

for Residential

Services 292.22(a)

Definitions 292.22(a)

General Provisions 292.23

Cost Studies 292.24

Rates Development

Methodology 292.26

Rate Proposals 292.28

Reimbursement Policies 292.29

Verification of Use of Rate

Increase Funds 292.30

Nonresidential Service

Vendor Rate-Setting

Provisions 292.33

Definitions 292.33

General Provisions 292.34

Vouchers 292.35

Rates of Reimbursement Based

on the Schedule of Maximum

Allowances or the Vendor's

Usual and Customary Rate 292.35

Rate-Setting Procedures

for Community-Based Day

Programs 292.36(b)

(Reserved) 292.36(b)

General Provisions 292.36(b)

Submission of Required

Information 292.36(b)

Review Requirements 292.37

Rate-Setting Methodology
for Community-Based Day
Programs 292.39

Permanent Payment Rates 292.39

Temporary Payment Rate 292.42

Non-Mobile Supplemental

Rate 292.42

Service Contracts 292.43

Schedule of Payment Rates
for Community-Based Day
Programs 292.44

General Provisions 292.44

Schedule of Payment Rates
forFiscal Year 1990-91 292.44

Schedule of Payment Rates

for Fiscal Year 1991-92 292.44

Title Table of Contents

Page

Schedule of Payment Rates
for Fiscal Year 1996-97 and
Each Alternate Fiscal Year
Thereafter 292.45

Schedule of Payment Rates
for Fiscal Year 1997-98 and
Each Alternate Fiscal Year
Thereafter 292.45

Timelines for Rate
Establishment and Written
Notification 292.46

Reporting Requirements

for Community-Based Day

Programs 292.47

Annual Report to the

Legislature 292.47

Calculation of the Statewide

Fiscal Impact of the Gap 292.47

Rate Adjustments, Audit
Adjustments and Rate
Appeals for Community-
Based Day Programs 292.47

General Provisions 292.47

Rate Adjustments 292.49

Audit Adjustments 292.50

Rate Appeals 292.50

Rate-Setting Procedures

for In-Home Respite

Services Agency Vendors 292.62

Definitions 292.62

General Provisions 292.62

Submission of Required
Information 292.63

Review Requirements 292.66

Rate-Setting Methodology

for In-Home Respite

Services Agency Vendors 292.67

Permanent Payment Rates 292.67

Temporary Payment Rate 292.69

Supplemental Rate for
Respite Worker Travel

Costs 292.69

Negotiating the Level of

Payment When Serving More

than One Consumer 292.70

Payment Rates for Existing

In-Home Respite Services

Agency Vendors 292.70

Schedule of Payment Rates

for In-Home Respite

Services Agency Vendors 292.70

Subchapter 6.

Article 1.
Article 2.
Article 3.
Article 4.

Article 5.
Article 6.
Article 7.

Subchapter 7.

Article 1.
Article 2.
Article 3.
Article 5.

Subchapter 8.

Article 1.
Article 2.
Article 3.

Article 4.
Subchapter 9.

Article 1.
Article 2.
Article 3.

Article 4.
Subchapter 10.

Article 1.
Article 2.

Article 3.

Article 4.

Article 5.

Article 6.

Subchapter 11.

Article 1.
Article 2.
Subchapter 12.

Article 1.
Article 2.
Article 3.
Article 4.
Subchapter 13.

Article 1.
Article 2.
Article 3.

Article 4.
Subchapter 14.

Article 1.
Article 2.
Article 3.

Article 4.

Article 5.

Subchapter 15.

Page xi

Title Table of Contents BARCLAYS CALIFORNIA

Page

Article 1. General Provisions 292.70

Article 2. Schedule of Payment Rates

for Fiscal Year 1990-91 292.71

Article 3. Schedule of Payment Rates

for Fiscal Year 1991-92 292.71

Article 4. Schedule of Payment Rates
for Fiscal Year 1 996-97 and
Each Alternate Fiscal Year
Thereafter 292.71

Article 5. Schedule of Payment Rates
for Fiscal Year 1997-98 and
Each Alternate Fiscal Year
Thereafter 292.72

Article 6. Timelines for Rate

Establishment and Written
Notification 292.73

Subchapter 16. Reporting Requirements
for In-Home Respite
Services Agency Vendors 292.73

Article 1 . Annual Report to the

Legislature 292.73

Article 2. Calculation of the Statewide

Fiscal Impact of the Gap 292.74

Subchapter 17. Rate Adjustments, Audit
Adjustments and Rate
Appeals for In-Home
Respite Services Agency
Vendors 292.74

Article 1 . General Provisions 292.74

Article 2. Rate Adjustments 292.74

Article 3. Audit Adjustments 292.74(b)

Article 4. Rate Appeals 292.74(b)

Subchapter 18. Transportation Service 292.74(h)(6)

Article 1. Definitions 292.74(h)(6)

Article 2. General Provisions 292.74(h)(6)

Article 3. Standards for Transportation

Service Vendors 292.74(h)(7)

Article 4. Competitive

Procurement 292.74(h)(9)

Article 5. Noncompetitive

Procurement 292.74(h)(l0)

Article 6. Noncompetitive Procurement
Based on Cost
Statement 292.74(h)(ii)

Article 7. Appeals 292.74(h)(13)

Article 8. Transitory Provisions 292.74(h)(i5)

Subchapter 19. Supported Living Service 292.74(m)

Article 1 . Definitions 292.74(m)

Article 2. General Provisions 292.74(n)

CODE OF REGULATIONS Title 17

Page

Article 3. Consumer Rights 292.76

Article 4. Service Design 292.77

Article 5. Standards for Vendors 292.78

Article 6. Training Requirements 292.79

Article 7. Rate Negotiation 292.80

Article 8. SLS Contract Standards 292.81

Article 9. Performance Evaluations 292.82

Subchapter 2 1 . Habilitation Services

Program 292.82

Article 1. Definitions 292.82

Article 2. General Requirements for All

Habilitation Services 292.85

Article 3. Standards for Work Activity

Programs 292.86

Article 4. Standards for Supported

Employment Programs 292.88

Article 5. Coordination of Services
With the Department of
Rehabilitation 292.90

Article 6. Quality Assurance Monitoring
and Corrective Actions for
Habilitation Services
Programs 292.91

Article 7. Work Activity Program

Ratesetting Procedures 292.92

Article 8. Ratesetting Methodology for

Work Activity Programs 292.94

Article 9. Billing and Payment 292.98

Chapter 4. Case Management 292.99

Subchapter 1 . General 292.99

Article 1. Definitions 292.99

Article 2. Case Management

Services 292.100

Article 3. Assessment Procedures 292.100

Article 4. Billings and Collections 292.100

Division 3. Air Resources 293

Chapter 1 . Air Resources Board 293

Subchapter 1. Administrative

Procedures 293

Article 1. Board Meetings and Hearings 293

Article 2. State Board Review of

Executive Officer Actions 294

Article 3. Permit Procedures 294

Subchapter 1.25. Administrative Procedures —

Hearings 295

Article 1. Adjudicatory Hearings 295

Article 2. Administrative Hearing
Procedures for Petitions
for Review of Executive
Officer Decisions 297

Page xii

(7-25-2008)

Title 17

Public Health

Page

General Provisions 297 Subarticle

Hearing Officers 298.2 Subarticle

Ex Parte Communications 298.2 Subarticle

Filing and Initial Review

of Petitions for Review Subarticle

and Executive Officer's Subarticle

Response 298.3

Prehearing Procedures 298.4 Article 4

Contempt and Sanctions 298.8

Hearings 298.9

„ . . r.i TT • Subarticle

Decisions oi the Hearing

Officer 298.10 Subarticle

Reconsideration 298.1 1

Final Order or Decision;

Judicial Review 298.1 1 Subarticle

Administrative Procedures Subarticle

for Review of Executive

Officer Determinations Subarticle

Regarding Service

Information for 1 994 and c u .• i

A * . , xr Subarticle

Subsequent Model Year

Passenger Cars, Light-Duty

Trucks, and Medium-Duty

Engines and Vehicles and Subarticle

2007 and Subsequent Model

Year Heavy-Duty Engines 298.12 Subarticle

General Provisions 298.12 Subarticle

Hearing Officers 298.12(b) Subarticle

Ex Parte

Communications 298.12(c) Subarticle

Filing Requests for

Administrative Hearing Subarticle

Review 298.12(c) Article 6.

Pre-Hearing Procedures . . . 298.12(e)
Contempt and Sanctions . . . 298.12(1)

Review Proceedings 298.12(g) ^ , ,

Subchapter 1.5.

Decisions of the Hearing

Officer 298.12(h) . ., ,

Article 1.

Judicial Review 298.i2(i)

Administrative Hearing Article 1.5.

Procedures for Review of * • , ^

„ , . Article 2.

Complaints 298.12(1)

General Provisions 298.12(1) * _.• i -,

Article 3.

Hearing Officers 298.13

Ex Parte Communications . . . 298.14 Article 5.

Issuance of and Response Article 6.

to Complaints 298.15 Article 1

Prehearing Procedures 298.16

Title Table of Contents
Page

6. Contempt and Sanctions 298.20

7. Hearings 298.21

8. Decisions of the Hearing

Officer 298.22

9. Reconsideration 298.23

10. Final Order or Decision;

Judicial Review 298.24

Administrative Hearing

Procedures for Review of

Citations 298.24

1. General Provisions 298.24

2. Issuance and Service of
Citations 298.27

3. Hearing Officers 298.28

4. Ex Parte Communication 298.28

5. Initiating Proceeding to

Contest a Citation 298.29

6. Resolution of Proceeding
Without Hearing 298.30

7. Discovery, and Subpoenas
and Subpoenas Duces

Tecum 298.31

8. Contempt and Sanction

Orders 298.33

9. Hearings 298.33

10. Decisions After Hearing 298.36

1 1 . Reconsideration by the
Executive Officer 298.37

12. Final Orders or

Decisions 298.38

13. Judicial Review 298.38

Definition of Minor

Violation and Guidelines

for Issuance of Notice to

Comply 298.38

Air Basins and Air

Quality Standards 298.40

Description of California

Air Basins 298.40

Area Pollutant Designations 300

Ambient Air Quality

Standards 304

Criteria for Determining

Area Designations 308

Transported Air Pollutants 312.1

Transport Mitigation 312.2

Emission Accounting

Procedure 312.3

Subarticle 1.
Subarticle 2.
Subarticle 3.
Subarticle 4.

Subarticle 5.
Subarticle 6.
Subarticle 7.
Subarticle 8.

Subarticle 9.
Subarticle 10.

Article 2.5.

Subarticle 1.
Subarticle 2.
Subarticle 3.

Subarticle 4.

Subarticle 5.
Subarticle 6.
Subarticle 7.
Subarticle 8.

Subarticle 9.
Article 3.

Subarticle 1.
Subarticle 2.
Subarticle 3.
Subarticle 4.

Subarticle 5.

Page xiii

(7 2S 2()0S)

Title Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Subchapter 1.6.
Subchapter 2.

Article 1.
Article 2.

Article 3.
Subchapter 2.5.

Subchapter 2.6.

Subchapter 2.7.

Subchapter 3.
Article 1 .
Article 2.
Article 3.

Article 4.
Subchapter 3.5.

Article 1.

Article 2.

Article 3.

Page

Local Air Pollution

Control District

Regulations 312.4

Smoke Management

Guidelines for

Agricultural and

Prescribed Burning 312.5

General Provisions 312.5

District Smoke Management
Program 314

Page

Meteorological Criteria for
Regulating Agricultural and
Prescribed Burning 317

Compliance Schedule

Regarding Visible

Emissions from Specified

Vessels 321

Air Pollution Control

District Rules 321

Large Confined Animal

Facilities 322

Subventions

General Provisions

Application Procedures

Application Processing,
Disbursements, and Reports

Appeals

, . 322
, . 322
322.1

322.2
, . 323

Acid Deposition Fee
Program

Fee Program to Be
Implemented by Air
Pollution Control Districts
and Air Quality Management
Districts for Fiscal Year
1983-1984

323

Fee Program to Be
Implemented by Air
Pollution Control Districts
and Air Quality Management
Districts for Fiscal Year
1984-1985

323

Fee Program to Be
Implemented by Air
Pollution Control Districts
and Air Quality Management
Districts for Fiscal Year
1985-1986

Article 4.

Article 5.

Article 6.

Subchapter 3.6.

Article 1.

Article 2.

Article 3.

Subchapter 3.8.

Subchapter 4.

Article 1.
Article 2.

Article 3.

Subchapter 5.

Article 1.

Article 2.
Subchapter 5.5.

Article 1.
Subchapter 5.6.

Article 1.

Article 2.
Article 3.

Fee Program to Be
Implemented by Air
Pollution Control Districts
and Air Quality Management
Districts for Fiscal Year
1986-1987

324

Fee Program to Be
Implemented by Air
Pollution Control Districts
and Air Quality Management
Districts for Fiscal Year
1987-88

324

Fee Requirements to Be
Implemented by Air
Pollution Control Districts
and Air Quality Management
Districts for the
Atmospheric Acidity
Protection Act Program

Air Toxics "Hot Spots"
Fee Regulation

General

325

325
325

Applicability 327

Fees 328

Nonvehicular Source,

Consumer Products, and

Architectural Coatings

Fee Regulations 333

Disclosure of Public

Records 337

General 337

Board's Requests for

Information 337

Inspection of Public

Records 337

Emission Data, Sampling,

and Credentials for

Entry 338

Determination of Emissions 338

Source Testing 338

341

Interchangeable Air
Pollution Emission
Reduction Credits . .

Scope and Policy;
Definitions

341

324

Credit Exchange Function 342

Criteria and Methodology for
Generation and Use of
Interchangeable Credits 342

Page xiv

(7-25-2008)

Title 17

Public
Page

Abrasive Blasting 344

General Provisions 344

Prohibitions 344

Source Evaluation 345

Performance Standards 345

Toxic Air Contaminants 346

Airborne Toxic Control

Measures 348

Emission Inventory

Criteria and Guidelines 358.44

General 358.44

Applicability 358.45

Requirements for Preparing
Emission Inventory Plans 358.45

Requirements for Emission
Inventory Reports 358.46

Other Requirements 359

Updates 360

Compliance with

Nonvehicular Emission

Standards 361

Vapor Recovery Systems in

Gasoline Marketing

Operations 361

Test Methods for Determining
Compliance with District
Nonvehicular Emission
Standards 364

Distributed Generation

Certification Program 368.3

Consumer Products 368.6

Health

Title Table of Contents

Page

Antiperspirants and

Deodorants 368.6

Consumer Products 373

Aerosol Coating Products 395

Alternative Control Plan 396.8

Hairspray Credit Program 404

6. Maximum Incremental

Reactivity 41 ]

Tables of Maximum

Incremental Reactivity

(MIR) Values 411

Conflict of Interest

Code 417

General Provisions 417

Appendix: Designated
Employees and Disclosure
Categories 417

Office of Environmental Health
Hazard Assessment 419

Pesticide Program 419

Pesticide-Related Illness

and Injury 419

Reporting 419

California Institute for

Regenerative Medicine 421

Human Embryonic Stem Cell

Research 423

Intellectual Property and

Revenue Sharing Requirements

for For-Profit Organizations 431

Subchapter 6.

Article 1.

Article 2.

Article 3.

Article 4.
Subchapter 7.
Subchapter 7.5.

Subchapter 7.6.

Article 1.
Article 2.
Article 3.

Article 4.

Article 5.

Article 6.

Subchapter 8.

Article 1.

Article 2.

Article 3.
Subchapter 8.5.

Article 1.

Article 2.
Article 3.
Article 4.
Article 5.
Subchapter 8

Article 1.

Subchapter 9

Article 1.
Article 2.

Division 3.5.

Chapter 2.
Subchapter 1

Article 1.
Division 4.

Chapter 2.

Chapter 4.

Page XV

Barclays Official

California

Code of
Regulations

Title 17. Public Health

Division 1. State Department of Health Services

Vol. 22

XMOIVISOIM

^A/EST

Barclays Official California Code of Regulations

425 Market Street • Fourth Floor • San Francisco, CA 94105
800-888-3600

Title 17

State Department of Health Services

Table of Contents

Division 1. State Department of Health Services

Table of Contents

Chapter 1 .
Subchapter 1 .

Subchapter 2.

Article 1 .
§ 100.
§ 101.
§ 102.
§ 103.

Subchapter 3.
Group 1.
Group 2.
Subgroup 2.

Group 3.
Group 4.

Group 5.
Subchapter 4.
Article 1.

§901.

ij902.
§903.

Article 2.

§908.

Article 3.

§910.
§911.

§912.

Article 4.

§915.
§916.

Subchapters.

Page

Administration l

State Department of

Health Services i

Hospital Districts l

Liability Loans i

Eligibility Requirements.
Loan Application.
Coverage.
Repayment of Loans.

Hospital Inspection i

Clinics and Dispensaries 2

Health Facilities 2

Requirements for Outpatient

Clinics 2

Nonprofit Hospitals 2

Establishments for Handicapped
Persons 2

Public Medical Institutions 2

Records and Statistics 2

Access to the Records in the

Office of the State

Registrar and in the

Offices of Local

Registrars 2

Access to the Records in the Office

of the State Registrar and in the

Offices of Local Registrars.

Conditions of Examination.

Fee for Examination or Search.

Late Registration of Births

and Deaths 3

Late Registration of Births and

Deaths.

Birth Certificates of

Deceased Persons 3

Responsibilities of Local Registrar

or County Recorder.

Identification of Deceased

Registrants by Local Registrars and

County Recorders.

Certified Copies of Birth

Certificates of Deceased Persons.

Definitions of Live Birth

and Fetal Death 3

Live Birth.
Fetal Death.

Home Health Agency

Licensing Requirements 4

Page

Chapter 2. Laboratories 4

Subchapter 1 . Service Laboratories 4

Group 1. Production and Distribution of

Biologies 4

Article 1 . Licenses 4

§ 950. General Provisions.

§ 951 . Issuance of License.

§ 952. Application for Renewal of License.

§953. License Fees.

Article 2. Exemptions 4

§ 956. Autogenous Vaccines.

Article 3. Inspection and Records 4

§ 962. Inspection by Department.

§ 963. Records.

Article 4. Storage 5

§ 967. Storage.

Article 5. Containers and Labeling 5

§ 972. Containers and Labeling.

Article 6. Advertising 5

§ 977. Advertising.

Article 7. Samples 5

§ 982. Potency.

Article 8. Vaccine Culture 5

§ 987. Vaccine Culture.

Article 9. Preparation and Distribution

of Whole Blood (Human) 5

§ 997. Definitions.

§ 998. Personnel of Blood Banks and Their

Auxiliaries.
§ 999. Blood Bank Equipment. Facilities

and Manual.
§ 1000. Blood Bank Records; Identification

of Human Blood with Its Donor.
§ 1001. Labels.

§ 1002. Requirements — Donors, Medical

History, Blood Collection, Storage

and Testing.
§ 1002.1. Use of AIDS Antibody (HTLV-III)

Test by Blood Banks.
§1003. Excepfions for Emergency

Purposes.
§ 1004. Reporting Requirements.

Article 10. Preparation and Distribution

of Normal Human Plasma 8

§ 1010. Procurement of Blood for Plasma

Processing.
§1011. Personnel and Equipment.

§ 1012. Single Donor Plasma and Single

Donor Fresh Frozen Plasma

(Antihemophilic).
§ 1013. Storage.

§1014. Expiration Date.

§1015. Other Tests.

§ 1016. Filling the Final Container

§ 1017. Labeling.

Page

(7 :'i 2(1(1S|

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§ 1018.

Diluent for Dried Plasma.

§ 1021.

Rcquiiements for Release.

Article 11.

Preparation of Other Blood

Derivatives 8

§ 1024.

Red Blood Cells (Human).

§ 1024.1.

Frozen Red Blood Cells.

§ 1025.

Plasmapheresis.

§ 1026.

Other Blood Fractions; Procedures;

Standards; Consultative Service.

Article 12.

Transportation of Etiologic

Agents 9

§ 1027.

Definitions and Procedures to Be

Followed.

Article 13.

Research Projects 9

§ 1028.

Waiver of Regulations.

Group 2.

Clinical Laboratory

Regulations 9

Article 1.

Definitions 9

§ 1029.

General Definitions.

§ 1029.5.

Accreditation Body.

§ 1029.6.

Accredited Institution.

§ 1029.7.

Accredited College or University.

§ 1029.9.

Accredited Institution.

§ 1029.10.

Accusation.

§ 1029.11.

Antigen.

§ 1029.13.

Approved Public Health Laboratory.

§ 1029.15.

Alternative Sanction.

§ 1029.17.

CLIA Certificate.

§ 1029.19.

CLIA Exempt Status.

§ 1029.20.

Antibody.

§ 1029.23.

Direct Patient Care.

§ 1029.25.

Antigen.

§ 1029.27.

HHS.

§ 1029.30.

Approved Public Health Laboratory.

§ 1029.31.

Arterial Puncture.

§ 1029.32.

Certified Phlebotomy Technician I.

§ 1029.33.

Certified Phlebotomy Technician II.

§ 1029.34.

Certifying Organization.

§ 1029.35.

Chapter 3.

§ 1029.37.

Instrument.

§ 1029.39.

Licensed General Acute Care

Hospital.

§ 1029.40.

Civil Money Penalties.

§ 1029.43.

Patient.

§ 1029.44.

Preceptor.

§ 1029.45.

CLIA Certificate.

§ 1029.47.

Respiratory Care Practitioner.

§ 1029.49.

Specimen.

§ 1029.50.

CLIA Exempt Status.

§ 1029.51.

Clinical Consultant.

§ 1029.52.

Clinical Cytogenetics.

§ 1029.53.

Clinical Genetic Molecular Biology.

§ 1029.55.

Condition Level Deficiency.

§ 1029.57.

Test Purposes.

§ 1029.59.

Unprofessional Conduct.

§ 1029.60.

Condiuon Level Requirement.

§ 1029.65.

Deficiency.

§ 1029.70.

Direct Patient Care.

§ 1029.75.

Directed Plans of Correction.

§ 1029.80.

Electrolytes.

§ 1029.81.

Evidence of Satisfactory

Performance.

§ 1029.82.

Field Related to Genetics.

§ 1029.83.

General Supervisor.

§ 1029.85.

HHS.

§ 1029.86.

High Complexity Tests or

Examinations.

§ 1029.90.

Human Immunodeficiency Virus.

§ 1029.95.

Immediate Jeopardy.

§ 1029.100.

Instrument.

§ 1029.105.

Intermediate Sanction.

§ 1029.108.

License.

§ 1029.110.

Licensed General Acute Care

Hospital.

§ 1029.111.

Licensed Healthcare Professional.

§ 1029.115.

Licensed Surgical Clinic.

5$ 1029.116.

Limited Phlebotomy Technician.

§ 1029.117.

Medical Laboratory Technician.

§ 1029.118.

Moderate Complexity Laboratory

Technical Consultant.

§ 1029.119.

Moderate Complexity Tests or

Examinations.

§ 1029.120.

Notice of Defense.

§ 1029.124.

On-the-job Experience in

Phlebotomy.

§ 1029.125.

Onsite Monitoring.

§ 1029.126.

Oral and Maxillofacial Pathology

Laboratoi7 Director.

§ 1029.127.

Oral Pathology.

§ 1029.130.

Patient.

§ 1029.132.

Phlebotomist.

§ 1029.133.

Phlebotomy.

§ 1029.134.

Practical Experience.

§ 1029.135.

Preceptor.

§ 1029.140.

Principal Sanction.

§ 1029.145.

Provider of Service.

§ 1029.150.

Respiratory Care Practitioner.

§ 1029.153.

Satisfactory Performance.

§ 1029.154.

Skin Puncture.

§ 1029.155.

Specimen.

§ 1029.160.

State License.

§ 1029.165.

State Registration.

§ 1029.168.

Statement of Issues.

§ 1029.169.

Subspecialty of Histocompatibility.

§ 1029.170.

Temporary Suspension of a License,

Registration or Approval.

§ 1029.171.

Technical Supervisor.

§ 1029.173.

Temporary Suspension of a License,

Registration or Approval.

§ 1029.175.

Temporary Suspension of a Provider

of Service Under the Medi-Cal

Program.

§ 1029.180.

Test Purposes.

§ 1029.185.

TesUng Event.

§ 1029.190.

Unprofessional Conduct.

§ 1029.195.

Venipuncture.

§ 1029.196.

Waived Laboratory Supervisor.

§ 1029.197.

Waived Tests.

icle 1.5.

Licensure of Clinical

Laboratory Personnel 19

§ 1030.

Examination for Bioanalysts'

Licenses.

§ 1030.5.

Licensure of Chnical Chemists,

Clinical Microbiologists, Clinical

Toxicologists, Clinical Genetic

Molecular Biologists and Clinical

Cytogeneticists.

§ 1030.6.

Licensure of Clinical

Cytogeneticists.

§ 1030.7.

Licensure of Clinical Genetic

Molecular Biologists.

§ 1030.8.

Licensure of Oral Pathology

Laboratory Directors.

§ 1031.

Licensure of Clinical Laboratory

Specialists.

§ 1031.1.

Licensure of Clinical

Histocompatibility Scientists.

§ 1031.2.

Licensure of Clinical Cytogeneticist

Scienfists.

§ 1031.3.

Licensure of Clinical Genetic

Molecular Biologist Scienfists.

§ 1031.4.

Requirements and Timeframes for

ApplicaUons for Licensure and

Certificafion.

§ 1031.5.

Requirements and Timeframes for

Renewal of Licenses and

Certificates.

Page

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

Page

§ 1031.7.

§ 1031.8.

§ 1031.9.

•

§ 1032.

Examination for Clinical Laboratory

Technologist's License.

§ 1032.5,

Licensure of Medical Laboratory

Technicians.

§ 1033.

Trainee Requirements.

§ 1034.

Certification of Phlebotomy

Technicians.

§ 1034.1.

Unlicensed Personnel. Laboratory

Aides.

§ 1034.2.

Unlicensed Personnel,

Cytotechnologist.

Article 2.

Training 20.10

§ 1035.

Training Schools.

§ 1035.1.

Phlebotomy Training Program

Requirements.

§ 1035.3.

Medical Laboratory Technician

Training Program Standards.

§ 1035.4.

Timeframes for Approval of

Training Programs.

Article 2.3.

Clinical Laboratory

Supervisors 20.13

§ 1036.

Chnical Consultant.

§ 1036.1.

General Supervisor.

§ 1036.2.

Moderate Complexity Laboratory

Technical Consultant.

§ 1036.3.

Waived Laboratory Supervisor.

§ 1036.4.

Technical Supervisor.

Article 2.5.

Continuing Education 20.15

§ 1038.

Definitions.

§ 1038.1.

Continuing Education

Requirements.

§ 1038.2.

Accrediting Agencies.

§ 1038.3.

Approval of Providers.

§ 1038.4.

Approved Providers.

§ 1038.5.

Waiver of Requirement.

§ 1038.6.

Inactive Status.

§ 1038.7.

Fees.

Article 2.8.

CLIA Certification/State

Licensure 22

§ 1039.1.

Recognition of CLIA Certification

for Limited Purpose and Period.

§ 1039.2.

Clinical Laboratory Personnel

Requirements.

§ 1039.3.

State Licensure or Approval

Required During CLIA Exemption.

Article 3.

License 22

§ 1040.

Forfeited Licenses.

§ 1041.

Fee Credits.

§ 1042.

Substantial Relationship Criteria.

§ 1042.1.

Criteria for Evaluating

Rehabilitation.

Article 4.

Personnel Report 22.1

§ 1045.

Personnel Report.

Article 5.

Issuance of License 22.1

§ 1050.

Clinical Laboratory Standards.

§ 1051.

Proficiency Testing Services.

§ 1052.

Satisfactory Performance in

§ 1053.5,

Article 5.3.

§ 1054.1.
§ 1054.2.

Article 5.5.

§ 1054.5.

Article 5.6.

§ 1054.6.

§ 1054.7.

Proficiency Testing.

Article 6.

§ 1055.
§ 1056.

§ 1057.

Article 7.

§ 1060.

§ 1061.
§ 1062.

Article 8.

§ 1065.
§ 1065.5.
§ 1065.10.
§ 1065.15.
§ 1065.20.
§ 1065.25.

§ 1065.30.

§ 1065.35.
§ 1065.40.

§ 1065.45.

22.3

22.4

Definitions.
Test Kits Approved for Over-
the-Counter Sale to the
Public by the United States
Food and Drug
Administration

HIV Tests.

Blood Electrolyte Analysis
by Respiratory Care
Practitioners

Conditions for Performance.

Training.

Use of Point-of-Care
Laboratory Testing Devices

by Registered Nurses

Conditions for Performance.

Moderately Complex

Laboratory Testing by

Licensed Psychiatric

Technicians, Licensed

Vocational Nurses, Licensed

Midwives, Certified Nurse

Assistants, and Certified

Home Health Aides 22.4(a)

Tesdng Authority for Licensed

Psychiatric Technicians, Licensed

Vocational Nurses, Licensed

Midwives, Certified Nurse

Assistants, and Certified Home

Health Aides.

Preceptor Program Requirements for

Licensed Psychiatric Technicians,

Licensed Vocational Nurses,

Licensed Midwives, Certified

Elmergency Medical Technicians II,

Paramedics, Certified Nurse

Assistants, and Certified Home

Health Aides Performing Moderate

Complexity TesUng on

Point-of-Care Laboratory Testing

Devices.

Laboratory Reports 22.4(a)

Reports.

Prenatal and Neonatal Blood

Typing.

Prenatal Blood Typing Reports.

Cytotechnology 22.4(b)

Definitions: Cytotechnologist

License.

Cytotechnology Licensure.

Cytotechnologist Competency

Testing Services Or Programs.

Enforcement 22.5

Imposition of Sanctions.

Principal Sancdons.

Intermediate Sanctions.

Alternative Sancfions.

Automatic Suspension.

State-Initiated Exclusions from

Medicaid and Medi-Cal.

Exclusion from Ownership or

Operation.

Civil Suit to Enjoin Violations.

Criminal Sanctions for Unlawful

Activity.

Revocation for Referral of

Proficiency Testing Samples.

Page iii

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 1066.
§ 1067.

§ 1067.5.

§ 1067.10.

§ 1067.15.

Group 3.

Article 1.

§ 1075.
§ 1076.
§ 1076.1.
§ 1077.
§ 1078.
§ 1079.

§ 1080.
§ 1081.

§ 1082.

§ 1083.
§ 1084.

Group 4.

Article 1.

§ 1125.
§ 1126.
§ 1127.
§ 1128.
§ 1129.
§ 1130.
§1131.
§1132.
§ 1133.
§ 1134.

Group 5.

Article 1.

§ 1150.

Article 2.

§ 1151.

§ 1152.
§ 1153.

§ 1154.

Article 3.

§ 1155.
§ 1156.
§ 1157.
§ 1158.

Article 4.

§ 1159.

Group 5.5.

Article 1.

§ 1160.

Article 2.

Page

Condition Level Requirements.
Procedures for the Imposition of
Directed Plans of Conection.
Procedures for the Imposition of
Civil Money Penalties.
Procedures for the Imposition of
On-site Monitoring.
Procedures for the Imposition of a
Temporary Suspension of a
Laboratoi7 or Clinical Laboratory
under the Medi-Cal Program.

County and Municipal

Laboratories 22. li

Official Public Health

Laboratory Service

Required 22.11

Local Health Departments.

Certificates of Approval Required.

Public Health Laboratory.

Reports Required.

Minimum Requirements Specified.

Professional Personnel to Be

Certified.

Professional Training.

Certain Cultures and Specimens to

Be Sent to the State Laboratory.

Certain Specimens to Be Sent to

Approved Laboratories.

Inspections to Be Made.

Health Departments May Contract

with Private Laboratories.

Tests for Syphilis Under the
Premarital and Prenatal Laws 23

Serologic Tests 23

Application Required.

Approved Tests.

Method of Conducting Tests.

Evaluation Sera.

Marriage Health Certificates.

Persons Permitted to Perform Tests.

Change of Personnel.

Change of Director or Location.

Advertising Prohibited.

Withdrawal of Approval.

Care of Laboratory Animals 24

Definitions 24

Definitions.

Certification Requirements 25

Issuance of the Certificate of

Approval.

Fees.

Application for Renewal of

Certificate of Approval.

Records.

Minimum Standards 25

Care and Treatment of Animals.

Quarters.

Personnel.

Feeding.

Filing of Complaint 26

Filing of a Complaint.

Methadone Drug Analysis
Laboratories 26

Application 26

Application of Subchapter.

Definitions 26

§ 1164.

§1165.

§1166.

§ 1167.

§ 1168.

§ 1169.

§ 1170.

Article 3.

§ 1171.

§ 1172.

§ 1173.

§ 1174.

Article 4.

§ 1175.

§ 1176.

§1177.

§ 1178.

§1179.

§ 1180.

§ 1181.

Page

§1161. Methadone Drug Analysis.

§ 1162. Methadone Drug Analysis

Laboratory.
§ 1163. Methadone Drug Analysis

Supervisor.

Method.

Instrument or Device.

Sample or Specimen.

Department.

May, Shall.

Methadone.

Primary Metabohte of Methadone.

Requirements for Methadone

Drug Analysis Laboratories 26

Licensing Requirement.

Qualifications for Licensing.

Qualifications of Methadone Drug

Analysis Supervisor.

Use or Access of Patients.

Licensing Procedures 27

Qualifying for License.
Renewal of Licenses.
Application Forms.
Report of Change or
Discontinuance.
License Implications.
Display of Licenses.
Fees.

Article 5. Substances Approved for
Analysis, Requirements for
Collection and Handling of
Samples 27

§1182. Urine.

§ 1183. General.

§ 1 1 84. Sample Preservation.

Article 6. Methods of Analysis and

Standards of Performance 28

§ 1185. General.

§1186. Standards of Performance.

§ 1187. Specificity.

§ 1188. Evaluation of Standards of

Performance.
§ 1189. Expression of Analytical Results.

Article 7. Inspections, Quality

Control, Proficiency

Testing 28

§ 1190. Inspections and Proficiency Testing.

§ 1191. Access to Premises.

§ 1192. Quality Control Program and

Proficiency Testing.
§1193. Standard of Performance in

Proficiency Testing Program.
§ 1 1 94. List of Certified Methad one

Laboratories.

Article 8. Records 29

§1195. General.

§ 1196. Methadone Drug Analysis

Laboratory Records.

Group 6. Water Laboratories 29

Group 7. Human Tissue Preservation 29

Article 1 . Approval 29

§ 1200. Definifions.

§ 1201. Approval Required for Tissue

Preservation.

§ 1202. Provisions for Approval.

§ 1203. Exemptions from Approval.

§ 1204. Records.

§ 1205. Labels.

•

Page iv

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

Page

Group 8.

Forensic Alcohol Analysis and

§ 1218.
§ 1218.1.
§ 1218.2.

Article 5.

§ 1219.
§ 1219.1.
§ 1219.2.
§ 1219.3.

Article 6.

§ 1220.
§ 1220.1.
§ 1220.2.
§ 1220.3.
§ 1220.4.

Article 7.

§ 1221.
§ 1221.1.
§ 1221.2.
§ 1221.3.
§ 1221.4.
§ 1221.5.

Article 8.

§ 1222.
§ 1222.1.

§ 1222.2.
Group 9.

Article 1.

§ 1230.

Article 1.

General

§ 1215.

Authority.

§ 1215.1.

Definitions.

Article 2.

Requirements for Forensic

Alcohol Laboratories ....

§ 1216.

Authorization Requirement.

§ 1216.1.

Qualifications for Licensing.

Article 3.

Licensing Procedures

§ 1217.

Forensic Alcohol Laboratory

License.

§ 1217.1.

Renewal of Licenses.

§ 1217.2.

Application Forms.

§ 1217.3.

Report of Change or

Discontinuance.

§ 1217.4.

License Implications.

§ 1217.5.

Licensing Records.

§ 1217.6.

Inspection and Additional

Requirements.

§ 1217.7.

Surveys and Proficiency Tests.

§ 1217.8.

Fees and Other Procedures.

Article 4.

Training of Personnel

Training Program Approval.
Additional Requirements.
Contracts.

Collection and Handling of

Samples 32

General.

Blood Collection and Retention.

Urine Collection and Retention.

Breath Collection.

Methods of Forensic Alcohol
Analysis 33

General.

Standards of Performance.
Standards of Procedure.
Quality Control Program.
Expression of Analytical Results.

Requirements for Breath

Alcohol Analysis 34

General.

Authorized Procedures.

Standard of Performance.

Approved Instruments.

Standards of Procedure.

Expression of Analytical Results.

Records 35

General.

Forensic Alcohol Laboratory

Records.

Breath Alcohol Analysis Records.

HIV Antibody Testing 35

Approval of Laboratories 35

Approval of Laboratories for Use of
HIV Antibody Test.

Chapter 3. Local Health Service 36

Subchapter 1 . Standards for State Aid
for Local Health
Administration 36

Article 1.

Organization . .

§ 1250.
§ 1251.

§ 1252.

Health Officer.
Office.
Clerical Staff

§ 1253.
§ 1254.
§ 1255.
§ 1256.

Article 2.

§ 1275.
§ 1276.

Article 3.

§ 1300.
§ 1301.
§ 1302.

§ 1302.1

§ 1303.
§ 1304.
§ 1305.
§ 1306.
§ 1307.
§ 1308.

Article 4.

§ 1325.
§ 1326.
§ 1327.
§ 1328.
§ 1329.

Subchapter 2.

Article 1.

§ 1351.

§ 1353.

Article 2.

§ 1355.
§ 1357.
§ 1359.
§ 1361.

Article 3.

§ 1363.
§ 1365.

§ 1367.

§ 1369.

Article 4.

§ 1371.
§ 1373.
§ 1375.

Subchapter 3.

Article 1.

§ 1401.
§ 1403.

Article 2.

§ 1405.
§ 1407.
§ 1409.
§1411.
§ 1411.1
§ 1413.
§ 1415.
§ 1417.
§ 1418.

Page

Public Health Nursing Staff
Environmental Health Staff
Public Health Laboratory.
Provisional Approval of Health
Departments.

Program 37

Duties and Functions.
Basic Services.

Personnel 38

Health Officer.

Director of Public Health Nursing.

Director of the Public Health

Laboratory.

Director of a Branch Public Health

Laboratoiy.

Health Flducator.

Director of Health Education.

Public Health Nurse.

Occupational Health Trained Staff

Occupational Health Sanitarian.

Director of Environmental Health.

Finance 40

Use of Funds.

Restrictions on Matching Funds.

Deposit and Expenditure of Funds.

Budget and Program.

Reports.

Standards for State Aid

for Comprehensive

Environmental Agencies 41

Definitions 41

Comprehensive Environmental

Agency.

Environmental Health and

Sanitation Services and Programs.

Agency Personnel and

Facilities 41

Director of Environmental Health.

Environmental Health Staff

Clerical Staff

Office Facilities.

Organization 41

Conditions of Transfer.

Powers and Duties of the County

Health Officer.

Powers and Duties of the District

Health Officer.

Powers and DuUes of the Director of

Environmental Health.

Program 42

Basic Program.
Annual Program Plans.
State Financial Aid.

Standards for Maintaining

County Health Services 42

Application 42

Application of Subchapter.
Section Headings.

Definitions 43

Addendum.

Agreement.

Allocation.

Annual Local Jurisdiction Budget.

Benefits Chart.

Budget.

City Health Services.

County Health Services.

County Health Services Allocation.

Page V

(7 2S 2(H)S)

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§ 1419.
§ 1420.1.
§ 1420.2.

§ 1420.3.

§ 1420.4.

§ 1420.5.

County Health Services Fund.

County Medical Services Program.

County Medical Services Program

Account.

County Medical Services Program

Contract.

Declaration of Intent to Enter into

Contract.

County Medical Services Program

Reserve Account.

§ 1498.6.
§ 1498.7.
§ 1498.8.
§ 1498.9.

Administration.
Fiscal.
Liabilities.
Reporting.

§ 1421.

Department.

§ 1422.

Director.

§ 1 422 . 1 . Eligible (Contract County.

§1422.3. Eligibility Manual.

§ 1423.

Expenditures.

§ 1425.

Fixed Assets, Fixtures, Structures

and Improvements.

§ 1427

Inpatient/Outpatient Services.

§ 1428

Local .lurisdiction.

§ 1429

Maximum Allocation.

§ 1430

May, Shall, Should.

§ 1430.1. Medically Indigent Services

Account.

§ 1430

2. Medically Indigent Services

Allocation.

§1430.3. Multi-Yeai- Budget.

§1430.4. Multi-Yeiu- Plan.

§ 1431

Net City Costs for Health Services.

§ 1432

Net County Costs for Health

Services.

§ 1433

Plan.

§ 1435.

Public Health Services.

§ 1437.

Reported Net County Costs for

Fiscal Year 1977-78.

§ 1439

Revenues.

§ 1440

"Update."

Article 3.

County Health Services

Multi-Year Plan and Budget

§ 1445

Multi-Year Plan and Budget

Submission.

§ 1451

Multi-Year Plan and Budget and

Update Content.

§1457

Plan and Budget Review.

Article 4.

Allocations, Agreement,

Disbursement, Reporting and

Recoupment Procedures

§ 1465

County Health Services Allocation.

§ 1466

Medically Indigent Services

Allocation.

§ 1467

Medically Indigent Services

Application.

§ 1469

Agreement.

§ 1473

Disbursement.

§ 1475

Reports.

§ 1477

Recoupment.

§ 1481

Special Needs and Priorities.

Article 5.

Public Hearing Procedures

§ 1485

Purpose.

§ 1486

Conditions.

§ 1487

Scheduling.

§ 1489

Notification.

§1491

Conduct.

§ 1493

Findings.

§ 1495

Transmittal.

§1497

Determinations.

Article 6.

County Medical Services

Program

§ 1498

County Medical Services Program.

§ 1498

I . Declaration of Intent to Contract.

§ 1498

2. Small County Advisory Committee.

§ 1498

3. Contract.

§1498

4. Eligibility.

§1498

5. Benefits.

Article 1.

Definitions

§ 1500.

Indian.

§ 1501.

Indian Tribe.

§ 1502.

Existing Indian Health Programs.

§ 1503.

Direct Health Services.

§ 1504.

Licensed Provider of Health

Services.

§ 1505.

Department.

§ 1506.

Director.

§ 1507.

Indian Medicine and Traditional

Health Practices.

Article 2.

Indian Health Policy Panel

§ 1520.

Indian Health Policy Panel.

§1521.

Panel Membership.

Article 3.

Assistance to Indian Health

Programs

§ 1530.

§ 1531.

§ 1532.
§ 1533.
§ 1534.
§ 1535.

Article 4.

§ 1540.
§ 1541.

Financial Assistance to Indian
Health Programs.
Allocation of Financial Assistance
to Indian Health Programs.
Allocation Formula.
Reimbursement for Service.
To Qualify for Funding.
Criteria for Reimbursement of
Direct Services.

Standards of Service

Confidentiality of Information.
Informed Consent.

Chapter 3.5.

Subchapter 1 .

§ 2000.

Chapter 4.
Subchapter 1.

Article 1.

§ 2500.

§ 2501.

§ 2502.

§ 2503.

§ 2504.

§ 2505.
§ 2508.
§ 2509.
§ 2510.

§2511.

Article 2.

§ 2512,
§ 2514
§ 2515

Joint Regulations for

Handicapped Children 59

Interagency

Responsibilities for

Providing Services to

Handicapped Children 59

Joint Regulations for Handicapped

Children.

Preventive Medical Service 59

Reportable Diseases and

Conditions 59

Reporting 59

Reporting to the Local Health

Authority.

Investigation of a Reported Case,

Unusual Disease, or Outbreak of

Disease.

Reports by Local Health Officer to

State Department of Public Health.

Reporting Occurrence ol" Unusual

Diseases.

Report by Health Care Provider of

Out-of-State Laboratory Findings.

Notification by Laboratories.

Reporting by Schools.

Records of Local Health Officer.

Outbreaks of Nonreportable

Diseases.

Determination of Morbidity Level.

General Instructions 66

InvestigaUon of the Case.
Instructions to Household.
Definition of Isolation.

Page vi

(7-2S-2008)

Title 17

State Department of Health Services

Table of Contents

Page

§2516
§2518
§ 2520

§ 2522
§ 2524
§ 2526

§ 2528.

§ 2530.
§ 2534.

§ 2536.

§ 2538.
§ 2540.

Article 3.

Strict Isolation.

Modified Isolation.

Quarantine.

Observation.

Terminal Disinfection.

Exclusion and Readmission by

School Authorities.

Contamination by Pathogenic

Organisms of Milk. Milk Products

or Products Resembling Milk

Products.

Public Food Handlers.

Laboratory Tests for the Release of

Cases of Carriers of Communicable

Diseases.

Transportation of Conununicable

Disease Cases.

Funerals.

General Clause.

Specific Diseases and
Conditions

§ 2550.

Amebiasis.

§2551.

Anthrax. Cases and Suspect Cases

to Be Reported by Telephone.

§ 2552.

Botulism. Cases and Suspect Cases

to Be Reported by Telephone.

§ 2553.

Brucellosis (Undulant Fever). Cases

and Suspect Cases to Be Reported

by Telephone.

§ 2554.

Chancroid.

§ 2555.

Chickenpox.

§ 2556.

Cholera. Cases and Suspect Cases to

Be Reported by Telephone or

Telegraph.

§ 2558.

Coccidioidomycosis.

§ 2560.

Conjunctivitis, Acute Infectious of

the Newborn.

§ 2562.

Dengue. Cases and Suspect Cases to

Be Reported by Telephone or

Telegraph.

§ 2564.

Diarrhea of the Newborn.

§ 2566.

Diphtheria.

§ 2570.

Encephahtis, Acute (Including

Arthropod-Borne Viral,

Post-Infectious, and Others).

§ 2572.

Disorders Characterized by Lapses

of Consciousness, Alzheimer's

Disease and Related Disorders.

§ 2574.

Food Poisoning.

§ 2575.

German Measles (Rubella).

§ 2577.

Gonococcus Infection.

§ 2578.

Granuloma Inguinale.

§ 2579.

Hepatitis, Infectious.

§ 2580.

Influenza, Epidemic.

§2581.

Hepatitis, Serum (Homologous

Serum Jaundice).

§ 2582.

Leprosy (Hansen's Disease).

§ 2584.

Leptospirosis (Including Weil's

Disease).

§ 2585.

Lymphogranuloma Venereum.

§ 2586.

Malaria.

§ 2588.

Measles.

§ 2590.

Meningitis, Meningococcal or

Meningococcemia.

§ 2592.

Mumps.

§ 2593.

Neoplasm, Cancer.

§ 2594.

Pertussis (Whooping Cough).

§ 2595.

Physically Handicapped Children

§ 2596.

Plague. Cases and Suspect Cases to

Be Reported by Telephone.

§ 2597.

Q Fever.

§ 2598.

Pneumonia, Infectious (Except

Pneumonic Plague).

§ 2600.

Poliomyelitis, Acute Anterior.

§ 2602.

Psittacosis.

§ 2603.

Control of Pet Birds.

§ 2603.5.

Control of Psitlacine Birds.

§ 2604.

Rabies, Human.

§ 2606.

Rabies, Animal.

§ 2606.2.

Rabies Quarantine.

§ 2606.4.

Officially Declared Rabies Areas.

§ 2606.6.

Importation of Dogs.

§ 2606.8.

Skunk Rabies.

§ 2608.

Relapsing Fever.

§2610.

Rheumatic Fever, Acute.

§2611.

Rocky Mountain Spotted Fever.

§2612.

Salmonella Infections (Other Than

Typhoid Fever).

§2612.1.

Turtle Salmonellosis.

§2613.

Shigella Infections (Dysentery,

Bacillary).

§ 2614.

Smallpox (Variola). Cases and

Suspect Cases to Be Reported by

Telephone.

§ 2616.

Streptococcal Infections, Hemolytic

(Including Scarlet Fever and

Streptococcal Sore Throat).

§2617.

Syphilis.

§ 2618.

Tetanus.

§ 2620.

Trachoma.

§ 2622.

Trichinosis.

§ 2624.

Tuberculosis.

§ 2626.

Tularemia. Cases and Suspect Cases

to Be Reported by Telephone.

§ 2628.

Typhoid Fever.

§ 2630.

Typhus Fever (Flea-Borne,

Endemic Type).

§ 2632.

Typhus Fever (Louse-Borne,

Epidemic Type). Cases and Suspect

Cases to Be Reported by Telephone

or Telegraph.

§ 2636.

Venereal Diseases.

§ 2638.

Viral Hemorrhagic Fevers (e.g..

Crimean-Congo, Ebola, Lassa and

Marburg Viruses). Cases and

Suspect Cases to Be Reported by

Telephone.

§ 2640.

Yellow Fever Cases and Suspect

Cases to Be Reported by Telephone

or Telegraph.

Article 3.5. Reporting of Human

Immunodeficiency Virus

(HIV) Infection 76.2

Subarticle 1. Definitions 76.2

§ 2641.5. Alternative Testing Site.

§ 2641.10. Anonymous Counseling and Testing

Program.
§ 2641.15. Anonymous HIV Test.

§ 2641.20. Biological Specimen.

§ 2641 .25. Confidential HIV Test.

§ 2641 .30. Confirmed HIV Test.

§2641.35. Department.

§ 2641 .45. Health Care Provider.

§ 2641 .50. Health Officer and Local Health

Officer.
§ 2641 .55. HIV/AIDS Case Report.

§ 2641.56. HIV/AIDS Confidentiality

Agreement.
§ 2641.57. HIV Test Algorithm.

§ 2641.60. Laboratory.

§ 2641.65. Laboratory Test.

§ 2641.70. Local Health Department.

§ 2641.75. Non-Name Code. [Repealed]

§ 2641 .77. Partial Non-Name Code.

[Repealed]
§2641.80. Personal Information.

§ 2641 .85. Publicly-Funded Confidential

Counseling and Testing Program.
§2641.90. SoundexCode.

Page vii

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Subarticle 4

Reporting Requirements

§ 2643.5.

HIV Reporting by Health Care

Providers.

§2643.10

'. HIV Reporting by Laboratories.

§2643.15

HIV Repining by Local Health

Officers.

§ 2643.20

'. HIV Reponing Exemptions.

Article 4.

Approval Procedures for

Canine Rabies Vaccines

§ 2650.

Canine Rabies Vaccine Advisory

Committee.

§2651.

Approval of Canine Rabies

Vaccines.

§ 2652.

Immunity Duration-Challenge

Studies.

§ 2653.

Origin and Integrity of Rabies

Vaccine Virus.

Subchapter 2.
Subchapter 2.5.

Adult Health

Disorders Characterized

by Lapses of

Consciousness

Article 1.

Definitions

§ 2800.

Activities of Daily Living.

§ 2802.

Alzheimer's Disease and Related

Disorders.

§ 2804.

Diagnose.

§ 2806.

Disorders Characterized by Lapses

of Consciousness.

§ 2808.

Sensory Motor Functions.

Article 2.

Reporting

§2810.

Reporting Requirements.

§2812.

Exceptions to Reporting.

Subchapter 3.

Services for Physically

Page

76.4

Page

76.6

76.8

Group 1.

Handicapped Children 76.

Minimum Standards for the Care
of Physically Handicapped
Children for Local

Communities in California

. 76.

Article 1.

General

. 76.

§ 2890.

Confidential Nature of Crippled
Children's Records.

§ 2900.

Case Finding and Reporting.

§2901.

Definition.

§ 2902.

Records and Reports.

§ 2903.

Diagnostic Services.

§ 2904.

Treatment.

§ 2905.

After-Care Services.

§ 2906.

Authorizafion for Services.

Article 2.

Immunization Adverse

Reaction Fund

. 76.

§ 2907.

Bone Marrow Transplantation for
Cancer.

§2910.

Program Administration.

§2912.

Use of Fund.

§2914.

Extensive Medical Care.

Article 3. Podiatrist and Family
Practice Physician
Services 76.9

California Children Services (CCS).

California Children Services (CCS)

Panel.

Expertise in the Care of Children.

General Supervision.

Article 4. Genetically Handicapped

Persons Program 76.10

§ 2920.
§2921.

§ 2922.
§ 2923.

§ 2930.
§2931.

§ 2932.

Genetically Handicapped Persons

Program.

California Children

Services/Genefically Handicapped

Persons Program Special Care

Center.

Medical Eligibility — Conditions.

Group 2.

Registration as School

Audiometrists

...77

Article 1.

General

...77

§ 2950.
§2951.

Qualifications.
Testing Standards.

Subchapter 4.

The Infant Botulism
Treatment and Prevention

Program

. 78.1

Article 1.

Definitions

. 78.1

§ 3000.2.
§ 3000.4.

Botulism Immune Globulin.
Infant Botulism Treatment and

Article 2.

§ 3010.
Article 3.

§ 3020.

Prevention Program.
Distribution of Botulism
Immune Globulin

Distribution of Botulism Immune
Globulin.

78.1

Reporting Requirements for
Hospitals Receiving BIG 78.1

Reporting Requirements for

Hospitals.

Article 4.

Fees

78.1

§ 3030.

Fee.

Subchapter 5.

Public Health Nursing

.. 79

Group 1.

Public Health Nursing

.. 79

Article 1.

Issuance of Public Health

Nursing Certificates

.. 79

§ 4500.

Public Health Nurse Certificate.

§4501,

Qualifications and Requirements.

§ 4502.

AppUcation for Public Health Nurse
Certificate.

§ 4503.

Issuance of Application.

§ 4504.

Appeal Process.

Group 2.

Trained Attendants

.. 79

Subchapter 6.

Tuberculosis Hospitals
and Sanatoria Receiving

State Subsidy

.. 79

Subchapter?.

Venereal Diseases

.. 79

§5151.

Sexually Transmitted Diseases in
Minors.

Subchapter 8.

Immunization Against

Article 1.

§ 6000.
§ 6010.
§ 6015.

Article 2.

§ 6020.

Poliomyelitis,
Diphtheria, Pertussis,
Tetanus, Measles
(Rubeola), Rubella,
Haemophilus Influenzae
Type B (Hib), Mumps, and
Hepatitis B

Definitions

Admission.
Immunizing Agent.
Pupil.

Required Immunizations
Required Immunizations.

79
79

Page viii

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

Page

Article 3. Admission to School, Child

Care Center, Day Nursery,
Nursery School, Family Day
Care Home, or Development

Center 82

§ 6025. Unconditional Admission.

§ 6030. Conditional Admission to

Prekindergarten Level.
§ 6035. Conditional Admission.

§ 6040. Requirements for Continued

Attendance.
§ 6045. Special Immunization Schedules.

§ 6050. Conditional Admission with

Temporary Medical Exemption.
§ 6051. Unconditional Admission with

Permanent Medical Exemption or
Personal Beliefs Exemption.

Article 4. Exclusion 85

§ 6055. Conditions for Admission Not

Fulfilled.
§ 6060. Pupil Not Completely Immunized

and Exposed to Communicable

Disease.

Article 5. Records As Evidence of

Immunization 86

§ 6065. Documentary Proof.

§ 6070. School/Child Care Facility

Immunization Record.
§ 6075. Reporting.

Subchapter 8.1. Immunization Against

Measles (Rubeola) 87

Subchapter 8.2. Immunization Against
Diphtheria, Tetanus, and
Pertussis 87

Subchapter 9. Testing for Heritable

Disorders 87

Group 3. Newborn Screening Program 87

Article 1 . Definitions 87

§ 6500. Birth Attendant.

§6500.1. Days of Age.

§ 6500.5. Discharge.

§6500.19. Inadequate Specimen.

§ 6500.25. Initial Positive Test.

§ 6500.28. Initial Specimen.

§6500.31. Initial Test.

§ 6500.35. Newborn.

§ 6500.39. Newborn's Physician.

§ 6500.45. Newborn Screening Area Service

Center.

§ 6500.46. Newborn Screening Laboratory.

§ 6500.57. Perinatal Licensed Health Facility.

§ 6500.59. Preventable Heritable or Congenital

Disorder.

§ 6500.65. Recall Specimen.

§ 6500.67. Recall Test.

§ 6500.69. Repeat Specimen.

§ 6500.70. Repeat Test.

§ 6500.74. Sickle Cell Counselor.

§ 6500.77. Sickle Cell Education and

Counseling Program.

§ 6500.80. Transfer.

Article 2. Testing and Follow-Up

Program Requirements 89

§ 6501. Scope of Newborn Testing.

§ 6501.2. Religious Objection.

§ 6502. Fatal Condition.

§6502.1.

Confidentiality.

§ 6503.

Newborn Screening Laboratory

Requirements.

§ 6504.

Parent Education: Birth Attendants.

§ 6504.2.

Parent Education: Perinatal

Licensed Health Facilities.

§ 6504.4.

Specimen Collection Forms.

§ 6504.6.

Record Maintenance.

§ 6505.

Collection of Specimens.

§ 6506.

Medical Record Review.

§ 6506.2.

Newborns Discharged from a

Perinatal Licensed Health Facility

Without Testing.

§ 6506.6.

Follow-Up to Reports of Inadequate

Specimen.

§ 6506.8.

Follow-Up to Reports of Initial

Positive Result.

§6506.10.

Repeat and Recall Specimen

Collection and Transmittal.

§6506.12.

Diagnosis Reporting.

§ 6507.

Failure to Comply.

§6507.1.

Local Agency Responsibilities.

Article 3.

Sickle Cell Programs 92

§ 6507.2.

Sickle Cell Education and

Counseling Program Requirements.

§ 6507.3.

Certification of a Sickle Cell

Counselor.

§ 6507.4.

Voluntary Participation.

§ 6507.5.

Informed Consent.

§ 6507.6.

Approval of Hemoglobin Testing

Laboratories.

§ 6507.7.

Sickle Cell Trait Can-ier Follow-Up

Vendor.

Article 4.

Newborn Screening

Participation Fee 93

§ 6508.

Newborn Screening Fee Collection.

§6510.

Rhesus (Rh) Hemolytic Disease of

the Newborn.

Group 5.

Prenatal (Multiple Marker)

Testing Program 94

icle 1.

Definitions 94

§6521.

Alpha-Fetoprotein.

§6521.3.

Analyte.

§6521.5.

Birth Defect.

§6521.7.

Clinician.

§6521.9.

Differential Diagnostic Screening

Tests and Procedures.

§6521.11.

Expanded AFT Follow-Up Vendor.

§6521.13.

Expanded AFP Prenatal Birth

Defects Screening Laboratory.

§6521.15.

Expanded AFP Prenatal Screening

for Birth Defects.

§6521.17.

Gestational Age.

§6521.19.

Inadequate Specimen.

§6521.21.

Initial Screening Positive Test.

§6521.23.

Initial Specimen.

§6521.25.

Method.

§6521.27.

Neural Tube Defect.

§6521.29.

Prenatal Diagnosis Center.

§6521.31.

Repeat Specimen.

icle 3.

Testing and Follow Up

Program Requirements 94.2

§ 6523.

Expanded AFP Prenatal Birth

Defects Screening Laboratories and

Analytical Methods.

§ 6525.

Prenatal Diagnosis Centers and

Laboratories.

§ 6527.

Clinician Requirements.

§ 6529.

Rhesus (Rh) Hemolytic Disease.

§6531.

Reporting of Neural Tube Defects.

§ 6532.

Reporting of Chromosomal

Disorders.

Page ix

(7 25 2(l()Sl

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 4.

§ 6540.
§6540.1

Subchapter 10.

Article 1.

§ 6600.
§6601.
§ 6602.
§ 6603.
§ 6604.
§ 6605.
§ 6606.
§ 6607.

Article 2.

§ 6608.

Subchapter 11.

Article 1.

§6701.
§ 6702.

Article 2.

§ 6705.

Article 3.

§6710.
§6711.
§6712.
§ 6714.
§ 6715.
§6716.

Article 4.

§ 6720.
§6721.

§ 6722.

Subchapter 12.

Subchapter 13.

Article 1.

§ 6800.
§6801.
§ 6802.

§6804.
§ 6806.
§ 6808.
§6810.
§6812.
§6813.
§ 6814.
§6816.
§6817.
§6818.

Page

Prenatal Screening Fee

Collection 94.3

Program Participation Fee.

Prepaid Group Practice Plan.

Tuberculosis Screening of

Employees and Volunteers

in Private, Parochial

and Nursery Schools 94.4

Definitions 94.4

Employee.
Volunteer.

Private and Parochial Schools.
Nursery School.
Elementary School.
Secondary School.
Minimum Examination.
Approved Skin Test.

Records as Evidence of

Compliance 94.4

Records as Evidence of

Compliance.

First Aid and

Cardiopulmonary

Resuscitation Training

Standards for Public

Safety Personnel 94.4

General 94.4

Application and Scope.
Time Limitation for Training.

Definitions 94.4

Definitions.

Training Standards 94.4

Scope of Course.

Required Topics.

Special Requirements.

Testing.

Validation of Course Completion.

Retraining Requirements.

Designated Agencies 95

Course Approval.
Additional Requests for
Designation.
Program Review.

Ambulance Personnel 95

Child Health and

Disability Prevention

Program 95

Definitions 95

Health Assessment.

Conrmiunity.

Community Child Health and

Disability Prevention Program.

Contract Counties.

Department.

Diagnosis.

Director.

Governing Body.

Initiation of Treatment.

Medi-Cal Beneficiary.

Person.

Clinical Laboratory.

Screening.

Page

§ 68 1 9. Child Health and Disability

Prevention Services in Contract
Counties.

Article 2. Program Administration 97

§ 6820. Advisory Boards.

§ 6822. Director and Deputy Director.

§ 6824. State and Local Responsibilities.

§ 6826. State and Local Information and

Training Responsibilities.

§ 6828. Sanctions for Noncompliance.

Article 3. Eligibility for Services and

Reimbursement 99

§ 6830. Eligibility for Services.

§ 6832. Eligibility for Reimbursement.

Article 4. Required Services 100

§ 6840. Required Services.

§ 6842. Outreach and Health Education.

§ 6843. Referral to Dentist.

§ 6844. Referral to Health Assessment.

§ 6846. Health Assessment.

§ 6847. Periodicity of Health Assessments.

§ 6848. Certification for School Entry.

§ 6850. Referral to Diagnosis and

Treatment.

§ 6852. Diagnosis and Treatment.

Article 5. Providers of Health

Screening and Evaluation

Services 104

§ 6860. Condidons of Participation.

§ 6862. Types of Providers.

Article 6. Claiming for Services 105

§ 6866. Procedures.

§ 6868. Schedule of Maximum Allowances.

Article 7. Records, Reporting and

Confidentiality 106

§ 6870. Records.

§ 6872. Reporting.

§ 6874. Confidentiality.

Subchapter 1 4. Stop Tobacco Access to

Kids Enforcement (STAK13)

Act Program 107

§6901. Definitions.

§ 6902. Warning Sign; Identificafion.

§ 6903. Inspections; Decoys.

§ 6904. Defenses.

§ 6905. Annual Report of Tobacco Retail

Sites.

Chapters. Sanitation (Environmental) 108.1

Subchapter 1. Engineering (Sanitary) 108.1

Group 1 . Domestic Water Supplies

Quality and Monitoring 108.1

Group 1.1. Waterworks Standards 108.1

Group 2. Certification of Water

Treatment Facility Operators 108.1

Article 1. General 108.1

§ 7100. Purpose.

§7101. Definition.

Article 2. Responsibility of Water

Supplier 108.1

§ 7103. Employment of Certified Operator.

§ 7104. Operator-in-Training.

§7105. Remote Area.

Article 3. Responsibility of Operators 108.1

Page

(7-25-2008)

Title 17

State Department of Health Services
Page

Certification Requirements. Article 3.

Grade of Operator.

Issuance of Certificates 108.1

Requirements for Certification. § T17-7603

Application. § T 17-7604
Processins an Application for A t' ^ A
Certification. Article 4.
Processing Time.

Application Review. § j \ 7_76 1 5

Notification to Applicants. § T17-7616

Certification Without Examination § T 17-76 17

for Certain Persons Employed Prior § Tl 7-76 18
to April 30, 1973.

Minimum Qualifications for § T 17-76 19

Examination. § T 17-7620

^ r^ -,- . §117-7621

Types 01 Certiiication 108.2

Regular Certification. § T 17-7622

Temporary Certification. a t' 1 '>

Limited Certification. Article D.

Certification Issuance, § 7523.

Renewal, Suspension and § 7624.

Revocation 108.2 ^ l?z^^

8 7626.
Issuance and Renewal. s 7577

Suspension for Failure to Renew s -7^28

Certificate. ^ -7^29

Revocation of Certificate.
Posting of Certificate. §7630

Examination 108.3

Frequency of Examinations. Article 1 1 .

Examination Content.
Examination Procedure.

Fees 108.3

Application Fee.

Renewal Fee.

Reexamination Fee. Article 12.

Penalty Fee.

Duplicate Certificate Fee.

Group 5.

Drain Wells 108.4

Article 1.

Drain Wells 108.4 § 7706.

Drain Wells.

§ 7707.

Drinking Water Supplies 109

§ 7708.

General 109

Definitions. ^ __„„

„ § 7709.

Purpose.

Responsibility and Scope of s 771 fl

Program. s 7711

Evaluation of Hazard. X nn^-^

TIC- 8 7712.

User Supervisor. I 77 n

Cross-Connecfion .

Approved Water Supply.

Auxiliary Supply. S 7714

Approved Check Valve.

Approved Double Check Valve

Assembly. Article 2.

Air-Gap Separation.

Approved Reduced Pressure

Principle Backflow Prevention ^ /719.

Device.

§ 7720.

Protection of Water System 110

Approval of Backflow Preventers. Article 3.

Construction of Backflow s 7725.

Preventers.

Locafion of Backflow Preventers. Article 4.

Type of Protection Required. §7730.

Testing and Maintenance of

Backflow Preventers. § 7731.

Table of Contents

§7106.
§7107.

Article 4.

§ 7109.
§7110.
§7110.1.

§7110.2.
§7111.
§7112.
§7113.

§7114.

Article 5.

§7116.
§7117.
§7118.

Article 6.

§7120.
§7121.

§7122.
§7123.

Article 7.

§7125.
§7126.
§7127.

Article 8,

§ 7130.
§7131.
§7132.
§7133.
§ 7134.

Group 3.

Article 1.

§ 7557.

Group 4.

Article 1.

§ 7583.
§T1 7-7583
§ 7584.

§ 7585.
§ 7586.
§ T 17-7588
§ Tl 7-7589
§ T 17-7590
§T1 7-7591
§ T 17-7592

§ T 17-7593
§TI 7-7594

Article 2.

§7601.
§ 7602.

§ 7603.
§ 7604.
§ 7605.

Page

Protection of Public Water

System at Service

Connection 112

Where Protection Is Required.

Type of Protection.

Protection of Potable Water

System Within Premises 112

Separate Drinking Water Systems.

Fire System.

Process Waters.

Sewage Treatment Plants and

Pumping Stations.

Plumbing Connections.

Pier and Dock Hydrants.

Marking Safe and Unsafe Water

Lines.

Water Supervisor.

Domestic Water Supply

Reservoirs 112

Intent of Regulations.

Application of Regulations.

Definitions.

Application for Permit.

Data to Accompany Application.

Guides to Evaluating Application.

Reservoirs for Which Permits May

Be Granted.

Kinds of Recreational Use Allowed

or Prohibited.

Delegation of Authority

Pursuant to Section 4025 of

the Health and Safety Code

(Permits for Small Water

Systems) 113

Production and Distribution

of Bottled Water 113

Sanitary Control of Shellfish 113

Shellfish Certificates 113

Shellfish Bed Certificate Issuable by

the State Board of Public Health.

Shellfish Plant Certificate Issuable

by the State Board of Public Health.

Authority of State Board of Public

Health to Revoke or Suspend

Certificate.

Expiration and Renewal of

Certificates.

Definition.

Types of Certificates.

Application for Certificate.

No Shellfish Grown in the State of

California to Be Sold or Distributed

Unless Certified.

No Shucked Shellfish to Be Sold or

Distributed Unless Certified.

Safety of Shellfish and

Health of Employees 114

Safety of Shellfish for Human

Consumption.

Persons Infected With

Communicable Diseases.

Records 114

Record of Operations.

Shellfish Beds 1 14

Cleanliness of Shellfish Growing

Areas.

Boat Sanitation.

Page xi

(7 2^ 2(H)S)

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 7732.

§ 7733.

Article 5.

§ T 17-7738
§ 7739.
§ 7740.
§7741.
§ 7742.

§ 7743.
§117-7744
§ 7745.
§117-7746
§117-7747
§ T 17-7748
§117-7749
§ T 17-7750
§117-7751
§ T 17-7752
§ 7753.
§ 7754.
§ 7755.

§ 7756.
§ 7757.
§ 7758.
§ 7759.
§ 7760.
§7761.
§ 7762.

Group 6.
Group 7.

Article 1.

§7861.

Article 2.

§ 7862.

Article 3.

§ 7863.

Article 4.

§ 7864.
§ 7865.
§ 7866.

§ 7867.
§ 7868.

Article 5.

§ 7869.

Article 6.

§ 7870.
§7871.
§ 7872.
§ 7873.
§ 7874.
§ 7875.

§ 7876.
§ 7877.
§ 7878.
§ 7879.
§ 7880.
§7881.
§ 7882.
§ 7883.

Page

Shellfish from Uncertified Aieas
Brought into Certified Beds.
Water Quality.

Plants and Operations 114

Culling Plants.

Storage.

Cleanliness of Shellstock.

Shipping.

Shucking and Packing Plants and

Equipment.

Washing.

Plant Anangement.

Floors.

Walls and Ceilings.

Screening.

Light.

Ventilation.

Toilet Facilities.

Handwasliing Facilities.

Sewers and Drains.

Water Supply.

Benches and Stands.

Construction of Utensils and

Equipment.

Aprons and Finger Cots.

Refrigeration.

Ice.

Cleaning.

Sterilization of Equipment.

Packing and Shipping.

Repacking Shucked Stock.

Public Swimming Pools 116

Bottled Water and Water

Vending Machines 116

Water Bottler and Water

Vendor Responsibilities 116

General.

Definitions 116

Definitions.

Water Quality 116

Bottled and Vending Machine Water
Quality.

Good Manufacturing

Practices 116

Water Bottling Plants.

Water Vending Machines.

Cleaning and Sanitizing of

Containers.

Water Dispensers.

Labels and Advertising.

Out-of-Stale Bottler or

Distributor 117

Apphcations.

Licenses and Fees 117

Licenses.

Doors and Windows.

Toilet — Handwashing Facilities.

Plant Maintenance.

Personnel — Cleanliness .

Cleaning and Sanitizing of

Containers.

Filling and Closures.

Dry Storage.

Water Dispensers.

Water Vending Machines.

Records.

Labels and Signs.

Applications.

Licenses.

Group 8.

Article 1.

§ 7925.

Article 2.

§ 7933.

§ 7934.

§ 7935.

§ 7936.

§ 7937.

Group 9.

Article 1.

§7941.1.

Article 2.

§7941.2.

§7941.3.

Article 3.

§7941.4.

Article 4.

§7941.5.
§7941.6.

§ 7942.
Article 5.

§ 7943.

§ 7944.
§ 7945.
§ 7946.

Group 10.

Article 1.

Article 2.

§ 7952.

§ 7953.
§ 7954.
§ 7955.
§ 7956.

Article 3.

Article 4.

§ 7957,
§ 7958.
§ 7959.
§ 7960.
§7961.

§ 7962.

Article 5.
Group 10.1.

Page

Sanitary Inspections 118

Sale of Rat Exterminators 118

Sale of Rat Exterminators.
Capture, Holding, Shipment
and Sale of Wild Rodents 118

Definitions.

Registration.

Disinfeslation, Quarantine and

Shipment of Wild Rodents.

Reports.

Disposition of Trapped Wild

Rodents.

Registered Sanitarians GTP 119

Internship Program 119

Internship Program.

Approval of Educational

Institutions 119

Approved Educational Institution.

Review of Curriculum.

Registration Procedures 119

Certification of Registration.

Minimum Educational and
Experience Qualifications
for Admission to the
Examination for Registered
Sanitarians 119

Educational and Experience

Requirements.

Cross-Certification with

Department of Food and

Agriculture.

Excepdons.

Application Procedures for
Sanitarian Registration 120

Application Submission,

Completion and Nofification.

Application Review Period.

Apphcation Decision Period.

Median, Minimum, and Maximum

Application Processing Times.

Sanitation, Healthfulness and

Safety of Ocean Water-Contact

Sports Areas 120

Intent of Regulations 120

Definitions 120

Public Water-Contact Sports Area

Defined.

Public Beach Defined.

Safety Program Defined.

Refuse Defined.

Storm Drain.

Sanitation 120

Healthfulness 120

Physical Standard.
Bacteriological Standards.
Bacteriological Sampling.
Corrective Action.
Pubhc Beaches Visited by More
Than 50,000 People Annually and
Adjacent to Storm Drains.
Duties Imposed on a Local Public
Officer or Agency.

Safety 121

Sanitation of Public Beaches 121

Page xii

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

Page

Article 1. Intent of Regulations 121

Article 2. Definitions and Exemptions 121

§7971. Beach.

§ 7972. Saltwater Body.

§ 7973. Freshwater Body.

§ 7974. Refuse.

§ 7975. Sanitation.

§ 7976. Recreational Purposes.

§ 7977. Public Health and Safety.

§ 7978. Health Officer.

§ 7979. Exemption.

§ 7980. Review by Health Officer.

Article 3. Day Use Beaches 122

§7981. Application.

§ 7982. Toilets.

§ 7983. Water Supply.

§ 7984. Maintenance.

§ 7985. Refuse Handling.

§7985.1. Animals.

§ 7986. Implementation.

Article 4. Beaches Allowing Overnight

Camping 122.1

§ 7987. Application.

§ 7988. Refuse Handling.

§7988.1. Animals.

§ 7989. Campsites.

§ 7990. Sanitary Facilities.

§ 7991. Maintenance.

§ 7992. Disposal of Sewage Wastes.

§ 7993. Laundry Facilities.

§ 7994. Water Supply.

Group 1 1 . Food Crop Growing and

Harvesting Sanitation 123

Article 1. Intent of Regulations 123

§ Tl 7-8000. Intent of Regulations.

Article 2. Definitions 123

§T1 7-8001. Food Crop.

§ T17-8002. Privacy,

§ 8003. Toilet Facilities.

Article 3. Toilet Facilities 123

§ 8004. General Standards.

§ 8005. Chemical Toilet Standards.

Article 4. Servicing of Units 123

§ 8006. Suitable Chemicals.

§ 8007. Disposal of Contents of Chemical

Tanks.

§ 8008. Standards.

§ 8009. Privies.

§ 8010. Toilets.

Article 5. Supplies 124

§ 80 1 1 . Toilet Paperholder.

Article 6. Handwashing Facilities 124

§ 8012. Standards.

Article 7. Waste Wash Water Disposal 124

§ 801 3. Water Flush Toilets and

Handwashing Facilities.

Group 12. Reclaimed Waste Water 124

§ 8025. Intent.

Subchapter 1.5. Regulations for

Implementation of the

California Environmental

Quality Act of 1970 124

Subchapter 2. Foods and Drugs 124

Group 1 . Rules and Regulations 124

§ 10101.

Order Promulgating Regulations.

§ 10102.

General Regulations.

§ 10103.

Constitutionality.

§ 10150.

Cosmetic Regulations.

Article 1.

Definitions 125

§ 10200.

Dietary Supplement.

Article 2.

Drugs and Devices

Regulations 125

§ 10350.

Labeling Defined (26207).

§ 10355.

Truth of Labeling (26208).

§ 10360.

New Drugs — Definition.

§ 10365.

Drugs— Name (26230).

§ 10370.

Poisonous In.secticides and

Rodenticides, Use of (26234(2)).

§ 10371.

Drugs: Current Good Manufacturing

Practice in Manufacture, Processing,

Packaging, Labeling or Holding

(26234(3)).

§ 10375.

Blending of Certified Coal Tar

Colors (26235 (2)).

§ 10376.

Drug and Device Manufacturing

Licenses.

§ 10377.

Definitions.

§ 10377.1.

Qualifications.

§ 10377.2.

Revocation and Suspension.

§ 10377.3.

Compliance.

§ 10377.4.

Requirements for the Storage and

Handling of Human Prescription

Drugs.

§ 10377.5.

Requirements for the Establishment

and Maintenance of Human

Prescription Drug Records.

§ 10377.6.

Written Policies and Procedures for

the Handling of Human Prescription

Drugs.

§ 10377.7.

Inspection by Federal, State, and

Local Law Enforcement Officials.

§ 10377.8.

Manufacturers of Active Ingredient

Components of Human Prescription

Drugs.

§ 10380.

Labeling, Misbranding (26240).

§ 10381.

Label Non-Prescription Drugs.

Pregnancy/Nursing.

§ 10385.

Labeling Requirements (26241).

§ 10386.

Manufacturer of Finished Dosage

Form.

§ 10390.

Forms of Making Required

Statements (26242).

§ 10395.

Statements of Ingredients and

Proportions (26243).

§ 10400.

Hoxsey Method for Treatment of

Cancer.

§ 10400.1.

Beta-Cyanogenetic Glucosides

("Laetriles") Agent for Treatment of

Cancer.

§ 10400.2.

Bolen Test for Diagnosis of Cancer.

§ 10400.3.

Koch Agents for Treatment of

Cancer.

§ 10400.4.

Lincoln Staphage Lysate Agent for

Treatment of Cancer.

§ 10400.5.

Mucorhicin Agent for Treatment of

Cancer.

§ 10400.6.

Anthrone Test for Diagnosis of

Cancer.

§ 10400.7.

Krebiozen for Treatment of Cancer.

§ 10401.

Drugs for Use in the Diagnosis,

Treatment, Alleviation or Cure of

Cancer in Human Beings.

§ 10401.1.

Investigation of Various Agents for

the Diagnosis or Treatment of

Cancer.

§ 10401.2.

American Board of Oncology.

§ 10405.

Directions for Use — FIxemptions

Thereto.

§ 10409.

Prescription Ophthalmic Devices.

§ 10410.

Exemption for Prescription Devices.

Page xiii

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§ 10415.

E.xemption for Prescription Dnigs

and Veterinary Drugs,

§ 10416.

Exemptions for Drugs Dispensed by

Licensed Practitioners.

§ 10417.

Formulary of Inequivalent Generic

Drug Types and Drug Products for

Which Substitution Poses a Threat

to Health and Safety.

§ 10420.

Label Requirements (26254).

§ 10425.

Applications.

§ 10430.

Notification of AppHcant (26289),

§ 10435.

Insufficient Information in

Application (26290).

§ 10437.

Suspension of Effective Application

(26290.5).

§ 10438.

Untrue Statements in Applications

(26290) (e) and 26290.5 (2).

§ 10440.

Exemptions from Section 26670.

§ 10445.

Exemptions from Section 26288 of

the Code (26292 (2) (3)).

§ 10446.

Exemptions for Dental

Laboratories.

§ 10450.

Form of Guaranty (26297).

§ 10455.

Expiration of Guaranty (26301).

§ 10460.

Presentation (26341).

icle 3.

Food Regulations 132

§ 10750.

Label Requirements for Foods and

Dietary Supplements.

§ 10755.

Truth of Labeling (26456).

§ 10760.

Metal Coated Dragees and

Ornaments (26470 (2)).

§ 10765.

Toxic Substances — Use of (26470

(2)).

§ 10770.

Secondhand Use of Barrels.

§ 10775.

Custard Fillings for Pastry (26470

(4)).

§ 10780.

Containers, Cadmium Plated (26470

(6)).

§ 10785.

Packing Materials (26470 (6)).

§ 10786.

Apricot Kernels.

§ 10790.

Candy, Trinkets in. Prohibited

(26472 (b)).

§ 10795.

Blending and Dilution of Certified

Coal Tai- Colors (26472 (c)).

§ 10800.

Labeling. Misbranding (26490 (1)).

§ 10805.

Required Statements, When Exempt

(26491).

§ 10810.

Prominence of Required Statements

(26492).

§ 10815.

Prepackaged Candy and Cookies,

Retail Sale of Food from Bulk

Containers (Label Exemptions)

(26492).

§ 10820.

Exemption upon Proper Labeling.

§ 10825.

Conformity to Definitions and

Standards of Identity (26493).

§ 10826.

Temporal^ Permits for Intrastate

Shipment of Experimental Packs of

Food Varying from the

Requirements of Definitions and

Standards of Identity.

§ 10830.

Designation of Ingredients (26495).

§ 10835.

Listing Ingredients in Order of

Predominance (26495 (2)).

§ 10840.

Dietary Food Labeling (26496 (1)).

§ 10841.

Label Statements Relating to

Emergency Food Packs.

§ 10842.

Saccharin Warning Labeling.

§ 10845.

Artificial Flavoring or Coloring,

Chemical Preservatives (26496 (2)).

§ 10850.

Form of (Guaranty (26521).

§ 10855.

Expiration of Guaranty (26525).

§ 10860.

Exemptions from Labeling

Requirements (26542).

§ 10862.

Adoption of Federal Requirements.

§ 10865.

Presentation (26565).

Article 3.1.

Food Additives Regulations ....

. . 134

Article 3.5.

Foods Under Agricultural

Code Regulations

. . 134

Article 3.6.

Poultry Meat and Poultry

Products

. . 134

§11375.

Sources of Poultry Meat .

§ 11376.

Conditions for Use.

§ 11377.

Methods for Treating.

§ 11378.

Disposal of Unfit Poultry Meats.

Article 3.7.

Raw Milk and Raw Milk

Products

134.1

§ 11380.

Required Health Warning on Labels
of Raw Milk and Raw Milk
Products.

Article 4.

Horse Meat Regulations

134.1

Article 5.

Cold Storage Regulations

134.1

§ 11600.

Cold Storage Regulations.

§11601.

Cold Storage Licenses.

Article 5.5.

Low Acid Frozen Foods in
Hermetically Sealed

Containers, Regulations

134.1

Article 6.

Bakery Sanitary Regulations . . .

134.1

§ 12001.

Custard and Cream Fillings for
Pastry (28208).

Article 6. 1 .

Local Enforcement of the
Sherman Food, Drug and
Cosmetic Law As It Relates
to Retail Food

Establishments

. . 135

§ 12100.

Definitions.

§ 12101.

Application for Participation.

§ 12102.

Local Enforcement Authorization.

§ 12103.

Laboratory Examinations.

§ 12104.

Personnel Training.

§ 12105.

Staff Qualificadons.

§ 12106.

Reporting Requirements.

§ 12107.

Enforcement Authority for Menu
Misrepresentation.

§ 12108.

Personnel Training.

§ 12109.

Staff Qualifications.

§12110.

Reporting Requirements.

Article 7.

Food Sanitation Regulations . . .

.. 136

§ 12200.

Vegetable Juice, Preparation and
Sale of Fresh (28281-28282).

§ 12205.

Premises.

§ 12210.

Materials.

§ 12215.

Extracting Machines.

§ 12220.

Storage and Sale.

§ 12225.

Employees.

§ 12230.

Revocation of Permit.

§ T 17- 12235

'<. Light, Ventilation, and Plumbing
(28281).

§ 12240.

Water Supply.

§ T17-1224f

i. General Plant Sanitation: Floors,
Walls, Ceilings, Etc.

§ 12250.

Areas. Equipment, and Operations
to Be Sanitary.

§ 12255.

Use of Poisonous Insecticides and
Rodenticides.

§ 12260.

Empty Container Storage.

§ 12265.

Bactericidal Treatment of Utensils
and Equipment in Food Processing
Establishments (28282(c)).

§ 12270.

Tagging Insanitary Equipment.

§ 12275.

Personal Hygiene.

§ 12280.

Sanitary Facilities.

§ 12285.

Surroundings of Food Packing
Establishments (28298).

Page xiv

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

Page

•

^ 12290.

Labeling Exemption (28322).

§ 12295.

Form of Affidavit.

§ 12300.

Purchase of Walnut Meats from

Producers, Etc. (28336).

§ 12302.

Walnut Shelling Licenses.

S 12305.

Production Record Specifications.

§ 12310.

Bill of Sale Specification.

§ 12315.

Condition of Walnut Meats.

icle 8.

Cannery Inspection

Regulations

§ 12400.

Applicability.

§ 12405.

Acid Requirements.

§ 12410.

Titration by Inspectors.

§ 12415.

Low Acid Ingi-edients in Acid

Foods.

§ 12420.

Formulated Products.

§ 12425.

Test Equipment.

§ 12430.

Samples to Laboratory.

§ 12435.

Production Records.

§ 12440.

Inspectors' Reports.

§ 12445.

Releases.

§ 12450.

Responsibility of Canners.

§ 12451.

Cannery Licenses.

§ 12455.

Official Sterilization Processes.

§ 12460.

Initial Temperature.

§ 12465.

Cleanliness of Materials.

§ 12470.

Record of Cooks.

§ 12475.

Coding.

§ 12480.

Requirements.

§ 12481.

Examination of Can Closures and

Can Closure Machines.

§ 12482.

Required and Optional Seam

Measurements.

§ 12485.

Standards for Water Used in Fish

Canneries.

§ 12490.

Establishments and Premises in or

•

§ 12495.
§ 12500.
§ 12505.

§ 12510.
§ 12515.
§ 12520.

§ 12525.
§ 12530.
§ 12535.
§ 12540.
§ 12545.
§ 12550.
§ 12555.
§ 12560.
§ 12565.
§ 12570.
§ 12575.
§ 12580.
§ 12585.
§ 12590.
§ 12595.
§ 12600.
§ 12605.
§ 12610.

§ 12615.

§ 12620.
§ 12625.
§ 12630.
§ 12635.
« 12640.

138

on Which Food Products Are

Prepared, Handled, Stored, or

Packed Shall Be Maintained in a

Sanitary Condition.

Water Supply.

Floors, Walls, Ceilings, Etc.

Use of Poisonous Insecticides and

Rodenticides in Food Processing

Establishments.

Animals in Plant.

Sanitary Facilities.

Areas. Equipment, and Operations

to Be Sanitary.

Personal Hygiene.

Surroundings.

Employment of Diseased Persons.

Empty Container Storage.

Tagging Insanitary Equipment.

Recanning.

Reporting Spoilage.

Segregation.

Examination.

Monthly Reports.

Sale to Salvage Company.

Application.

Venting of Canned Food Products.

Tolerance per Batch.

Supervision of Flip Testing.

Segregation of Flip-Tested Cans.

Holding After Flip Test.

Cans Having Less Than 1 1/2"

Internal Vacuum.

Cans Having 1 1/2" or More

Internal Vacuum.

Normal Cans; No Spoilage.

Normal Cans; Spoilage.

Overfills and Hydrogen Swells.

Sampling.

Decision to Flip Test.

§ 12645.

Prevention of Salvage of Unfit

Canned Foods.

§ 12650.

Applications.

§ 12652.

Exemption.

§ 12655.

General Rules.

§ 12660.

Standards for Inspection of Raw

Fish.

§ 12665.

Inspection Service — Tuna.

§ 12670.

Raw Fish Reports.

§ 12675.

Fishing Vessels.

§ 12680.

Disposal of Condemned Fish.

§ 12685.

Sampling Canned Tuna.

§ 12690.

Horse Mackerel.

§ 12695.

Sanitary Boat Certificates.

§ 12700.

Supervision of Cleaning.

§ 12705.

Method of Cleaning.

§ 12710.

Application.

§ 12715.

Permission.

§ 12720.

Official Wording.

§ 12725.

Notification of Intention to Install

Retorts.

§ 12730.

Obtaining Approval.

§ 12735.

Types of Retorts.

§ 12740.

Definition of Terms.

§ 12745.

Required Equipment for All Types

of Retorts When Sterilizing Food in

Tin or in Glass Jars with Closures

Such That They May Be Processed

in Steam.

§ 12750.

Additional Equipment Suggested

but Not Required by the Department

of Public Health.

§ 12755.

Venting of Retorts for Removal of

Air, General Considerations.

§ 12760.

Venting of Horizontal Retorts for

Removal of Air.

§ 12765.

Venting of Vertical Retorts for

Removal of Air.

§ 12767.

Diagrams of Venting Systems.

§ 12770.

Notification of Intention to Install

Retorts.

§ 12775.

Obtaining Approval.

§ 12780.

Equipment Required.

§ 12785.

Installation of Equipment.

§ 12790.

General.

§ 12795.

Animal Food Sterilization

Processes.

§ 12800.

Asparagus Sterilization Processes.

§ 12805.

Beans, Dry: Sterilization Processes.

§ 12810.

Beans, Green and Wax, Whole or

Cut: Sterilization Processes.

§ 12815.

Beans, Lima and Soy: Sterilization

Processes.

§ 12820.

Bean Sprouts: Sterilization

Processes.

§ 12825.

Beets: Sterilization Processes.

§ 12830.

Broccoli: Sterilization Processes.

§ 12835.

Brussels Sprouts: Sterilization

Processes.

§ 12840.

Cabbage: Sterilization Processes.

§ 12845.

Carrots: Sterilization Processes.

§ 12850.

Carrot Juice: Sterilization

Processes.

§ 12855.

Carrots and Peas: Sterilization

Processes.

§ 12860.

Cauliflower: Sterilization Processes.

§ 12865.

Celery: Sterilization Processes.

§ 12870.

Chili Products: Sterilization

Processes.

§ 12875.

Com: Sterilization Processes.

§ 12880.

Com Meal Mush: Sterilization

Processes.

§ 12885.

Fish Products: Sterilization

Processes.

§ 12890.

Hominy: Sterilization Processes.

Page XV

(7 2^ 2i)im

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§ 12895.

§ 12900.
§ 12905.

§ 12910,
§ 12915.
§ 12920.
§ 12925.
§ 12930.

§ 12935.

§ 12940.
§ 12945.
§ 12950.
§ 12955.

§ 12960.

§ 12965.

§ 12970.

§ 12975.

Lentils in Unthickened Sauce:

Sterilization Processes.

Mushrooms: Sterilization Processes.

Mushroom Sauce — Spaghetti Sauce:

Sterilization Processes.

Olives: Sterilization Processes.

Parsnips: Sterilization Processes.

Peas: Sterilization Processes.

Potatoes: Sterilization Processes.

Potatoes, Sweet: Sterilization

Processes.

Poultry Meat — Turkey: Sterilization

Processes.

Pumpkin: Sterilization Processes.

Ravioli: SteriUzation Processes.

Spaghetti: Sterilization Processes.

Spinach, Packing and Sterilization

Processes.

Tamales, Cup: Sterilization

Processes.

Vegetables, Chopped: Sterilization

Processes.

Vegetables for Salad: Sterilization

Processes.

Vegetables, Strained: Sterilization

Processes.

§ 12976.

Cookroom Personnel.

§ 12977.

Posting of Cooks

§ 12978.

Marking Containers.

§ 12979.

Time Limits.

§ 12980.

Double Door Retorts.

§ 12981.

Retort Markers.

§ 12982.

Care of Containers.

§ 12983.

Blanching.

§ 12984.

Posting Regulations.

Article 9.

Olive Oil Regulations

§ 13500.

Olive Oil Regulations.

Article 10.

Mobile Food Preparation

Units

§ 13600.

Order Promulgating Standards.

§ 13601.

Definitions.

§ 13602.

Exterior Requirements.

§ 13603.

Interior Requirements.

§ 13604.

Temperature Requirements.

§ 13605.

Ventilation.

§ 13606.

Storage.

§ 13607.

Service Openings.

§ 13608.

Power Supply.

§ 13609.

Water Supply, Plumbing.

Article 10.1.

Commissaries Servicing

152

Mobile Food Preparation
Units

§T17-13611. General Requirements .

§13612. Waste Handling and Disposal.

§ 13613. Water Supply and Plumbing.

§ T17-13614. Electrical Hook-Up Facilities.

§ T17-13615. Toilet and Lavatory.

§ T17-13616. Facilities for Food Storage.

155

Article 10.2.

§ 13620.
§ 13621.

Article 10.3.

§ 13650.

Requirements for the Sale of
Imitation Hamburger in
Restaurants

155

Definitions.
Wallboard and Placard
Requirements in Restaurants
Without Menus.

Requirements for Roadside
Stands, Food Establishments
Open to the Outside Air,

and Retail Dairies

Definitions.

155

Page

§13651. Structural and Operational

Requirements.
§ 13652. Health Requirements.

§ 13653. Enforcement and Inspection.

Article 10.4. Ventilation Standards for

Retail Food Establishments 156

§ 1 3670. Adoption of the 1976 Uniform

Mechanical Code.
Building Plan Approval.

Raw Oysters 1 56

Raw Gulf Oysters: Labeling,
Written Warnings and Additional
Requirements.
Request for Verification.

Frozen Food Locker

Regulations 156.3

Frozen Food Locker Regulations.

Licenses for Frozen Food Locker

Plants.

Hazardous Substances

Regulations 157

Definitions and Standards 157

Food Standards 157

Order Promulgating Standards.

General Regulations.

Examinations and

Investigations — Samples.

General Methods for Water Capacity

and Fill of Containers.

General Statements of Substandard

Quality and Substandard Fill of

Container.

Flour and Cereal

Products 157

Corn Flour and Related

Products 157

Rice and Related

Products 157

Bakery and Bakery

Products 157

Alimentary Pastes 157

Macaroni Products: Identity; Label
Statement of Optional Ingredients.
Enriched Macaroni Products:
Identity; Label Statement of
Optional Ingredients.
Milk Macaroni Products: Identity;
Label Statement of Optional
Ingredients.

Whole Wheat Macaroni Products:
Identity; Label Statement of
Optional Ingredients.
Wheat and Soy Macaroni Products:
Identity; Label Statement of
Optional Ingredients.
Vegetable Macaroni Products:
Identity; Label Statement of
Optional Ingredients.
Noodle Products: Identity; Label
Statement of Optional Ingredients.
Enriched Noodle Products: Identity;
Label Statement of Optional
Ingredients.
§ 15445. Wheat and Soy Noodle Products:

Identity; Label Statement of
Optional Ingredients.

§ 13671.

Article 10.5.

§ 13675.

§ 13676.

Article 11.

§ 13700.
§ 13701.

Article 12.

Group 2.

Article 13.

§ 15200.
§ 15205.
§ 15210.

§ 15215.

§ 15220.

Subarticle 1.

Subarticle 2.

Subarticle 2A,

Subarticle 3.

Subarticle 4.

§ 15405.

§ 15410.

§ 15415.

§ 15420.

§ 15425.

§ 15430.

§ 15435.

§ 15440.

•

Page xvi

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

Page

•

§ 15450. Vegetable Noodle Products:

Identity; Label Statement of
Optional Ingredients.

§ 15455. Oriental Style Noodles, Chinese

Style Noodles, Japanese Style
Noodles, Korean Style Noodles:
Identity; Label Statement of
Ingredients.

§ 15460. Tagliarini: Identity; Label Statement

of Optional Ingredients.

§ 15465. Use of Secondhand Boxes for

Alimentary Pastes.

Subarticle 1 . Canned Vegetables 158

Subarticle 2. Canned Vegetable Other
Than Those Specifically
Regulated 158

Subarticle 3. Canned Tomatoes 158

Subarticle 4. Tomato Products 158

Subarticle 5. Tomato Products, Mold

Filament Tolerance 158

§ 15575. Tomato Catsup, Puree, and Paste.

§ 15580. Tomato Juice.

§15585. Comminuted Tomato Products.

Subarticle 1 . Canned Fruit 158

Subarticle 2. Fruit Preserves and

Jellies 158

Subarticle 3. Fruit Butters 158

Subarticle 3.5. Citrus Products 158

Subarticle 4. Carbonated Beverages 158

Subarticle 1 . Dressings for Salads 159

Subarticle 1 . Canned Shrimp 159

Subarticle 2. Canned Oysters 159

Subarticle 3. Raw Oysters 159

Subarticle 4. Sea Food Cocktails 159

§ 15825. Sea Food Cocktails.

Subarticle 5. Canned Tuna Fish 159

§ 15830. Eggs.

§ 15835. Liquid Eggs, Mixed Eggs, Liquid

Whole Eggs, Mixed Whole Eggs:

Identity.
§ 15840. Frozen Eggs, Frozen Whole Eggs,

Frozen Mixed Eggs: Identity.
§ 15845. Dried Eggs, Dried Whole Eggs;

Identity.
§ 15850. Egg Yolks, Liquid Egg Yolks, Yolks,

Liquid YoUcs:
§ 15855. Frozen Yolks, Frozen Egg Yolks:

Identity.
§ 15856. Egg Whites, Liquid Egg Whites,

Liquid Egg Albumen; Identity.
§ 15857. Frozen Egg Whites, Frozen Egg

Albumen; Identity.
§ 15860. Dried Egg Yolks, Dried Yolks;

Identity.
§ 1 586 1 . Dried Egg Whites, Egg White

Solids, Dried Egg Albumen, Egg

Albumen Solids; Identity.
§ 15865. Cacao Nibs, Cocoa Nibs, Cracked

Cocoa: Identity; Label Statement of

Optional Ingi'edients.

§ 15870.

Chocolate Liquor, Chocolate,

Baking Chocolate, Bitter Chocolate,

Cooking Chocolate, Chocolate

Coating, Bitter Chocolate Coating;

Identity: Label Statement of

Optional Ingredients.

§ 15875.

Breakfast Cocoa, High Fat Cocoa:

Identity; Label Statement of

Optional Ingredients.

§ 15880.

Cocoa, Medium Fat Cocoa: Identity;

Label Statement of Optional

Ingredients.

§ 15885.

Low-Fat Cocoa: Identity; Label

Statement of Optional Ingredients.

§ 15890.

Sweet Chocolate, Sweet Chocolate

Coating: Identity; Label Statement

of Optional Ingredients.

§ 15895.

Milk Chocolate, Sweet Milk

Chocolate, Milk Chocolate Coating,

Sweet Milk Chocolate Coating:

Identity; Label Statement of

Optional Ingredients.

§ 15900.

Skim Milk Chocolate, Sweet Skim

Milk Chocolate, Skim Milk

Chocolate Coating, Sweet Skim

Milk Chocolate Coating: Identity;

Label Statement of Optional

Ingredients.

§ 15905.

Buttermilk Chocolate, Buttermilk

Chocolate Coating: Identity; Label

Statement of Optional Ingredients.

§ 15910.

Mixed Dairy Product Chocolate,

Mixed Dairy Product Chocolate

Coating: Identity; Label Statement

of Optional Ingredients.

§ 15915.

Sweet Chocolate and Vegetable Fat

(Other Than Cacao Fat) Coatings:

Identity; Label Statement of

Optional Ingredients.

§ 15920.

Sweet Cocoa and Vegetable Fat

(Other Than Cacao Fat) Coatings:

Identity; Label Statement of

Optional Ingredients.

§ 15925.

Distinction Between "Extract" and

"Flavor."

Subarticle 1.

Extracts 160

Subarticle 2.

Flavors 160

Subarticle 3.

Labeling 160

§ 15975.

Labeling Defined.

§ 15980.

Where Label Statements Must

Appear.

§ 15985.

Name and Address of Manufacturer

or Distributor.

§ 15990.

Quantity of Contents Statement.

§ 15995.

Listing of Ingredients.

§ 16000.

Artificial Coloring.

§ 16005.

Artificial Flavoring.

§ 16010.

Chemical Preservatives.

§ 16015.

Guaranty Statements.

§ 16020.

Misleading Containers.

§ 16025.

Definitions.

§ 16030.

Sirup.

§ 16035.

Sugar-Cane Sirup.

§ 16040.

Sorghum Sirup.

§ 16045.

Maple Sirup.

§ 16050.

Sugar Sirup.

§ 16055.

Imitation Sirups.

§ 16060.

Labeling of Sirups.

§ 16065.

Vinegar, Cider Vinegar, Apple

Vinegar.

§ 16070.

Distilled Vinegar, Spirit Vinegar,

Grain Vinegar.

§ 16075.

Wine Vinegar, Grape Vinegar.

§ 16080.

Malt Vinegar, Beer Vinegar.

§ 16085.

Spices.

Page xvii

(7 2S 2()()S)

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 16090.
§ 16095.
§ 16100.

Subarticle 1,

§ 16105.

§ 16110.

Subarticle 2

§ 16112.
§ 16113.

Article 13.1.

§ 16200.
§ 16201.

Article 14.

§ 17000.

§ 17001.

§ 17005.

§ 17010.

§ 17015.

§ 17075.
§ 17076.
§ 17090.
§ 17100.
§ 17105.
§17116.

Article 15.

§ 18000.

Article 16.

§ 19000.
§ 19001.
§ 19005.
§ 19010.
§ 19015.
§ 19020.
§ 19025.
§ 19030.
§ 19035.

§ 19040.

§ 19041.
§ 19043.

Subchapter 3.

Group 1.

Group 2.

Article 1.

30001.

Page

Labeling of Vinegai^s.
Adulteration.
Imitation Vinegar.

Olives, Ripe, Sold in

Bulk 161

Manner of Holding Bulk Ripe

Olives.

Label Stipulations of Bulk Ripe

Olives.

Canned Whole and Pitted

Ripe Olives 161

Definitions.

Labeling.

Actionable Defect Levels for
Processed Foods 163

General Provisions.

Heat Processed Canned Peaches:

Actionable Defect Levels for

Insects.

Wine Standards and

Prohibited Practices 163

Order Promulgating Regulations

and Standards.

Adoption and Application of

Regulations and Standards.

Standards of Identity and Quality for

Wine Produced in California or

Elsewhere.

Provisions Applicable to Wine

Produced in California.

Wines Bearing the Appellation of

Origin "California" or a

Geographical Subdivision Thereof.

Labeling.

Combination Wines.

Advertising of Wine.

Sanitation.

Enforcement.

Constitutionality.

Distilled Spirits Standards 164

California Brandy.

Processed Pet Food

Regulations 165

Order Promulgating Standards.

Intent of Regulations.

Definitions.

Chemical Analysis.

Exemptions.

Required Verifications.

Labeling and Restrictions.

Manufacturing Requirements.

Magnet to Remove Ferrous

Material.

Arsenic and Lead Tolerance in

Animal Food.

Pet Food Licenses and Certificates.

Sources of Poultry Meat.

Vector Control 167

Standards Governing State Aid

to Local Moscjuilo Control

Agencies 167

Standards Governing

Certification of Local Vector

Control Agency Personnel 167

Definitions 167

Certified Technician.

§ 30003.
§ 30005.
§ 30007.
§ 30009.
§30011.
§ 30013.
§ 30015.
§ 30017.
§ 30019.
§ 30054.

Article 2.

§ 30055.
§ 30056.
§30056.!
§ 30056.:
§ 30056.;
§ 30056.-

§ 30056
§ 30057
§ 30058
§ 30059

Article 3.

§ 30061

Subchapter 3.1.

Article 1.

§ 30062.

Article 2.

§ 30064.
Article 3.

§ 30066.
Subchapter 3.2.

Article 1.

§ 30070.
§30071.

Article 2.

§ 30072.
§ 30073.
§ 30073.1

§ 30073.2

§ 30074.
§30074.1

§ 30075.

§ 30076.
Article 3.

§ 30077.

Page

Certified Technician (Limited).

Continuing Education Unit.

In-Service Training.

Pesticide Label.

Relevant Vectors.

Under the Direct Supervision of.

Vector.

Vector Control Aide.

Vector Control Agency.

Definitions,

Certification Examination 168

Examination Requirements.

Exainination Content.

Interpretation of Dates.

Applications.

Admission to Examination,

Notification of Examination

Results.

Processing Times.

Expiration.

Denial, Suspension, or Revocation.

Records.

Continuing Education 170

Confinuing Education
Requirements.

Implementation of the

Emergency Mosquito

Abatement Funding Act of

1983 170

General Provisions 170

Definitions.
Conditions Governing
Expenditure of the
Emergency Mosquito
Abatement Trust Account or
Fund 171

Application for Expenditure.
Criteria for Determining If
a Local Agency Has
Established Adequate
Emergency Mosquito
Abatement Procedures 171

Criteria for Emergency Mosquito

Abatement Procedures.

Importation of Wild

Animals 171

General 171

Purpose and Scope.
Definidons.

Import Permits 171

Wildlife Admitted by Permit,
Application for Import Permits.
Determination of Application
Completeness and Notification,
Application Time Periods for
Processing a Permit Based on
Actual Performance.
Issuance of Import Permits.
Importation of Animals Under
Special Permit.
Conditions of Quarantine for
Personal Pets.
Permit Fees.

Quarantine Facilities and

Operating Standards 174

Animal Holding Facility.

•

Page

XVllI

(7-25-20

Title 17

State Department of Health Services
Page

Alternative Housing Facilities. Article 3.
Primary Enclosures. S 30180

Animal Health and Husbandry

Standards. §30181.

Approved Quarantine Facilities. ^ 3018''

Quarantine Provisions 174.1 Article 4.

Quarantine. § 30190.

Tuberculin Test. §30191

Quarantine Records 174.2 ^ ^0192.

Record Keeping.

Animal Identification. (. -,^,f,^ ,

8 30192.1

Quarantine Reporting 174.2

Reporting of Tests Results, Physical § 30192.2

Examinations, Illnesses, Deaths.

§ 30192.3
Cooperation with Other

Governmental Agencies 174.2 §30192.4

Cooperating Agencies. S lOig'' 5

Exceptions 174.2 § 30192.6

Exceptions.
^ ,. . §30193.

Radiation 175

General .75 « ^''""'■

Definitions 175 ^3^,,^,

General Dermitions.

Registration Requirement. e 10194 ^

Communications. s 30195 ~

Exemptions and Enforcement 176

Exemptions. §^0195.1

Deliberate Misconduct.

Registration of Sources of § 30195.2

Radiation 176

Registration Procedure 176 § 30195.3

Registration Requirement.

Initial Registration.

Renewal of Registration.

Registration Form. §30196.

Separate Installations. = 30197.

Report of Change. „

8 301 98
Report of Discontinuance. s jui^o.

Registration Shall Not Imply § ^^-O^-

Approval.

Vendor Obligation.

Reportable Sources of Radiation. Article 5.

Exclusions from § 30210.

Registration 177 ^ 30210 "^

Excluded Material and Devices.

Exempt Possessors.

Records 177

Radiation Protection Standards.
Records to be Maintained.
Violations.

Article 6.

^^^^ ^"^^ § 30220.

Registration Fees. .

Registration Fee, Mammography Article 7.

Exception.

Payment of Fee. 6 30225

Licensing of Radioactive
Materials 178 Article 8.

^ 1 „ §30230.

General 178 § 30231

Authority. § 30232.

License Requirement. Arf' 1 Q

Communications. Article V.

r^ .. . . § 30235.

Deiimtions 179 § 30236.

General Definitions.

Table of Contents

•

§ 30077.
§ 30078.
§ 30079.

§ 30080.

Article 4.

§30081.
§30081.

Article 5.

§ 30082.
§ 30083.

Article 6.

§ 30084.

Article 7.

§ 30085.

Article 8.

§ 30086.

Subchapter 4.
Group 1.

Article 1.

§ 30100.
§ 30102.
§ 30103.

Article 2.

§ 30104.
§ 30105.

Group 1.5.

Article 1.

§ 30108.

§30110.

§30111.

§30112.

§30113.

§30115.

§30116.

§30117.

§30118.

§ 30120.

Article 2.

§ 30125.

§ 30126.

Article 3.

§ 30130.

§30131.

§ 30140.

Article 4.

§ 30145.

§ 30145.1

§ 30146.

Group 2.

Article 1.

§ 30170.

§ 30172.

§30173.

Article 2.

§ 30175.

Page

Exemptions 179

Exempt Persons. Products,
Concentrations and Quantities.
Persons Exempt.
Other Exemptions.

Licenses 180

Types of Licenses.

General Licenses-Source Material.

General Licenses — Static

Elimination or Ion Generation

Devices.

General Licenses — Gauging and

Controlling.

General Licenses — Aircraft Safety

Devices.

General Licenses — Calibration or

Reference Sources.

General Licenses — Ice Detection

Devices.

General Licenses — In Vitro Testing.

General Licenses — Depleted

Uranium.

Application for Specific Licenses

and Amendments.

Approval of Applications and

Specific Terms and Conditions for

Licenses.

Criteria for Authorizing Multiple

Locations of Use.

Amendment Requests.

Special Requirements for Issuance

of Specific Licenses.

Special Requirements for Issuance

of Specific Licenses — Financial

Surety for Decommissioning.

Special Requirements for Issuance

of Specific Licenses — Emergency

Plans.

Special Requirements for Issuance

of Specific Licenses for Use of

Sealed Sources in Industrial

Radiography.

Issuance of Specific Licenses.

Specific Terms and Conditions of

Licenses.

Expiration of Licenses.

Modification, Suspension,

Revocation and Termination of

Licenses.

Transfer of Material I86

Authorization for Transfer.
Verification Required.
Labeling Requirements for the
Manufacture, Preparation or
Transfer for Commercial
Distribution of Drugs Containing
Radioactive Material for Human
Use as Authorized by a Specific
License.

Enforcement I86

Violations.

Reciprocal Recognition of

Licenses 186

Persons Licensed by Other

Agencies.

License Fees I86.1

License Fees.
Fee Schedule.
Fee Limitations.

Schedules 187

Schedule A. Exempt Quantities.
Schedule B, Table I, In Vitro
Clinical Tests.

Page xix

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 30237.
Group 3.

Article 1.

§ 30250.
§30251.
§ 30252.
§ 30253.

Article 2.

Schedule C.

Standards for Protection
Against Radiation

Page

191

§ 30254.
§ 30255.

§ 30256.

§ 30257.
§ 30258.

Article 3.

§ 30265.
§30265.1.
§ 30266.

§ 30268.

§ 30269.

§ 30275.
§ 30276.
§ 30277.
§ 30278.
§ 30278.1.

§ 30279.

§ 30279.1

§ 30280.

§ 30281.

§ 30282.
§ 30285.
§ 30287.

§ 30288.
§ 30289.

Article 3.1.

§ 30293.
§ 30294.

§ 30295.
§ 30297.

§ 30298.
§ 30299.

Article 4.

§ 30305.
§ 30306.
§ 30307.

General 191

Authority.

Purpose.

Scope and Puipose.

Standards for Protection Against

Radiation.

Notices, Instructions, and

Reports to Workers;

Inspections and

Investigations 192

Inspection.

Notices, Instructions, and Reports to

Personnel.

Vacating Installations: Records and

Notice.

Bankruptcy Notification.

General Definitions.

Surveys and Tests 195

Occupational Dose Limits.

Determination of Prior Dose.

Exposure of Individuals to

Concentrations of Radioactive

Material in Controlled Areas.

Permissible Levels of Radiation in

Uncontrolled Areas.

Concentrations in Effluents to

Uncontrolled Areas.

Surveys and Tests.

Personnel Monitoring.

Bio- Assays and Medical Review.

Caution Signs and Labels.

Removal of Caution Labels from

Empty Containers.

Special Requirements for High

Radiation Areas and Radiation

Machines Capable of Producing

High Radiation Areas.

Additional Special Requirements for

Very High Radiation Areas.

Notices, Instructions, and Reports to

Personnel.

Storage and Control of Radioactive

Material.

Procedures for Opening Packages.

General Requirement.

Disposal by Release into Sanitary

Sewerage Systems.

Disposal by Burial in Soil.

Treatment or Disposal by

Incineration.

Records and Notification 196.1

Records.

Reports of Theft or Loss of Sources

of Radiation.

Notification of Incidents.

Reports of Overexposures and

Excessive Levels and

Concentrations.

Vacating Installations.

Bankruptcy Notification.

Special Requirements for the
Use of X-Ray in the Healing
Arts 197

General Provisions.

Definitions.

Fluoroscopic Installations

Page

§ 30308. Radiographic Installations (Other

Than Dental and Veterinary

Medicine).
§ 30309. Special Requirements for Mobile

Radiographic Equipment.
§ 30310. Special Requirements for Chest

Photofluorographic Installations.
§ 30311. Dental Radiographic Installations.

§ 30312. Therapeutic X-Ray Installations.

§ 30313. Special Requirements for X-Ray

Therapy Equipment Operated at

Potentials of 50 kV and Below.
§ 30314. Veterinary Medicine Radiographic

Installations.

Article 4.5. Requirements for the Use of

X-Ray in Mammography 202.1

§30315.10. Definitions.

§ 30315.20. Facility Accreditation Certificate

and Interim Facility Accreditation

Certificate.
§ 30315.22. Ehgibihty for a Facility

Accreditation Certificate.
§ 30315.23. Renewal of a Facility Accreditation

Certificate.
§ 30315.24. Interim Facility Accreditation

Certificate.
§ 30315.33. Complete Facility Application.

§ 30315.34. Application Processing Times.

§30315.35. Clinical Image Review.

§30315.36. Mammography Review.

§30315.50. Interpreting Physician

Requirements.
§ 30315.51. Personnel Requirements for

Individuals Who Perform

Mammography.
§ 30315.52. Medical Physicist Requirements.

§ 30315.60. Authorization and Renewal of

Authorization to Conduct

Mammography Surveys, Revocation

and Suspension of Authorization

and Application Processing Times.
§30316. Mammography System

Requirements.
§ 303 16.10. Evaluations of New, Replaced or

Repaired Equipment.
§ 30316.20. Quality Assurance Testing.

§ 30316.22. Acceptable Phantoms.

§ 30316.30. Phantom Image Scoring Protocol.

§ 30316.40. Processing of Mammogiams and

Phantom Images.
§ 30316.50. Mammographic Image

Identification.
§ 30316.60. Medical Physicist Survey Reports.

§ 30316.61 . Instruments Used by Medical

Physicists.
§ 30317. General Facility Requirements.

§ 30317.10. Mammography Quality Assurance

Program.
§ 30317.20. Quality Assurance Manual.

§ 303 17.30. Mammography Procedures Manual .

§ 30317.40. Maimnographic Examination

Reports.
§ 30317.50. Mammogi^am and Report Retention.

§ 30317.60. Manmiography Medical Outcomes

Audit.
§30317.70. Consumer Complaints.

§ 30318.10. Additional Requirements for Mobile

Service Providers.
§ 30318.11. Posting Requirements for Mobile

Service Providers.
§ 30319. Notification Requirements.

§ 30319.20. Record Keeping Requirements.

§ 30320.90. Grounds for Suspension,

Revocation, Amendment or

Restriction of a Facility

Accreditation Certificate.

•

Page XX

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

Article 5.

Page

203

§30321.

§ 30321.1.
§ 30322.

Article 6.

§ 30330.
§30331.

§ 30332.

§30332.1.

§ 30332.2.

§ 30332.3.
§ 30332.4.

§ 30332.5.

§ 30332.6.
§ 30332.7.

§ 30332.8.
§ 30333.

§ 30333.05.

§ 30333.07.

§30333.1.

§ 30333.2.
§ 30333.3.

§ 30334.

§ 30335.

§30335.1.

§ 30335.2.

§ 30335.3.
§ 30335.4.

§ 30335.5.

§ 30335.6.

§ 30335.10.

§ 30336.

§30336.1.

§ 30336.5.

Special Requirements for the
Use of Radioactive Material
in the Healing Arts

Accountability, Storage, and

Transit.

Confirming Removal of Implants.

Records and Reports of

Misadministration.

Special Requirements for
Radiographic Operations in
Industrial Radiography 203

Definitions Specific to Industrial

Radiography.

Eligibility for and Renewal of

Approval as a Radiation Safety

Training Provider and Provider

Requirements.

Performance Requirements for

Radiographic Exposure Devices,

Storage Containers, and Source

Changers.

Security of Radiographic Exposure

Devices, Storage Containers and

Source Changers.

Security of Permanent Radiographic

Installations.

Radiation Survey Instruments.

Leak Testing, Repair, Tagging,

Opening, Modification, and

Replacement of Sealed Sources and

Depleted Uranium Shielding.

Quarterly Inventory of Sealed

Sources.

Utilization Logs.

Inspection and Maintenance of

Radiographic Exposure Devices,

Storage Containers, Source

Changers and Survey Instruments.

Reporting Requirements.

Training and Supervision for

Radiographers and Radiographer's

Assistants Using Sealed Sources.

Radioactive Materials Radiographer

Trainer Requirements.

Radioactive Material Radiation

Safety Officer Requirements.

Operating and Emergency

Procedures.

Personnel Monitoring Control.

Location of Documents and

Records.

Precautionary Procedures in

Radiographic Operations Using

Sealed Sources.

Minimum Subjects to Be Covered in

Training Radiographers. [Repealed]

Radiographer Certification

Categories.

Eligibility for and Renewal of a

Radiographer Certificate.

Reciprocal Recognition.

Provisional Radiographer

Certificates.

Complete Radiographer Certificate

Application.

Notification of Change of Name or

Address.

Radiation Safety Training

Curriculum.

Requirements for Shielded-Room

Radiography.

Requirements for Field

Radiography.

Requirements for Radiation

Machine Radiographer's Assistants.

§ 30336.6.
§ 30336.7.
§ 30336.8.
§ 30337.
§ 30338.

Article 7.

§ 30345.1.
§ 30345.2.
§ 30345.3.
§ 30346.

§ 30346.1.
§ 30346.2.
§ 30346.3.
§ 30346.4.
§ 30346.5.
§ 30346.6.

§ 30346.7.

§ 30346.8.
§ 30346.9.
§ 30346.10.
§30346.11.

§30346.12.

§30348.1.
§ 30348.2.

§ 30348.3.
§ 30348.4.
§ 30348.5.
§ 30350.
§ 30350.1.

§ 30350.2.

§ 30350.3.

§ 30353.
§ 30355.

§ 30356.
§ 30357.

§ 30358.

Group 4.

Article 1.

§ 30373.

Group 5.

§ 30385.
§ 30390.

Page

Radiation Machine Radiographer
Trainer Requirements.

Radiation Machine Radiation
Safety Officer Requirements.

Industrial Radiography
Certification and Provider Fees.
Requirements for Use of Cabinet
X-ray Systems.

Grounds for Suspension,
Revocation, Amendment, or
Restriction of Radiogi'apher
Certificates and Radiation Safety
Training Provider Approvals.

Radiation Safety

Requirements for Well

Logging Operations 208.8

Scope.

Definifions.

Specific License for Well Logging.

Agreement with Well Owner or

Operator.

Labels, Security and Transportation.

Radiation Detection Instruments.

Leak Testing of Sealed Sources.

Physical Inventory.

Records of Material Use.

Design and Performance Criteria for

Sealed Sources.

Inspection, Maintenance and

Opening of a Source Holder.

Subsurface Tracer Studies.

Radioactive Markers.

Uranium Sinker Bars.

Use of Energy Compensation

Sources.

Use of Tridum Neutron Generator

Target Sources.

Training Requirements.

Operating and Emergency

Procedures.

Personnel Monitoring.

Radiation Surveys.

Radioactive Contamination Control.

Security.

Documents and Records Required at

Field Stations.

Documents and Records Required at

Temporary Jobsites.

Notification of Incidents and Lost

Sources; Abandonment Procedures

for Irretrievable Sources.

Particle Accelerators For Well

Logging.

Appendix A. Concentrations in Air

and Water Above Natural

Background.

Appendix B.

Form RH 2364— Notice to

Employees.

Form RH 2365— Current

Occupational External Radiation

Exposure.

Transportation of Radioactive

Material 214

Requirements for
Transportation of

Radioactive Material 214

Transportation Reguladons.

Participation by Local Health
Departments 215

Authority.

General Definitions.

Page xxi

(7 2.S 2()()S)

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

Article 1. Local Health Departments 215

§ 30393. Participalion in Control Program.

§ 30394. Application for Participation.

§ 30395. Contract Authorizing Participation.

§ 30397. Terms of Participation.

Subchapter 4.5. Radiologic Technology 233

Group 1.

Article 1.

§ 30400.
§ 30400.5.

§ 30400.40.
§ 30400.60.
§ 30400.85.
§ 30400.95.
§30401.
§30401.6.

Article 2.

§ 30402.

Article 3.

§ 30403.

§ 30403.5.
§ 30403.8.

Article 4.

§ 30404.

Article 5.

§ 30405.

Article 6.

§ 30406.

Article 7.

§ 30408.

Article 8.

§ 30410.
§ 30410.2.

Group 2.

Article 1.

§ 30420.

Article 2.

§30421.
§ 30422.

Article 3.

§ 30423.

Article 4.

Administration

Definitions

Fluoroscopy.

Approved Continuing Education

Credit.

Fluoroscopy.

Mammographic Examination.

Radiography.

X-ray Bone Densitometry.

Radiography.

X-ray Bone Densitometry.

Special Permits

Special Permits.

Requirements for Continuing
Education Performance, and
Renewal of Certificates and
Permits

Requirements for Continuing
Education and Performance of
Mammographic Examinations.
Renewal Procedures.
Recordkeeping Requirement.

Display of Certificates and

Permits

Display.

Deadlines

Deadlines.

Change of Name and Address
Change of Name and Address.

Fees

Fees.

233
233

233

234

235

Authorization to X-Ray

Technicians to Perform

Digital Radiography 235

Authorization to X-Ray Technicians

to Perform Digital Radiography.

Instruction in Digital Radiologic

Technology.

Training of Students of

Radiologic Technology 236

General 236

Application Procedure.

Radiologic Technology

Schools 236

Diagnostic Radiologic Technology

Schools.

Therapeutic Radiologic Technology

Schools.

Radiologic Technologist
Fluoroscopy Permit Schools 237

Radiologic Technologist

Fluoroscopy Permit Schools.

Limited Peniiit X-Ray

Technician Schools 238

Page

§ 30424. Limited Permit X-Ray Technician

Schools Teaching the Chest,
Extremities, Gastrointestinal,
Genitourinary, Leg-Podiatric, Skull,
or Torso-Skeletal Categories.

§ 30425. Limited Permit X-Ray Technician

Schools Teaching the Dental
Laboratory Category.

§ 30426. Photofluorographic Chest X-Ray

Technician Courses of Study.

§ 30427. Liinited Permit X-Ray Technician

Schools Teaching the Dermatology
X-Ray Therapy Category.

§ 30427.2. Limited Permit X-Ray Technician

Schools Teaching the X-Ray Bone
Densitometry Category.

Article 5. On-the-Job Training for X-

Ray Technicians 239

§ 30428. Approval of On-the-Job Training.

Article 6. Notification 239

§ 30435. Notification Requirements.

Article 7. Disciplinary Action 239

§ 30436. Standards for Suspension or

Revocation of Approval.

Article 8. Additional School

Requirements and

Recordkeeping 240

§ 30437. Additional School Requirements

and Recordkeeping.

Group 3. Certificates for Radiologic

Technologists and Permits for

Limited Permit X-Ray

Technicians 240

Ai'ticle 1 . Certification of

Technologists 240

§ 30440. Issuance of Certificates.

§30441. Acceptable Applications.

Article 2. Permits for Limited Permit X-

Ray Technicians 240

§ 30442. Categories.

§ 30443. Scopes.

§ 30444. Issuance of Limited Permits.

§ 30445. Acceptable Applications.

§ 30445.1. Acceptable Applications: X-ray

Bone Densitometry.

§ 30446. Title.

§ 30447. Restrictions.

Group 4. Use of Fluoroscopy Equipment

by Radiologic Technologists 240.1

Article 1 . Radiologic Technologist

Fluoroscopy Permits 240.1

§ 30450. Permit Requirement.

§ 30451. Issuance of Technologist

Fluoroscopy Permits.
§ 30452. Acceptable Applications.

Group 4.5. Use of Mammography Equipment

by Radiologic Technologists 240.2

Article 1 . Mammographic Technology

Certificates 240.2

§ 30455. 1 . Issuance of a Mammographic

Radiologic Technology Certificate.

Group 5. Certification of Licentiates 240.2

Article 1 . Licentiate Certificates and

Permits 240.2

Page xxii

(7-25-2008)

Title 17

State Department of Health Services

Table of Contents

§ 30460.
§30461.
§ 30462.
§ 30463.
§ 30464.
§ 30465.
§ 30466.

§ 30467.

§ 30468.
Group 7.

Article 1 .

§ 30470.
§30471.

Article 2.

§ 30473.

Article 3.

§ 30475.

Article 4.

§ 30477.

§ 30479.

§30481.
Article 5.

§ 30483.

Article 6.

§ 30485.

Article 7.

§ 30487.

§ 30489.
§ 30491.

Article 8.

Page

Licentiate Certificate.

Licentiate Permits.

Radiology Certificate.

Fluoroscopy Permits.

Radiography Permits.

Dermatology Permits.

Issuance of Licentiate Certificates or

Permits.

Certification of Qualified

Licentiates.

Acceptable Applications.

Requirements for Land Disposal

of Radioactive Waste 240.2(a)

Applicable Federal

Regulations 240.2(a)

Low-Level Radioactive Waste

Disposal.

Transfer for Disposal, Manifests and

Record Keeping.

Article 2.

Certification of Nuclear
Medicine Technologists

Page

240.3

General

Definitions.

240.2(a)

§ 30520.

Competency Criteria.

§30521.

Supervision Requirements.

Article 3.

Administration 240.4

§ 30530.

Acceptable Applications.

§30531.

Application Process and Deadlines.

§ 30532.

Issuance of Certificates.

§ 30533.

Scopes of Certificates.

§ 30534.

Title.

§ 30535.

Fees.

§ 30536.

Renewal Procedures.

§ 30537.

Notification Requirements.

Article 4.

Exemptions and Enforcement . . 240.5

§ 30540.

Students of Nuclear Medicine

Technology.

§30541.

Special Permits.

§ 30542.

Display.

§ 30543.

Inspection.

§ 30550.

Fuel Tank Emissions.

§ 30560.

Carburetor Hot Soak Emissions.

§ 30570.

Exhaust Odor and Irritation.

Proprietary Documents 240.2(a)

Proprietary Documents.
Selection of License
Designee 240.2(a)

Application for Selection as License

Designee.

Standards for Selecting the License

Designee.

Acceptance by License Designee.

Forfeiture of Performance

Bond 240.2(b)

Standards for Forfeiture of the

Performance Bond.

Subchapter 5. Air Sanitation 241

Article 1 . Standards for Ambient Air

Quality 241

§ 30690. Table of Standards and Explanatory

Footnotes.

Subchapter 6. Organized Camps 242

Fees

License Fee.

240.2(b)

Financial Assurances 240.2(b)

Additional Licensee Requirements
and Financial Assurances.
Funding for Disposal Site Closure
and Stabilization.
Liability Insurance.

Rate Review and Approval

Process 240.2(c)

§ 30493. Establishment and Approval of

Rates.
§ 30495. Calculation of the Rate Schedule.

§ 30497. Rate Review Documentation.

§ 30499. Adjustment of Rate Schedule.

Subchapter 4.6. Nuclear Medicine

Technology 240.2(c)

Article 1.

§ 30500.

§30501.
§ 30502.
§ 30503.
§ 30504.
§ 30505.
§ 30506.
§ 30507.

§ 30508.
§ 30509.

§ 30510.

Definitions 240.2(c)

Certified Technologist, Nuclear

Medicine.

Direct Supervision.

General Supervision.

In Vitro Test.

In Vivo Test.

Licensed Clinical Bioanalyst.

Nuclear Medicine Physician.

Nuclear Medicine Technology

Procedures.

Special Permit.

Student of Nuclear Medicine

Technology.

Supervisor.

Article 1.

General

. 242

§ 30700.

Definitions.

§30701.

Limitation of Scope.

§ 30702.

General Camp Safety
Requirements.

§ 30703.

Notice of Intention to Operate.

§ 30704.

Requirements for Camps.

Article 2.

Utilities

. 243

§ 30710.

Water Supply.

§30711.

Drinking Water.

§30712.

Handwashing Facilities.

§30713.

Showers.

§ 30714.

Toilets.

§ 30715.

Plumbing. [Repealed]

Article 3.

Housing

. 243

§ 30720.

Building Structures.

§30721.

Sleeping Accommodations.

§ 30722.

Repair, Safety, Maintenance and
Sanitation.

§ 30723.

Overhead Electrical Line
Construction.

§ 30724.

Mechanical Installation. [Repealed]

Article 4.

Food Service Facilities and

Operations

. 244

§ 30730.

Food Service Facilities.

§30731.

Light, Ventilation and Sanitary
Facilities.

§ 30732.

Cleaning and Sanitizing of Multiuse
Utensils.

§ 30733.

Storage of Food, Utensils and
Equipment.

§ 30734.

Health Requisites for Food Service
Personnel.

Article 4. 1 .

Food Service Facilities and

Operations at Intermittent
Short-Term Organized Camps
[Repealed]

244

Page xxiii

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§ 30734.1. Food Service Facilities and

Operations at Intermittent
Short-Term Organized Camps.
[Repealed]

Article 5. Solid Waste 244

§ 30735. Garbage and Refuse.

Article 6. Vector Control 244

§ 30736. Vectors and Pests.

Article 7. Swimming and Bathing 245

§ 30740. Swimming Facilities.

§ 30741 . Lake, Stream, River or Ocean

Swimming.

Article 8. Supervision 245

§ .30750. Health Supervision.

§ 30751. General and Safety Supervision.

§ 30752. Firearms.

§ 30753. Emergency Plan.

Subchapter 7. Wiping Rags 246

Article 1 . Definitions 246

Article 2. Minimum Standards for

Sanitizing 246

§30801. Standards.

Subchapter 8. Drinking Utensils and Ice

Buckets 246

Article 1. Definitions 246

§ 30850. Single Service.

§30851. Multiuse.

Article 2. Washing, Sanitizing, and
Handling of Drinking
Utensils and Ice Buckets in
Hotels, Motels, and Other
Pubhc Places 246.1

§ 30852. Utensils and Containers, Conditions

of Use and Storage.
§ 30853. Hand Dishwashing and Sanitizing.

§ 30854. Sanitizing Solutions for Hand

Dishwashing.
§ 30855. Machine Washing and Sanitizing.

§ 30856. Sanitizing Requirements for

Dishwashing Machines.
§ 30857. Maintenance and Construction

Requirements.
§ 30858. Inspection Authority.

Chapter 6.

Lead Poisoning Prevention
Programs

247

icle 1.

Definitions

§33001.

Applicant.

§ 33002.

Architectural Coating.

§ 33003.

Architectural Coating Distribution.

§ 33004.

Architectural Coating Distributor.

§ 33005.

Appurtenance.

§ 33006.

Business Entity.

§ 33007.

Department.

§ 33008.

Environmental Lead

Contamination.

§ 33009.

Fee.

§ 33010.

Historically Associated.

§33011.

Industry.

§ 33012.

Motor Vehicle Fuel.

§ 33013.

Motor Vehicle Fuel Distribution.

§ 33014.

Motor Vehicle Fuel Distributor.

§ 33015.

Ongoing and Chronic Exposure.

Article 2.

Fees

248.2

§ 33020. Fees Attributable to Leaded

Architectural Coatings.
§ 33025. Fees Attributable to Leaded

Gasoline.
§ 33030. Fees Attributable to Facilities

Releasing Lead into Ambient Air in

California.

Article 3. Exemption from Fees 248.3

§ 33040. Exemption From Fees.

Article 4. Application to Reassess Fee — 248.4

§ 33050. Apphcation to Reassess Fee.

Chapter 7. Health Facilities Planning 248.4

Chapter 7.5. Eminent Domain Procedures for

Nonprofit Hospitals 248.4

Chapter 7.7. Fire Protection Loans 248.4

Chapter 8. Accreditation, Certification and
Work Practices for Lead-Based
Paint and Lead Hazards 248.4

Article 1. Definitions 248.4

§35001. Abatement.

§ 35002. Accreditation.

§ 35003. Accredited Training Provider.

§ 35004. CDPH-Approved Course.

§ 35005. Certified Lead Inspector/Assessor.

§ 35005. 1 . Certified Lead Project Designer.

§ 35006. Certified Lead Project Monitor.

§ 35007. Certified Lead Sampling

Technician.

§ 35008. Certified Lead Supervisor.

§ 35009. Certified Lead Worker.

§ 35010. Certificate.

§35011. Guest Instructor.

§ 35012. Certified Industrial Hygienist.

§ 35013. Clearance Inspection.

§ 35014. Component.

§35015. Contact Hour.

§ 35016. Containment.

§ 35017. Job Tasks.

§35018. Continuing Education.

§ 35019. Course Completion Form.

§ 35020. Demonstration Testing.

§35021. Department.

§ 35022. Deteriorated Lead-Based Paint.

§ 35023. DHS-Approved Course. [Repealed]

§ 35024. Photo Identification Number.

§ 35025. Guest Instructor.

§ 35026. Hands-on Training.

§ 35027. Industrial Building.

§ 35028. Instructor.

§ 35029. Interactive/Participatory Teaching

Methods.

§ 35030. Interim Certificate.

§35031. Job Tasks.

§ 35032. Lead Activities.

§ 35033. Lead-Based Paint.

§ 35034. Lead Certification Examination.

§ 35035. Lead-Contaminated Dust.

§ 35036. Lead-Contaminated Soil.

§ 35037. Lead Hazard.

§ 35038. Lead Hazard Evaluation.

§ 35039. Lead Inspection.

§ 35040. Lead-Related Construction Work.

§ 35041. Photo Identification Number.

§ 35042. Postsecondary Education.

§ 35043. Presumed Lead-Based Paint.

§ 35044. Provisional Accreditation.

§ 35045. Public Building.

§ 35046. Residential Building.

§ 35047. Risk Assessment.

§ 35048. Train-the-Trainer Course.

Page xxiv

(7-25-2008)

Title 17

State Department of Health Services Table of Contents

Page Page

Training Director. Article 13. Eligibility Requirements and

^"'''^ ^'^^- Application Procedures for

Eligibility Requirements for Certification or Interim

Accreditation and Course Certification 248.18(g)

Approval 248.14 § 35081 . Representation of Certification

Representation of Accreditation Status.

Status. § 35082. Application Timeliness.

Eligibility Requirements. § ^50^^- Inspector/Assessor.

Personnel Requirements. § -''-''085. Supervisor.

Operational Requirements. § ^-^087. Project Monitor.

§ 35088. Project Designer.

Core Instruction 248.16 § 35089. Sampling Technician.

Core Instructional Requirements. § 35091. Worker.

§ 35093. Interim Certification and Renewal.

Lead-Related Construction § 35095. Application Requirements.

Inspection and Assessment § -^-^O^^. Certification, Interim Certification.

_ and Renewal Procedures.

Course 248.16

Course Requirements. Article 14. Suspension or Revocation ot

Certification or Interim

Lead-Related Construction /- .f .■ ^..,,0,

Certification 248.i8(k)

Supervision and Project ^ 33097 ^^^-^^ ^^ ^^^^^^^ ^^ r^^„^.

Monitoring Course 248.17 Certification or Interim

Course Requirements. Certification.

Lead-Related Construction ^^i^le 15. Enforcement 248.18(1)

Sampling Technician § ^^^^"^^ ^""^^'"2 ^^^^ Enforcement.

(^Q^j-gg 748 18(a) Article 16. Work Practice Standards 248.18(1)

Course Requirements. § ^^000. Requirements for Lead Hazard

Evaluation for Public and

Lead-Related Construction Residential Buildings.

Work Course 248.18(a) f ,^^?^^- ^ead-Safe Work Practices.

§36100. Requirements for Abatement for

Course Requirements. Pubjjc .^^ Residential Buildings.

Lead-Related Construction Chapter 9. Screening for Childhood Lead

Supplemental Supervision Poisoning 248.18(n)

and Project Monitoring

Course 248.18(b) ^"i^^^ ^- Definitions 248.18(n)

Course Requirements § ^"^^00. Health Care Provider.

t^ourse Kequirements. ^ ^^^^^ Physician.

Lead-Related Construction § 37010. Physician's Assistant.

r tT AT A t ■ 1 §37015. Primary Medical Care.

L^ertllied industrial ^ 3-7020. Publicly Funded Program for Low

Hygienist Course 248.18(c) Income Children.

Course Requirements. § 37025. Screening.

Continuing Education 248.18(d) Article 2. Standard of Care on

Continuing Education for Workers Screening for Childhood

Requirements. Lead Poisoning 248.18(0)

General Continuing Education §37100. Requirements.
Requirements.

Application Requirements and ^^^P^^^ ^ ^ • Occupational Lead Poisoning

Procedures for Training Prevention Program 248.l8(o)

Provider Accreditation, Article 1. Definitions 248.1 8(0)

Renewal, or Course § 38001. Occupational Lead Poisoning

» 1 ^..r, 10.JX Prevention Program: Definitions.

Approval 248.18(d) ^

Application Requkements. Article 2. Waivers of the Occupational

Accreditation Procedures. Lead Poisoning Fee 248.l8(p)

Suspension or Revocation of f ^^002. Fee Waiver Eligibility.

. . 8 38003. Procedures for Application of a

Accreditation, Provisional Waiver.

Accreditation, or DHS § 38004. Periods for Which Fee Waivers Are

Course Approval 248.18(g) *^'''^^''''^-

Action to Suspend or Revoke Article 3. Applicable Industries 248.19

Accreditation, Provisional § 38005. Occupational Lead Poisoning Fee:

Accreditation, or Course Approval. Applicable Industries.

§ 35049.
§ 35050.

Article 2.

§35051.

§ 35052.
§ 35053.
§ 35054.

Article 3.

§ 35055.
Article 4.

§ 35056.
Article 5.

§ 35057.

Article 6.

§35061.

Article 7.

§ 35065.
Article 8.

§ 35066.
Article 9.

§ 35067.

Article 10.

§ 35070.

§ 35072.
Article 11.

§ 35076.
§ 35078.

Article 12.

§ 35080.

Page XXV

•

Title 17

State Department of Health Services

§103

TITLE 17. PUBLIC HEALTH

Division 1 . State Department of Health
Services

(Originally Printed 8-15-45)

Chapter 1. Administration

Subchapter 1.

State Department of Health
Services

(Originally Printed 6-30-73)

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Chapter 1252, Statutes of 1977.

History

1 . New Subchapter 1 (Sections 1 through 4) filed 6-29-73 as an emergency; desig-
nated effective 6-30-73 (Register 73, No. 26).

2. Certificate of Compliance filed 10-24-73 (Register 73, No. 43).

3. Amendment filed 6-30-78 as an emergency; designated effective at 1 1 :59 p.m.
on 6-30-78 (Register 78, No. 26).

4. Certificate ofCompliance transmitted to OAH 10-27-78; filed 10-31-78 (Reg-
ister 78, No. 44).

5. Repealer of Subchapter 1 (Sections 1-5) filed 9-27-85; effective thirtieth day
thereafter (Register 85, No. 40). For prior history, see Register 78, No. 44; 78,
No. 26; and 74, No. 41.

Subchapter 2. Hospital Districts

Article 1. Liability Loans

§100. Eligibility Requirements.

(a) Hospital districts may apply for State loans to pay for medical inju-
ry tort claims or judgments that are in excess of $300,000. Such hospital
districts shall meet all of the following:

( 1 ) Be the Chowchilla Memorial Hospital District, or a hospital district
which has entered into a joint powers agreement with the Chowchilla
Memorial Hospital District.

(2) Be located in a county that has areas that are designated as rural
medically undeserved areas by the Health Manpower Policy Commis-
sion, pursuant to Section 1 188.4, Chapter 4, Part 4, Health and Safety
Code (Rural Health Services, October 1976).

(3) Have a licensed bed capacity of less than 100 beds.

(4) Have submitted to the Department on or before September 8, 1977,
a statement which includes the following:

(A) A utilization review plan or its equivalent which has been official-
ly adopted by the governing body of the hospital districts and which:

1 . Provides for the participation of the entire medical staff in a review
committee.

2. Provides that at least one committee member is a nonphysician
health professional.

3. Prohibits the participation on the committee of any person who has
a financial interest in the hospital.

4. Prohibits any person from participation in the review of any care in
which that person has been professionally involved.

5. Provides for at least monthly meetings of the review committee.

6. Provides for the retention for at least seven years of records of the
review committee's activities, including the number and types of cases

received, the findings and recommendations, and the subsequent actions
taken.

(B) Proof of either insurance against medical injury liability claims or
judgments up to $300,000 or the establishment of a reserve account in
that amount, along with a plan for the investment of such reserves.

(C) A written plan for the preliminary investigation of medical injury
claims and for procurement of legal counsel when indicated.

(D) A written plan to repay the State loan within forty (40) years detail-
ing the resources available to the hospital district including taxing pow-
ers.

NOTE: Authority cited: Sections 32351-32355 and 32358, Health and Safety
Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety
Code. Division 23.

History

1. New Subchapter 2 (Sections 100-103) filed 12-6-79; effecdve thirtieth day
thereafter (Register 79, No. 49).

§101. Loan Application.

(a) The hospital district shall make application for a State loan to the
Director of Health Services, 714 P Street, Sacramento, CA 95814.

(b) Within ninety (90) days after the receipt of the application the De-
partment of Health Services will notify the applicant of its preliminary
finding and recommendation. The notice will contain the information
that the Department's final recommendation to the Legislature must be
made within the next thirty (30) days and that any information that the
applicant has that will affect the preliminary recommendation should be
forwarded immediately.

NOTE; Authority cited: Secfions 32351-32355 and 32358, Health and Safety
Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety
Code, Division 23.

§102. Coverage.

(a) The Department shall grant all loans which qualify, to the extent
that funds are available, provided that:

(1) Such amount represents an excess of $300,000 in a medical injury
tort judgment or settlement, the $300,000 being covered by insurance or
reserve account, as specified in Section 100(a)(4)(B).

(2) The total amount of such loans does not exceed $1 ,000,000 in the
aggregate.

(b) Physicians in the local community who are employees of the hospi-
tal district shall be covered for medical injury tort liability by the district.

NOTE: Authority cited: Sections 32351-32355, Health and Safety Code, Division
23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division

23.

§ 103. Repayment of Loans.

(a) Repayment of loans shall be on an amortized schedule agreed upon
by the Department and the hospital district. The repayment period shall
not exceed forty (40) years. The interest rate shall not exceed the five-
year average on the return on the investment of State funds pursuant to
Chapter 3 (commencing with Secfion 16430), Part 2, Division 4, Title 2
of the Government Code.

(b) In event of default of repayment of a loan, the Department may at-
tach real property and assets of the hospital district to recover the amount
of the loan and appropriate interest as specified in (a) above.

NOTE: Authority cited: Sections 32351-32355, Health and Safety Code. Division
23. Reference: Sections 32351, 32353, 32355 and 32358, Health and Safety Code,
Division 23.

Subchapter 3. Hospital Inspection

(Originally Printed 8-15-^5)
Revision (except Group 1) filed 3-30-51
Revision of Group 2 filed 1-19-54 and 6-13-75
Revision of Group 1 filed 7-15-57

Page 1

(4-1-90)

§901

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Group 1. Clinics and Dispensaries

Note; Authority cited: Sections 1231 and 141 1, Health and Safety Code.

History

1. Subchapter 3 originally printed 8-15^5 (Title 17).

2. Additions and amendments to Subchapter 3 jiled between 8-15-45 and 7-6-57
published in Registers 5; 8; 10, No. 3; 11, No. 4: 12, No. 4; 12, No. 5; 12, No.
6: 14, No. 1; 14, No. 6: 53, No. 9; 54, No. 2; 56, No. 10.

3. Revision of Subchapter 3 (except Group 1 ) filed 3-30-5 1 ; effective thirtieth day
thereafter (Register 23, No. 7).

4. Revision of Subchapter 3, Group 1 (i.e. Repealer of §§ 161, 166, 171, 176. 181.
186, and new §§ 161-167, 169-178. 180, 183, 186, 187. 190, 193, 194, 197,
198, 201 , 204, 207-224) filed 7-1 5-57; effective thirtieth day thereafter (Regis-
ter 57, No. 1 1 ).

5. Repealer of Group 1 (Sections 161 through 198) filed 10-1 1-74; effective thir-
tieth day thereafter (Register 74, No. 4 1 ). For prior history, see Registers 64, No.
14; 71, No. 10;and72rNo. 16.

Group 2. Health Facilities

NOTE: Authority cited: Sections 102, 208 and ] 41 1, Health and Safety Code. Ref-
erence: Sections 1400-1433, Div. 2, Chap. 2, Health and Safety Code.

History

1. New section filed 7-21-70 as an emergency: effective upon filing (Register 70,
No. 30).

2. Certificate of Compliance-
ister 70, No. 47).

-Section 1 1422.1, Gov. Code, filed 1 1-17-70 (Reg-

3. Amendment filed 1-31-73 as an emergency: effective upon filing (Register 73,

No. 5).

4. Amendment filed 6-22-73 as an emergency; effective upon filing. Certificate
of Compliance included (Register 73, No. 25).

5. Repealer of Subgroup 1 and Subgroup 1 .5 (Sections 229 through 395.4, not con-
secutive) of Group 2 filed 6-13-75; effecdve thirtieth day thereafter (Register
75. No. 24). For prior history, see Registers 56, No. 10; 58, Nos. 10, 12; 59, No.
12; 63, Nos. 14, 20; 64, Nos. 4, 10, 16, 22; 65, No. 1 1 ; 66,Nos. 8, 25, 34, 44; 67,
Nos. 1 1, 50; 68, Nos. 14, 49; 69, Nos. 13, 19, 29, 39, 52; 70, Nos. 12, 30, 33,47;
71, Nos. 10, 31, 48; 72, Nos. 16, 32, 44; 73, Nos. 5, 25; and 74, No. 18.

Subgroup 2. Requirements for Outpatient
Clinics

NOTE: Authority cited: Secfions 102, 208 and 1411, Health and Safety Code. Ref-
erence: Sections 1400-1433, Div. 2, Ch. 2, Health and Safety Code.

History

1 . New Subgroup 2 (Sections 400-488, not consecutive) filed 6-22-73 as an emer-
gency; effective upon filing. Certificate of C'ompliance included (Register 73,
No. 25). For history of former Subgroup 2, see Register 73, No. 14.

2. Amendment filed 10-1 1-74; effective thirtieth day thereafter (Register 74, No.
41).

3. Amendment filed 1 1-12-76 as an emergency, effecdve upon filing (Register
76, No. 46).

4. Certificate of Compliance filed 3-8-77 (Register 77, No. 11).

5. Repealer of Subgroup 2 (Sections 400-488, not consecuUve) filed 1-18-82; ef-
fective thirtieth day thereafter (Register 82, No. 4).

Group 3. Nonprofit Hospitals

(Originally Printed 8-15-45)
Note: Authority cited: Sections 11501, 1 1502, and 1 1503 of Insurance Code.

History
1 . Repealer of Group 3 (SecUon 850) filed 6-13 -75; effective thirtieth day thereaf-
ter (Register 75, No. 24).

Group 4. Establishments for Handicapped
Persons

NOTE: Authority cited for Secfions 860.0-875.0: Secfion 1509, Health and Safety
Code.

History
1. New §§ 860 to 896, inclusive, filed 12-24-47 as an emergency designated to
be effective 1-1-48 (Register 10, No. 8).

2. Revision (§§ 860-875.0) filed 9-13-48 (Register 14, No. 1).

3. Repealer of Group 4 (Sections 860.0-875.0) filed 8-1-75; effective thirtieth day
thereafter (Register 75, No. 3 1 ). For prior history, see Register 10, No. 8; 1 4, No.

1; 23, No. 7; 24, No. 5; 25, No. 2; 71, No. 10; 72, No. 16; 72, No. 32.

Group 5. Public Medical Institutions

NOTE: Authority cited for Sections 880 and 881: Section 212, Health and Safety
Code.

History

1 . New Group 5 (§§ 880 and 881 ) filed 5-28-53, as an emergency effective upon
filing (Register 53, No. 9).

2. Repealer of Sections 880 and 881 filed 6-13-75; effective thirtieth day thereaf-
ter (Register 75, No. 24).

Subchapter 4. Records and Statistics

(Originally Printed 8-15^5)

Article 1. Access to the Records in the

Office of the State Registrar and in the

Offices of Local Registrars

§ 901 . Access to the Records in the Office of the State
Registrar and in the Offices of Local
Registrars.

Records of birth, death, and marriage in the Office of the State Regis-
trar and in offices of local registrars for which access is not specifically
prohibited by statute shall be open for examination by the public during
regularly scheduled office hours subject to the restrictions listed in
Health and Safety Code Sections 10125.5 and 10129.

The principal researcher who needs access to confidential information
shall submit a signed agreement to the State Registrar with a copy to the
local registrar when appropriate, assuring that any report shall not identi-
fy an individual and that working papers which may permit such identifi-
cation shall be destroyed as set forth in the agreement. Any breach of the
signed agreement shall result in denial of further access to the data.

No person, except as authorized by law, shall copy or retain copies of
confidential data unless procedures in this section are followed.
NOTE: Authority cited: Secfion 6253, Government Code; and Secfions 10001 and
10001.1(b), Health and Safety Code. Reference: Sections 10066 and 10125.5,
Health and Safety Code.

History

1 . Amendment filed 1-9-78; effecfive thirtieth day thereafter (Register 78, No. 2).
For prior history, see Register 76, No. 12.

2. Amendment filed 2-8-78 as an emergency; effective upon filing (Register 78,
No. 6).

3. Certificate of Compliance filed 5-1-78 (Register 78, No. 1 8).

4. Amendment filed 2-13-85; effecfive thirtieth day thereafter (Register 85, No.

V).

§ 902. Conditions of Examination.

(a) Authorization to examine the index or records in the Office of the
State Registrar and in offices of the local registrars must be obtained from
the registrar or deputy in charge.

Written application shall be made by the applicant stating sufficient in-
formation to identify the record or records to be examined.

The following information for the type of record specified below
should, whenever possible, be provided by the applicant:

(1) Birth

(A) Name of child;

(B) Maiden name of mother;

(2) Death

(A) Name of decedent;

(B) Date or year of death, or date last known alive;

Page 2

(4-1-90)

Title 17

State Department of Health Services

§916

(3) Marriage

(A) Name of Groom or Maiden name of Bride;

(B) Date or year of marriage.

Where the above information is not available, tlie applieant shall pro-
vide whatever information is available, and the State Registrar or local
registrar shall make all reasonable effort to locate the requested records.

(b) The State Registrar or local registrar shall supervise the examina-
tion of the records.

NOTH: Authority cited: Section 6253, Government Code; and Sections 10001 and
10001.1, Health and Safety Code. Reference: Section 10066, Health and Safety
Code.

History

1. Amendment filed 12-24-7.5 as an emergency; effective upon filing (Regi.ster
75, No. 52). For prior history, see Register 64, No. 4.

2. Amendment filed 2-27-76 as an emergency; effective upon filine (Register 76,
No. 9).

.3. Certificate of Compliance as to the 1 2-24-75 and 2-27-76 filings filed 3-1 8-76
(Register 76, No. 12).

4. Amendment filed 2-13-85; effective thirtieth day thereafter (Register 85, No.
7).

§ 903, Fee for Examination or Search.

NOTK: Authority cited: Secfions 10001 and 10001.1(b), Health and Safety Code.
Reference: Section 10066, Health and Safety Code.

History

1 . Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No.
18).

2. Amendment filed 2-1 1-64; effective thirtieth day thereafter (Register 64, No.

4).

3. Repealer filed 2-13-85; effective thirtieth day thereafter (Register 85, No. 7).

Article 2.

Late Registration of Births and
Deaths

§ 908. Late Registration of Births and Deaths.

The local registrar and the State Registrar of Vital Statistics shall ac-
cept for registration only those records of birth and death which are re-
ceived by the local registrar within one year of the date of occurrence of
the event, except as provided under Division 9, Chapters 9 and 10 of the
Health and Safety Code.

NOTH: Authority cited: Section 10001, Health and Safety Code. Reference: Sec-
tion 10577, Health and Safety Code.

History

1 . New section filed 2^-47 (Register 7).

2. Amendment filed 3-8-55; effective thirtieth day thereafter (Register 55, No. 4).

3. Amendment tiled 10-22-57; effective thirtieth day thereafter (Register 57, No.
18).

4. Editorial correction of NOTE filed 3-22-84 (Register 84, No. 12).

Article 3.

Birth Certificates of Deceased
Persons

§ 910. Responsibilities of Local Registrar or County
Recorder.

(a) Upon notification by the State Registrar that a person whose birth
is registered in the local office is deceased, the local registrar or county
recorder of such office shall make at least one of the following:

( 1 ) A notation of the death in the birth index.

(2) A notation of the date of death and the death certificate number
upon the record of birth.

(b) The local registrar or county recorder shall notify the State Regis-
trar of any application for a certified copy of a deceased person's birth
certificate in which it is indicated that the requested birth record is the
applicant's own birth record.

NOTK: Authority cited: Sections 1 0001 and 1 0575.5, Health and Safety Code. Ref-
erence: Sections 10038, and 10575.5, Health and Safety Code.

History

1. Renumbering of Article 3 to Article 4 and new Article 3 (Sections 910-912)
filed 5-1-78; effective thirtieth day thereafter (Register 78, No. 18).

2. Editorial correction of NOTE filed .3-22-84 (Regi.ster 84, No. 12).

§ 911 . Identification of Deceased Registrants by Local
Registrars and County Recorders.

Local registrars and county recorders may match deaths occurring in
their jurisdictions to births registered in their office and, for any regis-
trants thereby identified as deceased, make any of the notations specified
in Secuon 910(a)(1) and (2).

Note: Authority cited: Sections 10001 and 10575.5. Health and SafetvCode. Ref-
erence: Sections 10038 and 10575.5, Health and Safety Code.

History
1 . New NOTE filed 3-22-84 (Register 84, No. 12).

§ 91 2. Certified Copies of Birth Certificates of Deceased
Persons.

(a) All certified copies of birth records for which the registrant is iden-
tified as deceased shall display the legend "DECEASED," which shall
be in boldface style not less than one-half inch in height, near the space
reserved for the registrant's name.

( 1 ) Unless produced by a photographic process or through the medium
of an overlay employed in the copying process, the legend "DE-
CEASED" shall be printed or stamped in indelible ink.

(2) The local registrar or county recorder shall obtain prior approval
by the State Registrar of the method to be employed in producing the leg-
end "DECEASED."

NOTE: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Ref-
erence: Sections 10038 and 10575.5, Health and Safety Code.

History
1. New NOTE filed 3-22-84 (Register 84, No. 12).

Article 4.

Definitions of Live Birth and Fetal
Death

§915. Live Birth.

"Live birth" means the complete expulsion or extraction from its
mother of a product of conception (irrespective of the duration of preg-
nancy) which, after such separation, breathes or shows any other evi-
dence of life such as beating of the heart, pulsation of the umbilical cord,
or definite movement of voluntary muscles, whether or not the umbilical
cord has been cut or the placenta is attached.

NOTE: Authority cited: Section 10001, Health and Safety Code. Reference: Sec-
tions 10100 and 10102, Health and Safety Code.

History

1 . New Article 3 (§§ 915 and 916) filed 6-14-.56; effective thirtieth day thereafter
(Register 56, No. 12). For history of former Article 3, see Register 55, No. 4.

2. Renumbering of Article 3 to Article 4 (Sections 915 and 916) filed 5-1-78; ef-
fective thirtieth day thereafter (Register 78, No. 1 8).

3. Editorial correction of NOTE filed .3-22-84 (Register 84, No. 12).

§916. Fetal Death.

"Fetal death" means a death prior to the complete expulsion or extrac-
tion from its mother of a product of concepfion (irrespective of the dura-
tion of pregnancy); the death is indicated by the fact that after such sepa-
rafion, the fetus does not breathe or show any other evidence of life such
as beating of the heart, pulsation of the umbilical cord or definite mo\e-
ment of voluntary muscles. Registration of fetal deaths is subject to the
provisions of Division 9, Chapter 4 of the Health and Safety Code.
Note: Authority cited: Section 10001, Health and Safety Code. Reference: Sec-
tion 10175, Health and Safety Code.

History

1 . Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57. No.
18).

2. New NOTE filed 3-22-84 (Register 84, No. 12).

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Title 17

Subchapter 5. Home Health Agency
Licensing Requirements

NciTH; Authority cited: Section 208(a), Health and Safety Code. Reference: Sec-
tions 1725. 1726, 1727, 1728, 1728.1, 1729. 1731, 1734. 1735. 1736, 1737,
1737.5, 3123 and 3124, Health and Safety Code.

History

1. New Subchapter 5 (§§ 917 through 947) filed 7-1-66 as an emergency; effec-
tive upon filing (Register 66, No. 20).

2. Certificate of Compliance— Section 1 1422. 1. Gov. Code, filed 10-25-66, as to
emergency filing on 7-1-66 (Register 66, No. 37).

3. Amendment filed 10-25-66; effective thirtieth day thereafter (Register 66. No.

4. Amendment filed 12-1 3-66; effective thirtieth day thereafter (Register 66. No.

44).

5. Repealer of Subchapter 5 (Articles 1-9, Sections 917-948) filed 6-21-79; ef
fective thirtieth day thereafter (Register 79, No. 25). For prior history, see Reg-
isters 67, No. 2; 69. No. 13; 72, No. 36; 72, No. 53; 75, No. 24; 76, No. 41; 77,
No. 5; 78, No. 45; and 79, No. 18.

Chapter 2. Laboratories

(Originally Printed 8-15-45)

Subchapter 1. Service Laboratories

Group 1.

Production and Distribution of
Biologies

Article 1 . Licenses

§ 950. General Provisions.

(a) As used in this chapter "person" includes firm, association and cor-
poration.

(b) As used in this chapter "department" means State Depaitment of

Health.

NOTE: Authority cited for Group 1 (§§ 950 to 1021, inclusive): Secfions 208,
1600, 1603, 1604, 1605, and 1606, Health and Safety Code. Issuing agency: State
Department of Public Health.

History

1. Amendment of subsection (b) filed 3-5-76; effective thirtieth day thereafter
(Register 76, No. 10). For prior history, see Register 20, No. 6.

§ 951 . Issuance of License.

(a) All persons desiring to produce process or distribute biologies shall
make application to the department on a form provided by the depart-
ment, and shall supply such other information as may be required by the
department for the intelligent appraisal of the status of the laboratory, the
product to be licensed, and the personnel with respect to the intent and
purpose of the law.

(b) Licenses shall not be issued to any person not at the time fully pre-
pared, equipped and actually processing (though not distributing), but
the department will provide anyone contemplating the establishment of
a processing laboratory with full information concerning the require-
ments and conditions for the preparation of the products that it is pro-
posed to manufacture or distribute.

(c) A license shall not be issued unless and until the estabhshment is
prepared to operate under the direct supervision of a competent person
trained in bacteriological technic and in the preparation of biologies as
defined in Section 1601, Health and Safety Code, whose qualifications
have been approved by the department.

(d) A license shall not be issued unless the condition of the establish-
ment and methods of preparation are such as to reasonably insure that the
biologies produced will not be contaminated, dangerous, or harmful.

(e) A license shall not be issued for the preparation of any biologic as
defined in Section 1601, Health and Safety Code, if advertised so as to
mislead or deceive the purchaser, or if the package or container in which
the same is intended to be sold, bartered, exchanged, or shipped, bears
or contains any statement, design, or device which is false or misleading
in any particular.

(f) A license shall not be issued for a biologic product that has been
specifically forbidden or disapproved by the United States Department
of Health, Education and Welfare excepting products that may be specifi-
cally approved by the department, for experimental purposes but not for
general sale and distribution.

(g) A license shall not be issued for the processing or distributing of
any product without satisfactory scientific evidence of therapeutic or
prophylactic value.

History
1. Amendment of subsection (f) filed 3-5-76; effective thirtieth day thereafter
(Register 76, No. 10).

§ 952. Application for Renewal of License.

Each licensee applying for renewal of license shall be subject to such
review of his activities during the previous licensing period, and to such
inspections of his premises, equipment and biologies produced by him
as may be determined by the department for consideration in passing
upon the application for renewal. Similarly, such licensee shall submit
such data, records, and samples of products as may be designated by the
department.

History
1 . Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No.

10).

§ 953. License Fees.

The fees for license application and for annual license renewal are six
hundred dollars ($600).

NOTE; Authority cited: Secfions 102, 208, Health and Safety Code. Reference:
Sections 1600-1616, Health and Safety Code.

History
1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No.

10).

Article 2. Exemptions

§ 956. Autogenous Vaccines.

Laboratories whose principal activity is general clinical work and
whose only biologic product is autogenous bacterial vaccines do not re-
quire a license for the preparation of autogenous vaccines unless the
making of autogenous vaccines constitutes 10 percent or more of the ac-
tivity or source of income of the laboratory.

Article 3. Inspection and Records

§ 962. inspection by Department.

(a) Each licensee or applicant shall permit any duly authorized em-
ployee of the department to enter his establishment at any reasonable
hour, and shall permit said representative of the department to inspect
without previous notification the entire premises of such establishment,
including all buildings, compartments, and other places, and all equip-
ment, such as chemicals, instruments, apparatus, and the like, as well as
the methods used in the manufacture of, and all records maintained rela-
tive to biologies as defined in Section 1601, Health and Safety Code.

(b) Each licensee or applicant shall provide to the department such
stock cultures or other materials from which biologies are produced and
such completed products as may be required by the department for test-
ing of identity, purity, potency or other analysis.

§ 963. Records.

The licensee shall keep records of the source of the preparation, of tests
for purity and potency, and of the methods of preparation of each batch
of biologies as defined in Section 1601 , Health and Safety Code, and the

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§997

sale, shipment or other disposition of the same. The licensee shall supply
to the department monthly, on forms provided by the department, such
information from said records as the department may require, the licens-
ee retaining a full and complete copy thereof in his files.

Article 4. Storage

§ 967. Storage.

Each licensee shall maintain a refrigerator of sufficient capacity to
store all of those products in his possession which require refrigeration
and the entire stock of such products shall be kept within the refrigerator
at all times. The temperature of the refrigerator shall not be permitted to
rise above 10 degrees C. or fall below 1 degree C, as indicated by a re-
quired standard mercury thermometer, except that storage below 1 de-
gree C. is allowed if not specifically damaging to the product. Licensee
shall not sell or distribute for resale or redistribution biologies which re-
quire refrigeration unless the purchaser or distributor for resale or redis-
tribution is equipped to store said biologies in the manner above pro-
vided.

Article 5. Containers and Labeling

§ 972. Containers and Labeling.

(a) No biological product either for human or animal use shall be dis-
tributed except in the original final container bearing the original label
of the manufacturer; provided, however, that a licensed laboratory may
purchase products from other producers likewise licensed by the State,
and repack and relabel such products in smaller containers; provided,
there are no changes, substitutions or additions in the product or the label,
and further provided, that all such repacked biological products shall bear
on the label the name of the manufacturer as well as the name of the dis-
tributor together with a statement that the product has been repacked. All
such repacked products are subject to the requirements of Sections 1 600
to 1621, inclusive. Health and Safety Code, and are not exempted from
inspection and license by the department.

(b) The labels of all biologic products on the containers for general dis-
tribution shall show the name of the product, the lot number that will
identify the lot or batch in the record of the manufacturer, the expiration
date, and the name of the manufacturer. The expiration date shall be
based on a period of duration approved by the department.

(c) The labels on all bottles and individual packages of bacterial vac-
cines (bacterins) shall give the correct name of the organism concerned
and mixed bacterins shall give the names of each organism according to
the classification of Bergey in the mixture and the proportion that each
organism represents in the mixture. The concentration may be expressed
in number per mil or in terms of a turbidity standard acceptable to the de-
partment.

(d) The labels on products requiring refrigeration or maintenance of
uniform temperatures to avoid deterioration, shall specify the tempera-
ture range within which the product shall be maintained.

(e) To prevent accidental use, all stocks of labels and advertising not
accepted by the department shall be destroyed.

History
1 . Repealer of subsection (e) and relettering of subsection (f) to (e) filed 8-16-7 1 ;
effective thirtieth day thereafter (Register 71, No. 34).

Article 6. Advertising

§ 977. Advertising.

(a) No statements regarding preventive or therapeutic value shall be
made either on labels or circulars or in any form of advertising that are
not in accord with the opinion held by the recognized authorities of the
medical profession and no descriptive matter or discussion of mode of

action of the product or theory of its applicability may be used that is not
acceptable to the same authorities.

(b) No mention of the department shall be made in advertising either
directly or indirectly.

(c) All advertising matter, statements, and representations pertaining
to biologies licensed under Sections 1600 to 1620, Health and Safety
Code, shall be submitted to the department at least 30 days prior to their
use by the licensee.

History
1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76. No.
10).

Article 7. Samples

§ 982. Potency.

Licensees producing, processing or distributing biologies for which a
potency test is recognized or prescribed by the United States Department
of Health, Education, and Welfare, shall upon the request of the depart-
ment, provide a representative sample of each lot of such product for pur-
poses of checking. The particular lot so sampled shall not be distributed
until approval is given by the department.

History
1. Amendment filed 3-5-76; effective thirtieth dav thereafter (Register 76, No.

10).

Article 8. Vaccine Culture

§ 987. Vaccine Culture.

No culture shall be used in the preparation of live culture vaccine un-
less it is nonvirulent or has sufficiently low virulence as not to be reason-
ably likely to produce the disease in the inoculated person, or be danger-
ous from the standpoint of contagion. Such cultures must be tested and
approved by the department before use.

History
1. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
10).

Article 9. Preparation and Distribution of
Whole Blood (Human)

The following condifions must be met and observed in the procure-
ment, processing, storage, and distribution of whole blood (human) or
blood derivadves for transfusion purposes:

§ 997. Definitions.

As used in this article:

(a) Blood Bank is a medical facility designed, equipped, and staffed
to procure, to process, to store, or to distribute human whole blood or
blood derivadves for transfusion purposes.

(b) For implementadon of these reguladons, a blood bank depository
also is designated as a transfusion service.

A transfusion service shall be a component of a clinical laboratory
holding a license in accordance with the provisions of Chapter 3 (com-
mencing with Secdon 1200) Division 2 of the Business and Professions
Code, or such other place where services essendally equivalent are main-
tained as determined by the department.

A transfusion service shall be responsible for all functions related to
storage and preparation of blood for transfusion, except those activities
requiring a biologies license, in accordance with the Health and Safety
Code, Division 2, Chapter 4 (commencing with Section 1 600).

Institutions which fulfill criteria for both a clinical laboratory license
and a biologies license may maintain the combined services of a blood
bank and a transfusion service.

(c) Blood collection center is a stationary auxiliary to a blood bank
which is designed, equipped and staffed to procure human whole blood
and to transport this blood to the blood bank for processing, storing and
distribution.

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(d) Mobile unit is a transportable auxiliary to a blood bank designed,
equipped, and staffed to procure human whole blood and to transport this
blood to the blood bank for processing, storing and distribution.

(e) Whole blood is the fluid component of the human cardiovascular
system composed of liquid and cellular elements.

(f) Plasma is the extracellular portion of anticoagulated whole blood.

(g) Blood derivatives or fractionation products are the individual ele-
ments of whole blood which have been processed or manufactured into
their individual component parts, in accordance with procedures con-
tained in Articles 10 and 11.

(h) Donor means the individual from whom blood is procured.

(i) All references to temperature are expressed in degrees centigrade.
NOTE: Authority cited: Sections 1602.5, 1603, 100110 and 100275, Health and
Safety Code. Reference: Sections 1600-1620, Health and Safety Code.

History

1 . Repealer and new Article 10 (Sections 997 thiough 1003) filed 10-25-66; effec-
tive thirtieth day thereafter (Register 66, No. 37). For history of former Article
10, see Registers 56, No. 2, 59, No. 17, 60. No. 19 and 63, No. 17.

2. Amendment of subsection (b) filed 10-25-72; effective thirtieth day thereafter
(Register 72, No. 44).

3. Renumbering of Article 10 to Article 9 and amendment filed 3-5-76; effective
thirtieth day thereafter (Register 76. No. 10). For history of former Article 9
(Section 992) see Register 71, No. 34.

4. Change without regulatory effect repealing subsections (i)-(k), relettering sub-
sections, and amending Note filed 7-1 3-98 pursuant to section 100, title 1 , Cal-
ifornia Code of Regulations (Register 98, No. 29).

§ 998. Personnel of Blood Banks and Their Auxiliaries.

(a) Physicians and surgeons, clinical laboratory bioanalysts, clinical
laboratory technologists, clinical laboratory technologist trainees and
nurses who comprise the staff of the blood bank shall be duly licensed by
or registered in the State of California. The staff may include such other
persons, when approved by the director, as may be necessary for the
proper operation of the blood bank, including volunteer workers.

(b) Director of Blood Bank. The blood bank and its auxiliaries shall
be under the direction of a physician and surgeon duly licensed by the
State of California, and who shall have a minimum of six months experi-
ence in blood bank methods, transfusion principles, and transfusion prac-
tices, satisfactory to the department. Attending Physician refers to the
duly licensed physician and surgeon supervising blood collection activi-
ties.

(c) Laboratory Personnel. The laboratory personnel shall be licensed
pursuant to the Clinical Laboratory Laws (California Business and Pro-
fessions Code, Division 2, Chapter 3), except that unlicensed persons
may be used to assist licensed personnel under their supervision, so long
as such unlicensed persons do not perform laboratory tests or render
judgment on such tests.

NOTE: Authority cited: Sections 208 and 1603, Health and Safety Code. Refer-
ence: Section 1603(c), Health and Safety Code.

History

1. Amendment of subsection (b) filed 7-31-68; effective thirtieth day thereafter
(Register 68, No. 29).

2. New NOTE filed 3-20-84 (Register 84, No. 12).

§ 999. Blood Bank Equipment, Facilities and Manual.

NOTE: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref-
erence: Section 1602.5, Health and Safety Code.

History
1 . Change without regulatory effect repealing section and adopting new Note filed
7-1 3-98 pursuant to section 100, title 1 , California Code of Regulations (Regis-
ter 98, No. 29).

§ 1000. Blood Bank Records; Identification of Human
Blood with Its Donor.

(a) A system which carries through from donor to recipient must be
used to identify the blood. This shall be accomplished by having blood
container and pilot tube labels identified with the donor before venesec-
tion. The labels and personal history shall carry the same identification
number. These labels shall accompany the donor to the collection room
and shall be applied to the blood container and pilot tubes while it is still
possible to check accurately the identity of the blood with the donor and

his history. Other documents related to the blood such as invoices, if
used, shall also contain the same identification number.

(b) Every California licensed blood bank shall obtain reports of reac-
tions in individuals receiving its blood, or blood derivatives, where it ap-
pears that these materials from the blood bank may be implicated in such
reactions. Reporting shall include also any illness whose cause may be
related to transfusion of blood or blood derivatives provided by the blood
bank. Forms for these purposes may be devised by the blood bank as a
reminder to the transfusion services and as encouragement to them to
comply with this requirement.

(c) In addition to the applicable portions of the regulations set forth in
Section 963 and the first two paragraphs of this section, the blood bank
shall keep complete records of each donor, which shall include all infor-
mation specified in Section 1002. Records are required also which con-
tain information related to the disposition of all blood collected or distrib-
uted.

(d) These records shall be kept for an interval of not less than five years
after the expiration date of the blood unit involved. All such records shall
be correlated in such a way that checking the complete history of each
blood unit may be quickly and conveniently performed.

(e) Records of refrigerator temperatures shall fulfill the requirements
contained in Section 1002(g)(2) of these regulations.

(f) All blood bank records shall be dated.

NOTE: Authority cited: Sections 208 and 1603, Health and Safety Code. Refer-
ence: Section 1603, Health and Safety Code.

History
1 . New NOTE filed 3-20-84 (Register 84, No. 12).

§1001. Labels.

NOTE: Authority cited: SecUons 1 602.5 and 1 00275, Health and Safety Code. Ref
erence: Secfion 1602.5, Health and Safety Code.

History

1 . Repealer of subsecrion (k) filed 4-20-77; effective thirtieth day thereafter (Reg-
ister 77, No. 17). For prior history, see Register 76, No. 10.

2. Change without regulatory effect repealing section and adopting new Note filed
7-1 3-98 pursuant to section 1 00, fitle 1 , California Code of Regulations (Regis-
ter 98, No. 29).

§ 1002. Requirements — Donors, Medical History, Blood
Collection, Storage and Testing.

(a) Responsibilities. Final responsibility for the acceptance of donors
rests with the attending physician.

Any time blood is collected under license, adequate medical care for
the donor shall be provided. Blood shall be drawn from the donor under
the supervision of a physician or registered nurse trained in the proce-
dure. Blood may be collected when a physician is not present on the
premises under the following conditions:

( 1 ) The medical director and his medical advisory committee, if he has
one, must approve.

(2) The employee placed in charge, in the absence of a qualified physi-
cian must be a registered nurse.

(3) The nursing staff and medical director must have a mutually clear
understanding of the criteria for donor selection. Consultation with the
medical director by telephone from mobile unit operations about certain
donors may be necessary.

(4) A qualified physician or emergency medical facility shall be avail-
able nearby. Having a physician or emergency medical facility available
is for the purpose of attending to donors who have a severe reaction or
accident related to the blood donation. "Available" means no longer than
15 minutes away.

(5) Written emergency standing orders for donor care must be pre-
pared by the medical director and be made available to the nursing staff.
Appropriate training and refresher courses in emergency resuscitative
methods must be planned. The nursing staff must be given special train-
ing on the symptomatology and emergency treatment of such conditions
as cardiac and vascular disease, syncope, fractures, etc.

The attending physician shall sign all donor records, except that he
may delegate the responsibility for signature to an employee of the blood

Page 6

Title 17

State Department of Health Services

§1004

bank whose license permits him to perform functions related to medical
practice when under medical supervision.

Irrespective of location, the blood bank under whose license the blood
is to be processed shall be responsible for all personnel engaged in ex-
amining donors and collecting blood, as well as the space and equipment
used.

(b) Collection of Blood. (Refer to Section 1000(a) for requirements
relative to donor identification.)

(1) Protection of the Donor Against Infection and Injury.

The preparation of the skin at the sites of venipuncture and of injec-
tions incidental to venipuncture shall be adequate to protect the donor
against infection.

Apparatus or instruments such as syringes, needles, and lancets or oth-
er blood-letting devices capable of transmitting infection from one donor
to another shall be sterile single-use instruments insofar as possible.

All such instruments intended for reuse shall be heat sterilized prior to
each use and protected against contamination. Heat sterilization shall be
by autoclaving for 30 minutes at 121.5 C (15 lb. p.s.i. pressure), by dry
heat for two hours at 1 70 C, or by boiling in water for 30 minutes. Times,
temperatures and pressures in excess of those stated are permissible.

Such heat sterilization shall include the use of a heat indicator satisfac-
tory to the department, which will serve as evidence of proper steriliza-
tion. The heat indicator used shall be retained for one year as a record re-
lating to the sterilization in which it was used. The record of temperature
attained shall be kept on file in the blood bank for five years. This record
may be kept either as hand-written chart showing temperatures at differ-
ent times, or as information from an automatic recorder.

Instruments used in puncturing the skin, if not prepared for reuse, shall
be disposed of in such a way that they cannot be reused.

Thermometers shall be sufficiently cleansed before use to minimize
the transmission of disease.

The staff concerned with blood collection shall be instructed in the
first aid procedures to be used in the event of a reaction, and suitable
drugs and supplies shall be immediately available for use. Donors shall
be kept under continuous observation throughout the entire procedure of
blood collection and for at least 15 minutes thereafter.

( 1 ) Serologic Tests for Syphilis. A serologic test for syphilis approved
by the department shall be made on a sample of blood taken from the do-
nor at the time of blood collection. Blood shall not be used for transfusion
unless the result of this test is nonreactive (negative), except in emergen-
cy situation with the consent of the blood bank director and the patient's
attending physician.

All California licensed blood banks must accept and test evaluation
sera provided by the department or a proficiency testing service approved
by the department, and report test results to the department. Any blood
bank laboratory showing unsatisfactory performance shall make changes
as recommended by the department.

(d) Issue of Blood. Issuance of blood shall be in compliance with the
provisions of the Health and Safety Code, Division 2, Chapter 4, Sections
1600.3 and 1604.

The laboratory tests and other procedures with respect to the prepara-
tion of blood for transfusion after it has been delivered to a transfusion
service by the blood bank shall be the sole responsibility of the transfu-
sion service. (See Section 1605 of the Health and Safety Code.)

As a condition to supplying blood, the blood bank director may inquire
into the pretransfusion procedures used by the transfusion service and he
may suggest as a minimum those described in the latest edition of "Stan-
dards for Blood Banks and Transfusion Services," published by the
American Association of Blood Banks. Blood banks shall not supply
blood to transfusion services in which the department finds pretransfu-
sion procedures which differ from these standards, or from such other
standards which are essentially equivalent to these, as determined by the
department.

NOTE: Authority cited: Sections 1602.5 and 1603, Health and Safety Code. Refer-
ence: Sections 1602.5 and 1603, Health and Safety Code.

History

1. Amendment of subsections (b) and (c) filed 5-25-77; effective thirtieth day
thereafter (Register 77, No. 22). For prior history, see Register 76, No. 10.

2. Amendment of subsections (a)(3), {c)(6), (g)(1) and (i) filed 1-1 8-78; effective
thirtieth day thereafter (Register 78, No. 3).

3. Amendment of subsection (b)(6) filed 2-6-79 as an emergency; effective upon
filing (Register 79, No. 6).

4. Certificate of Compliance filed 5-18-79 (Register 79, No. 20).

5. Amendment of subsection (a)(3) filed 4-10-86; effective thirtieth day thereafter
(Register 86, No. 15).

6. Amendment of subsection (a)(4) filed 10-2-87: operative 10-2-87 pursuant to
Government Code Section 1 1346.2(d) (Register 87, No. 41 ).

7. Editorial connection of subsection (a)(2) (Register 87, No. 41).

8. Change without regulatory effect repealing subsections (a)-(c)(6),
(e)(2)-(g)(5), (h)(2)-(i) and (k)-(/)(4), relettering subsections, amending newly
designated subsection (b) and amending NoTi: filed 7-13-98 pursuant to sec-
tion 100, title 1, California Code of Regulations (Register 98, No. 29).

§ 1 002.1 . Use of AIDS Antibody (HTLV-III) Test by Blood
Banks.

NOTE: Authority cited: Sections 208 and 1603, Health and Safety Code. Refer-
ence: Section 1603, Health and Safety Code.

History

1. New section filed 3-8-85 as an emergency; effective upon filing (Register 85.
No. 15). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 7-8-85.

2. Repealer filed 5-22-85 as an emergency; effective upon filing (Register 85, No.
22). A Certificate of Compliance must be transmitted to OAL within 120 days
or emergency language will be repealed on 9-19-85.

3. Emergency language filed 3-8-85 and 5-22-85 expired by operation of Gov-
ernment Code Section 1 1346.1 (Register 87, No, 2).

§ 1003. Exceptions for Emergency Purposes.

In the event that an emergency occurs as defined in Chapter 7 (Califor-
nia Emergency Services Act), Division 1 , Title 2 of the Government
Code deviation from the provisions of Section 1001 and subsections (a)
through (h) of Section 1002 of this Article will be permissible. The extent
of deviation shall be determined by the blood bank director with concur-
rence by the department and shall be commensurate with the degree of
emergency.

History

1 . Amendment filed 10-25-72; effecfive thirtieth day thereafter (Register 72, No.
44).

§ 1004. Reporting Requirements.

(a) Notification of Positive Laboratory Finding for Syphilis. To assist
the local health officer in the discharge of his duties under Section 3110
and 3 194 of the Health and Safety Code, any person who is in charge of
a blood bank in which a laboratory examination of any specimen derived
from a donor yields serological or other evidence of syphilis shall
promptly notify the health officer of the local health jurisdiction of the
address of the donor. This notification shall contain the type of specimen,
the date it was obtained, the nature and result of the test performed, and
the name, address, and the date of birth of the donor who provided the
specimen.

The notification may be made by mailing or otherwise delivering a
legible copy of the laboratory report containing all of the required infor-
mation or by a telephone communication which is documented in the
blood bank's records.

(b) The notifications required in this section are confidential and not
open for public inspection.

NOTE: Authority cited: Sections 1603, 1603.1(g), lOOllOand 100275, Health and
Safety Code. Reference: Sections 1600-1616, Health and Safety Code.

History

1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
10.)

2. Amendment of subsection (a) filed 3-8-85 as an emergency; effective upon fil-
ing (Register 85, No. 15). A Certificate of Compliance must be transmitted to
OAL within 120 days or emergency language will be repealed on 7-8-85.

3. Repealer and new subsection (a) filed 4-2-85 as an emergency; effective upon
filing (Register 85, No. 15). A Certificate of Compliance must be transmitted
to OAL within 120 days or emergency language will be repealed on 7-31-85.

4. Subsecfion (a) repealed by operation of Government Code Section 11346.1(g)
(Register 85, No. 37).

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§1010

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

5. Repealer and new subsection (a) filed 9-1 1-K3 as an emergency; effective upon
filing. Certificate of Compliance included (Register 83, No. 37).

6. Change without regulatory effect repealing subsections (a)-(c), relettering sub-
sections, and amending Noxti filed 7-1 3-98 ))ursuant to section 1 00, title 1 , Cal-
ifornia Code of Regulations (Register 98, No. 29).

Article 10. Preparation and Distribution of
Normal Human Plasma

The following must be met and observed for the procurement, process-
ing, storage and transportation of human blood for plasma:

§ 1010. Procurement of Blood for Plasma Processing.

NOTE: Authority cited: Sections 1603, 100110 and 100275, Health and Safety
Code. Reference: Sections 1600-1620, Health and Safety Code.

History

1 . Repealer and new Article 1 1 (Sections 1010 through 1022) filed 10-25-66; ef-
fective thirtieth day thereafter (Register 66, No. 37). For history of previous Ar-
ticle 1 1, see Registers 56, No. 2 and 59, No. 17.

2. Amendment of subsection (b) filed 1 1-24-69; effective thirtieth day thereafter
(Register 69, No. 48).

3. Renumbering of Article 11 to Article 10 and amendment filed 3-5-76; effective
thirtieth day thereafter (Register 76, No. 10).

4. Change without regulatory effect repealing section and amending NoTt- filed
7-13-98 pursuant to section 100, tide 1, California Code of Regulations (Regis-
ter 98, No. 29).

§ 1011. Personnel and Equipment.

Blood shall be processed into plasma only in blood banks adequately
staffed and equipped for that purpose. The individual directly in charge
of plasma processing shall be a physician and surgeon duly licensed by
the State of California or an individual sufficiently trained in laboratory
procedures relating to blood banking and plasma processing and whose
qualifications have been approved by the department. The staff may in-
clude other trained persons necessary for the proper operation of plasma
processing.

§ 1012. Single Donor Plasma and Single Donor Fresh
Frozen Plasma (Antihemophilic).

NOTE: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref-
erence: Section 1602.5, Health and Safety Code.

History

1. Amendment filed 4-1-71; effective thirtieth day thereafter (Register 71, No.
14).

2. Renumbering from Section 1022 and amendment filed 10-25-72; effective thir-
tieth day thereafter (Register 72, No. 44). For history of former Secfion 1012,
see Register 71, No. 14.

3. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 1 0.

4. Change without regulatory effect repealing section and adopting new Note filed
7-1 3-98 pursuant to secfion 1 00. title 1 , California Code of Regulations (Regis-
ter 98, No. 29).

§1013. Storage.

NOTE; Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref-
erence: Section 1602.5, Health and Safety Code.

History

1 . Renumbering from Section 1019 and amendment filed 1 0-25-72; effective thir-
tieth day thereafter (Register 72, No. 44). For history of former Section 1013,
see Register 71, No. 14.

2. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
10.)

3 . Change without regulatory effect repealing section and adopting new Note filed
7-1 3-98 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 98, No. 29).

§ 1014. Expiration Date.

NOTE: Authority cited: Sections 1602.5 and 1 00275, Health and Safety Code. Ref-
erence: Section 1602.5, Health and Safety Code.

History

1 . Renumbering from Section 1 020 and amendment filed 1 0-25-72; effective thir-
tieth day thereafter (Register 72, No. 44). For history of former Section 1020,
see Register 71, No. 14.

2. Amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
10.)

3. Change without regulatory effect repealing section and adopting new Note filed
7- 1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 98, No. 29).

§1015. Other Tests.

History
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72. No. 44).

§ 1 01 6. Filling the Final Container.

History
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§1017. Labeling.

History
1 . Repealer filed 10-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§ 1 01 8. Diluent for Dried Plasma.

History
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72, No. 44).

§ 1 021 . Requirements for Release.

History
1 . Repealer filed 1 0-25-72; effective thirtieth day thereafter (Register 72, No. 44).

Article 1 1 . Preparation of Other Blood
Derivatives

§ 1 024. Red Blood Cells (Human).

NOTE: Authority cited: Sections 1603, 100110 and 100275, Health and Safety
Code. Reference: Sections 1600-1620, Health and Safety Code.

History

1. Repealer of Article 12 (§§ 1025-1026) filed 10-25-66; effective thirtieth day
thereafter (Register 66, No. 37). for former history of Article see Registers 56,
No. 2 and 61, No. 3.

2. Amendment filed 4-1-71; effective thirtieth day thereafte:: (Register 71, No.
14).

3. Renumbering of Article 12 to Article 11 and amendment filed 3-5-76; effective
thirtieth day thereafter (Register 76, No. 10).

4. Change without regulator}' effect repealing section and amending Note filed
7-1 3-98 pursuant to section 100, title 1 , California Code of Regulations (Regis-
ter 98, No. 29).

§ 1 024.1 . Frozen Red Blood Cells.

NOTE; Authority cited: Sections 1602.5, 1001 10 and 100275, Health and Safety
Code. Reference: Sections 1600-1616, Health and Safety Code.

History

1. New section filed 3-5-76; effective thirtieth day thereafter (Register 76, No.
10).

2. Change without regulatory effect repealing section and amending Note filed
7-13-98 pursuant to section 1 00, tide 1 , Cahfomia Code of Regulations (Regis-
ter 98, No. 29).

§1025. Plasmapheresis.

(a) Requirements:

( 1 ) No more than 500 milliliters of whole blood shall be removed from
a donor at one time, unless the donor's weight is 175 pounds or greater
in which case no more than 600 milliliters of whole blood shall be re-
moved from the donor at one time.

(2) A duly licensed physician and surgeon shall be available as de-
scribed in Section 1002(a) when plasmapheresis is performed.

(3) A system shall be employed which gives maximum assurance
against any possibility of return of the separated red cells to an individual
other than their donor.

(b) Examination and Laboratory Tests. Examinations and laboratory
tests to assist in determining the donor's health shall include the follow-
ing:

(1) Within no more than one week prior to the initial plasmapheresis,
the donor shall be examined and certified to be in good health by a duly

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Title 17

State Department of Health Services

§1029

licensed physician and surgeon, as indicated in the applicable sections of
the regulations. All donors shall have a physical examination by a duly
licensed physician and surgeon at least once a year.

(2) A whole blood hemoglobin or hemoglobin or hematocrit concen-
tration shall be performed prior to each plasmapheresis procedure.

(3) Determination of total protein shall be done at the time of each plas-
mapheresis procedure, the total protein shall not be less than 6.0 grams
per 1 00 ml of plasma.

(4) The ratios of the various protein components of the donor's serum
shall be determined from a sample taken at the time of his initial plasmap-
heresis and at intervals of not more than four months thereafter so long
as he remains on a plasmapheresis program.

(5) To qualify for further plasmapheresis, all of the values determined
under this section must be within the acceptable normal range.

(c) Samples for Laboratory Tests. Samples for laboratory tests shall
not exceed 30 ml of whole blood in a seven-day period.
NOTE: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Ref-
erence: Section 1602.5, Health and Safety Code.

History

1 . Amendment filed 1 1-24-69; effective thirtieth day thereafter (Register 69, No.

48).

2. Amendment filed 3-5-76; effective thirtieth day thereafter (register 76, No. 10).

3. Change without regulatory effect repealing subsections (a)-(b)(2)(B),
(c)(l)-(c)(3) and (e)-(e)(l), relettering subsections, amending newly desig-
nated subsections (a)(2) and (b)(2) and adopting new Note filed 7-13-98 pur-
suant to section 100, title 1, California Code of Regulations (Register 98, No.
29).

§ 1026. Other Blood Fractions; Procedures; Standards;
Consultative Service.

Since procedures and standards for the preparation of other blood frac-
tions, such as immune serum globulin, albumin, etc., for transfusion pur-
poses are not as yet well suited for blood bank production, any biologies
producer operating under the license of the department shall submit a
complete protocol of procedures to be followed and shall be subject to
the current specifications of the department regarding such products.
This shall include specific licensure for the production of such materials,
inspection, and the maintenance of appropriate standards. Such stan-
dards as are necessary will, in general, follow the usual blood banking
procures with deviations general, follow the usual blood banking proce-
dures with deviations only for specific reason. Such deviations and spe-
cific procedures shall be outlined in writing to the department by the bio-
logics producer. Potential producers of such biologies should avail
themselves of the consultative services of this department in order to pro-
vide for a proper production procedure consistent with regulations of the
department, thus avoiding the installation of methods which must later
be amended or changed.

History

1 . Amendment filed 3-5-76; effective thirtieth day thereafter (register 76, No. 10).

Article 12.

Transportation of Etiologic
Agents

§ 1027. Definitions and Procedures to Be Followed.

(a) For the purpose of this article "person" includes laboratory, firm,
association, corporation, co-partnership, and educational institutions,
and "department" means State Department of Health.

(b) Etiologic Agents.

( 1 ) For the purpose of this article microorganisms which may produce
disease in man shall be referred to as etiologic agents.

(2) The provisions of this article do not apply to specimens transmitted
to a laboratory operated by the State Department of Health or equivalent
containers are used, or those of other public health department laborato-
ries operating under certificates issued by the department.

(3) The provisions of this article do not apply to biological products
licensed by the department or by the United States Department of Health,
Education and Welfare.

( 1 ) Containers shall be used which are constructed in a manner equiva-
lent to those referred to in (b)(2) of this section.

(2) In the case of frozen materials the etiologic agent shall be packed
in sufficient dry ice and insulation material to insure that the material will
remain frozen for at least 24 hours longer than the expected time in trans-
portation.

(3) The proposed recipient shall be notified when transportation of the
etiologic agent begins. This shall include type of transportation and prob-
able time of arrival at a designated place.

(4) The approved type of container, referred to in (b)(2) above, shall
be labeled in such a way that the etiologic agent which it contains is clear-
ly indicated in bold type. Tlie label shall state cleariy that material of an
infectious nature is present within the container.

(5) The label shall state that if breakage or leakage occurs whoever first
has knowledge of the accident will immediately notify the department
and the local health officer having jurisdiction at the site of the accident.
This report should also contain the names and addresses of those who
may have been exposed to the etiologic agent as a result of the accident.
If loss occurs the person first aware of this occurrence shall notify the de-
partment promptly and shall supply such additional details as may be
available.

NOTE: Authority cited: Secfions 102 and 208, Health and Safety Code. Reference:
Secfion 1603.5, Health and Safety Code.

History

1. New secfion filed 2-1 -6 l;effecdve thirtieth day thereafter (Register 61, No. 3).

2. Amendment filed 3-5-76; effecfive thirtieth day thereafter (Register 76, No.
10).

Article 13. Research Projects

§ 1 028. Waiver of Regulations.

Notwithstanding the other provisions of Group 1 , Subchapter 1 , Chap-
ter 2 of Part I (commencing with Section 950) of Title 17 relating to the
production and distribution of biologies, the Director may at his discre-
tion waive such regulations for research projects approved by the Direc-
tor. The waiver shall be for a specific period of time and subject to all con-
ditions which the Director finds necessary to protect the public health.
NOTE; Authority cited: Section 102 and 208, Health and Safety Code. Reference:
Secfions 1600-1616, Health and Safety code.

History
1. New Article 13 (Section 1028) filed 3-5-76; effecfive thirtieth day thereafter

(Register 76, No. 10).

Group 2. Clinical Laboratory Regulations

Article 1. Definitions

§ 1029. General Definitions.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209. 1220,
1241, 1244, 1265, 1281, 1282, 1285, 1288.5 and 1300, Business and Professions
Code.

History

1. Amendment of group, article and section headings, and renumbering and
amendment of former secfion 1053 to section 1029 filed 1-22-96 as an emer-
gency; operative 1-22-96 (Register 96, No. 4). A Certificate of Compliance
must be transmitted to OAL by 5-21-96 or emergency language will be re-
pealed by operation of law on the following day.

2. Amendment of section and Note filed 5-28-96 as an emergency; operative
5-28-96 (Register 96, No. 22). A Certificate of Compliance must be transmitted
to OAL by 9-25-96 or emergency language will be repealed by operation of law
on the following day.

3. Editorial correction of subsection (gg) (Register 96, No. 25).

Page 9

§ 1029.5

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Certificate of Compliance as to 1-22-96 order including amendment of Note
transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25).

5. Editorial correction of subsection (k)(l) (Register 96, No. 41).

6. Amendment of section and Noth refiled 10-7-96 as an emergency; operative
10-7-96 (Register 96, No. 4 1 ). A Certificate of Compliance must be transmitted
to OAL by 2-4-97 or emergency language w ill be repealed by operation of law
on the following day.

7. Amendment of article heading filed 11-6-96 as an emergency; operative
1 1-6-96 (Register 96, No. 45). A Certificate ofCompliance must be transmitted
to OAL by 3-5-97 or emergency language u ill be repealed by operation of law
on the following day.

8. Certificate ofCompliance as to 10-7-96 order, including repealer of section,
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

9. Certificate ofCompliance as to 1 1-6-96 order transmitted to OAL 3^1-97 and
filed 4-15-97 (Register 97, No. 16).

§1029.5. Accreditation Body.

"Accreditation body" means an approved accreditation organization
for laboratories, as defined in 42 Code of Federal Regulations, Section
493.2.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and
1288.5, Business and Professions Code.

History

1 . New secfion filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

§1029.6. Accredited Institution.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and
1288.5, Business and Professions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Change without regulatory effect renumbering former section 1029.6 to section
1029.9 filed 5-14-2001 pursuant to section l(To,fitle 1, California Code of Reg-
ulations (Register 2001, No. 20).

§ 1029.7. Accredited College or University.

"Accredited college or university" means an educational facility
which has met the standards of the United States of America Accrediting
ComiTiission for Senior Colleges and Universities or the Accrediting
Commission for Community and Junior (Colleges; or, if a non-United
States college or university, one that is evaluated and found equivalent
by the American Association of Collegiate Registrars and Admissions
Officers.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference; Sections 1260, 1261, 1261.5, 1263
and 1264, Business and Professions Code.

History

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate ofCompliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.9. Accredited Institution.

"Accredited institution" has the same meaning as given in Title 42 of
the Code of Federal Regulations, Section 493.2.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfion 120775, Health and Safety
Code.

History

1 . Change without regulatory effect renumbering former section 1029.6 to section
1029.9 filed 5-14-2001 pursuant to section 100, title 1, California Code of Reg-
ulafions (Register 2001, No. 20). For prior history, see Register 98, No. 7.

§1029.10. Accusation.

"Accusation" means a written statement filed in order to initiate a
hearing to determine whether a right, authority, license, or privilege
should be revoked, suspended, limited or conditioned, and which:

(a) Sets forth in ordinary and concise language the acts or omissions
with which a person, entity, or laboratory and its owners or directors are
charged with committing to the end that the person, entity or laboratory
and its owners or directors will be able to prepare a defense; and

(b) Specifies the statutes and regulations alleged to have been violated.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1265, 1 267, 1320, 1322 and
1 326, Business and Professions Code; Section 1 1 503, Government Code; and Sec-
fion 14123, Welfare and Institutions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate ofCompliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operafion of law on the following
day.

2. Certificate ofCompliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.11. Antigen.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 120775, Health and Safety
Code.

History

1. New secfion filed 1 1-6-96 as an emergency; operative 1 1-6-96 (Register 96,
No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate ofCompliance as to 1 1-6-96 order transmitted to OAL 3-4-97 and
filed 4-15-97 (Register 97, No. 16).

3. Renumbering of former section 1029.1 1 to new secfion 1029.25 filed 8-28-97
as an emergency; operafive 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

4. Certificate ofCompliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.13. Approved Public Health Laboratory.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5,
Business and Professions Code.

History

1. New section filed 3-19-97; operafive 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.13 to new section 1029.30 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.15. Alternative Sanction.

"Alternative sanction" means one or more of the following sanctions:

(a) Directed plan of correction;

(b) Civil money penalty; or

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Stats. 1995, c.510, Secfion 1; and
Section 1310, Business and Professions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumberine of former section 1 029. 1 5 to new section 1 029.35 and new secfion
1029.15 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate ofCompliance must be transmitted to O^^J^ by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

3. Certificate of Comphance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 7. CLIA Certificate.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and
1288.5, Business and Professions Code.

History
1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

Page 10

Title 17

State Department of Health Services

§ 1029.35

2. Renumbering of former section 1 029. 1 7 to new section 1 029.45 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.19. CLIA Exempt Status.

NoTE; Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 1 13) Section
1(a)(6).

History

1 . New .section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former secUon 1029.19 to new section 1029.50 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.20. Antibody.

"Antibody" means an immunoglobulin molecule that, due to its spe-
cific amino acid sequence, reacts to the antigen that induced its synthesis
in the cells of the lymphoid series.

NoTK: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 120775, Health and Safety
Code.

History

1. Renumbering of former section 1029.9 to new section 1029.20 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.23. Direct Patient Care.

NoTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 1206.5, Business and Profes-
sions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.23 to new section 1029.70 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98. No. 7).

§1029.25. Antigen.

"Antigen" means any viral component including, but not limited to,
proteins and nucleic acids.

NotE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 120775, Health and Safety
Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1 029.25 to new section 1029.80 and renumber-
ing of former section 1029.1 1 to new section 1029.25 filed 8-28-97 as an emer-
gency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance
must be transmitted to OAL by 12-26-97 or emergency language will be re-
pealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.27. HHS.

Note: Authority cited: Secdon 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business
and Professions Code.

History

1 . New section filed 3-19-97; operative 4-18-97 (Regi.ster 97, No. 12).

2. Renumbering of former section 1029.27 to new section 1029.85 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance mu.st be transmitted to OAL by 1 2-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.30. Approved Public Health Laboratory.

"Approved public health laboratory" means a laboratory that has been
issued a certificate of approval by the department after its determination
that the public health laboratory, as defined in Business and Profes.sions
Code section 1206(a)(1 1), is in conformity with chapter 7 (commencing
with section 1000) of part 2 of division 1 of the Health and Safety Code
and the regulations adopted thereunder.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5.
Business and Professions Code.

History

1. Renumbering and amendment of former section 1029.13 to new section
1029.30 filed 8-28-97 as an emergency; operative 8-28^97 (Register 97, No.
35). A Certificate of Compliance must be transmitted to OAL by 12 26 97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 1 2-24^97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.31. Arterial Puncture.

"Arterial puncture" means the penetration of an artery with a needle
to withdraw blood for clinical laboratory test or examination purposes.
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1242.6. 1243.
1246 and 1269, Business and Professions Code; and Section 120580, Health and
Safety Code.

History
1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003. No. 2). For

prior history, see Register 2001, No. 14.

§ 1029.32. Certified Phlebotomy Technician I.

"Certified phlebotomy technician I" means a person who has com-
pleted the education, training, experience and examination requirements
pursuant to Section 1034 and is certified by the department to perform
skin punctures and venipunctures.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206. 1208, 1212. 1242,
1242.5, 1246 and 1269, Business and Professions Code; and Section 120580,
Health and Safety Code.

History

1. New section filed 1-9-2003; operative 4^9-2003 (Register 2003, No. 2). For
prior history, see Register 2001, No. 14.

§ 1029.33. Certified Phlebotomy Technician II.

"Certified phlebotomy technician 11" means a person who has com-
pleted education, training, experience and examination requirements
pursuant to Section 1034 and is certified by the department to perform
skin punctures, venipunctures and arterial punctures.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1206, 1208, 1212, 1242,
1242.5, 1246 and 1269. Business and Professions Code; and Section 120580.
Health and Safety Code.

History
1. New secdon filed 1-9-2003; operative 4-9-2003 (Register 2003. No. 2). For

prior history, see Register 2001, No. 14.

§1029.34. Certifying Organization.

"Certifying organization", also called a national accreditation or ac-
crediting board or agency, means an organization, agency or body that
creates competency examinations that measure the skill, knowledge and
aptitude required of an individual in a profession, occupation or disci-
pline.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Sections 1246. 1262, 1264 and 1270,
Business and Professions Code; and Section 120580, Health and Safety Code.

History
1. New secdon filed 1-9-2003; operadve 4-9-2003 (Register 2003, No. 2).

§1029.35. Chapter 3.

"Chapter 3" means chapter 3 (commencing with section 1 200) of divi-
sion 2 of the Business and Professions Code.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 1224. Business and Profes-
sions Code.

History

1. New secdon filed 1 1-6-96 as an emergency; operative 1 1-6-96 (Register 96.
No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-97

Page 11

§ 1029.37

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 1 1-6-96 order transmitted to OAL 3-4-97 and
filed 4-15-97 (Register 97, No. 16).

3. Renumbering of former section 1029.35 to new section 1 029.90 and renumber-
ing and amendment of former section 1029.15 to new section 1029.35 filed
8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certifi-
cate of Compliance must be transmitted to OAL by 1 2-26-97 oremergency lan-
guage will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.37. Instrument.

NOTI;: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and
1269. Business and Professions Code.

History

1. New section filed 3-19-97; operaUve 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1 029.37 to new section 1 029. 1 00 filed 8-28-97
as an emergency; operative 8-28-97 (Regi.ster 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 oremergency language
will be repealed by operation of law on the iollowing day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.39. Licensed General Acute Care Hospital.

NoTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1224 and 1265, Business
and Professions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1 029.39 to new section 1 029 . 11 0 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.40. Civil Money Penalties.

"Civil money penalties" means the civil money penalties imposed by
the department under the procedures identified in section 1067.5.
NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Stats. 1995, c.510, Secfion 1. Reference:
SecUon 1310, Business and Professions Code.

History

1. New section filed 3-19-97; operative 4-1 8-97 (Register 97, No. 12).

2. Renumbering of former section 1029.40 to new section 1029.115 and new sec-
tion 1029.40 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.43. Patient.

NoTE: Authority cited: Section 1224. Business and Professions Code; and Section
100275, Heahhand Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220,
1241 and 1269, Business and Professions Code

History

1. New section filed 3-19-97; operafive 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1 029.43 to new secfion 1 029. 1 30 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.44. Preceptor.

NoTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1206, 1206.5, 1209, 1220
and 1265, Business and Professions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former secfion 1029.44 to new secfion 1029.135 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 1 2-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.45. CLI A Certificate.

"CLIA certificate" moans an unsuspended and unrevoked certificate
of compliance, certificate for provider-performed microscopy proce-
dures, certificate of accreditation, certificate of registration or a certifi-
cate of waiver, as defined in 42 Code of Federal Regulations section
493.2.

NoTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1224, 1265. 1281 and
1288.5. Business and Professions Code.

History

1. Renumberins and amendment of former section 1029.17 to new .section
1029.45 filed V28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.47. Respiratory Care Practitioner.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business
and Professions Code.

History

1. New secfion filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1 029.47 to new section 1 029. 1 50 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmiued to OAL by 1 2-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98. No. 7).

§1029.49. Specimen.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1206. 1209, 1225, 1241,
1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code.

History

1. New secfion filed 3-19-97; operafive 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.49tonew section 1029.155 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 oremergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.50. CLIA Exempt Status.

"CLIA exempt status" means that the United States Department of
Health and Human Services (HHS) has exempted clinical laboratories li-
censed, registered or otherwise approved by the department from the re-
quirements of CLIA pursuant to subsection (p) of section 263a of title 42
of the United States Code and secfion 493.5 13 of title 42 of the Code of
Federal Regulafions.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 1 13) Section
1(a)(6).

History

1. Renumbering and amendment of former section 1029.19 to new section
1029.50 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operafion of law on the following day.

2. Cerfificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.51 . Clinical Consultant.

"Clinical consultant" means a person who meets the requirements of
Section 493. 1455 of Title 42, Code of Federal Regulations, as published
October 1 , 1 994, and who provides clinical consultation of a laboratory
in accordance with Section 1036 of this title and Section 493.1457 of
Title 42, Code of Federal Regulations, as published October 1, 1994.
NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1203, 1204, 1207, 1209,
1209.1 and 1210, Business and Professions Code.

History

1. Renumbering of former secfion 1029.31 to section 1029.51 filed 4-3-2001 ; op-
erafive 4-3-2001 (Register 2001, No. 14). For prior histor/, see Register 98,

No. 7.

§1029.52. Clinical Cytogenetics.

"Clinical cytogenetics" means the techniques used to isolate, replicate
and identify whole or parts of human chromosomes including culturing,

Page 12

Title 17

State Department of Health Services

§ 1029.81

•

manipulation, banding, staining and Iiybridizing, and analysis with re-
spect to genotype and phenotype.

NoTIi: Authority cited: Section 1 224, Business and Professions Code; and Section
100275. Health'and Safety Code. Reference: Sections 1206, 1207. 1210, 1261.5
and 1264, Business and Professions Code.

History
1. Renumbering of former section 1029.32 to section 1029.52 filed 4-3-2001 ; op-
erative 4-3-2001 (Register 2001. No. 14). For prior history, see Register 98.
No. 7.

§ 1029.53. Clinical Genetic Molecular Biology.

"Clinical genetic molecular biology" means the determination of all
the aspects of molecular organizations of the nucleic acids of the human
genome with respect to genotype and phenotype.

NOTH: Authority cited: Section 1224. Business and Professions Code: and Section
100275. Health and Safety Code. Reference: Sections 1206. 1207. 1210. 1261.5
and 1264. Business and Professions Code.

History
1 . Renumberins of former section 1 029.33 to section 1 029.53 filed 4-3-2001 ; op-
erative 4-3-2001 (Register 2001, No. 14).

§ 1029.55. Condition Level Deficiency.

"Condition level deficiency" means noncompliance with one or more
condition level requirements.

NOTE: Authority cited: Section 1224. Business and Professions Code: Section
100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference:
Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.55 to new section 1029.185 and new sec-
tion 1029.55 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.57. Test Purposes.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6
and 1246. Business and Professions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.57 to new section 1029.1 80 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97. No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.59. Unprofessional Conduct.

NotE: Authority cited: Section 1224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Section 1320, Business and Profes-
sions Code.

History

1. New section filed 3-19-97; operative 4-18-97 (Register 97, No. 12).

2. Renumbering of former section 1029.59 to new section 1 029. 190 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2 9-98 (Register 98, No. 7).

§ 1029.60. Condition Level Requirement.

"Condition level requirement" means any of the requirements speci-
fied in section 1066.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Stats. 1995, c. 510, Section 1. Reference:
Stats. 1995. c. 510. Section 1; and Section 1310, Business and Professions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.65. Deficiency.

"Deficiency" or "Violation" means noncompliance with one or more
of the requirements in chapter 3, division 2 of the Business and Profes-
sions Code (commencing with section 1200) or any rule or regulation
adopted thereunder.

NoTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code: and Stats. 1995. c. 510, Section 1. Reference:
Stats. 1995, c. 510, Section 1 ; and Sections 1310, 1320, 1323 and 1.326, Bu.siness
and Professions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12 24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.70. Direct Patient Care.

"Direct patient care" means medical, psychiatric, nursing or other
health care which is legally provided by a care giver or healthcare provid-
er directly to a patient, and wliich includes ob.servation of the patient's
physical or mental condition to enable the care giver or healthcare pro-
vider to report changes in the patient's condition.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 1 206.5, Business and Profes-
sions Code.

History

1 . Renumbering of former section 1029.23 to new section 1029.70 filed 8 28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-^97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.75. Directed Plans of Correction.

"Directed plans of correction" means the directed plans of correction
imposed by the department under the procedures identified in section
1067.

NOTE: Authority cited: Section 1224. Business and Professions Code; Section
100275, Health and Safety Code; and Stats. 1995, c. 510. Secfion 1. Reference:
Stats. 1995, c. 510, Secfion I; and Section 1310. Business and Professions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.80. Electrolytes.

"Electrolytes" means ionized calcium, sodium, potassium and/or
chloride.

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 1206, Business and Profes-
sions Code.

History

1. Renumbering of former section 1029.25 to new section 1029.80 filed 8 28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.81 . Evidence of Satisfactory Performance.

"Evidence of satisfactory performance" means a copy of a document
issued to an examinee by the department for satisfactory performance on
a department-administered licensing written examination, or by a certi-
fying board or organization indicating satisfactory performance by the
examinee on a written certifying examination.

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261. 1261.5,
1262 and 1264, Business and Professions Code.

History
1 . New section filed 2-24-2000 as an emergency: operative 2-24-2000 ( Register

2000, No. 8). A Certificate of Compliance musl be transmitted to OAL by

6-23-2000 or emergency language wiU be repealed by operation of law on the

following day.

Page 13

§ 1029.82

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10 23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 1 0-1 9-2000 as an emergency, operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§ 1029.82. Field Related to Genetics.

"Field related to genetics" means a major in molecular biology, repro-
ductive biology, biochemistry, clinical genetics, medical genetics, clini-
cal cytogenetics, biochemical genetics, human genetics, clinical labora-
tory science, or clinical molecular genetics.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206 and 1210, Business
and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-1 9-2000 as an emergency; operative 10-2 4-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.83. General Supervisor.

"General supervisor" means a person who meets the requirements of
Section 493. 1461 of Title 42, Code of Federal Regulations, as published
October 1, 1994, and who provides general supervision of a laboratory
in accordance with Section 1036.1 of this title and Section 493.1463 of
Title 42, Code of Federal Regulations, as published October 1, 1994.
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209,
1209.1 and 1210, Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.85. HHS.

"HHS" means the federal Department of Health and Human Services,
or its designee.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business
and Professions Code.

History

1 . Renumbering of former section 1029.27 to new section 1029.85 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.86. High Complexity Tests or Examinations.

"High complexity tests or examinations" mean those clinical laborato-
ry tests or examinations classified as high complexity under CLIA.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1202.5, 1203. 1204, 1206,
1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code.

History

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operafive 10-24-2000 ( Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
secdon, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001 , No.
14).

§ 1029.90. Human Immunodeficiency Virus.

"Human Immunodeficiency Virus" or "HIV" means the etiologic vi-
rus of Acquired Immune Deficiency Syndrome, or AIDS.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfion 120775, Health and Safety
Code.

History

1, Renumbering of former section 1029.35 to new section 1029.90 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.95. Immediate Jeopardy.

"Immediate jeopardy" means a situation in which immediate correc-
tive action is necessary because the laboratory's noncompliance with one
or more conditions has already caused, is causing, or is likely to cause,
at any time, serious injury or harm, or death, to individuals served by the
laboratory or to the health or safety of the general public. This term is syn-
onymous with imminent and serious risk to human health and significant
hazard to the public health.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section
1 00275, Health and Safety Code; Stats. 1 995, c. 5 10, Section 1; and Section 14105,
Welfare and Institufions Code. Reference: Stats. 1995, c. 510, Section 1; and Sec-
tions 1310, 1320, 1323 and 1326, Business and Professions Code; and Section
14123, Welfare and Institufions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Comphance must be transmitted to OAL by 1 2-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.100. Instrument.

"Instrument" means a device, apparatus, implement, machine or con-
trivance that is used for the performance of a clinical laboratory test or
examination,

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209 and
1269, Business and Professions Code.

History

1. Renumbering of former section 1029.37 to new section 1029. 100 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.105. Intermediate Sanction.

"Intermediate sanction" means either or both:

(a) Temporary suspension of a license, registration or approval; or

(b) Temporary suspension of a provider of service under the Medi-Cal

program.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Secfion 14105, Welfai-e and Insfitutions
Code. Reference: Stats. 1995, c. 510, Section 1; and Section 1323, Business and

•

Page 14

Title 17

State Department of Health Services

§ 1029.119

Professions Code; Section 1002, Health and Safety Code: Section 14123, Welfare
and Institutions Code; 42 United States Code, Section 1393w-2 (Section 1846 of
the federal Social Security Act); and 42 United States Code, Section 1396a(a)(9)
(Section 1902(a)(9)(C) of the federal Social Security Act).

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.108. License.

For the purposes of this chapter, "license" means license, certificate,
registration or other means to engage in a business or profession regu-
lated by Chapter 3.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 23.7, 1203, 1204, 1205,
1206.5, 1207, 1208, 1209, 1210, 1220, 1227, 1242, 1246, 1246.5, 1260, 1260.1,
1261, 1261.5, 1262, 1263, 1264, 1265, 1267, 1269.5, 1270, 1275, 1280. 1281,
1285, 1288.5, 1300, 1301, 1301.1, 1310, 1320, 1322, 1323, 1324 and 1325, Busi-
ness and Professions Code; and Section 120580, Health and Safety Code.

History
1. New section filed 1-9-2003; operadve 4-9-2003 (Register 2003, No. 2).

§ 1029.110. Licensed General Acute Care Hospital.

"Licensed general acute care hospital" means a facility as defined in
section 1 250(a) of the Health and Safety Code that has been licensed pur-
suant to chapter 2 (commencing with section 1250) of division 2 of the
Health and Safety Code.

NOTIi: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business
and Professions Code.

History

1. Renumbering and amendment of former secfion 1029.39 to new section
1029. 1 10 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate of Compliance must he transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 1 1 . Licensed Healthcare Professional.

Note: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206.5 and 1208, Business
and Professions Code.

History

2. New secfion refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Comphance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including repealer of sec-
tion, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No.
14).

§ 1 029.1 1 5. Licensed Surgical Clinic.

"Licensed surgical clinic" means a facility as defined in section
1 204(b)( 1 ) of the Health and Safety Code that has been licensed pursuant
to chapter 1 (commencing with section 1200) of division 2 of the Health
and Safety Code.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1224 and 1265, Business
and Professions Code.

History

1. Renumbering and amendment of former section 1029.40 to new section
1 029. 1 1 5 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
3.5). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 1 6. Limited Phlebotomy Technician.

"Limited phlebotomy technician" means a person who has completed
the education, training and experience requirements pursuant to Section
1034 and is certified by the department to perform skin punctures.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Heaith'and Safety Code. Reference: Sections 1206, 1208, 1212, 1242,
1242.5, 1246 and 1269, Business and Professions Code; and Secfion 120580,
Health and Safety Code.

History
1. New section filed 1-9-2003; operaUve 4-9-2003 (Register 2003, No. 2).

§ 1 029.1 1 7. Medical Laboratory Technician.

"Medical laboratory technician" means a person who has completed
education, training or experience, and examination requirements pur-
suant to Section 1032.5(a), and who is authorized to perform clinical lab-
oratory tests and examinations specified in Section 1032.5(b).
NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1206, 1207, 1208, 1210.
1242, 1260.3, 1264 and 1300, Business and Professions Code.

History

1. New section filed 1-13-2005 as an emergency; operafive 1-13-2005 (Register
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-13-2005 or emergency language will be repealed by operation of law on the
following day.

2. New secfion refiled 5-12-2005 as an emergency; operafive 5-14-2005 (Regis-
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by
9-1 2-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-12-2005 order transmitted to OAL 8-3-2005
and filed 9-12-2005 (Register 2005, No. 37).

§ 1 029.1 1 8. Moderate Complexity Laboratory Technical
Consultant.

"Moderate complexity laboratory technical consultant" means a per-
son who meets the qualifications of Section 493.141 1 of Title 42, Code
of Federal Regulations, as published October 1, 1994, and who provides
technical oversight in accordance with Section 1036.2 of this title and
Section 493.1413 of Title 42, Code of Federal Regulations, as published
October 1. 1994.

NOTE: Authority cited: Secfion 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1203, 1204, 1207, 1209,
1209.1 and 1210, Business and Professions Code.

History

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New secfion refiled 6-21-2000 as an emergency; operafive 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New secfion refiled 10-1 9-2000 as an emergency; operafive 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§ 1029.119. Moderate Complexity Tests or Examinations.

"Moderate complexity tests or examinafions" mean those clinical lab-
oratory tests or examinations classified as moderate complexity under
CLIA.

NotE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1202.5, 1203, 1204, 1206,
1206.5, 1207, 1209.1, 1210 and 1265, Business and Professions Code.

History

2. New secfion refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

Page 15

§ 1029.120

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Resister 2001 , No.

14).

§ 1 029.1 20. Notice of Defense.

"Notice of Defense" means a writing signed by or on behalf of the per-
son, entity or laboratory, stating the maiUng address of the person, entity,
or laboratory, and may:

(a) Request a hearing.

(b) Object to the accusation upon the ground that it docs not state acts
or omissions upon which the agency may proceed.

(c) Object to the form of the accusation on the ground that it is so indef-
inite or uncertain that the person, entity, or laboratory cannot identify the
transaction or prepare a defense.

(d) Admit the accusation in whole or in part.

(e) Present new matter by way of defense.

(f) Object to the accusation upon the ground that, under the circum-
stances, compliance with the requirements of a regulation would result
in material violation of another regulation enacted by another department
affecting substantive rights.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and
1326, Business and Professions Code; Sections 11503 and 11504, Government
Code; and Section 14123, Welfare and Institutions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.124. On-the-Job Experience in Phlebotomy.

"On-the-job experience in phlebotomy" means employment as a
phlebotomist in a clinical laboratory performing the techniques pursuant
to Section 1035.1(f).

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1242.6,
1243, 1 246 and 1269, Business and Professions Code; and Section 120580, Health
and Safety Code.

History

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§ 1 029.1 25. Onsite Monitoring.

"Onsite monitoring" means the onsite monitoring imposed by the de-
partment under the procedures identified in section 1067.10.
NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Stats. 1995, c. 510, Secdon 1. Reference:
Stats. 1995, c. 510, Section 1; and Section 1310, Business and Professions Code.

History

1. New section filed 8-28-97 as an emergency; operafive 8-28-97 (Register 97.
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.126. Oral and Maxillofacial Pathology Laboratory
Director.

"Oral and maxillofacial pathology laboratory director" means a den-
tist who possesses a valid, unexpired license to direct an oral pathology
laboratory in all areas of anatomic and clinical pathology related to the
oral and maxillofacial region.

Note: Authority cited: Secdon 1224, Business :ind Professions Code; and Secdon
100275, Health and Safety Code. Reference: Secdons 1206, 1206.5, 1207, 1208
and 1209, Business and Professions Code.

History

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section heading and section, transmirted to OAL 2-21-2001 and filed
4-3-2001 (Register 2001, No. 14).

§ 1029.127. Oral Pathology.

"Oral pathology" means the subspecialty of pathology that deals with
the nature, identification and management of diseases affecting the oral
and maxillofacial regions, which investigates the causes, processes and
effects of these diseases, and includes research and diagnosis of diseases
using clinical, radiographic, microscopic, biochemical or other examina-
tions.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206 and 1207, Business
and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operadve 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New secdon refiled 1 0-1 9-2000 as an emergency; operadve 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Cerdficate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§1029.130. Patient.

"Patient" means a person who is an inpatient or outpatient of a licensed
health facility, licensed clinic or a clinic that is exempt from Hcensure,
licensed home health agency, or who is a patient of a h censed physician
and surgeon or osteopath, licensed dentist, or licensed podiatrist.
Note-. Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secdons 1206, 1206.5, 1209, 1220,
1241 and 1269, Business and Professions Code.

History

1 . Renumbering of former section 1029.43 to new section 1029.130 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.132. Phlebotomist.

"Phlebotomist" means a person who collects blood for clinical labora-
tory test or examination purposes.

Note: Authority cited: Secdon 1224, Business and Professions Code; and Secdon
100275, Health and Safety Code. Reference: Secdons 1206, 1208, 1212, 1242,
1242.5, 1246 and 1269, Business and Professions Code; and Section 120580,
Health and Safety Code.

History

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§1029.133. Phlebotomy.

"Phlebotomy" means the process of collecting blood by venipuncture,
arterial puncture or skin puncture for the purpose of obtaining blood for
clinical laboratory test or examination purposes.

Note: Authority cited: Secdon 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secdons 1206, 1242, 1242.5, 1246
and 1269, Business and Professions Code; and Secdon 120580, Health and Safety
Code.

History
I. New secdon filed 1-9-2003; operadve 4-9-2003 (Register 2003, No. 2).

§ 1029.134. Practical Experience.

"Practical experience" means hands-on, direct work experience in
clinical laboratory science and phlebotomy techniques on real patients in
a clinical laboratory certified by CLIA, using equipment, instruments,
kits and materials routinely found in clinical laboratories performing
moderate or high complexity tests or examinations, and does not include

Page 16

Title 17

State Department of Health Services

§ 1029.135

work done in academic, research, forensic, pharmaceutical or veterinary

laboratories.

NoTli: Authority cited: Section 1224, Business and Professions Code; and Section

100275. Health and Safety Code. Reference: Sections 1206, 1208, 1222.5, 1242,

1242..5. 1243, 1246, 1260, 1260.3, 1261, 1261.5, 1264, 1269 and 1286. Business

and Professions Code.

History

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-1.3-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis-
ter 2005, No. 19). A Certificate of Compliance must be transinitted to OAL by
9-12-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of CompUance as to 5-12-2005 order, including amendments, trans-
mitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

§1029.135. Preceptor.

"Preceptor" means:

(a) The laboratory director or the technical consultant of the laborato-
ry, as that term is defined under CLIA; or,

(b) A person who:

( 1 ) Meets the qualifications of a technical consultant under CLIA and
of chapter 3 to perform clinical laboratory tests or examinations classi-
fied as of moderate complexity; and,

(2) Is assigned by the laboratory director or the technical consultant of
the laboratory to act as a preceptor; or,

(c) Any person listed in subdivision (b) of section 1206.5 of the Busi-
ness and Professions Code, except for those persons listed in subsections
(10), (II), or (12) of subdivision (b), and who:

( 1 ) Has two years of experience performing moderate complexity tests
upon the instrument(s) for which she or he will act as a preceptor; and

(2) Meets any CLIA requirements necessary to perform his or her du-
ties and responsibilities in a preceptor program; and

(3) Is assigned by the laboratory director or the technical consultant of
the laboratory to act as a preceptor.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1206.5. 1209. 1220
and 1265, Business and Professions Code.

[The next page is 17.]

Page 16.1

Title 17

State Department of Health Services

§ 1029.168

History

1. Renumbering and amendment of former section 1029.44 (o new section
1029. 135 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
?>5). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.140. Principal Sanction.

"Principal sanction" means:

(a) Suspension or revocation of a registration or license issued under
chapter 3 of division 2 of the Business and Professions Code; or

(b) Suspension or revocation of the approval to operate a public health
laboratory granted under chapter 7 (commencing with section 1000) of
the Health and Safety Code; or

(c) Suspension of a provider of service from further participation in.
including reimbursement from, the Medi-Cal and Medicaid programs.
NoTIi: Authority cited: SecUon 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1 995, c. 5 10, SecUon 1; and Section 14105,
Welfare and Insdtutions Code. Reference: Stats. 1995, c. 510, Section 1; Sections
1320 and 1322, Business and Professions Code; Section 1002, Health and Safety
Code; and Section 14123, Welfare and Institutions Code.

History

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transinitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 45. Provider of Service.

"Provider of service" has the same meaning as given in 22 CCR 5 1 05 1 .

NOTE; Authority cited: Section 1224, Business and Professions Code; Section
100275. Health and Safety Code; Stats. 1995, c. 510, Section Land Section 14105,
Welfare and Institutions Code. Reference: Stats. 1995, c. 510, Section I ; and Sec-
tion 14123, Welfare and Institutions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.150. Respiratory Care Practitioner.

"Respiratory care practitioner" means an individual licensed pursuant
to chapter 8.3 (commencing with section 3700) of division 2 of the Busi-
ness and Professions Code.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206.5 and 1265, Business
and Professions Code.

History

1. Renumbering and amendment of former section 1029.47 to new section
1 029. 1 50 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Editorial correction (Register 98, No. 7).

3. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.153. Satisfactory Performance.

"Satisfactory performance" means achieving at least the minimum
grade that an examinee must obtain to get a passing score on a written or
oral examination.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1208, 1260, 1261, 1261.5,
1262 and 1264, Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§ 1 029.1 54. Skin Puncture.

"Skin puncture" means penetration of the .skin for the purpose of col-
lecting capillary blood for clinical laboratory test or examination pur-
poses.

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206. 1242, 1242.5. 1246
and 1269, Business and Professions Code; and Section 120580, Health and Safet}
Code.

History
1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003. No. 2).

§1029.155. Specimen.

"Specimen" has the same meaning as given for "biological specimen"
in section 1206(a)(1) of the Business and Professions Code.
NOTE; Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1209, 1225. 1241.
1244, 1269, 1288, 1288.5 and 1320, Business and Professions Code.

History

1. Renumbering and amendment of former section 1029.49 to new section
1029.155 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 60. State License.

"State license" or "license" means the license identified in section
1265(a)(1) of the Business and Professions Code.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5,
Business and Professions Code.

History

1. Renumbering and amendment of former section 1029.51 to new section
1029.160 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97. No.
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Comphance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 65. State Registration.

"State registration" or "registration" means the registration identified
in section 1265(a)(2) of the Business and Professions Code.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1265, 1281 and 1288.5,
Business and Professions Code.

History

1. Renumbering and amendment of former secdon 1029.52 to new section
1029. 165 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 68. Statement of Issues.

"Statement of issues" means a written statement served on the person,
entity or laboratory which:

(a) Specifies the statutes and regulations with which the person, entity
or laboratory must show compliance by producing proof at the hearing,
and

(b) Includes any particular matters which have come to the attention
of the department that could form the basis for a denial of the departmen-
tal action sought.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1265, 1267. 1320. 1322 and
1326, Business and Professions Code; Sections 11503 and 11504, Government
Code; and Section I4I23, Welfare and Institutions Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97.
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97

Page 17

§ 1029.169

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 ordei , including amendment of subsec-
tion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 69. Subspecialty of Histocompatibility.

"Subspecialty of histocompatibility" means those clinical laboratory
analyses of factors that determine the acceptance or rejection of grafted
tissues or organs and that are performed in a histocompatibility laborato-
ry as specified in Section 493.1265 of Title 42, Code of Federal Regula-
tions, as published October 1, 1994.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: .Sections 1206, 1209.1 and 1210,
Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10- 19-2000 as an emergency; operative 10-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transiiutted to OAL
by 2-2 1-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No.
14).

§ 1 029.1 70. Temporary Suspension of a License,
Registration or Approval.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Sec-
tions 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510,
Section l;Section 1323, Business and Professions Code; and Section 1002, Health
and Safety Code.

History

1. New secdon filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

3. Change without regulatory effect renumbering former section 1029. 1 70 to sec-
tion 1029. 173 filed 5-14-2001 pursuant to section 100, title 1 , CaUfornia Code
of Regulations (Register 2001, No. 20).

§ 1 029.1 71 . Technical Supervisor.

"Technical supervisor" means a person who meets the qualifications
of Section 493.1449 of Title 42, Code of Federal Regulations, as pub-
lished October 1 , 1 994, and who provides technical supervision in accor-
dance with Section 1036.4 of this title and Section 493.1451 of Title 42,
Code of Federal Regulations, as published October 1, 1994.
NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Secfions 1203, 1204, 1207, 1209,
1209.1 and 1210, Business and Professions Code.

History

2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
] 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-1 9-2000 as an emergency; operative 10-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day. .

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§ 1 029.1 73. Temporary Suspension of a License,
Registration or Approval.

"Temporary suspension of a license, registration or approval" means
immediate suspension or limitation of a public health laboratory's ap-
proval to perform testing or a clinical laboratory's license or registration
to perform tests or examinations in one or more, or all, specialties or sub-
specialties, prior to a hearing, based on a departmental finding of imme-
diate jeopardy.

NOTE: Authority cited: Section 1224, Business and Professions Code: and Sec-
tions 1002 and 100275, Health and Safety Code. Reference: Stats. 1995, c. 510,
Section 1 ; Secfion 1 323. Business and Professions Code; and Secfion 1002, Health
and Safety Code.

History
1 . Change without regulatory effect renumbering former secfion 1 029. 1 70 to sec-
tion 1029.173 filed 5-14-2001 pursuant to section 100, title 1 , California Code
of Regulations (Register 2001, No. 20).

§ 1 029.1 75. Temporary Suspension of a Provider of
Service Under the Medi-Cal Program.

"Temporary suspension of a provider of service under the Medi-Cal
program" means the immediate suspension imposed by the department
pursuant to 22 CCR 51529(g) under the procedures identified in section
1067.15.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Secfion 14105, Welfare and Institutions
Code. Reference: Stats. 1995, c. 510, Secfion 1; Section 14123, Welfare and Insfi-
tutions Code; 42 United States Code; Secfion 1395w-2 (Secfion 1846 of the feder-
al Social Security Act); and 42 United States Code, Secfion 1396a(a)(9) (Section
1902(a)(9)(C) of the federal Social Security Act).

History

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 80. Test Purposes.

"Test purposes," as it relates to arterial puncture, venipuncture, and
skin puncture, means withdrawal, or injection of any test materials spe-
cifically required for a clinical laboratory test, provided that appropriate
instructions relative to injection technique have been given and that a li-
censed physician and surgeon is immediately available when test materi-
als are injected. Unlicensed personnel may not inject test material for any
purpose.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1206, 1242, 1242.5, 1242.6
and 1246, Business and Professions Code.

History

1 . Renumbering of former secfion 1 029.57 to new secfion 1 029. 1 80 filed 8-28-97
as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of
CompUance must be transmitted to OAL by 1 2-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1 029.1 85. Testing Event.

"Testing evenf means the performance of the preanalytical, analyti-
cal, and postanalytical activities related to performing a clinical laborato-
ry test or examination on a biological specimen.

NOTE: Authority cited: Secfion 1 224, Business and Professions Code; and Secfion
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220,
1241, 1244, 1265, 1281, 1288.5 and 1300, Business and Professions Code.

History

1 . Renumbering of former section 1029.55 to new secfion 1029.185 filed 8-28-97
as an emergency; operafive 8-28-97 (Register 97, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-26-97 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1029.190. Unprofessional Conduct.

"Unprofessional conduct," pursuant to the provisions of Section
1320(m), Business and Professions Code, means:

Page 18

Title 17

State Department of Health Services

§ 1030.5

(a) Acts of gross negligence in the performance of duties authorized
by the license under chapter 3, division 2, Business and Professions
Code.

(b) Acts of gross incompetence in the performance of duties autho-
rized by the license under chapter 3, division 2, Business and Professions
Code.

NOTH: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 1320, Business and Profes-
sions Code.

History

1. Renumbering and amendment of former section 1029.59 to new section
1029. 190 filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No.
35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1029.195. Venipuncture.

"Venipuncture" means the penetration of a vein with a needle to with-
draw blood for clinical laboratory test or examination purposes.
NOTH: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1242, 1242.5, 1246
and 1269, Business and Professions Code; and Section 120580, Health and Safety
Code.

History
1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§ 1 029.1 96. Waived Laboratory Supervisor.

"Waived laboratory supervisor" means a person who meets the quali-
fications specified in Section 1036.3(a) or (c) and provides technical
oversight of a laboratory only performing waived tests.
NOTE: Authority cited: Sections 1208 and 1224, Business and Professions Code;
and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204,
1207. 1208, 1209, 1209.1 and 1210. Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 1 0-1 9-2000 as an emergency; operative 10-24—2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section heading and section, transmitted to OAL 2-21-2001 and filed
4-3-2001 (Register 2001, No. 14).

§ 1 029.1 97. Waived Tests.

"Waived tests" mean those clinical laboratory tests or examinations
classified as waived under CLIA.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 1 0-1 9-2000 as an emergency; operative 10-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-2 1-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No.
14).

Article 1.5. Licensure of Clinical Laboratory
Personnel

§ 1030. Examination for Bioanalysts' Licenses.

(a) The examination for license as a clinical laboratory bioanalyst shall
consist of three sections; namely, written, oral, and practical. The sub-
jects covered in this examination shall have to do with the technical pro-
cedures performed in clinical laboratories for the purpose of obtaining
scientific data which may be used to ascertain the presence, progress, and
source of disease.

(b) An official transcript of college or university training shall be fur-
nished by each applicant. The college or university training shall include
as a minimum the indicated number of semester or equivalent quarter
units of standard resident courses or their subject equivalent as follows:

General inorganic chemistry 8

Quantitative analysis 3

Organic chemistry 3

Biochemistry 8

Bacteriology 8

Physics 3

Biology or zoology 4

Physiology 3

Parasitology 3

Hematology 2

NOTE: Authority cited for Group 2: Section 208, Health and Safety Code, and Sec-
tions 1220 through 1223, Business and Professions Code. Additional authority
cited: Section 102, Health and Safety Code.

History

1. Originally pubhshed 8-15-45 (Title 17).

2. Revision filed 12-24-47 (Register 10, No. 8).

3. Repealer and new Group 2 filed 12-26-51; effective thirtieth day thereafter
(Register 26, No. 7).

4. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No.
18).

5. New article 1.5 heading (containing secfions 1030-1034.2) filed 1 1-6-96 as an
emergency; operative 11-6-96 (Register 96, No. 45). A Certificate of Com-
pliance must be transmitted to OAL by 3-5-97 or emergency language will be
repealed by operadon of law on the following day.

6. Certificate of Compliance as to 1 1-6-96 order transmitted to OAL 3-^97 and
filed 4-15-97 (Register 97, No. 16).

7. Amendment of article heading filed 2-24-2000 as an emergency; operative
2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be trans-
mitted to OAL by 6-23-2000 or emergency language will be repealed by opera-
tion of law on the following day.

8. Amendment of article heading refiled 6-21-2000 as an emergency; operative
6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be trans-
mitted to OAL by 10-23-2000 or emergency language will be repealed by op-
eration of law on the following day.

9. Amendment of article heading refiled 10-19-2000 as an emergency; operative
10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be
transmitted to OAL by 2-21-2001 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§ 1030.5. Licensure of Clinical Chemists, Clinical

Microbiologists, Clinical Toxicologists, Clinical
Genetic Molecular Biologists and Clinical
Cytogeneticists.

A written and oral examination shall be given to each applicant for li-
censure as a clinical chemist, clinical microbiologist, clinical loxicolo-
gist, clinical genetic molecular biologist or clinical cytogeneticist. In ad-
dition to the requirements for licensure as specified in Section 1 264 of the
Business and Professions Code, an applicant shall have completed one
year of training as a licensed trainee or equivalent in his or her specialty
or subspecialty pursuant to Section 1207 of the Business and Professions
Code. Also, each applicant shall have completed three years of experi-
ence in his or her specialty pursuant to Section 1210 of the Business and
Professions Code in a clinical laboratory thai possesses a certificate is-
sued under CLIA for performing high complexity testing in that special-
ty, two years of which shall have been at a supervisory level.

Page 19

§ 1030.6

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section
100275, Healtii and Safety Code. Reference: Sections 1204, 1205, 1207, 1210,
1264 and 1265, Business and Professions Code.

History

1 . New section filed 1 1-25-70 as procedural and organizational; designated effec-
tive 1 1-24-70 (Register 70, No. 48).

2. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register

71, No. 4).

3. Amendment of section heading, section and Noth tiled 2-24-2000 as an emer-
gency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Com-
pliance must be transmitted to OAL by 6-23-2000 or emergency language will
be repealed by operation of law on the following day.

4. Amendment of section heading, section ami NoTl-; refiled 6-21-2000 as an
emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of
Compliance must be transmitted to OAL by 10-23-2000 or emergency lan-
guage will be repealed by operation of law on the following day.

5. Amendment of section heading, section and NoTi: refiled 10-19-2000 as an
emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of
Compliance must be transmitted to OAL by 2-21-2001 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 10-19-2000 order, including amendment of
section.transmittedtoOAL2-21-2001 and filed 4-3-2001 (Register 2001, No.
14).

§ 1 030.6. Licensure of Clinical Cytogeneticists.

(a) Except for a clinical laboratory bioanalyst licensed by the depart-
ment who meets the laboratory director qualifications for high complex-
ity testing in Section 493.1443 of Title 42, Code of Federal Regulations,
as published October, 1 994, or a pathologist who meets the laboratory di-
rector qualifications in Section 493.1443(b)(1) of Title 42, Code of Fed-
eral Regulations, as published October 1, 1994, a laboratory director of
a clinical laboratory that performs tests or examinations in the subspe-
cialty of clinical cytogenetics within the specialty of genetics shall pos-
sess a valid clinical cytogeneticist license issued by the department. ,

(b) In order to be eligible for licensure as a clinical cytogeneticist, an
applicant shall:

( 1 ) Be a physician and surgeon licensed by the State to practice medi-
cine pursuant to Chapter 5 of the Business and Professions Code, and
have:

(A) Two years' training in clinical cytogenetics in a training program
approved by the American Board of Medical Genetics (ABMG) or the
Canadian Council of Medical Genetics (CCMG), and approved by the
department pursuant to Section 1286, Business and Professions Code,
Chapter 3, and

(B) Two years' experience directing or supervising high complexity
testing in the specialty of genetics in a clinical laboratory that possesses
a certificate issued under CLIA for performing high complexity testing;
and

(C) Evidence of satisfactory performance on a written examination in
clinical cytogenetics administered by the ABMG, CCMG or the depart-
ment; and

(D) Demonstrated satisfactory performance on an oral examination re-
garding Business and Professions Code, C'hapter 3, and Title 42, CFR,
Part 493, as published October 1, 1994; or

(2) Hold an earned doctoral degree in a biological science or field re-
lated to genetics from an accredited university with tliirty semester or
equivalent quarter hours of post-baccalaureate course credit in genetics
posted on an official transcript from the university registrar; and

(A) Have two years' training in clinical cytogenetics in a training pro-
gram approved by the ABMG or the CCMG, and approved by the depart-
ment pursuant to Section 1286, Chapter 3. of Business and Professions
Code; and

(B) Have two years' experience supervising or performing clinical
laboratory tests or examinations in clinical cytogenetics in a clinical lab-
oratory that possesses a certificate issued under CLIA for performing
high complexity testing; and

(C) Provide evidence of satisfactory performance on a written ex-
amination in clinical cytogenetics administered by the ABMG, CCMG
or the department; and

(D) Have demonstrated satisfactory performance on the oral examina-
tion administered by the Department regarding Business and Professions
Code, Chapter 3, and Title 42 Code of Federal Regulations, Part 493, as
published October 1, 1994; or

(3) Have served as a laboratory director of a clinical laboratory per-
forming laboratory tests limited to the subspecialty of cytogenetics on or
before December 31, 1997 and either;

(A) Meet the laboratory director qualifications of Section
493.1443(b)(2) or (b)(3) of Title 42. Code of Federal Regulations, as
published October 1, 1994; or

(B) Hold an earned doctoral degree, have four years' clinical cytoge-
netics training or experience in a clinical laboratory certified by HCFA
in clinical cytogenetics, and provide evidence of satisfactory perfor-
mance on a written certifying examination in cytogenetics administered
by the ABMG or the CCMG.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and
1282, Business and Professions Code.

History

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000, No. 8). A Certificate of Compliance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-21-2000 as an emergency; operafive 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 1 0-19-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
subsections (b)( 1 )(B) and (b)(2)(B), transmitted to OAL 2-21-2001 and filed
4-3-2001 (Register 2001, No. 14).

§ 1030.7. Licensure of Clinical Genetic Molecular
Biologists.

(a) Except for a clinical laboratory bioanalyst licensed by the depart-
ment pursuant to Business and Professions Code, Chapter 3, who meets
the laboratory director qualifications for high complexity testing in Sec-
tion 493. 1443 of Title 42, Code of Federal Regulations, as published Oc-
tober, 1994, and a pathologist who meets the laboratory director qualifi-
cations in Section 493. 1443 of Title 42, Code of Federal Regulations, as
published October 1 , 1 994, a laboratory director of a clinical laboratory
that performs tests or examinations in the subspecialty of molecular biol-
ogy related to the diagnosis of abnormalities related to human genetic
disorders shall possess a valid clinical genetic molecular biologist license
issued by the department.

(b) In order to be eligible for licensure as a clinical genetic molecular
biologist, an applicant shall:

( 1 ) Be a physician and surgeon licensed by the State, pursuant to Chap-
ter 5 of the Business and Professions Code, to practice medicine and
have:

(A) Two years of training in clinical genetic molecular biology in a
training program approved by the American Board of Medical Genetics
(ABMG) or the Canadian Council of Medical Genetics (CCMG), and ap-
proved by the department pursuant to Section 1286, Chapter 3 of the
Business and Professions Code; and

(C) Evidence of satisfactory performance on a written examination in
genetic molecular biology administered by the ABMG or CCMG or the
department; and

(D) Demonstrated satisfactory performance on an oral examination
administered by the department regarding Chapter 3 of the Business and
Professions Code and Part 493 of Title 42, Code of Federal Regulations,
as published October 1, 1994; or

Page 20

Title 17

State Department of Health Services

§1031

(2) Hold an earned doctoral degree in a biological science or field re-
lated to genetics from an accredited university with 30 semester or equiv-
alent quarter hours of post-baccalaureate course credit in genetics posted
on an official transcript from the university registrar; and

(A) Have two years' training in clinical genetic molecular biology in
a training program approved by the ABMG or the CCMG, and approved
by the department pursuant to Section 1286, Chapter 3 of Business and
Professions Code; and

(B) Have two years" experience supervising or performing clinical
laboratory tests or examinations in clinical genetic molecular biology in
a clinical laboratory that possesses a certificate issued under CLIA for
performing high complexity testing; and

(C) Provide evidence of satisfactory performance on a written certify-
ing examination in genetic molecular biology administered by the
ABMG or CCMG or the department; and

(D) Have demonstrated satisfactory performance in the oral examina-
tion regarding Chapter 3 of Business and Professions Code and Part 493
of Title 42 Code of Federal Regulations as published October 1, 1994;
or

(3) Have served as a laboratory director of a clinical laboratory per-
forming laboratory tests limited to the subspecialty of molecular biology
related to the diagnosis of human genetic abnormalities on or before De-
cember 31,1 997, and either:

(A) Meet the qualifications of Section 493.1443(a), (b)(2), or (b)(3) of
Title 42, Code of Federal Regulations, as published October 1, 1994; or

(B) Hold an earned doctoral degree, have four years' clinical genetic
molecular biology training or experience in a clinical laboratory that pos-
sesses a certificate issued under CLIA for performing high complexity
testing in the subspecialty of molecular biology, and provide evidence of
satisfactory performance on a written certifying examination in genetic
molecular biology administered by the ABMG or CCMG.

NOTl-.: Authority cited: Section 1224. Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Sections 1207, 1209, 1264, 1265 and
1282, Business and Professions Code.

History

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000, No. 8). A Certificate of Comphance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-2 1-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-2 1-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001 , No.
14).

§ 1030.8. Licensure of Oral Pathology Laboratory
Directors.

(a) Except for a pathologist who meets the laboratory director qualifi-
cations of Section 493.1443(b)(1) of Title 42, Code of Federal Regula-
tions, as published October 1, 1994, a laboratory director of an oral
pathology laboratory shall possess a valid oral pathology laboratory di-
rector license issued by the department.

(b) In order to be eligible for licensure as an oral pathology laboratory
director, an applicant shall:

( 1 ) Be a doctor of dental surgery licensed by the State pursuant to
Chapter 4 of the Business and Professions Code to practice dentistry, and
have:

(A) Advanced training in oral and maxillofacial pathology in a training
program approved by the American Dental Association (ADA) Commit-
tee on Accreditation of Dental and Dental Auxiliary Education Programs
in an educational institution; and

(B) Full time experience in oral pathology which, together with ad-
vanced training approved by the ADA, shall total a minimum of four
years; and

(C) Evidence of satisfactory performance on the oral pathologist certi-
fication examination administered by the American Board of Oral
Pathology (ABOP); and

(D) Demonstrated satisfactory performance on an oral (verbal) ex-
amination administered by the department regarding Chapter 3 of the
Business and Professions Code and Title 42. Code of Federal Regula-
tions, Part 493 as published October 1,1994; or

(2) Have served as a laboratory director of an oral pathology laborato-
ry on or before January 1 , 1 996, and be a doctor of dental surgery licensed
by the State pursuant to Chapter 4 of the Business and Professions Code
to practice dentistry, and provide evidence of satisfactory performance
on a certifying examination in oral and maxillofacial pathology adminis-
tered by the ABOP.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Sections 1206, 1206.5, 1207, 1208,
1209 and 1264, Business and Profession Code.

History

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000, No. 8). A Certificate of Compliance must be transinitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-21-2000 as an emergency: operative 6-24-2000 ( Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-1 9-2000 as an emergency; operative 1 0-24-2000 ( Reg-
ister 2000, No. 42). A Certificate of Compliance must be transinitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section heading and section, transmitted to OAL 2-21-2001 and filed
4-3-2001 (Register 2001, No. 14).

§ 1 031 . Licensure of Clinical Laboratory Specialists.

(a) The minimum requirements for admission to the limited scientist
examinations shall be as follows:

( 1 ) An applicant for admission to the examination for a clinical chem-
ist scientist license shall meet both of the following requirements:

(A) Hold a baccalaureate or higher degree in chemistry or equivalent
major which shall include at least 25 semester or 38 quarter units in chem-
istry including courses in analytical chemistry and instrumentation. This
coursework shall be verified by an official transcript showing college or
university courses, training and degree posted by an accredited college
or university; and

(B) Have completed one year of post-baccalaureate training or experi-
ence in all areas of the specialty of chemistry, as listed in (b)(1) below,
in a clinical laboratory that possesses a certificate issued under CLIA for
performing high complexity testing in the specialty of chemistry.

(2) An applicant for admission to the examination for a clinical micro-
biologist scientist shall meet both of the following requirements:

(A) Hold a baccalaureate or higher degree in microbiology or an
equivalent major which shall include at least 25 semester or 38 quarter
units in microbiology including courses in medical or pathogenic micro-
biology or bacteriology. This coursework shall be verified by an official
transcript showing college or university courses, training and degree
posted by an accredited college or university; and

(B) Have completed one year of post-baccalaureate training or experi-
ence in all areas of the specialty of microbiology, as listed in (b)(2) below,
in a clinical laboratory that possesses a certificate issued under CLIA for
performing high complexity testing in the specialty of microbiology.

(3) An applicant for admission to the examination for a clinical immu-
nohematologist scientist license shall meet both of the following require-
ments:

(A) Hold a baccalaureate or higher degree in biology, clinical labora-
tory science or equivalent major which shall include at least 25 semester
or 38 quarter units in biology, including genetics and immunology. This
coursework shall be verified by an official transcript showing college or

Page 20.1

§ 1031.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

university courses, training and degree posted by an accredited college
or university; and

(B) Have completed one year of post-baccalaureate training or experi-
ence in all areas of the specialty of immunohematology, as listed in (b)(3)
below, in a clinical laboratory that possesses a certificate issued under
CLIA for performing high complexity testing in the specialty of immu-
nohematology.

(4) An applicant for admission to the examination for clinical toxicolo-
gist scientist license shall meet both of the following requirements:

(A) Hold a baccalaureate or higher degree in chemistry or equivalent
major which shall include at least 25 semester or 38 quarter units in chem-
istry including analytical chemistry or quantitative analysis. This course-
work shall be verified by an official transcript showing college or univer-
sity courses, training and degree posted by a college or university from
an accredited college or university; and

(B) Have completed one year of post-baccalaureate training or experi-
ence in the specialty of toxicology, as specified in (b)(4) below, in a clini-
cal laboratory that possesses a certificate issued under CLIA for perform-
ing high complexity testing in the subspecialty of toxicology.

(5) An applicant for admission to the examination for a clinical he-
matologist scientist hcense shall meet both of the following require-
ments:

(A) Hold a baccalaureate degree from an accredited college or univer-
sity in biology, clinical laboratory science or an equivalent major which
shall include at least 25 semester or 38 quarter units in biology, including
hematology. This coursework shall be verified by an official transcript
showing college or university courses, training and degree posted by an
accredited college or university; and

(B) Have one year of post-baccalaureate training or experience in all
areas of the specialty of hematology, as specified in (b)(5) below, in a
clinical laboratory that possesses a certificate issued under CLIA for per-
forming high complexity testing in the specialty of hematology.

(b) Any license issued under this section shall specify the particular
specialty or subspecialty in which the licentiate may perform tests under
such license. A license issued for:

( 1 ) A clinical chemist scientist shall specify that the Ucentiate is autho-
rized to perform clinical laboratory tests or examinations classified as
high complexity under CLIA in the specialty or subspecialties of chemis-
try, including routine chemistry, clinical microscopy, endocrinology and
toxicology; immunology, including diagnostic immunology and syphilis
serology; and molecular biology.

(2) A clinical microbiologist scientist shall specify that the licentiate
is authorized to perform clinical laboratory tests or examinations classi-
fied as high complexity under CLIA in the specialty or subspecialties of
microbiology including bacteriology, mycobacteriology, mycology,
parasitology, and virology; immunology, including diagnostic immunol-
ogy and syphilis serology; and molecular biology.

(3) A clinical immunohematologist scientist shall specify that the li-
centiate is authorized to perform clinical laboratory tests or examinations
classified as high complexity under CLIA limited to the specialty of im-
munohematology including ABO/Rh Type or Group, unexpected anti-
body detection, compatibility testing and antibody identification.

(4) A clinical toxicologist scientist shall specify that the licentiate is
authorized to perform clinical laboratory tests or examinations classified
as high complexity under CLIA limited to the subspecialty of toxicology.

(5) A clinical hematologist scientist shall specify that the Hcentiate is

authorized to perform clinical laboratory tests or examinations classified

as high complexity under CLIA limited to the specialty of hematology

including routine hematology and coagulation.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Healthand Safety Code. Reference Sections 1206, 1206.5, 1209, 1209.1,
1210 and 1261, Business and Professions Code.

History

1. Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No.
18).

2. Amendment filed 6-13-69; effective thirtieth day thereafter (Register 69, No.

24).

3. Amendment filed 1 1-25-70 as procedural and organizational; designated effec-
tive 1 1 -24-70 (Register 70, No. 48).

4. Certificate of Comphance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register
71. No. 4).

5. Amendment of section heading, section and Note filed 2-24-2000 as an emer-
gency: operative 2-24-2000 "(Register 2000, No. 8). A Certificate of Com-
pliance must be transmitted to OAL by 6-23-2000 or emergency language will
be repealed by operation of law on the following day.

6. Amendment of section heading, section and NoTi-, refiled 6-21-2000 as an
emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of
Compliance must be transmitted to OAL by 10-23-2000 or emergency lan-
guage will be repealed by operation of law on the following day.

7. Amendment of section heading, section and Note refiled 10-19-2000 as an
emergency: operative 10-24-2000 (Register 2000, No. 42). A Certificate of
Compliance must be transmitted to OAL by 2-2 1-2001 or emergency language
will be repealed by operation of law on the following day,

8. Certificate of Compliance as to 10-19-2000 order, including amendment of
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001, No.
14).

§ 1 031 .1 . Licensure of Clinical Histocompatibility
Scientists.

(a) Each person performing high complexity laboratory tests or ex-
aminations in the subspecialty of histocompatibility in a licensed clinical
laboratory shall possess a valid clinical histocompatibility scientist li-
cense except for the following persons:

( 1 ) A physician and surgeon licensed by the State to practice medicine
pursuant to chapter 5 of the Business and Professions Code; or

(2) A histocompatibility laboratory director licensed pursuant to chap-
ter 3 of the Business and Professions Code; or

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3 of
the Business and Professions Code; or

(4) A clinical laboratory scientist licensed pursuant to chapter 3 of the
Business and Professions Code.

(b) In order to be eligible for licensure as a clinical histocompatibility
scientist an applicant shall have been certified as a Clinical Histocompa-
tibility Technologist by the American Board of Histocompatibility and
Immunogenetics, either:

(1) Prior to January 1, 1997 and have had at least 6 years' experience
in all areas of clinical histocompatibility testing in a clinical laboratory,
or

(2) After January 1 , 1 997 and have a baccalaureate degree in biologi-
cal or clinical science and one year of clinical laboratory experience in
all areas of clinical histocompatibility testing in a clinical laboratory.
NotE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209. 1 ,
1210 and 1261, Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section, transmitted to OAL 2-2 1-2001 and filed 4-3-2001 (Register 2001, No.
14).

§ 1 031 .2. Licensure of Clinical Cytogeneticist Scientists.

(a) Each person performing high complexity tests or examinations in
the specialty of cytogenetics in a licensed clinical laboratory shall pos-
sess a valid clinical cytogeneticist scientist license except for the follow-
ing persons:

( 1 ) A physician and surgeon licensed by the State to practice medicine
pursuant to chapter 5 of division 2 of the Business and Professions Code;
or

(2) A clinical cytogeneticist licensed to direct a cytogenetics laborato-
ry pursuant to chapter 3; or

Page 20.2

Title 17

State Department of Health Services

§ 1031.4

•

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or

(4) A clinical laboratory scientist licensed pursuant to chapter 3.

(b) In order to be eligible for licensure as a clinical cytogeneticist sci-
entist, an applicant shall:

( 1 ) Hold a baccalaureate or an equivalent or higher degree, which shall
include at least 25 semester or 38 quarter hours in biology, chemistry or
clinical laboratory science from an accredited college or university, and

(2) Provide evidence of satisfactory performance on a written ex-
amination in the specialty of cytogenetics administered by the National
Credentialing Agency for Laboratory Personnel (NCA), and either:

(A) On or after March 14, 2003, have completed at least one year train-
ing and/or experience in clinical cytogenetics in a clinical laboratory cer-
tified by the Centers for Medicare and Medicaid Services (CMS) in clini-
cal cytogenetics. This training shall be approved by the department
pursuant to Section 1035 and acceptable for admission to an examination
by the NCA in the specialty of cytogenetics; or

(B) Prior to March 14, 2003, have completed training and/or experi-
ence in clinical cytogenetics, which is acceptable for admission to an ex-
amination by the NCA in the specialty of cytogenetics, in a clinical labo-
ratory certified by CMS in clinical cytogenetics or in histopathology
(cytogenetics).

NoTE; Authority cited: Sections 1224, 1261 and 1261. 5, Business and Professions
Code; and Section 100275, Health and Safety Code. Reference: Sections 1203,
1205, 1206. 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Business
and Professions Code.

History

1 . New section filed 3-13-2003 as an emergency; operative 3-13-2003 (Register
2003, No. 11 ). A Certificate of Compliance must be transmitted to OAL by
7-1 1 -2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 3-13-2003 order transmitted to OAL
7-10-2003 and filed 8-21-2003 (Register 2003, No. 34).

§ 1 031 .3. Licensure of Clinical Genetic Molecular Biologist
Scientists.

(a) Each person performing high complexity tests or examinations in
the subspecialty of genetic molecular biology in a licensed clinical labo-
ratory shall possess a valid clinical genetic molecular biologist license
except for the following persons:

( 1 ) A physician and surgeon licensed by the State to practice medicine
pursuant to chapter 5 of division 2 of the Business and Professions Code;
or

(2) A clinical genetic molecular biologist licensed to direct a genetics
laboratory pursuant to chapter 3; or

(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or

(4) A clinical laboratory scientist licensed pursuant to chapter 3.

(b) In order to be eligible for licensure as a clinical genetic molecular
biologist scientist, an applicant shall hold a baccalaureate or an equiva-
lent or higher degree in a biological or clinical laboratory science, or field
related to genetics from an accredited college or university; and

( 1 ) Have completed at least one year training and/or experience in clin-
ical genetic molecular biology in a clinical laboratory certified by the
Center for Medicare & Medicaid Services (CMS), performing high com-
plexity testing in clinical genetic molecular biology. This training and/or
experience shall be acceptable for admission to an examination by the
National Credentialing Agency for Laboratory Personnel (NCA) in the
specialty of molecular biology. On or after March 14, 2003, this training
shall be approved by the department pursuant to Section 1035; and

(2) Provide evidence of satisfactory performance on a written ex-
amination in molecular biology administered by the NCA.

NOTE; Authority cited: Sections 1224, 1261 and 1261.5, Business and Professions
Code; and Section 100275, Health and Safety Code. Reference: Sections 1203,
1205, 1206, 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Bu.siness
and Professions Code.

History

1. New section filed 3-1 3-2003 as an emergency; operative 3-13-2003 (Register
2003, No. 11). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 3-13-2003 order transmitted to OAL
7-10-2003 and filed 8-21-2003 (Register 2003, No. 34).

§ 1 031 .4. Requirements and Timeframes for Applications
for Licensure and Certification.

(a) Applications for admission to a state-administered Hcensing ex-
amination shall be complete when the information specified in Section
103 1 .4(b) has been received by the department. For an applicant to be eli-
gible for a scheduled examination, the completed application must be
postmarked at least 120 days prior to the examination date as published
by the Department of Health Services. When applying for admission to
the examination, the applicant shall state whether he or she has previous-
ly applied to the department for admission to an examination.

[The next page is 20.3.

Page 20.2(a)

•

Title 17

State Department of Health Services

§ 1031.4

(b) An application for licensure to direct a clinical laboratory or to per-
form clinical laboratory tests or examinations under Chapter 3 shall be
considered complete when the following is provided to the department:

( 1 ) Name and address of the applicant, including city, state and zip
code; and

(2) Social security number of the applicant (Pursuant to the authority
found in Section 1224 of the Business and Professions Code and in Sec-
tion 100275 of the Health and Safety Code, and as required by Section
17520 of the Family Code, it is mandatory to provide the social security
number. The social security number will be used for purposes of identifi-
cation.); and

(3) Gender and birthdate; and

(4) License for which the applicant is applying; and

(5) Whether the applicant has or has not been convicted of any felonies
or misdemeanors other than minor traffic violations; and

(6) Documentation of the applicant's education including:

(A) Name, address, major course of study, dates of attendance, num-
ber of credits, and degree/completion date for all colleges and universi-
ties attended by the applicant; and

(B) Official transcripts from the registrar of all accredited colleges or
universities attended by the applicant showing all courses, course credits,
degrees conferred and date of conference; and

(C) Official transcripts from non-United States colleges or universi-
ties which are not in English shall be returned to the applicant to obtain
translation from a translation service approved in the United States for
legal or government documents.

(7) Documentation of the applicant's training including:

(A) Name and address of training program, dates of training, specialty
and subspecialty areas of training, length of time in each specialty and
subspecialty area of training; and

(B) Signed documentation from the training program director that this
training has been successfully completed; and

(8) Documentation of the applicant's experience, appropriate to the
specific license for which the applicant is applying, including the follow-
ing:

(A) Facility name, address, dates of employment, number of hours per
week employed, the specialties and subspecialties in which clinical labo-
ratory tests or examinations were performed and a description of clinical
laboratory tests or examinations performed; and

(B) Signed documentation of such experience from the director of the
laboratory; and

(9) Evidence of satisfactory performance on a licensing examination
pursuant to Section 1029.81; and

(10) Signature of the applicant, telephone number and date of appUca-
tion; and

(11) Payment of license application fee pursuant to Business and Pro-
fessions Code Section 1300.

(c) An application for certification in phlebotomy shall be considered
complete when the following is provided to the department:

(1) Name and address of the applicant, including city, state and zip
code; and

(3) Gender and birthdate; and

(4) Category of phlebotomy certification for which the applicant is ap-
plying; and

(5) Whether the applicant has or has not been convicted of any felonies
or misdemeanors other than minor traffic violations; and

(6) Documentation of the applicant's education including;

(A) Name, address, dates of attendance, coursework completed and
graduation as verified by official school transcripts; or

(B) Documentation of a passing score on the general educational de-
velopment (GEO) test or equivalent education as evaluated by the Amer-
ican Association of Collegiate Registrars and Admissions Officers for
secondary education; or

(C) For official school transcripts which are not in English, documen-
tation of equivalent education as obtained through translation into Eng-
lish from a translation service approved in the United States for legal or
government documents; and

(7) Certification of the applicant's instruction in phlebotomy as speci-
fied in Section 1035.1(h); and

(8) Cerfification of the applicant's on-the-job experience in phleboto-
my, if applicable, including:

(A) Name and address of laboratory where employed, dates of em-
ployment, number of hours of experience in techniques specified in Sec-
tion 1035. 1(f) and an estimate of the number of skin punctures, venipunc-
tures or arterial punctures performed pursuant to the Business and
Professions Code Secfion 1 220(d)( 1 ) or (d)(2)(A) that fulfills all the sam-
pling requirements of all clinical laboratory tests or examinafions; and

(B) Signed documentation from the director of the laboratory that the
above informafion accurately represents the applicant's experience in
phlebotomy; and

(9) Evidence of satisfactory performance on a certification examina-
tion in phlebotomy administered by a certifying organization that was ap-
proved by the department pursuant to Section 103 1.7 at the time the ex-
amination was administered; and

(10) Signature of the applicant, telephone number and date of applica-
tion; and

(11) Payment of a two-year certification fee of $50.

(d) Timeframes for processing applications for licensure to direct a
clinical laboratory or to perform clinical laboratory tests or examinations
or for certification to perform phlebotomy pursuant to Chapter 3 shall be
as follows:

( 1 ) The department shall notify the applicant in writing, within 90 days
of receipt of an application, of one of the following:

(A) The application is complete and will be processed by the depart-
ment; or

(B) The application is incomplete and not accepted for processing. The
department's written notification shall include the specific information,
documentation or fee in which the application is deficient; or

(C) The application has been reviewed and does not meet the require-
ments and that approval is denied. The department shall give written noti-
fication of the basis for the denial.

(2) The department shall notify the applicant within 90 days of post-
mark date of resubmission of application requirements pursuant to Sec-
tion 1031.4(d)(1)(B) whether the application has been approved or de-
nied.

(3) Written notification by the department to applicants shall be
deemed to occur on the date of the postmark from the department.

(4) The department shall deem an application abandoned by an appli-
cant who fails to respond or to supply all information, documents, verifi-
cations or payment of applicable fees within 30 days of notification by
the department.

(5) The department's time periods for processing an application for li-
censure or certification from the date the application is complete to the
date the final decision is made regarding an approval are as follows:

(A) The median time for processing an application is 90 days;

(B) The minimum time for processing an application is 30 days; and

(e) Certification shall be valid for a period of 2 years unless revoked.
(0 Failure to meet the requirements of this section shall be good cause

for denial or revocation of approval by the department.

(g) All applicants, licensees and certificants pursuant to Section
1031.4 shall notify the department in writing of any change(s) of name
and /or address within 30 days after the change(s) has occurred.

Page 20.3

§ 1031.5

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Section 17520. Family Code. Reference:
Sections 1203, 1204, 1205, 1207, 1209. 1209,1, 1210, 1220, 1241. 1242, 1242.5,
1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301, 1301.1 and 1320, Busi-
ness and Professions Code; Section 120580, Health and Safety Code; and Section
15376, Government Code.

History

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register

2000, No. 8). A Certificate of Compliance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000. No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-2 1-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section and Note, transmitted to OAL 2-2 1- 2001 and filed 4-3-2001 (Register

2001, No. 14).

5. Amendment of section heading, section and Note filed 1-9-2003; operative
4-9-2003 (Register 2003, No. 2).

§ 1031.5. Requirements and Timeframes for Renewal of
Licenses and Certificates.

(a) In order to maintain a license in active status, licenses shall be re-
newed by filing a renewal application within 60 days prior to the end of
the license period.

(b) A complete license renewal application shall include name and ad-
dress of the licensee, license number, current work location(s), documen-
tation of continuing education credits, an attestation stating whether the
licensee has or has not been convicted of any felonies or misdemeanors
other than minor traffic violations in the previous two years, license re-
newal fee, signature and date of application for renewal.

(c) In order to maintain a phlebotomy certificate in active status, certif-
icates once approved shall be renewed at biennial intervals by filing a re-
newal application within 60 days prior to the end of the certificate period.

(d) A complete phlebotomy certificate renewal application shall in-
clude name and address of the certificant, certificate number, current
work location(s), documentation of continuing education performed dur-
ing the previous 24 months, an attestation stating whether the certificant
has or has not been convicted of any felonies or misdemeanors other than
minor traffic violations in the previous two years, certification renewal
fee of $50, signature and date of application for renewal.

NOTE; Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1203, 1204, 1205, 1207,
1209, 1209.1, 1210. 1226, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263,
1264, 1282, 1300, 1301 and 1301.1, Business and Professions Code; and Section
120580, Health and Safety Code.

History

2. New secUon refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 1 0-19-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No.
14).

5. Amendment of section heading, section and Note filed 1-9-2003; operative
4-9-2003 (Register 2003, No. 2).

§ 1031.7. Conditions for Approval of Certifying

Organizations to Administer Phlebotomy
Certification Examinations.

(a) In order for a certifying organization to be eligible for approval by
the department to administer a phlebotomy certification examination for

state certification purposes, the certifying organization shall meet the fol-
lowing conditions:

( 1 ) The certifying organization shall be a national, independent, not-
for-profit, professional certifying organization; and

(2) The certifying organization shall offer examinations in phleboto-
my; and

(3) The certifying organization shall provide the following to the de-
partment:

(A) The organization's name and address; and

(B) Names of the organization's officers and board of directors; and

(D) The identity of the person designated by the organization to be re-
sponsible for overseeing the administration and coordination of all ex-
amination activities; and

(E) A schedule of dates and times that the examination will be con-
ducted within the state; and

(F) Listing of procedures for monitoring the content, quality, validity
and relevance of the phlebotomy examinations pursuant to Section
1031.7(b); and

(G) The philosophy of the organization, demonstrating a commitment
to accurate assessment of a candidate's preparation for phlebotomy certi-
fication.

(b) In order for a certifying organization's examination to be approved
for certification purposes, the organization shall document the following
standards to support a request for approval:

(1) Evaluation of relevant standards in phlebotomy and how the orga-
nization's examinations address knowledge and skills that would assure
competence of the candidate; and

(2) Explanation of how the examinations are developed by the orga-
nization and the qualifications of person(s) who develop the examination
questions; and

(3) Documentation that the organization's examinations are subject to
annual review for current relevance; and

(4) Demonstration of the ability of the organization to evaluate its ex-
aminations, subjecting the examinations to validity and reliability assess-
ments using psychometric performance standards, and the capability of
the organization to provide this information at least once yearly or upon
request to the department.

(1) Agree to make the content of its examinations available to the de-
partment for confidential review; and

(2) Demonstrate how it will maintain security during administration
of the examination, ensure the identity of the examinee, and maintain the
confidentiality of the examination; and

(3) Document how it will make its records accessible to the department
regarding those persons participating in the examination and their scores;
and

(4) Provide verification of those persons successfully passing the cer-
tification examination to the department and shall maintain these records
for five years; and

(5) Issue a certificate to those passing the examination with the exam-
inee's name, name of the cerufying organization, type of certificate, ef-
fective date and official signature.

(d) Timeframes for processing apphcations for approval of a certify-
ing organization's certification examinafion shall be as follows:

(1) Within 90 calendar days of receipt of an application, the depart-
ment shall inform the organization in writing that the application is either
complete and accepted for review or that it is deficient and what specific
information or documentation is required to complete the application.

(2) Within 180 calendar days from the date of filing a completed ap-
plication, the department shall inform the applicant certifying organiza-
tion in writing whether the organization has been approved or denied as
a certifying organization for the administration of the certification ex-
amination.

Page 20.4

Title 17

State Department of Health Services

§ 1031.8

•

(3) The department shall deem an application abandoned by an appli-
cant certifying organization that fails to respond or to supply all informa-
tion, documents, or verifications within 30 days of notification pursuant
to Section 1031.7(d)(1).

(4) The department' s time periods for processing an application for ap-
proval as a certifying organization, from the receipt of the initial applica-
tion to the final decision regarding the approval, are as follows:

(A) The median time for processing is 180 calendar days.

(B) The minimum time for processing is 90 calendar days.

(e) Approval shall be valid for a period of four years unless revoked.

(0 To apply for renewal, a certifying organization shall file a renewal
application at least 120 days prior to the end of the approval period pro-
viding the following:

( 1 ) The name and address of the certifying organization; and

(2) Names of the organization's officers and board of directors; and

(3) Name of the person designated by the organization to be responsi-
ble for overseeing the administration and coordination of all examination
activities; and

(4) A schedule of dates and times that the examination will be con-
ducted within the state for the next 12 months; and

(5) A copy of the current examination; and

(6) Signature of the program director and date of application for re-
newal.

(g) Failure to meet the requirements of this section shall be good cause
for denial or revocation of approval by the department.

(h) A certifying organization shall notify the department in writing of
any change(s) in the information and material required by Subsections
(a) through (c) within 30 days after the change(s) has occurred.
NOTH: Authority cited: Sections 1224 and 1320, Business and Professions Code;
and Section 100275. Health and Safety Code. Reference: Sections 1242, 1242.5,
1246 and 1269, Business and Professions Code; and Section 120580, Health and
Safety Code.

History

1. New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§ 1 031 .8. Conditions for Approval of a Certifying
Organization to Administer a Certifying
Examination for Licensure Purposes.

(a) In order for a certifying organization to be eligible for approval by
the department to administer a category of certifying examination, the or-
ganization shall file a complete application that consists of the following:

( 1 ) Documentation that the certifying organization is a national, inde-
pendent, not-for-profit, professional certifying organization; and

(2) The organization's name and address; and

(3) Names of the organization's officer(s) and board of directors; and

(4) Description of the organization's structure and organizational
chart; and

(5) The identity of the person designated by the organizadon to be re-
sponsible for overseeing the administration and coordination of ex-
amination activities; and

(6) A mission statement that demonstrates the philosophy of the certi-
fying organization commits to an accurate assessment of a candidate's
preparation in the clinical laboratory science category in which the candi-
date is examined; and

(7) Schedule of dates that the examination will be available to Califor-
nia licensure applicants during the next four years; and

(8) Listing of procedures for monitoring the content, quality, validity,
reliability and relevance of the examination in the specialty being tested,
and

(9) Demonstration of how the organization's examination addresses
the relevant standards in the clinical laboratory science category being
examined, and how it evaluates the knowledge and skills that would as-
sure competence of the candidate; and

( J 0) Exp]anaUon of how the examination structure is developed by the
organization, and the qualifications of person(s) who develop the ex-
amination questions; and

(11) Documentation that the organization's examination is subject to
annual review for current relevance; and

(12) Demonstration of the ability of the organization to evaluate its ex-
amination, subjecting it to validity and reliability assessments using psy-
chometric performance standards, and the capability of the organization
to provide this information at least annually or upon request to the depart-
ment; and

(13) Explanation of how the examination is developed and weighted
using a job task survey to determine knowledge and skills required to be
competent in the examination category; and

(14) Explanation of how examination questions are established, eva-
luated and updated to match current practice for the category; and

(15) Explanation of how the cutoff score for those successfully passing
the examination is determined; and

(16) Documentation of performance statistics for the examination dur-
ing the previous five years, including pass/fail rate, number of applicants
and number accepted to the examination for each time that the examina-
tion has been administered by the certifying organization during the five
years immediately prior to the date of application, or, for specialties that
have been established for less than five years, during the period dating
from the establishment of the specialty to the date of the application; and

( 1 7) Submission of printed copies of examinations given each year for
the previous four years, if the examinations were offered. These ex-
amination shall be subject to confidential review by the department, shall
not be copied, and shall be returned to the organization; and

( 1 8) Submission of an agreement to provide the examination to candi-
dates who have been approved for admission to the examination by the
department; and

(19) Submission of an agreement to provide verification of those per-
sons successfully passing the examination to the department and to main-
tain these records for five years; and

(20) Submission of an agreement to give evidence of satisfactory per-
formance as official notification to those passing the examination with
the examinee's name, name of the certifying organization, examination
category, effecUve date and official signature; and

(21) Demonstration how the organization will maintain security dur-
ing development and administration of the examination, ensure the iden-
dty of the examinee, and maintain the confidentiality of the examination;
and

(22) Listing of procedures in use and required of the organization's
personnel to ensure security and confidentiality of the examination, and
steps to be taken if a breach is discovered; and

(23) An agreement that a breach of security shall be reported to the de-
partment and that the department is authorized to investigate and with-
draw approval of the examination category; and

(24) Documentation how the organization will make its records acces-
sible to the department regarding those persons participating in the ex-
amination and their scores; and

(25) The name, tide, and signature of the person who is responsible for
overseeing the administration and coordination of all examinadon activi-
ties, and the date the application was signed.

(b) Initial approval of an organization's examination category shall in-
clude confidential review of an examination given each year up to four
years immediately preceding the date of approval, so that examinations
taken during this time shall be acceptable for licensure purposes.

(c) Timeframes for processing applications for approval of a certifying
organization's examination in a clinical laboratory science category for
licensure purposes shall be as follows;

(1) The department shall nodfy the applicant organization within 90
days of submission of an application of one of the following:

(A) That the application is complete and acceptable for processing by
the department; or

(B) That the application is incomplete and not accepted for processing.
This notification shall include the specific information or documentation
that the applicant shall submit within 30 days in order for the department
to consider the application acceptable; or

Page 20.5

§ 1031.9

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(C) That the appHcation has been reviewed and does not meet the re-
quirements of this section and that approval is denied.

(2) The department shall consider an application to have been aban-
doned by any applicant who fails to respond to the department's request
to submit specific information or documentation within 30 days of notifi-
cation pursuant to Section 1031.8(c)(1)(B).

(d) Written notification by the department to the applicant organiza-
tion shall be considered to occur on the date the documents are post-
marked.

(e) A certifying organization shall notify the department in writing of
any change in the information and materials required by this section with-
in 30 days after the change has occurred.

(f) Failure to meet and maintain the requirements of this section shall
be good cause for denial or revocation of approval by the department.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5,
1262, 1263 and 1264, Business and Professions Code.

History

1. New section filed 1-13-2005 as an emergency; operative 1-1 3-2005 (Register
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-13-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis-
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by
9-12-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub-
sections (a)(12), (a)(17), (a)(20). (a)(25) and (b) and repealer of subsection (c)
with subsection relettering, transmitted to OAL 8-3-2005 and filed 9-12-2005
(Register 2005, No. 37).

§ 1 031 .9. Conditions for Renewal of a Certifying

Organization's Approval to Administer
Examinations Acceptable for Licensure
Purposes.

(a) Approval of a certifying organization shall be valid for a period of
four years unless revoked. At least 120 days prior to the end of the ap-
proval period, the certifying organization that wants to continue approval
of its examination shall apply for reapproval. Failure to reapply 120 days
in advance shall cause a lapse in approval after which time the examina-
tion would not be acceptable for licensure purposes until the certifying
organization regains approval. A certifying organization that fails to
reapply at least 1 20 days in advance and subsequently elects to seek ap-
proval shall make application pursuant to Section 1031.8.

(b) To apply for renewal of a certifying organization' s approval to ad-
minister examinations, the organization shall provide the following:

(1) The name and address of the certifying organization; and

(2) Names of the organization's officer(s) and board of directors; and

(3) Name of the person designated by the organization to be responsi-
ble for overseeing the administration and coordination of all examination
activities; and

(4) A schedule of dates that the examination will be available to
California applicants during the next four years; and

(5) A summary of the performance statistics of the examination during
the previous approval period, including the number of California appli-
cants applying for, and successfully passing, the certifying examination,
the applicant scores, what efforts have been made to evaluate the ex-
amination and update the examination questions to match cun-ent prac-
tice for the category; and

(6) The name, title and signature of the person responsible for oversee-
ing the administration and coordination of all examination activities and
date of application for renewal.

(c) The timeframes for processing an application of a certifying orga-
nization seeking renewal of its examination approval shall be as follows:

(1 ) The certifying organization shall submit an application for renewal
of approval of its examination at least 120 days prior to the end of the ap-
proval period.

(2) Within 30 days of receipt of a renewal application, the department
shall inform the organization in writing that the renewal application is

complete and accepted for review, or deficient and what specific in-
formation or documentation is required to complete the application.

(3) Within 30 days of receiving a completed renewal application, the
department shall inform the applicant organization in writing whether the
examination has been reapproved or denied.

(d) Failure to meet and maintain the requirements of this .section shall
be good cause for denial of reapproval by the department.
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5,
1262, 1263 and 1264, Business and Professions Code.

History

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-13-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub-
sections (a), (b)(6) and (c)(2), transmitted to OAL 8-3-2005 and filed
9-12-2005 (Register 2005, No. 37).

§ 1032. Examination for Clinical Laboratory Technologist's
License.

With the exception as provided in Section 1 262 of the Business and
Professions Code, written, oral, or practical examinations shall be con-
ducted by the department to aid it in judging the qualifications of appli-
cants for licensure as clinical laboratory technologists. In addition to the
requirements for licensure as specified in Section 1261 of the Business
and Professions Code, the prerequisites for entrance into the licensing ex-
amination shall be one of the following:

(a) Graduation from a college or university maintaining standards
equivalent, as determined by the department, to those institutions accred-
ited by the Western Association of Schools and Colleges, or an essential-
ly equivalent accrediting agency, with a baccalaureate and a major in
clinical laboratory science, the last year of which course shall have been
primarily clinical laboratory procedures in a clinical laboratory training
school acceptable to the department; or

(b) Graduation from a college or university maintaining standards
equivalent, as determined by the department, to those institutions accred-
ited by the Eastern Association of Schools and Colleges, or an essentially
equivalent accrediting agency, with a baccalaureate and courses perti-
nent to the clinical laboratory field as may be determined by the depart-
ment plus one year as a clinical laboratory technologist trainee or the
equivalent as determined by the department in a clinical laboratory ac-
ceptable to the department; provided, however, that a baccalaureate ob-
tained after July 1, 1973, must include at least:

(1)16 semester or equivalent quarter hours of chemistry, including in-
struction in analytical and biological chemistry;

(2) 18 semester or equivalent quarter hours of biological science, in-
cluding instruction in immunology, hematology and medical microbiol-
ogy which may include bacteriology, mycology, virology and parasitolo-
gy;

(3) 3 semester or equivalent quarter hours of physics, including in-
struction in principles of light and electricity; or

(c) A minimum of two years of experience as a licensed trainee or the
equivalent as determined by the department doing clinical laboratory
work embracing the various fields of clinical laboratory activity in a clin-
ical laboratory acceptable to the department and 90 semester hours or
equivalent quarter hours of university or college work in which are in-
cluded the following coursed, or essential equivalent as may be deter-
mined by the department: general inorganic chemistry — 8; quantitative
analysis — 3; basic biological sciences — 8; bacteriology — 4; provided,
however, that university or college work completed after July 1, 1973,
must include at least:

(1)16 semester or equivalent quarter hours of chemistry, including in-
struction in analytical and biological chemistry;

Page 20.6

Title 17

State Department of Health Services

8 1033

(2) 18 semester or equivalent quarter hours of biological science in-
cluding instruction in immunology, hematology and medical microbiol-
ogy which may include bacteriology, mycology, virology and parasitolo-
gy;

(3) 3 semester or equivalent quarter yours of physics, including in-
struction in principles of light and electricity.

NOTK: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Sections 1246, 1261, 1262, 1263, 2164 and 1301. Business and Professions Code.

History

1 . New section filed 1 1-25-70 as procedural and oraanizational; designated effec-
tive 1 1-24-70 (Register 70, No. 48).

2. Certificate of Compliance— Sec. 11422.1, Gov. code, filed 1-20-71 (Register
71. No. 4).

3. Amendment filed 6-8-72; effective thirtieth day thereafter (Register 72. No.
24).

§ 1 032.5. Licensure of Medical Laboratory Technicians.

(a) In order to qualify for licensure as a medical laboratory technician,
a person shall apply for a license pursuant to Section 1 03 1 .4 (b) and meet
the following requirements:

( 1 ) Have successfully completed at least 60 semester (90 quarter) units
from an accredited college or university. The coursework shall consist of
at least 36 semester units of physical and biological sciences with an em-
phasis on applied clinical science. Coursework shall include 6 semester
units of chemistry and 6 semester units of biology appropriate for transfer
to a baccalaureate program in science, taken prior to, or concurrendy
with, training or experience; and

(2) Have met the following training or experience requirements by
documenting one of the following:

(A) Graduating from a medical laboratory technician training program
accredited by the National Accrediting Agency for Clinical Laboratory
Sciences (NAACLS); or

(B) Graduating from a medical laboratory technician training program
approved by the department pursuant to Section 1035.3; or

(C) Meeting admission requirements for a clinical laboratory scientist
licensing examination, as determined by the department pursuant to Sec-
tion 1032; or

(D) Completing a minimum of three years on-the-job practical expe-
rience within the previous five years, in a clinical laboratory outside
California as a medical laboratory technician, with evidence of satisfac-
tory performance on an examination given by a certifying organization
for medical laboratory technicians, performing tests in the specialties of
chemistry, hematology, microbiology, and immunology. This work ex-
perience shall include at least 480 hours in each of these specialties and
shall be documented by the laboratory director(s) of the laboratory(ies)
employing the applicant pursuant to Secdon 1031.4(b)(8); or

(E) Completing a minimum of three years on-the-job practical experi-
ence within the previous five years, in a clinical laboratory outside
California as a clinical laboratory scientist, with evidence of sadsfactory
performance on an examination given by a certifying organizadon for
clinical laboratory scientists, performing tests in the specialties of chem-
istry, hematology, microbiology, and immunology. This clinical labora-
tory scientist, also called medical technologist in some states, need not
be California licensed pursuant to Business and Professions Code section
1204, but shall have work experience outside California of at least 480
hours in each of these specialties as documented by the laboratory direc-
tor(s) of the laboratory(ies) employing the applicant pursuant to Section
1031.4(b)(8); or

(F) Completing a minimum of three years on-the-job pracdcal experi-
ence within the previous five years, as a medical laboratory technician
or clinical laboratory sciendst in a California physician office laboratory
or in a laboratory owned and operated by the United States of America.
This person shall have evidence of satisfactory performance on an ex-
amination given by a cerdfying organizadon for medical laboratory tech-
nicians or clinical laboratory scientists, respecdvely, and have performed
tests in the specialties of chemistry, hematology, microbiology and im-
munology. This work experience shall include at least 480 hours in each
of these specialdes, and shall be documented by the physician(s) direct-

ing the laboratory(ies) employing the applicant pursuant to Section
1031.4(b)(8); and

(3) Have passed a written examination for medical laboratory techni-
cians administered by a certifying organization for medical laboratory
technicians approved by the department pursuant to Section 1 03 1 .8. The
department shall, for licensure purposes, accept evidence of satisfactory
performance on examinations taken within the four years previous to de-
partment approval of a certifying organizadon's medical laboratory tech-
nician examination. The applicant shall have also passed a separate writ-
ten, self-administered examinadon on California clinical laboratory law
provided by the department. This self-administered test shall accompany
the applicafion. A minimum passage rate of 70 percent shall be required.

(b) A licensed medical laboratory technician shall be authorized to:

( 1 ) Perform tests and examinations classified as waived and moderate
complexity by Centers for Disease Control and Prevention in the special-
des of chemistry, including roudne chemistry, urinalysis, endocrinology
and toxicology; hematology including coagulation; microbiology, in-
cluding bacteriology, mycobacteriology. mycology, parasitology and
virology; and immunology, including syphilis serology and general im-
munology, with the excepUon of those moderate complexity tests requir-
ing microscopy, or in the specialty of immunohematology.

(2) Perform phlebotomy, but shall not perform skin tests for specific
diseases pursuant to Secdon 1242 of the Business and Professions Code.

(3) Perform tests and examinations under the supervision of a licensed
physician and surgeon, or a doctoral scientist, clinical laboratory bioana-
lyst, clinical laboratory scienUst, or clinical laboratory specialist licensed
under Chapter 3. On-site supervision shall be required during the entire
dme the medical laboratory technician performs moderate complexity
clinical laboratory tests or examinadons. The ratio of medical laboratory
technician to supervisor at the site of moderate complexity testing shall
not exceed four to one.

(4) Report test results and perform phlebotomy only after competency
has been documented by the laboratory director pursuant to Section
1209(e) of the Business and Professions Code.

(5) Supervise Limited Phlebotomy Technicians or Cerdfied Phleboto-
my Technician Is.

(c) The license applicafion fee and license renewal fee for a medical
laboratory technician shall be the same as the license applicadon fee and
hcense renewal fee for a clinical laboratory scientist pursuant to Section
1300(c) and (e) of the Business and Professions Code.

(d) A medical laboratory technician shall complete twelve hours of
continuing educadon each year as a condition for renewal.

Note: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1202.5, 1204, 1206, 1206.5,
1208, 1209, 1210, 1242, 1260.3, 1261, 1275, 1300 and 1 320, Business and Profes-
sions Code.

History

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-13-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-12-2005 as an emergency; operative .5-14-2005 (Regis-
ter 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by
9-12-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub-
secdons (a)(3), (b)( 1 ), (b)(3) and (b)(5), transmitted to OAL 8-3-2005 and filed
9-12-2005 (Register 2005, No. 37).

§1033. Trainee Requirements.

In addifion to the requirements for licensure as specified in Section
1263 of the Business and Professions Code, the prerequisites for licen-
sure as a trainee shall be as follows:

(a) Clinical Laboratory Technologist Trainee. Applicants shall ha\ e
graduated from a college or university maintaining standards equiv alent,
as determined by the department, to those insdtufions accredited by the
Western Associafion of Schools and Colleges or an essentially equiva-
lent agency with a baccalaureate and a major in clinical laboratory sci-
ence, or a baccalaureate and courses pertinent to the clinical laboratory
field as may be determined by the department. An individual who is not

Page 20.7

§1034

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

a graduate but possesses at least 90 semester hours or equivalent quarter
hours of university or college work may be licensed as a clinical laborato-
ry technologist trainee, provided he will be granted a baccalaureate at the
conclusion of 1 2 months of training, and have completed at least 90 se-
mester hours or equivalent quarter hours, must have included in the col-
lege work the following courses or essential equivalent as may be deter-
mined by the department: general inorganic chemistry — 8; quantitative
analysis — 3; basic biological sciences — 8; bacteriology— 4; provided,
however, that university or college work completed after July 1, 1973,
must include at least:

(1)16 semester or equivalent quarter hours of chemistry, including in-
struction in analytical and biological chemistry;

(2) 1 8 semester or equivalent quarter hours of biological science, in-
cluding instruction in immunology, hematology and medical microbiol-
ogy which may include bacteriology, mycology, virology and parasitolo-
gy;

(3) 3 semester or equivalent quarter hours of physics including instruc-
tion in principles of light and electricity.

(b) Limited Technologist Trainee. Aj^plicants shall have graduated
from a college or university maintaining standards equivalent, as deter-
mined by the department, to those institutions accredited by the Western
Association of Schools and Colleges or an essentially equivalent accred-
iting agency with a baccalaureate and a major in the specialty for which
licensure is sought. If the major is not designated by the college or univer-
sity as one of those required under this chapter for limited technologist
licenses in clinical chemistry, clinical microbiology, immunohematolo-
gy, or toxicology, the department may determine the essentially equiva-
lent major.

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
sections 1246, 1261, 1262, 1263, 1264 and 1301, Business and Professions Code.

History

1 . New section filed 1 1-25-70 as procedural and organizational; designated effec-
tive 1 1-24-70 (Register 70. No. 418).

2. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register
71, No. 4).

3. Amendment of subsection (a) filed 6-8-72; effective thirtieth day thereafter
(Register 72, No. 24).

§ 1034. Certification of Phlebotomy Technicians.

(a) The education, training and experience required for certification in
phlebotomy shall be as follows:

( 1 ) For a person to be eligible for certification as a Limited Phlebotomy
Technician, he or she shall:

(A) Be a high school graduate or have achieved a passing score on the
general educational development (GED) test or documentation of equiv-
alent education pursuant to Section 1031 .4(c)(6)(B); and

(B) Have completed a minimum of 20 hours basic didactic instruction
pursuant to Section 1035.1(e)(1) from a phlebotomy training program
approved by the department; and

(C) Have completed a minimum of 25 skin punctures, performed pur-
suant to the Business and Professions Code Section 1220(d)(1) or
(d)(2)(A) that fulfill all sampling requirements of all clinical laboratory
tests or examinations, in a clinical setfing on patients, under the supervi-
sion of a licensed physician and surgeon, licensed physician assistant, li-
censed clinical laboratory bioanalyst, registered nurse, or licensed clini-
cal laboratory scientist, who will certify in writing with a signed
certificate that this training has been completed; and

(D) Apply to the department for cerUfication as a Limited Phlebotomy
Technician pursuant to Section 1031.4(c).

(2) For a person with no on-the-job experience in phlebotomy to be
eligible for cerUfication as a Certified Phlebotomy Technician L he or she
shall:

(A) Be a high school graduate, or have achieved a passing score on the
general educational development (GED) test or documentation of equiv-
alent education pursuant to Section 1031.4(c)(6)(B); and

(B) Have completed a minimum of 40 hours didactic instruction pur-
suant to Section 1035.1(e) from a phlebotomy training program ap-
proved by the department; and

(C) Have completed a minimum of 40 hours practical instruction from
a phlebotomy training program approved by the department pursuant to
Section 1035.1(f), which instruction shall include completion of a mini-
mum of 10 skin punctures performed pursuant to the Business and Pro-
fessions Code Section 1 220(d)( 1 ) or (d)(2)(A) that fulfill all sampling re-
quirements of all clinical laboratory tests or examinations and 50
venipunctures performed pursuant to the Business and Professions Code
Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of
all clinical laboratory tests or examinations; and

(D) Have passed a written examination in phlebotomy administered
by a certifying organization approved by the department pursuant to Sec-
tion 1031.7; and

(E) Apply to the department for certification as a Certified Phlebotomy
Technician I pursuant to Section 1031.4(c).

(3) For a person who has less than 1040 hours on-the-job experience
in phlebotomy to be eligible for certification as a Certified Phlebotomy
Technician I, he or she shall:

(A) Be a high school graduate or have achieved a passing score on the
general educational development (GED) test or documentation of equiv-
alent education pursuant to Section 1031.4(c)(6)(B); and

(B) Have completed a minimum of 40 hours didactic instruction pur-
suant to Section 1035.1(e) from a phlebotomy training program ap-
proved by the department; and

(C) Have a letter signed by a licensed physician and surgeon or li-
censed clinical laboratory bioanalyst directing the laboratory employing
the person attesting his or her completion of a specified number of hours
of on-the-job experience in phlebotomy within the previous five years,
which shall include the activities listed in Section 1035.1(f) and comple-
tion of a minimum of 10 skin punctures performed pursuant to the Busi-
ness and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all
sampling requirements of all clinical laboratory tests or examinations
and 50 venipunctures performed pursuant to the Business and Profes-
sions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling re-
quirements of all clinical laboratory tests or examinations; and

(D) Have passed a written examination in phlebotomy administered
by a certifying organization approved by the department pursuant to Sec-
tion 1031.7; and

(E) Apply to the department for certification as a Certified Phlebotomy
Technician I pursuant to Section 1031.4(c).

(4) For a person who has 1 040 hours or more of on-the-job experience
in phlebotomy to be eligible for certification as a Certified Phlebotomy
Technician I, he or she shall:

(A) Be a high school graduate or have achieved a passing score on the
general educational development (GED) test or documentation of equiv-
alent education pursuant to Section 1031.4(c)(6)(B); and

(B) Have completed a minimum of 20 hours advanced didactic
instruction pursuant to Section 1035.1(e)(2) from a phlebotomy training
program approved by the department; and

(C) Have a letter signed by a licensed physician and surgeon or li-
censed clinical laboratory bioanalyst directing the laboratory employing
the person attesting his or her completion of a specified number of hours
of on-the-job experience in phlebotomy within the previous five years
which shall include the activities listed in Section 1035.1(f) and comple-
tion of a minimum of 10 skin punctures performed pursuant to the Busi-
ness and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all
sampling requirements of all clinical laboratory tests or examinations
and 50 venipunctures performed pursuant to the Business and Profes-
sions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling re-
quirements of all clinical laboratory tests or examinations; and

(D) Have passed a written examination in phlebotomy administered
by a certifying organization approved by the department pursuant to Sec-
tion 1031.7; and

(E) Apply to the department for certification as a Certified Phlebotomy
Technician I pursuant to Section 1031.4(c).

(5) For a person to be eligible for certification as a Certified Phleboto-
my Technician H, he or she shall:

Page 20.8

Title 17

State Department of Health Services

§ 1034.2

(A) Be a Certified Phlebotomy Technician I who holds a current, valid
certificate from the department or who meets certification requirements
as a Certified Phlebotomy Technician I pursuant to Section
1034(a)(4)(A)-(D) and who has at least 1040 hours on-the-job experi-
ence in phlebotomy in the previous 5 years as certified in writing by the
director(s) of the laboratory(ies) employing the person; and

(B) Have completed a minimum of 20 arterial punctures performed
pursuant to the Business and Professions Code ^Section 1220(d)(1) or
(d)(2)(A) that fulfill all sampling requirements of all clinical laboratory
tests or examinations and performed under the general overall responsi-
bility of a licensed physician and surgeon, licensed physician assistant,
licensed clinical laboratory bioanalyst, registered nurse, respiratory care
practitioner or a licensed clinical laboratory scientist, who will certify in
writing that this person has completed this practical instruction; and

(b) Performance of phlebotomy by a person certified by the depart-
ment shall be limited as follows:

( 1 ) A Limited Phlebotomy Technician shall perform skin punctures
only when he or she:

(A) Maintains a current, valid certification with the department as a
Limited Phlebotomy Technician; and

(B) Performs skin punctures under the supervision of a licensed physi-
cian and surgeon, licensed physician assistant, licensed clinical laborato-
ry bioanalyst, registered nurse, licensed clinical laboratory scientist or a
designee. A designee shall be licensed or certified under Chapter 3 and
shall be accountable to the laboratory director for skin punctures and oth-
er duties related to blood collection performed by the Limited Phleboto-
my Technician. The supervisor shall review the work of the technician
at least once a month and be accessible to the location where the techni-
cian is working to provide on-site, telephone, or electronic consultation
when blood is being collected; and

(C) Ls shown to be competent to perform skin punctures after employ-
ment without direct and constant supervision before being allowed to
perform skin puncture on patients. Documentation of competency shall
be done at least annually; and

(D) Has completed at least three hours per year, or six hours every two
years, of continuing education in phlebotomy related courses from a pro-
vider of continuing education approved pursuant to Article 2.5; and

(E) Has posted at the work location in the laboratory employing the
person, a current, valid state certificate as a Limited Phlebotomy Techni-
cian. When performing skin punctures away from the posted location, the
Limited Phlebotomy Technician shall carry a current, valid identification
card issued by the department attesting the person's name, certificate
type and effective dates of certification as a Limited Phlebotomy Techni-
cian.

(2) A Certified Phlebotomy Technician I shall perform skin punctures
and venipunctures only when he or she:

(A) Maintains a current, valid certification with the department as a
Certified Phlebotomy Technician I; and

(B) Performs skin punctures and venipunctures under the supervision
of a licensed physician and surgeon, licensed physician assistant, li-
censed clinical laboratory bioanalyst, registered nurse, licensed clinical
laboratory scientist or a designee. A designee shall be a person licensed
or certified under Chapter 3 and shall be accountable to the laboratory di-
rector for skin punctures, venipunctures and other duties related to blood
collection performed by the Certified Phlebotomy Technician L The su-
pervisor shall review the work of the technician at least once a month and
be accessible to the location where the technician is working to provide
on-site, telephone, or electronic consultation as needed; and

(C) Is shown to be competent to perform skin puncture and venipunc-
ture after employment without direct and constant supervision before be-
ing allowed to perform skin punctures or venipunctures on patients. Doc-
umentation of competency shall be done at least annually; and

(E) Has posted at the work location of the laboratory employing the
person, a current, valid state certificate as a Certified Phlebotomy Tech-
nician I. When performing skin punctures or venipunctures away from
the posted location, the Certified Phlebotomy Technician I shall carry a
current, valid identification card issued by the department attesting the
person's name, certificate type and effective dates of certification as a
Certified Phlebotomy Technician I.

(3) A Certified Phlebotomy Technician II shall perform skin punctures
and venipunctures only under conditions pursuant to Section I ()34(b)(2),
and shall be limited to performing arterial punctures only when a licensed
physician and surgeon, Hcensed physician assistant, licensed clinical lab-
oratory bioanalyst, registered nurse, licensed clinical laboratory scientist
or a respiratory care practitioner is present at the location during perfor-
mance of an arterial puncture, and when he or she:

(A) Maintains a current, valid certification with the department as a
Certified Phlebotomy Technician II; and

(B) Is shown to be competent to perform arterial punctures after em-
ployment by direct, personal observation and documentation of his or her
expertise in arterial punctures by a licensed physician and surgeon, li-
censed physician assistant, licensed clinical laboratory bioanalyst, regis-
tered nurse, licensed clinical laboratory scientist or a respiratory care
practitioner. Documentation of competency shall be done at least annual-
ly; and

(C) Has completed at least three hours per year, or six hours every two
years, of continuing education in phlebotomy related courses from a pro-
vider of continuing education approved pursuant to Article 2.5; and

(D) Has posted at the work location in the laboratory employing the
person, a current, valid state certificate as a Certified Phlebotomy Tech-
nician II. When performing arterial punctures, skin punctures, or veni-
punctures away from the posted location, the Certified Phlebotomy
Technician II shall carry a current, valid identification card issued by the
department attesting the person's name, certificate type and effective
dates of certification as a Certified Phlebotomy Technician II.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1208, 1212, 1220,
1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section
120580, Health and Safety Code.

History
\. Amendment filed 7-2-73 as an emergency; effective upon filing (Register 73,
No. 27). For prior history, see Register 72, No. 32.

2. Certificate of Compliance filed 10-24-73 (Register 73, No. 43).

3. Amendment filed 1-18-74; effective thirtieth day thereafter (Register 74, No.
3).

4. Amendment filed 1 2-1 2-75; effective thirtieth day thereafter (Register 75, No.
50).

5. Repealer and new section filed 1-9-2003; operative 4-9-2003 (Register 2003,

No. 2).

§ 1034.1. Unlicensed Personnel, Laboratory Aides.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: SecUon 1224, Business and Profes-
sions Code; and Section 100275, Health and Safety Code.

History

1. New secfion filed 6-8-72; effective thirtieth day thereafter (Register 72, No.
24).

2. Repealer of section and new Note filed 1-9-2003; operative 4-9-2003 (Regis-
ter 2003, No. 2).

§ 1034.2. Unlicensed Personnel, Cytotechnologist.

NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section
208, Health and Safety Code. Reference: Secfion 1270, Business and Professions
Code; Section 1002, Health and Safety Code.

History
1. Amendment filed 12-12-78; effecfive thirtieth day thereafter (Register 78, No.
50). For prior history, see Register 74, No. IH.

Page 20.9

§ 1035

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Repealer filed 1 1-18-93 as an emergency; operative 11-18-93 (Register 93,
No. 47). A Certificate ofCompliance must be transmitted toOAL by 3-18-94
or emergency changes will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 1 1-18-93 order transmitted to OAL 3-18-94
and filed 4-29-94 (Register 94, No. 17).

Article 2. Training

§1035. Training Schools.

(a) Any person operating a school or conducting any course for the
purpose of training or preparing individuals for a license under the provi-
sions of Chapter 3, Division 2 of the Business and Professions Code shall
submit, on forms provided by the department and subject to periodic re-
newal, such information as may be required by the department to satis-
factorily evaluate the personnel, equipment, quality of instruction, and
scope of activities of said schools.

(b) Persons providing instruction in general or specialized technic
shall provide training which when successfully completed will fully
qualify individuals to meet the minimum requirements for licensure un-
der the provisions of Article 4, Chapter 3, Division 2 of the Business and
Professions Code.

(c) A training school shall accept a person licensed for training in clini-
cal laboratory procedures only if there are on active duty in the laboratory
a minimum of two full-time actively employed persons who possess any
of the following licenses: clinical laboratory technologist, clinical labo-
ratory bioanalyst, physician and surgeon, or appropriate laboratory spe-
cialty.

(d) The ratio of licensed clinical laboratory personnel to trainees shall
be no less than 2:1.

(e) The following shall be minimum requirements for approval of lab-
oratories to employ clinical laboratory technologist trainees as provided
for in Article 2 of Chapter 3, Division 2 of the Business and Professions
Code:

( 1 ) There shall be adequate space and necessary equipment as defined
by the department to carry out the procedures of the laboratory and to pro-
vide training for the clinical laboratory technologist trainees.

(2) The workload of the laboratory training clinical laboratory tech-
nologist trainees shall meet minimum standards set by the department
and shall include at least the following: routine chemical determinations
commonly required on blood, spinal fluid, and other body fluids; mor-
phological, cultural, chemical and immunological tests for microbial
pathogens; tests for helminths and protozoa; examinations for normal
and abnormal blood cells; sedimentation rates, bleeding and coagulation
time determinations and other commonly employed tests in hematology;
precipitation, flocculation, agglutination or complement fixation tests;
blood typing, Rh factor determinations and pretransfusion procedures;
commonly employed serological tests; routine and microscopic urinaly-
ses and such other technics as may be required to properly instruct clini-
cal laboratory technologist trainees in current clinical laboratory proce-
dures.

(3) The amount of practical training required by each clinical laborato-
ry technologist trainee in order to fulfill the minimum requirements for
admission to the licensing examinations shall be in accordance with the
provisions of Article 4, Chapter 3, Division 2 of the Business and Profes-
sions Code. When one year of practical training in all subjects is neces-
sary, the minimum time devoted to each shall be as follows:

Biochemistry 12 Weeks

Hematology 8 Weeks

Pretransfusion Procedures 4 Weeks

Urinalysis 4 Weeks

Bacteriology 9 Weeks

Serology 4 Weeks

Parasitology 3 Weeks

Miscellaneous and review 8 Weeks

(4) When less than one or more than one year of practical training is
required toward admission to the clinical laboratory technologists' ex-
amination, the above time devoted to the various subjects shall be de-

creased or increased proportionately after the laboratory director has se-
cured approval from the department for the modification.

(5) However, when one or more years of practical training in any one
basic science or specialty is necessary, the laboratory director shall
modify this schedule, subject to prior approval by the department, so that
the area of concentration is in one or more subjects.

(6) Unless a trainee is a college graduate, he must receive during the
course of his training program a minimum of 40 clock hours of recitation
or instruction in the subjects covered in clinical laboratory work other
than that received as practical training in the laboratory. Any laboratory
school approved for specialist or limited technologist training must pro-
vide the department with adequately documented workload and program
information and must comply with the minimum requirements hereto-
fore stated in that special field of training.

(7) The requirements for the members of the teaching staff must be
those considered minimum for licensure, and in addition, persons with
an advanced degree in one or more of the fields covered in the curriculum
may be included on the teaching staff.

(8) The director of any school shall supply sufficient information to the
department to satisfy the department that adequate specimen material
will be made available for training purposes.

(9) There shall be available to persons receiving training a technical
library adequate in the number of copies of each text book.

(10) The names and addresses of persons receiving training are to be
reported to the department at the time of entrance to course and again at
completion of course.

(11) The department may require such other information as may be
necessary to satisfactorily evaluate the application for approval includ-
ing periodic on-site reviews.

(12) Approval for training granted by the department pursuant to re-
quirements of this section may be denied or withdrawn if the school is
unable to meet or maintain these requirements.

(f) Colleges or universities accredited by the Western College Associ-
ation or the Northwest Association of Secondary and Higher Schools or
an essentially equivalent accrediting agency, as determined by the de-
partment, conducting courses for the purpose of training or preparing
persons for a license under the provisions of Chapter 3, Division 2 of the
Business and Professions Code, shall be considered approved by the de-
partment. Provided, however, that when such training is carried out in
cooperation with other laboratories than those of said institutions, specif-
ic approval shall be obtained.

History

1 . Amendment filed 10-22-57; effective thirtieth day thereafter (Register 57, No.
18).

2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No.
21).

3. Amendment filed 5-18-64; effective thirtieth day thereafter (Register 64, No.
11).

4. Repealer and new section filed 12-28-71; effective thirtieth day thereafter
(Register 72, No. 1).

§ 1035.1. Phlebotomy Training Program Requirements.

(a) In order to be eligible for approval by the department to provide di-
dactic and/or practical phlebotomy instruction leading to certification of
phlebotomists, a phlebotomy training program shall meet the require-
ments of this section and be offered by either a:

(1) National Accrediting Agency for Clinical Laboratory Sciences
(NAACLS) approved program for training phlebotomists; or

(2) Accredited college or university; or

(3) Private, post-secondary program or occupational program regis-
tered or approved by the Bureau for Private Postsecondary and Vocation-
al Education; or

(4) California Adult Education or Regional Occupational Program
(ROP); or

(5) United States of America military medical laboratory specialist
program; or

(6) California licensed clinical laboratory.

Page 20.10

Title 17

State Department of Health Services

§ 1035.1

(b) A phlebotomy training program shall be directed by a licensed phy-
sician and surgeon, licensed physician assistant, registered nurse, or per-
son licensed under Chapter 3, who shall be responsible for:

( 1 ) Overall operation and administration of the phlebotomy training
program; and

(2) Ensuring the quality of the technical, scientific and clinical instruc-
tion; and

(3) Ensuring that the person(s) providing instruction meets the qualifi-
cations of this section; and

(4) Ensuring that the person(s) providing instruction is competent and
that his or her work performance is periodically evaluated, monitored and
documented.

(1) Licensed physician and surgeon; or

(2) Licensed physician assistant; or

(3) Registered nurse; or

(4) Person licensed under Chapter 3; or

(5) Respiratory care practitioner with a minimum of 2 years experi-
ence in the previous 5 years; or

(6) Certified phlebotomy technician with a minimum of 3 years of ex-
perience in the previous 5 years or a phlebotomist with 3 years of experi-
ence in the previous 5 years and employed as a phlebotomy instructor,
who shall meet certification requirements pursuant to Section 1034(a)(4)
on or before December 31, 2003.

(d) Person(s) specified in Subsection (c)(1) through (5) shall pass a
written examination in phlebotomy, administered by a certifying orga-
nization approved by the department pursuant to Section 1031.7 either:

( 1 ) Prior to employment by a phlebotomy training program approved
by the department pursuant to this section; or

(2) No later than December 31, 2003, if employed as a phlebotomy
instructor on or before April 9, 2003.

(e) An approved phlebotomy training program shall provide the fol-
lowing didactic instruction to its students:

( 1 ) A basic phlebotomy curriculum consisting of a minimum of 20
hours lecture and testing for knowledge of:

(A) Basic infection control, universal precautions and safety; and

(B) Basic anatomy and physiology of body systems with emphasis on
the circulatory system, the appropriate medical terminology; and

(D) Proper selection and preparation of skin puncture site, including
selection of antiseptic; and

(E) Blood collection equipment, types of tubes and additives, proper
order of draw when additives are required, special precautions; and

(F) Post-puncture care; and

(G) Appropriate disposal of sharps, needles and waste.

(2) An advanced phlebotomy curriculum consisting of a minimum of
20 hours of lecture and testing for knowledge of:

(A) Advanced infectious disease control and biohazards; and

(B) Anti-coagulation theory; and

(D) Anatomical site selection and patient preparation; and

(E) Risk factors and appropriate responses to complications which
may arise from phlebotomy; and

(F) Recognition of, and corrective actions to take, with problems in
test requisitions, specimen transport and processing; and

(G) Applications of basic concepts of communication, interpersonal
relations, stress management, professional behavior, ethics and legal im-
plications of phlebotomy; and

(H) Quality assurance in phlebotomy necessary to provide accurate
and reliable laboratory test results; and
(I) Legal issues related to blood collection.

(f) An approved phlebotomy training program shall provide a clinical
setting for a minimum of 40 hours of practical instruction in phlebotomy.

This setting shall provide access to patients whose blood is being tested
by a clinical laboratory. In order for a program to be eligible for approval
by the department, it shall provide documentation of a training curricu-
lum that includes:

(1) Selection of blood collection equipment appropriate to test requisi-
tions; and

(2) Preparation of the patient and infection control; and

(3) Skin punctures for testing purposes from patients of varying ages,
including pediatric and geriatric, and of varying health and obesity status;
and

(4) Venipunctures from patients of varying ages, health and obesity
status; and

(5) Post-puncture care; and

(6) Processing of blood containers after collection, including centrifu-
gation; and

(7) Proper disposal of needles, sharps and medical waste; and

(8) Observation of arterial punctures; and

(9) A practical examination showing evidence of successful comple-
tion of Subsections (f)(1) through (7).

(g) A phlebotomy training program shall be responsible for assuring
that a student completes a minimum of 10 skin punctures performed pur-
suant to the Business and Professions Code Section 1220(d)(1) or
(d)(2)(A) that fulfill all sampling requirements and 50 venipunctures per-
formed pursuant to the Business and Professions Code Section
1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clini-
cal laboratory tests or examinations during or after his or her practical
instruction.

(h) A phlebotomy training program shall provide a certificate of
completion to its students upon satisfactory completion of the program.
The program shall maintain a copy of this certificate for five years. This
certificate shall be signed by the director of the program and shall in-
clude:

(1) Name and address of the training program; and

(2) Name of the student; and

(3) Statement of satisfactory completion of the program; and

(4) Dates that training began and ended.

(i) A phlebotomy training program seeking approval from the depart-
ment shall provide documentation to substantiate that its program objec-
tives meet training criteria stated in this section. Verification may include
an on-site inspection of the program.

(j) A complete application for phlebotomy training program approval
shall include the following:

( 1 ) Name and address of the training program; and

(2) Location(s) of all sites where didactic and practical instruction oc-
cur; and

(3) Name(s) and license number(s) of the physician and surgeon, phy-
sician assistant, registered nurse, or person licensed under Chapter 3 who
is directing the program; and

(4) Name(s), license number(s) or certificate number(s), experience in
phlebotomy, and evidence of satisfactory performance on a phlebotomy
certification examination administered by a certifying organization with
departmental approval in effect at the time the examination was adminis-
tered, of every physician and surgeon, physician assistant, registered
nurse, person licensed under Chapter 3, respiratory care practitioner, cer-
tified phlebotomy technician, or phlebotomist pursuant to Subsection
(c)(6) who is supervising or providing instruction; and

(5) List of equipment, supplies and educational materials used for
instruction; and

(6) Curriculum and instructional objectives, including hours spent at
each activity.

(k) Timeframes for approval of training programs shall be as follows:

( 1 ) Submission of an application for approval shall be deemed to occur
on the date the complete application is received by the department.

(2) Written notification by the department to the applicant shall be
considered to occur on the date the documents are postmarked.

Page 20.11

§ 1035.3

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(3) The department shall notify the applicant within 60 days ofsubmis-
sion of an application for training program approval, of one of the follow-
ing:

(A) That the application is complete and acceptable for processing by
the department; or

(C) That the application has been reviewed and does not meet the re-
quirements of this section and that approval is denied.

(4) The department shall consider an application to have been aban-
doned by any applicant who fails to respond to the department's request
to submit specific information or documentation within 30 days of notifi-
cation pursuant to Section 1035.!(k)(3)(B).

(5) The department's time periods for processing an application, from
the date the initial application is received to the date the final decision is
made regarding approval, are as follows:

(A) The median time for processing an application is 90 days.

(B) The minimum time for processing is 30 days.

(m) To apply for renewal, a training program shall file a renewal ap-
plication at least 60 days prior to the end of the approval period and pro-
vide the following:

( 1 ) The name and address of the training program; and

(2) The name and license number of all directors; and

(3) The name, license or certificate number of all instructors; and

(4) The name(s) and location(s) of all didactic and practical instruc-
tion; and

(5) The curriculum and instructional objectives, including hours spent
at each activity; and

(6) The schedule of didactic and practical instruction for the next 24
months; and

(7) The listing of students who completed its program and the total
number of students who enrolled in its program in the previous approval
period; and

(8) The signature of the director(s) and date of the application for re-
newal.

(n) Failure to meet the requirements of this section shall be good cause
for denial or revocation of approval by the department.

(0) The training program shall notify the department in writing of any
change(s) in the information and material required by Subsections (a)
through (h) within 30 days after the change(s) has occurred.

NOTE: Authority cited: Sections 1224 and 1320, Business and Professions Code;
and Section 100275, Health and Safety Code. Reference: Sections 1208, 1220,
1222, 1222.5, 1242, 1242.5, 1246, 1269 and 1300, Business and Professions Code;
and Section 120580, Health and Safety Code.

History
1 . New section filed 1-9-2003; operative 4-9-2003 (Register 2003, No. 2).

§ 1035-3. Medical Laboratory Technician Training Program
Standards.

(a) In order to be eligible for approval by the department, a medical
laboratory technician training program shall be offered by either a:

(1) California licensed clinical laboratory; or

(2) Accredited college or university in the United States of America;
or

(3) United States of America military medical laboratory specialist
program of at least 26 weeks duration; or

(4) Laboratory owned and operated by the United States of America.

(b) The program director of a medical laboratory technician training
program shall be a physician and surgeon licensed under Chapter 5, or
a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory sci-
entist or clinical laboratory specialist licensed under Chapter 3. The pro-
gram director shall be responsible for the content, quality and conduct of
the training program and shall:

( 1 ) Employ instructors who are physicians and surgeons licensed un-
der chapter 5; doctoral scientists, clinical laboratory bioanalysts, clinical
laboratory scientists, or clinical laboratory specialists licensed under
chapter 3; medical laboratory technicians with five years practical expe-
rience licensed under Chapter 3; or public health microbiologists certi-
fied pursuant to Health and Safety Code Section 101 160.

(2) Assure that training includes at least 26 weeks, consisting of at least
1040 hours, of instruction and practical experience in moderate complex-
ity testing in chemistry, including routine chemistry, urinalysis, endo-
crinology and toxicology: hematology; microbiology, including bacteri-
ology, mycobacteriology, mycology, parasitology and virology; and
immunology, including syphilis serology and general immunology. The
training shall include at least 160 hours each in chemistry, hematology,
microbiology and immunology.

(3) Provide didactic training in:

(A) Pre-analytical skills including phlebotomy, specimen processing,
reagent preparation, and infection control, as specified in Secfion
1035.1(e) and (f); and

(B) Analytical skills required for performing tests of waived or moder-
ate complexity, including quality control, test calibration, quality assur-
ance, legal requirements for documentation of testing, data storage and
retrieval, safety and standard precautions, troubleshooting, preventive
maintenance, reagent preparafion and storage; and

(C) Post-analytical skills such as knowledge of factors that influence
test results and the ability to access and verify the validity of patient test
results through review of quality control values prior to reporting patient
test results; and

(D) Test methods commonly used in chemistry, hematology, micro-
biology and immunology, including clinical significance of test results,
how the tests interrelate and how the tests impact diagnosis and treat-
ment, quality assessment of test results, information processing and regu-
latory compliance in state and federal law.

(4) Provide practical training in:

(A) Phlebotomy that shall include 40 hours instruction and successful
completion of a minimum of 10 skin punctures and 50 venipunctures, as
specified in Section 1035.1(f); and

(B) Instruction and practical experience in the use of instruments; and

(D) Knowledge of instrument and test parameters to assess reason-
ableness of results; and

(E) Validation of moderate complexity test methods and clinical cor-
relation of test results.

(c) A medical laboratory technician training program shall provide a
certificate of completion to its students upon satisfactory completion of
the program. The program shall maintain a copy of this certificate for at
least five years. This certificate shall be signed by the director of the pro-
gram and shall include:

(1) Name and address of the training program; and

(2) Name of the student; and

(3) Statement of satisfactory completion of the program; and

(4) Dates that training began and ended.

(d) A program approved to train medical laboratory technicians shall
maintain records of its students for at least five years and shall make
available to the department documentation of the students successfully
completing their training.

(e) A medical laboratory technician training program seeking approv-
al from the department shall provide documentation to substantiate that
its program objectives meet training criteria stated in this section.

(f) A medical laboratory technician training program shall be allowed
to document program compliance with the requirements of this section
for a period dating up to four years prior to their initial application, after
the date of implementation of these standards. The program shall docu-
ment that, during the time preceding initial approval, the training pro-
gram met the standards pursuant to Section 1035.3(a) and (b).

Page 20.12

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(g) A complete application for a medical laboratory technician train-
ing program shall include the following:

( 1 ) The name and address of the primary training program, including
city, state, county and zip code; telephone number, FAX number and e-
mail address; and

(2) The location(s) of all sites where training will be conducted, in-
cluding city, stale and zip code; and

(3) The name{s) and qualifications of the person(s) directing and
instructing in the program including a copy of current licensure for each
person. Training programs in the United States of America but outside
California shall provide evidence that the director(s) and instructor(s)
substantially meet this licensure requirement by documenting inclusion,
licensure or certification in a class of personnel similar to those required
in Chapter 3 or requiring equivalent standards; and

(4) Dates the training program was conducted if prior approval is re-
quested as specified in Section 1035.3(f); and

(5) The didactic curriculum listing each class or topic with instruction-
al objectives, the instractorCs) and the amount of time allocated for each
class or topic, pursuant to Section 1035.3(b)(3); and

(6) Documentation of practical training in pre-analytical, analytical
and post-analytical skills, including instructor(s) and hours spent at each
activity, list of equipment, supplies and materials used pursuant to Sec-
tion 1035.3(b)(4); and

(7) The signature(s) of the program director(s), telephone number(s)
and date of application.

(h) A medical laboratory technician training program approval shall
be valid for a four-year period. To apply for renewal, the training pro-
gram shall file an application at least 1 20 days prior to the end of the ap-
proval period providing the following:

( 1 ) The name and address of the primary training program, including
city, state, county and zip code, telephone number, FAX number and e-
mail address; and

(2) The name, address, and telephone number(s) of the director(s) and
instructor(s), providing documentation of their current licensure; and

(3) Any changes in training locations, didactic and practical instruc-
tion, course objectives, equipment, supplies and materials, that shall be
made to the program from that approved in the previous application; and

(4) A listing of all students who completed its program and the total
number of students who enrolled in its program during the previous ap-
proval period; and

(5) The signature(s) of the program director(s) and the date of applica-
tion for renewal.

(i) The training program shall notify the department in writing of any
change(s) in the information and materials required by Section 1035.3(b)
through (d) within 30 days after the change(s) has occurred.

(j) Failure to meet and maintain the requirements of this section shall
be good cause for denial or revocation of approval by the department.
NOTE; Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206.5, 1208, 1209, 1222,
1222.5, 1242, 1246, 1260.3, 1269,1286 and 1300, Business and Professions Code.

History

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-1 3-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-12-2005 order, including amendment of sub-
section (b)(4)(E). transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register
2005, No. 37).

§ 1 035.4. Timeframes for Approval of Training Programs.

(a) Timeframes for approval of training programs to train clinical labo-
ratory personnel for licensure pursuant to Chapter 3 shall be as follows:

( 1 ) Submission of an application for approval shall be deemed to occur
on the date the application is received by the department.

(2) Written notification by the department to the applicant program
shall be considered to occur on the date the documents are postmarked.

(3) The department shall notify the applicant within 60 days of submis-
sion of an application for training program approval, of one of the follow-
ing:

(A) That the application is complete and acceptable for processing by
the department; or

(C) That the application has been reviewed and does not meet the re-
quirements of this section and that approval is denied.

(4) The department shall consider an application to have been aban-
doned by any applicant program which fails to respond to the depart-
ment's request to submit specific information or documentation within
30 days of notification pursuant to Section 1035.4(a)(3)(B).

(b) Timeframes for processing applications for renewal of approval to
train clinical laboratory personnel for licensure pursuant to Chapter 3
shall be as follows:

(1) The training program shall submit a renewal application at least
120 days prior to the end of the approval period.

(2) Within 30 days of receipt of a renewal application, the department
shall inform the training program in writing that the application is com-
plete and accepted for review, or deficient and what specific information
or documentation is required to complete the applicafion.

(3) Within 30 days of submitdng a completed renewal application, the
department shall inform the training program in writing whether its ap-
plicafion has been approved or denied.

(4) The department may authorize a training program to extend its ap-
proval during the fime its application is being reviewed when that train-
ing program is in good standing and its application was submitted at least
120 days prior to the end of the approval period.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1261.5, 1263, 1264, 1286
and 1302, Business and Professions Code.

History

1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register
2005, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-13-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Regis-
ter 2005, No. 1 9). A Certificate of Compliance must be transmitted to OAL by
9-12-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-12-2005 order, including subsection (b)(2),
transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).

Article 2.3. Clinical Laboratory Supervisors

§ 1036. Clinical Consultant.

(a) Every clinical laboratory director, under whom moderate or high
complexity tests or examinations are performed, shall either perform the
dufies of a clinical consultant or employ a clinical consultant who can
provide consultation about the appropriateness of testing ordered and in-
terpretation of test results, as specified in Section 1 209, chapter 3 of the
Business and Professions Code.

(b) The clinical consultant shall possess a current, valid license issued
by the State to direct a clinical laboratory pursuant to chapter 3, Business
and Professions Code, or to practice medicine, osteopathy or podiatry
pursuant to chapter 5, Business and Professions Code appropriate to the
specialties and subspecialties for which he or she is consulting.

(1) Provide clinical consultation to the clients of the laboratory; and

(2) Assist in ordering tests appropriate to meet clinical expectations;
and

(3) Ensure that test results include pertinent information required for
interpretation; and

Page 20.13

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(4) Communicate matters about quality of test results reported and in-
terpretation in relation to specific patient conditions.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275. Health and Sattty Code. Reference: Sections 1206, 1207, 1208, 1209,
1209.1 and 1210. Business and Professions Code.

History

1 . New article 2.3 (sections 1 036-1 036.4) and section filed 2-24-2000 as an emer-
gency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Com-
pliance must be transmitted to O AL by 6-23 -2000 or emergency language will
be repealed by operation of law on the follow ing day. For prior history, see Reg-
ister 72, No. 1.

2. New article 2.3 (sections 1036-1036.4) and section refiled 6-21-2000 as an
emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of
Compliance must be transmitted to OAL by 10-23-2000 or emergency lan-
guage will be repealed by operation of law on the following day.

3. New article 2.3 (sections 1036-1036.4) and section refiled 10-19-2000 as an
emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of
Compliance must be transmitted to OAL by 2-2 1-200 1 or emergency language
will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
subsections (a) and (b), transmitted to OAL 2-21-2001 and filed 4-3-2001
(Register 2001, No. 14).

§ 1036.1. General Supervisor.

(a) Every clinical laboratory director, under whom high complexity
tests or examinations are performed, shall either perform the duties of a
general supervisor or employ a general supervisor who shall be responsi-
ble for day-to-day supervision of laboratory operation and personnel
performing and reporting high complexity tests, pursuant to Section
1209, chapter 3 of Business and Professions Code.

(b) A general supervisor shall:

( 1 ) Possess an active, valid license issued by the State to perform high
complexity testing pursuant to chapter 3 of Business and Professions
Code or to practice medicine, osteopathy or podiatry pursuant to chapter
5 of Business and Professions Code appropriate to the specialty or spe-
cialties they are supervising; and

(2) Have a minimum of two years' experience in high complexity test-
ing in the specialty or specialties they are supervising.

(c) The general supervisor shall be accessible to testing personnel at
all times testing is performed by providing on-site, telephone or electron-
ic consultation to resolve technical problems.

(d) The general supervisor shall be responsible for ensuring that tests
and examinations are performed in compliance with chapter 3 of the
Business and Professions Code and Title 42, Code of Federal Regula-
tions, Part 493 standards as published October 1 , 1 994, regarding clinical
laboratories.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209,
1209.1 and 1210, Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New secdon refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

§ 1036.2. Moderate Complexity Laboratory Technical
Consultant.

(a) Every laboratory director, under whom moderate complexity tests
or examinations are performed, shall either perform the duties of a mod-
erate complexity laboratory technical consultant or employ a moderate
complexity laboratory technical consultimt who is responsible for pro-
viding technical and scientific consultation for each of the specialties and
subspecialties performed.

(b) A moderate complexity laboratory technical consultant of a labora-
tory performing moderate complexity testing shall:

(1) Possess an active, valid license issued by the State pursuant to
chapter 3 of the Business and Professions Code to perform high complex-
ity testing, or to practice medicine, osteopathy or podiatry pursuant to
chapter 5 of Business and Professions Code appropriate to the specialty
or specialties for which he or she is consulting; and

(2) Have a minimum of two years' experience in moderate or high
complexity testing in the specialty or specialties for which he or she is
consulting.

(c) A moderate complexity laboratory technical consultant shall be re-
sponsible for the technical and scientific oversight of the laboratory as
specified in Section 493. 1413, Title 42, Code of Federal Regulations, as
published October 1 , 1 994.

NOTE: Authority cited: Secfion 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209,
1209.1 and 1210. Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order, including amendment of
subsecfions (a) and (b)(l)-(2), transmitted to OAL 2-21-2001 and filed
4-3-2001 (Register 2001, No. 14).

§ 1036.3. Waived Laboratory Supervisor.

(a) A laboratory director of a clinical laboratory performing waived
tests may delegate or reapportion his or her responsibilities, as allowed
by Section 1209 of the Business and Professions Code, by utilizing a
waived laboratory supervisor. Except for a waived laboratory supervisor
of a laboratory performing blood glucose testing by a person certified as
an Emergency Medical Technician 11 or Paramedic pursuant to Division
2.5 (commencing with section 1797) of the Health and Safety Code and
pursuant to subsection (c) and (d), a waived laboratory supervisor shall:

(1) Be Usted in Section 1206.5 of the Business and Professions Code;
and

(2) Possess at least a baccalaureate degree from an accredited college
or university; and

(3) Have at least one year of training or experience in clinical laborato-
ry testing in those tests or examinations that he or she will be supervising;
and

(4) Document competency in those tests he or she will be supervising
to the laboratory director at least semiannually during the first year and
annually, or whenever new instrumentation is added, thereafter.

(b) Except for a waived laboratory supervisor of a laboratory perform-
ing blood glucose testing by a person certified as an Emergency Medical
Technician II or Paramedic pursuant to Division 2.5 (commencing with
section 1797) of the Health and Safety Code, a waived laboratory super-
visor shall be responsible for:

(1) Selecting, in consultation with the laboratory director, the test
methodology appropriate for clinical use of test results; and

(2) Establishing a quality control program appropriate for the tests per-
formed, which follows the test manufacturer' s parameters for acceptable
levels of analytical performance and ensures that these levels are main-
tained throughout the entire testing process from initial receipt of the
specimen through sample analysis and test result reporting; and

(3) Resolving technical problems and ensuring remedial actions are
taken and documented whenever test systems deviate from the manufac-
turer's established performance specifications; and

(4) Ensuring patient test results are not reported until all corrective ac-
tions have been taken and the test system is performing properly; and

Page 20.14

Title 17

State Department of Health Services

§ 1038

(5) Identifying training needs and assuring that each individual per-
forming tests receives regular in-service training and education ap-
propriate for waived testing; and

(6) Evaluating and documenting that the staff maintain their compe-
tency to perform test procedures and report tests promptly, accurately
and proficiently by:

(A) Directly observing routine test performance, including patient
preparations (if applicable), specimen handling, processing and testing;
and

(B) Monitoring the recording and reporting of test results; and

(D) Directly observing performance of instrument maintenance and
function checks; and

(E) Assessing problem solving skills; and

(F) Evaluating and documenting the performance of individuals re-
sponsible for waived testing at least semiannually during the first year the
individual tests patient specimens. Thereafter evaluations shall be per-
formed at least annually unless test methodology or instrumentation
changes (in which case and prior to reporting patient test results, the indi-
vidual's performance shall be re-evaluated to include the use of the new
test methodology or test instrumentation).

(c) A waived laboratory supervisor of a laboratory performing blood
glucose testing by a person certified as an Emergency Medical Techni-
cian II or Paramedic pursuant to Division 2.5 (commencing with section
1797) of the Health and Safety Code shall:

(1) Hold a current, active license as an Emergency Medical Techni-
cian-Paramedic pursuant to Health and Safety Code Section 1797.194,
as a registered nurse pursuant to Chapter 6 (commencing with Section
2700) or as a person under Chapter 3 (commencing with Section 1 200)
authorized to engage in clinical laboratory practice or to direct a clinical
laboratory; and

(2) Have at least one year training or experience in blood glucose test-
ing in the method or procedure that he or she will be supervising.

(d) The waived laboratory supervisor of a laboratory performing blood
glucose testing as specified in subsection (c) shall be responsible for:

( 1 ) Documenting that each individual performing blood glucose is
competent to perform the test before he or she starts testing and whenever
new methodologies or technologies are added; and

(2) Ensuring that manufacturer's instructions for test performance,
equipment maintenance and quality control are followed; and

(3) Resolving technical problems and ensuring remedial actions are
taken and documented whenever test systems deviate from the manufac-
turer's established performance specifications.

(e) A waived laboratory technical supervisor shall be accessible to the
laboratory testing personnel to provide onsite, telephone or electronic
consultation. The laboratory director of a laboratory performing blood
glucose testing by a person certified as an Emergency Medical Techni-
cian II or Paramedic pursuant to Division 2.5 (commencing with section
1797) of the Health and Safety Code may designate a licensed physician
and surgeon or an authorized registered nurse at the hospital serving as
the base hospital to provide such consultation.

NoTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209,
1209.1 and 1210, Business and Professions Code.

History

1 . New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register
2000. No. 8). A Certificate of Compliance must be transmitted to OAL by
6-23-2000 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 1 0-1 9-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000. No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of CompHance as to 10-19-2000 order, including amendment of
section headina and section, transmitted to OAL 2-21-2001 and filed
4-3-2001 (Register 2001, No. 14).

§1036.4. Technical Supervisor.

(a) Every laboratory director, under whom high complexity tests or ex-
aminations are performed, shall either perform the duties of a technical
supervisor or employ a technical supervisor who is responsible for the
technical and scientific oversight of the laboratory.

(b) A technical supervisor of a laboratory performing high complexity
testing shall:

( 1 ) Possess an active, valid, license issued by the state to perform high
complexity testing pursuant to chapter 3 of Business and Professions
Code or to practice medicine, osteopathy or podiatry, pursuant to chapter
5 of Business and Professions Code appropriate to the specialty or spe-
cialties for which they are consulting; and

(2) Meet the experience requirements in Section 493. 1449 of Title 42
of the Code of Federal Regulations, as published October 1 , 1 994.

(c) While not required to be on site at all times testing is performed,
a technical supervisor shall be available to laboratory testing personnel
at all times to provide either on-site, telephone or electronic consultation.

(d) A technical supervisor shall be responsible for all the activities
Hsted in Section 493. 1 45 1 of Title 42 of the Code of Federal Regulations,
as published October 1, 1994.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Secfions 1206, 1207, 1208, 1209,
1209.1 and 1210, Business and Professions Code.

History

2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Regis-
ter 2000. No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-23-2000 or emergency language will be repealed by operation of law on the
following day.

3. New section refiled 10-19-2000 as an emergency; operative 1 0-24-2000 (Reg-
ister 2000, No. 42). A Certificate of Compliance must be transmitted to OAL
by 2-21-2001 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 10-19-2000 order transmitted to OAL
2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

Article 2.5. Continuing Education

§1038. Definitions.

(a) The definitions set forth in subsections b through j inclusive shall
govern the interpretation of this article.

(b) "Contact Hour" means the actual time a licensee participates in
continuing education offered by an approved provider, utilizing the fol-
lowing conversion standards:

50-60 minutes = 1 contact hour

0.1 continuing education unit (CEU) = 1 contact hour

1 quarter unit - 1 0 contact hours

1 semester unit = 15 contact hours

(c) "Accredited Academic Institution" means an academic institution
accredited by the Western Association of Schools and Colleges or an ac-
crediting organization recognized by the Council of Post Secondary Edu-
cation.

(d) "Accrediting Agency" means an organization approved by the De-
partment pursuant to Section 1038.2 which evaluates and grants approval
to providers of continuing education who comply with the standards of
that agency, and who are other than those identified in (c) above.

(e) "Approved Provider" means an accredited academic institution or
any person or entity offering continuing education who has been ap-
proved by an accrediting agency.

(f) "Licensee" means those persons other than clinical laboratory tech-
nologist trainees licensed pursuant to Chapter 3 (commencing with sec-
tion 1200) of Division 2 of the Business and Professions Code.

Page 20.15

§ 1038.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(g) "Quarter Unit" and "Semester Unit" means the hours of instruction
offered by an accredited academic institution which are credited by that
institution as a quarter unit and semester unit respectively.

(h) "Active Status" means a current license in good standing which au-
thorizes the licensee to perform the functions described in this chapter.

(i) "Inactive Status" means a license which is not in good standing be-
cause the holder has not completed the continuing education require-
ments of this article or has voluntarily requested that the license be made
inactive.

(j) "Continuing Education Program" means a presentation given by an
approved provider at a scheduled time or times which conforms to the re-
quirements of section 1038.3.

NOTE: Authority cited: Sectionsl224 and 1273. Business and Professions Code;
and Section 208, Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History
1. New Article 2.5 (sections 1038-1038.7) and section filed 1-28-94; operative

1 -28-94 pursuant to Government Code section 1 1 346.2(d) (Register 94, No. 4).

§ 1038.1. Continuing Education Requirements.

(a) All persons licensed under Division 2, Chapter 3 of the Business
and Professions Code, commencing with Section 1 200, whose license is
in active status shall complete 12 contact hours of continuing education
each calendar year. All persons licensed with more than one active li-
cense type pursuant to Division 2, Chapter 3 of the Business and Profes-
sions Code shall be able to renew all license types after completion of a
total of 1 2 contact hours of continuing education each calendar year.

(b) At the time of renewal, each licensee shall provide the Department
with the date, name and number of contact hours received for each con-
tinuing education program successfully completed by the licensee in the
previous calendar year.

(c) The licensee shall retain continuing education documents received
from approved providers under Section 1038.4 for a minimum of four
years.

(d) A random sample of licensees shall be audited by the Department
to determine compliance with the continuing education requirement.
Those licensees selected for audit shall submit to the Department, within
30 calendar days of notification of selection, a copy of each document
provided the Hcensee under section 1038.4(c) since the date of last li-
cense renewal.

(e) Any licensee who is found to have not successfully completed the
continuing education requirement of this article will be placed in inactive
status. The licensee shall have the right to appeal such findings to the De-
partment. An appeal shall be conducted in compliance with chapter 5
(commencing with section 1 1500) of Part I of Division 3 of Title 2 of the
Government Code.

NOTE: Authority cited: Sections 1224 and 1275, Business and Professions Code;
and Section 208, Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History

1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code
section 11346.2(d) (Register 94, No. 4).

§1038.2. Accrediting Agencies.

(a) Any organization seeking approval as an accrediting agency shall
submit an application to the Department which shall include documenta-
tion of the following:

(1) The organization's name, address, and owner(s);

(2) The organization's structure, function, and philosophy for moni-
toring the content, quality, and faculty of approved programs; and,

(3) The person designated by the organization to be responsible for
overseeing the administration and coordination of all continuing educa-
tion providers approved by the organization.

(b) The Department' s review of an accrediting agency shall include an
evaluation of the following:

( 1 ) Whether the organization' s philosophy shows an identifiable com-
mitment to continuing education;

(2) Whether the organization's mechanism for monitoring the content,
faculty, education methods, quality, and facilities of approved providers
meets the criteria of section 1038.3; and,

(3) Effective mechanisms for responding to complaints about ap-
proved providers and the ability to take effective action to insure that ap-
proved providers comply with sections 1038.3 and 1038.4.

(c) The Department shall approve an organization as an accrediting
agency and issue an approval upon satisfactory review under subsections
(a) and (b). Such approval may be subject to special terms as specified
by the Department.

(d) Within 30 calendar days of receipt of an application by an organi-
zation for approval as an accrediting agency, the Department shall inform
the organization in writing that the application is either complete and ac-
cepted for review or that it is deficient and what specific information or
documentation is required to complete the application.

(e) Within 30 calendar days from the date of filing of a completed
application, the Department shall inform the applicant organization in
writing whether the organization has been approved as an accrediting
agency.

(f) The Department's time periods for processing an application for
approval as an accrediting agency, from the receipt of the initial applica-
tion to the final decision regarding the approval, are as follows:

(1) The median time for processing is 60 calendar days.

(2) The minimum time for processing is 45 calendar days.

(3) The maximum time for processing is 90 calendar days.

[The next page is 21.]

Page 20.16

Title 17

State Department of Health Services

§ 1038.7

(g) An accrediting agency sliall maintain for five years and shall make
available to the Department, the name of each approved provider, the
title, date, and number of contact hours awarded for each program of-
fered by its approved providers, and a list of all participants in each pro-
gram offered.

(h) An accrediting agency shall be subject to review by the Department
to determine adherence to requirements of this ardcle. Failure of an ac-
crediting agency to meet the requirements of this article or its terms of
approval is good cause for revocation of approval by the Department.
NOTH: Authority cited: Sections 1224 and 1275, Business and Professions Code;
and Section 208, Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code
section 1 1.146.2(d) (Register 94. No. 4).

§1038.3. Approval of Providers.

(a) An accrediting agency shall approve only providers who offer con-
tinuing education programs that meet all of the following criteria:

( 1 ) Use instructors who are competent in subject matter by education,
training or experience;

(2) Are a minimum of 50 minutes in duration excluding evaluation by
participants of the continuing education program;

(.S) Are relevant to the scope of practice of clinical laboratory science
and may include education, supervision, and management;

(4) Have clearly stated, measurable, education objectives; and,

(5) Use teaching methods which are consistent with the objectives of
the continuing education program.

Noi K: Authority cited: Sections 1224 and 1275, Business and Professions Code;
and Section 208. Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code
section 11 346.2(d) (Register 94, No. 4).

§ 1038.4. Approved Providers.

(a) No person or entity shall represent itself as an approved provider
unless approved by an accrediting agency or unless it is an accredited
academic institution.

(b) Approved providers shall issue certificates to participants which
include:

(A) The participant's name;

(B) Contact hours;

(D) Name and address of both program provider and accrediting
agency; and,

(E) Signature of instructor and/or provider or provider designee.

(c) Accredited academic institutions shall provide certificates to every
participant upon completion of a continuing education program which
includes all the information in subsection (b), except the approved pro-
vider will not be required to issue a certificate when the continuing edu-
cation program is a regularly scheduled class and documented on a stu-
dent transcript.

(d) An approved provider shall maintain an official record verifying
all participants' attendance at continuing education programs for at least
four years after the completion date. The provider shall include the par-
ticipant on the official record of attendance only if the participant's signa-
ture was obtained at the time of attendance at the program. The official
record of attendance shall contain the name of the participant and shall
identify the time, date, location, subject matter, and length of the continu-
ing education program and shall be provided to the Department upon re-
quest at no cost to the Department.

(e) If two or more approved providers jointly provide a continuing
education program, the providers shall designate the provider responsi-
ble for keeping records and issuing certificates to participants.

(f) An approved provider shall evaluate the effectiveness of continu-
ing education programs to determine whether the program objectives re-
quired under section 1038.3 subsection (a)(5) were met. This evaluation

shall include a written evaluation by the participants, or pre- and post-
examination.

(g) An approved provider shall allow, at no cost, in-pcrson observa-
tion of continuing education programs by employees of the Depai'tment
of Health Services for purposes of monitoring compliance with sections
1038.3 and 1038.4.

NOTE: Authority cited: Sections 1224 and 1275, Business and Professions Code;
and Section 208, Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code

section 1 1346.2(d) (Register 94, No. 4).

§1038.5. Waiver of Requirement.

(a) At the time of making application for renewal of a license issued
pursuant to Division 2, Chapter 3 of the Business and Professions Code
(BPC), a licensee may request a waiver of all or part of the continuing
education requirement. To be eligible for a waiver, a license holder shall
verify in writing that he or she:

( 1 ) Was residing in another country for at least half the license period
since the license was issued or, if the license was previously renewed,
since it was last renewed, and that this reasonably prevented completion
of the continuing education requirements; or

(2) Was absent from California for at least half the license period since
the license was issued or, if previously renewed, since it was last re-
newed, because of military service, and that this reasonably prevented
completion of the continuing education requirements; or

(3) Was prevented from completing the continuing education require-
ments for reasons of ill health or other good cause, including, but not lim-
ited, to:

(A) Total physical and/or mental disability of the licensee for at least
half of the period since the license was issued or, if previously renewed,
since it was last renewed; or

(B) Total physical and/or mental disability of an immediate family
member for at least half of the period since the license was issued or, if
previously renewed, since it was last renewed, where the licensee has to-
tal responsibility for the care of that family member.

(4) Verification of a disability under paragraph (3) shall include a cor-
roborating statement by a licensed physician.

Note-. Authority cited: Sections 1224 and 1275, Business and Professions Code;
and Section 208, Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code
section 11346.2(d) (Register 94, No. 4).

§ 1 038.6. inactive Status.

A licensee whose license issued pursuant to Division 2, Chapter 3 of
the Business and Professions Code is in inactive status shall document
12 hours of continuing education for the year prior to reinstatement or
pass the examination for licensure prior to reinstatement to active status.
Note: Authority cited: Sections 1224 and 1275. Business and Professions Code;
and Section 208, Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History
1. New section filed 1-28-94; operative 1-28-94 pursuant to Government Code

secdon 1 1346.2(d) (Register 94, No. 4).

§1038.7. Fees.

(a) A fee of $250.00 shall accompany an application for approval or
renewal as an accrediting agency.

(b) At the time of initial application or renewal of a clinical laboratory
personnel license, an additional fee of $8.00 shall be paid by each licens-
ee to support the costs of administering and enforcing the continuing edu-
cation requirements of this article.

Note: Authority cited: Sections 1224 and 1275, Business and Professions Code;
and Section 208, Health and Safety Code. Reference: Section 1275, Business and
Professions Code.

History

1. New section filed 1-28-94; operafive 1-28-94 pursuant to Government Code
secdon 1 1346.2(d) (Register 94, No. 4).

Page 21

§ 1039.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 2.8. CLIA Certification/State
Licensure

§ 1 039.1 . Recognition of CLIA Certification for Limited
Purpose and Period.

(a) Except for a certificate of accreditation issued by HHS, a CLIA cer-
tificate issued to a clinical laboratory that on December 31,1 995 was not
required to obtain a stale license pursuant to Section 1241 of Chapter 3,
shall be considered to be a state license or registration issued pursuant to
Chapter 3 until such time as CLIA exempt status is obtained, provided
that the CLIA certificate is for the type and complexity of clinical labora-
tory tests or examinations performed and that it remains in effect, unsus-
pended and unrevoked during the entire period covering January 1 , 1 996
to when CLIA exempt status is granted by HHS.

(b) A certificate of accreditation issued by HHS to a clinical laboratory
that on December 31,1 995 was not required to obtain a state license pur-
suant to Section 1241 of Chapter 3, shall be considered a state license or
registration issued pursuant to Chapter 3 until such time as the accredita-
tion body, upon whose accreditation the certificate of accreditation was
issued by HHS, fails to be approved by the department as having accredi-
tation standards that are equal to, or more stringent than, state require-
ments for licensure; and, provided that:

(1) The certificate of accreditation issued by HHS is for the type and
complexity of clinical laboratory tests or examinations performed and
that it remains in effect, unsuspended and unrevoked; and

(2) After exempt status is obtained, the accredited laboratory pays the
department the $100 annual certificate of accreditation renewal fee.

(c) A certificate of waiver issued by HHS, to a clinical laboratory that
on December 31,1 995 was required to obtain a state license, and that per-
forms only waived tests, physician performed microscopy, or both, shall
be considered to be a state registration issued pursuant to Chapter 3 until
such time as CLIA exempt status is obtained, provided that the certificate
of waiver remains in effect, unsuspended and unrevoked during the en-
tire period covering January 1, 1996 to when CLIA exempt status is
granted by HHS.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275. Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265,
1281 and 1288.5, Business and Professions Code.

History

1. New article 2.8 (sections 1039.1-1039.3) and section filed 5-28-96 as an emer-
gency; operative 5-28-96 (Register 96, No. 22). A Certificate of Compliance
must be transmitted to OAL by 9-25-96 or emergency language will be re-
pealed by operation of law on the following day.

2. New article 2.8 (sections 1039.1-1039.3) and section refiled 10-7-96 as an
emergency, including amendment of subsections (a) and (c); operative 1 0-7-96
(Register 96, No. 41). A Certificate of Compliance must he transmitted to OAL
by 2^1-97 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 10-7-96 order, including amendment of subsec-
tion (b), transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§ 1039.2. Clinical Laboratory Personnel Requirements.

(a) All persons performing, supervising, consulting on, or directing
clinical laboratory tests or examinations m California shall meet the re-
quirements for performing, supervising, consulting on, or directing labo-
ratory tests or examinations as set forth in Chapter 3 for the type and com-
plexity of tests performed and irrespective of whether the clinical
laboratory is operated under a CLIA certificate or under a state license
or registration.

(b) All persons performing, supervishig, consulting on, or directing
clinical laboratory tests or examinations outside California on biological
specimens originating in California, and irrespective of whether the clin-
ical laboratory where the tests or examinations are performed is operated
under a CLIA certificate or under a state license or registration, shall meet
all personnel requirements set forth in Chapter 3 for the type and com-
plexity of testing performed, or shall pro\ ide evidence to the department

that they substantially meet those requirements by documenting inclu-
sion, licensure or certification in a class of personnel similar to those re-
quired in Chapter 3 or requiring equivalent standards.
NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206, 1206.5. 1209, 1241.
1244, 1265, 1281 and 1288.5, Business and Professions Code.

History

1 . New section filed 5-28-96 as an emergency; operative 5-28-96 (Register 96,
No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96
or emergency language will be repealed by operafion of law on the following
day.

2. New section refiled 1 0-7-96 as an emergency; operative 1 0-7-96 (Register 96.
No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-7-96 order, including amendment section,
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§ 1039.3. State Licensure or Approval Required During
CLIA Exemption.

All clinical laboratories except those idenUfied in subdivision (b) of
Section 1241, or in Section 1244 of the Business and Professions Code,
shall have in effect a state license or state registration, and all public
health laboratories shall be approved public health laboratories during
any period for which HHS grants CLIA exempt status for chnical labora-
tories or public health laboratories licensed, registered or approved by the
department.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Heahh and Safety Code. Reference: Secdons 1206, 1241, 1244, 1265,
1281 and 1288.5, Business and Professions Code.

History

1. New section filed 5-28-96 as an emergency; operative 5-28-96 (Register 96,
No. 22). A Certificate of Compliance niust be transmitted to OAL by 9-25-96
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-7-96 as an emergency; operative 10-7-96 (Register 96,
No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-97
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-7-96 order transmitted to OAL 2-3-97 and
filed 3-19-97 (Register 97, No. 12).

Article 3. License

§ 1 040. Forfeited Licenses.

(a) No license which has been forfeited for failure to pay the required
fee shall be reinstated until a written request for reinstatement and all un-
paid fees have been received by the department.

(b) If the renewal fee is not paid for five or more years, an examination
will be required in addition to the requirements of subsection (a) above
before the license may be reinstated, except as otherwise provided in Di-
vision 2, Chapter 3. Section 1301 of the Business and Professions Code.
NOTE: Authority cited: Sections 1 02 and 208, Health and Safety Code. Reference:
Section 1303, Business and Professions Code.

History

1. Amendment filed 2-18-58; effective thirtieth day thereafter (Register 58, No.
3).

2. Amendment filed 1 1-25-70 as procedural and organizational; designated effec-
tive 11-24-70 (Register 70, No. 48).

3. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register

71, No. 4).

§1041. Fee Credits.

Each clinical laboratory that pays a fee subject to reduction under sub-
division (u) of Section 1300 of the Business and Professions Code shall
have any reduction credited against the clinical laboratory's future li-
cense, registration or other fees payable under Chapter 3.
NOTE: Authority cited: Section 1224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Section 1300, Business and Profes-
sions Code.

History
1 . New section filed 1 1-25-70 as procedural and organizational; designated effec-
tive 1 1-24-70 (Register 70, No. 48).

Page 22

Title 17

State Department of Health Services

§ 1050

2. Certificate of Compliance— Sec. 1 1422.1, Gov. Code, filed 1-20-71 (Register

71, No. 4).

3. Amendment of subsection (a) filed 6-5-78; effective thirtieth day thereafter
(Register78. No. 23).

4. Repealer filed 4-22-82; effective thirtieth day thereafter (Register 82, No. 17).

5. New section heading, section and Note filed 5-28-96 as an emergency; opera-
tive 5-28-96 (Register 96, No. 22). A Certificate of Compliance must be trans-
mitted to OAL by 9-25-96 or emergency language will be repealed by opera-
tion of law on the following day.

6. New section heading, section and Noti-; refiled 10-7-96 as an emergency: op-
erative 10-7-96 (Register 96, No. 41). A Certificate of Compliance must be
transmitted to OAL by 2-4-97 or emergency language will be repealed by oper-
ation of law on the following day.

7. Certificate of Compliance as to 1 0-7-96 order, including amendment of section,
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§ 1042. Substantial Relationship Criteria.

Four purposes of denial, suspension or revocation of a license, certifi-
cate or permit pursuant to Division L5 (commencing with Section 475)
of the Business and Professions Code, a crime or act shall be considered
to be substantially related to the qualifications, functions, or duties of a
person who is an applicant or holder of a license, certificate or permit un-
der Chapter 3, Division 2, of the Business and Professions Code if to a
substantial degree it evidences present unfitness of a person holding a li-
cense, certificate or permit to perform the functions authorized by such
license, certificate or permit in a manner consistent with the public
health, safety or welfare. Such crimes or acts shall include but not be lim-
ited to the following:

(a) Violating or attempting to violate, directly or indirectly, or assist-
ing in or abetting the violation of, or conspiring to violate, any provision
of Chapter 3, Division 2 of the Business and Professions Code.

(b) Acts of dishonesty, fraud or deceit with intent to substantially bene-
fit himself or another, or substantially injure another.

(c) Acts of gross negligence in the performance of functions autho-
rized by the license, certificate or permit under Chapter 3, Division 2, of
the Business and Professions Code.

A license, certificate or permit shall not be denied, suspended or re-
voked because of a lack of good moral character or any similar ground
relating to a person's character, reputation, personality or habits.

NOTE: Authority cited: secfions 208, 3901, 15020 and 25800-25870, Health and
Safety Code; section 1224, Business and Professions Code. Reference: Secfions
3901, 15000-15023 and 2581 1, Health and Safety Code; Sections 475, 480, 481,
482, and 1242.5, Business and Professions Code.

History
1 . New section filed 1 2-1 2-75; effective thirtieth day thereafter (Register 75, No.
50). For former history, see Register 71, No. 4.

§ 1 042.1 . Criteria for Evaluating Rehabilitation.

(a) When considering the denial of a license, permit or certificate un-
der Section 480 of the Business and Professions Code, for which applica-
tion has been made under Chapter 3, Division 2, of the Business and Pro-
fessions Code, the Department, in evaluating the rehabilitation of the
applicant and his present eligibility for a Hcense, permit or certificate,
shall consider the following criteria:

( 1 ) The nature and severity of the act(s) or crime(s) under consider-
ation as grounds for denial.

(2) Evidence of any act(s) committed subsequent to the act(s) or
crime(s) under consideration as grounds for denial which also could be
considered as grounds for denial under Section 480 of the Business and
Professions Code.

(3) The time that has elapsed since commission of the act(s) or crime(s)
referred to in subsection (a) (1) or (a) (2).

(4) The extent to which the applicant has complied with any terms of
parole, probation, restitution or any other sanctions lawfully imposed
upon the applicant.

(5) Evidence, if any, of rehabilitation submitted by the applicant.

(b) When considering the suspension or revocation of a license, permit
or certificate issued under Chapter 3, Division 2 of the Business and Pro-
fessions Code on the grounds of conviction of a crime, the Department,

in evaluating the rehabilitation of such person and his present eligibility
for a license, permit or certificate shall consider the following criteria:

( 1 ) Nature and severity of the act(s) or offense(s).

(2) Total criminal record.

(3) The time that has elapsed since commission of the act(s) or of-
fense(s).

(4) Whether the licensee has complied with any terms of parole, proba-
tion, restitution or any other sanctions lawfully imposed against the li-
censee.

(5) If applicable, evidence of expungement proceedings pursuant to
Section 1203.4 of the Penal Code.

(6) Evidence, if any, of rehabilitation submitted by the licensee.

(c) When considering a petition for reinstaiement of a license, permit
or certificate, the Department shall evaluate evidence of rehabilitation,
considering those criteria of rehabilitation listed in subsection (h).
NOTE: Authority cited: Sections 208, 3901. 15020 and 25800-25870, Health and
Safety Code: Section 1224, Business and Professions Code. Reference: Sections
3901, 15000-15023 and 2581 1. Health and Safety Code; Secfions 475, 480, 481,
482 and 1242.5, Business and Professions Code.

History
1 . New section filed 12-12-75; effective thirtieth day thereafter (Register 75, No.

50).

Article 4. Personnel Report

§ 1045. Personnel Report.

All clinical laboratory directors shall on or before December 1 5th of
each calendar year transmit to the department, on forms provided by the
department, the names of all persons performing clinical laboratory pro-
cedures including, but not limited to biochemical, bacteriological, para-
sitological, hematological, or serological procedures. All clinical labora-
tory directors shall keep the department advised of current changes in
employment of such technical personnel giving employment and/or sep-
aration dates of personnel.

Article 5. Issuance of License

§ 1050. Clinical Laboratory Standards.

(a) All licensed cHnical laboratories shall be conducted, maintained,
and operated without injury to the public health and shall maintain re-
cords, equipment, and facilities which are adequate and appropriate for
the services rendered and demonstrate satisfactory performance in a pro-
ficiency program approved by the department.

(b) Proficiency Testing.

(1) The laboratory must participate in a state approved proficiency
testing program and demonstrate satisfactory performance in all of the
laboratory speciaUies that include tests performed in the laboratory. Pro-
ficiency shall be tested in the following specialties: microbiology, serol-
ogy, clinical chemistry, hematology, and immunohematology.

(2) The participating laboratory must test applicable materials each
time they are distributed by the approved proficiency testing service ac-
cording to a schedule approved by the department.

(3) Those procedures performed by the laboratory for which test mate-
rials are provided by the approved proficiency testing service and which
have been designated by the department as a requirement for measuring
test performance, must be proficiency tested by the participating labora-
tory each time test materials are received.

(4) The pardcipafing laboratory must authorize the approved profi-
ciency testing service to report proficiency test results to the department.

(5) The participating laboratory must test applicable materials only in
the laboratory to which the license and the proficiency testing require-
ment applies using personnel and equipment used in that facility in pro-
viding services.

(6) A laboratory may be required to discontinue providing a service in
a procedure or category of procedures if:

Page 22.1

§1050

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(A) For three consecutive quarters the laboratory fails to report on test
materials received for procedures for which the laboratory is required to
be proficiency tested, or

(B) For three consecutive quarters the laboratory demonstrates unsat-
isfactory performance in a procedure or category of procedures. A deter-
mination of satisfactory performance for a procedure shall be based upon
results being within acceptable limits established by the proficiency test-
ing service for that procedure and approved by the department. A deter-
mination of satisfactory performance for a category of procedures shall
be based upon an average of performance within the category over four
consecutive quarters.

(7) A laboratory whose services have been disapproved because of un-
satisfactory performance may apply to the department for reapproval to
provide these services after demonstrating satisfactory performance dur-
ing the two consecutive quarters or testing periods immediately prior to
requesting reapproval.

(c) Direction. The person or persons directing a licensed clinical labo-
ratory shall assume the following responsibilities:

( 1 ) Determine what laboratory procedures will be performed, the tech-
niques that will be followed, and the equipment and reagents that will be
used.

(2) Determine the scope and nature of procedures to control the reli-
ability of test performance and personally monitor these control pro-
grams.

(3) Regularly assess the activities of the laboratory by personal obser-
vation, evaluation, and review of reports of laboratory findings.

(4) Establish qualification criteria of laboratory personnel.

(5) Determine the format of laboratory report forms and decide what
information is to be contained on these report forms.

(6) Regularly consult with supervisors and other staff members.

(7) Confer with those served by the laboratory on matters that relate
to test performance and determine the nature and scope of technical and
administrative information to be released by the laboratory staff.

(8) Be available daily in any laboratory performing cytology and serve
as director of no more than three (3) laboratories.

(9) Cause a licensed physician or dentist, quahfied in cytopathology,
to personally examine and report findings on abnormal or questionable
gynecologic and all non-gynecologic specimens.

(d) Facilities. The laboratory must pro\ ide for and assure that:

(1) There is adequate space including working surface to conduct and
control the performance of all test procedures performed in the laborato-
ry.

(2) There is adequate area for safe storage and use of equipment and
supplies.

(3) All areas are well lighted and properly ventilated.

(4) Fume hoods and biological safety cabinets, properly installed and
regulated, are used if required for safe performance of tests or for safe
preparation of materials.

(5) Instructions to be followed in case of fire and other emergencies
are posted in a conspicuous place.

(e) Equipment and Test Materials.

( 1 ) The laboratory must provide for and assure that equipment, instru-
ments, glassware, and reagents are maintained in proper working order
by periodic inspection, testing, or calibration in a manner acceptable to
the department.

(2) All reagents and stains shall be dated at the time of preparation and
initialed by the person making the reagents or stains, or the date received
and date opened if commercially prepared reagents or stains are used. All
reagents and stains shall be labeled to indicate identity, and titer, strength,
or concentration. Recommended storage temperature and expiration
date, and other pertinent information necessary for quaUty control must
be on the label.

(f) Records.

(1) Retention of Records: The laboratory must maintain for a period
of at least two years documentation of the following:

(A) Records of specimens received and tested, including identification
of the patient, name of the submitter, dates of receipt and report, type of
test performed, and test results.

(B) Records of inspection, validation, calibration, repair, and replace-
ment to insure proper maintenance and operation of equipment and prop-
er reactivity of test materials.

1 . Name of procedure.

2. Source or reference for the test method.

3. Date the procedure was last reviewed or modified by the director or
supervisor.

4. Current specific instructions for test performance.

5. The standards and controls required.

6. Instructions for collecting and handling specimens to insure test re-
liability.

(D) Records of quality control procedures in use in the various techni-
cal areas of the laboratory, including results on standards and reference
materials and action limits when appropriate.

(E) Additional requirements for cytology. The laboratory shall retain
all cytology slides and cell blocks for a minimum of five (5) years and
all cytology reports for a minimum of ten (10) years.

(2) Cytology Specimen Documents. The laboratory shall maintain cy-
tology records indicating the daily accession of specimens, each of which
is numbered, and an appropriate cross-filing system according to pa-
tient's name.

(A) Requests shall contain at least the following information:

1 . The laboratory accession number when assigned by the laboratory.

2. The name of the person from whom the specimen was taken.

3. The name of the licensed physician or other authorized person or
clinical laboratory who submitted the specimen.

4. Minimum information provided shall include: source of specimen
(anatomic site), age of patient, previous therapy (endocrine, surgical, ra-
diation, birth control, etc.), gynecologic history on cervical-vaginal
specimens, including date and normalcy of patient's last menstrual peri-
od, duration of patient's current pregnancy, if any, and patient's meno-
pausal status or essential history on non-gynecologic specimen.

5. The date the specimen was collected.

(B) Reports shall contain at least the following information:

1 . The dates the specimen was collected, received in the laboratory and
reported by the laboratory; and the accession number.

2. The result of the laboratory examination.

(3) Cytology Laboratory Records.

(A) The laboratory director shall be responsible for the final laboratory
report and shall sign all abnormal and all non-gynecological reports.
Each report, or a laboratory copy, shall be signed or initialed by the cyto-
pathologist and/or cytotechnologist who examined the preparation and
evaluated the final report. The names of all persons who examined the
specimen and their evaluation, if inconsistent with the final report, shall
be indicated on the laboratory work sheet or report copy.

(B) Duplicate copies of laboratory reports are filed in a manner which
permits ready identification and accessibility.

(C) Laboratories shall utilize reporting systems that are as explicit as
is cytologically feasible and must include acceptable morphologic termi-
nology.

(D) If a specimen is judged by the laboratory director or cytotechnolo-
gist to be suboptimal, an accompanying statement shall indicate the rea-
son, e.g., samples of sparse cellularity, poor preservation, or exhibiting
other factors interfering with the laboratory evaluation, such as, exces-
sive blood, inflammatory cells, etc.

(g) Quality Control.

(1) The laboratory must conduct, maintain, and operate programs for
controlling the quality of test performance in a maimer acceptable to the
department.

(2) Additional Cytology.

Page 22.2

Title 17

State Department of Health Services

§ 1053.5

(A) Specimen Identification. All smears and other specimens shall be
labelled for patient identification and appropriately prepared by the sub-
mitter.

(B) Specimen Preparation.

1. The laboratory shall use the Papanicolaou staining technique or its
equivalent as determined by the laboratory director.

2. Staining quality of cytologic specimens shall be checked at least
once daily, with suboptimal results corrected immediately.

3. Gynecologic specimens shall be processed totally separately from
non-gynecologic specimens.

1 . Each specimen shall be evaluated to determine whether the material
is satisfactory and consistent with the patient source. For satisfactory
specimens, a cytologic evaluation shall be rendered according to the re-
porting system, as outlined in Section 1 050(0(3 )(C).

2. The laboratory shall have a sufficient number of certified cytotech-
nologists to handle, under general supervision, the volume and diversity
of tests performed requiring the exercise of independent judgment. No
cytotechnologist shall be required to examine more than 75 one-shde gy-
necologic cases or 50 two-slide gynecologic cases per day; not including
aspiration cytology specimens, cell block specimens, and other not nor-
mally examined by a cytotechnologist. Work load ratios for cytotechnol-
ogists who also prepare and stain slides shall be based on time spent in
examining cytologic preparations.

3. The director or a supervising cytotechnologist shall examine (to
verify proper staining and correct interpretation) at least ten (10) percent
of all gynecologic smears previously examined and classified as not ab-
normal or questionable, including smears initially examined by a super-
vising cytotechnologist.

(3) Clinical Correlation. The laboratory shall maintain records for a
minimum of 10 years of histologic or clinical confirmation of cytologic
findings on abnormal cases and false negative and false positive results
for each category of specimens, when such results are made available to
them.

(h) Clinical Laboratory Test Results. Clinical laboratory test results
shall not be reported from the laboratory until these results have been crit-
ically reviewed and verified for accuracy, reliability, and validity by a h-
censed physician and surgeon or a person, other than a trainee, duly li-
censed under Chapter 3, Division 2, Business and Professions Code
(commencing with Section 1200).

NOTE; Authority cited: Sections 1224 and 1245, Business and Professions Code.
Reference: Sections 1220, 1224 and 1245, Business and Professions Code.

History

1. New subsection (h) filed 2-17-77; effective thirtieth day thereafter (Register
77, No. 8). For prior history, see Register 76, No. 51.

2. Amendment of subsections (c), (f)(2)(A) and (B), (f)(3)(A), (g)(2)(A) and (B)3,
(g)(2)(C)2. (g)(3) filed 1 0-1 3-78; effective thirtieth day thereafter (Register 78,
No. 41).

§ 1 051 . Proficiency Testing Services.

A service may be approved by the department for proficiency testing
laboratories providing the service:

(a) Makes available to each participating laboratory

( 1 ) Materials not less than four times during each calendar year for
testing those procedures which have been designated by the department
for evaluation,

(2) Acceptable forms for reporting results of proficiency testing,

(3) An evaluation of test results reported by the participating laborato-
ry showing acceptable results based on a reference system approved by
the department, and

(4) A summary of results reported by all participating laboratories pre-
pared at least annually.

(b) Provides the department with an adequate description of accept-
able procedures for

( 1 ) The preparation and distribution of test materials,

(2) The determination of limits of acceptable test results, and

(3) The reporting of results of performance to the laboratories sub-
scribing to the service.

(c) Establishes and maintains an adequate reference system for each
procedure evaluated. The names and addresses of all laboratories used as
reference or referee laboratories by the service must be provided to and
approved by the department.

(d) Maintains records of proficiency testing including reports for par-
ticipating laboratories for a period of not less than five years, such records
being available to the department for reference upon request. These re-
cords must include:

( 1 ) The names and addresses of laboratories subscribing to the service.

(2) The test procedures evaluated,

(3) The results of performance reported by each laboratory, and

(4) The results or range of results which were considered acceptable
performance by the service.

(e) Makes application for approval on forms provided by the depart-
ment.

History

1. New section filed 12-28-71; effective thirtieth day thereafter (Register 72,
No. 1).

§ 1052. Satisfactory Performance in Proficiency Testing.

The standards for satisfactory performance for laboratories operating
in accordance with Subsections (b) and (g), Sections 1241, Division 2.
Chapter 3, Business and Professions Code shall be those outlined in Sec-
tion 1050(b) of this Title.

NOTE: Authority cited: Sections 1224 and 1241.1, Business and Professions
Code.

History

1 . New section filed 1 2-28-7 1 ; effective thirtieth day thereafter (Register 72, No.
1).

2. Amendment filed 2-17-77; effective thirtieth day thereafter (Register 77,
No. 8).

§1053. Definitions.

NOTE: Authority cited: Sections 1220(a), 1224 and 1245, Business and Profes-
sions Code. Reference: Sections 1206, 1209, 1220(a), 1224, 1245, 1265, 1282 and
1285, Business and Professions Code.

History

1. New section filed 6-8-72; effective thirtieth day thereafter (Register 72, No.
24).

2. Amendment of subsection (e) and new subsections (f), (g) and (h) filed
2-17-77; effective thirtieth day thereafter (Register 77, No. 8).

3. New subsection (i) filed 10-13-78; effective thirtieth day thereafter (Register
78, No. 41).

4. Amendment of section and Note filed 12-27-94 as an emergency; operative
12-27-94 (Register 94. No. 52). A Certificate of Compliance must be trans-
mitted to OAL 4-26-95 or emergency language will be repealed by operation
of law on the following day.

5. Amendment of section and Notk refiled 5-5-95 as an emergency; operative
5-5-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted
to OAL by 9-4-95 or emergency language will be repealed by operation of law
on the following day.

6. Amendment refiled 9-15-95 as an emergency; operative 9-15-95 (Register 95.
No. 37). A Certificate of Compliance must be transmitted to OAL by 1-15-96
or emergency language will be repealed by operation of law on the following
day.

7. Reinstatement of section as it existed prior to 1 2-27-94 emergency amendment
by operation of Government Code section 1 1346.1(f) (Register 96, No. 4).

8. Renumbering and amendment of former section 1053 to section 1029 filed
1-22-96 as an emergency; operative 1-22-96 (Register 96, No. 4). A Certifi-
cate of Compliance must be transmitted to OAL by 5-2 1-96 or emergency lan-
guage will be repealed by operation of law on the following day.

9. Certificate of CompHance as to 1-22-96 order transmitted to OAL 5-2 1-96 and
filed 6-18-96 (Register 96, No. 25).

Article 5.2. Test Kits Approved for
Over-the-Counter Sale to the Public by the
United States Food and Drug Administration

§1053.5. HIV Tests.

The Department hereby adds to the tests that may be requested and re-
ported pursuant to Business and Professions Code section 1246.5 any

Page 22.3

§ 1054.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

laboratory test or examination to identify HIV, a component of HIV, or
antibodies or antigens to HIV when the test or examination has been ap-
proved by the United States Food and Drug Administration for sale to the
public without a prescription in the form of an over-the-counter test kit.
NOTE: Authority cited: Sections 1224 and 1246.5, Business and Professions
Code; and Section 100275, Health and Safety Code. Reference: Section 1246.5,
Business and Professions Code; and Section 120775, Health and Safety Code.

History

1 . New article 5.2 (section 1 053.5) and section filed 1 1-6-96 as an emergency; op-
erative 11-6-96 (Register 96, No. 45). A Certificate of Compliance must be
transmitted to OAL by 3-5-97 or emergency language will be repealed by oper-
ation of law on the following day.

2. Certificate of Compliance as to 1 1-6-96 order transmitted to OAL 3-4-97 and
filed 4-15-97 (Register 97, No. 16).

Article 5.3. Blood Electrolyte Analysis by
Respiratory Care Practitioners

§ 1 054.1 . Conditions for Performance.

(a) A Respiratory Care Practitioner may engage in clinical laboratory
practice by performing a blood electrolyte analysis when all of the fol-
lowing conditions are met:

( 1 ) The blood electrolyte analysis is performed on an instrument which
is designed to perform both blood gas analysis and blood electrolyte anal-
ysis simultaneously or concurrently and from the same blood specimen;

(2) The blood electrolyte analysis is performed in a licensed laboratory
that:

(A) is within a licensed surgical clinic or a licensed general acute care
hospital;

(B) has a CLIA certificate to perform blood gas analysis and blood
electrolyte analysis; and

(C) has established and maintains protocols for the performance and
reporting of blood gas analysis and blood electrolyte analysis simulta-
neously or concurrently from the same blood specimen by Respiratory
Care Practitioners;

(3) The blood electrolyte analysis is performed:

(A) under the overall operation and administration of the laboratory
director, as required in Section 1029 of the Business and Professions
Code; and

(B) in conformity with the protocols required in (2)(C), above; and

(4) The Respiratory Care Practitioner:

(A) has been trained in accordance with Section 1054.2; and,

(B) performs and reports simultaneous or concurrent blood gas analy-
sis and blood electrolyte analysis in compliance with the requirements in
(3), above; and

NOTE: Authority cited: Secfion 1224, Business and Professions Code. Reference:
Sections 1206, 1209, 1220, 1265, 1282 and 1285, Business and Professions Code.

History

1. New Article 5.3 (sections 1054.1 - 1054.2) and section filed 12-27-94 as an
emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Com-
pliance must be transmitted to OAL 4-26-95 or emergency language will be re-
pealed by operation of law on the following day.

2. New article 5.3 (sections 1054. 1-1054.2) and section refiled 5-5-95 as an emer-
gency; operative 5-5-95 (Register 95, No. 18). A Certificate of Compliance
must be transmitted to OAL by 9^1-95 or emergency language will be repealed
by operation of law on the following day.

3. New article 5.3 and section refiled 9-15-95 as an emergency; operative
9-15-95 (Register95, No. 37). A Certificate of CompUance must be transmitted
to OAL by 1-1 5-96 or emergency language will be repealed by operation of law
on the following day.

4. Repealed by operation of Government Code section 11346.1(g) (Register 96,

No. 4).

5. New section filed 1-22-96 as an emergency; operative 1-22-96 (Register 96,
No. 4). A Certificate of Compliance must be transmitted to OAL by 5-21-96
or emergency language will be repealed by operation of law on the following
day.

6. Editorial correction of subsection {a)(2) (Register 96, No. 25).

7. Certificate of Compliance as to 1-22-96 order including amendment of Noth
transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25).

§1054.2. Training.

(a) Prior to perforining a blood electrolyte analysis, a Respiratory Care
Practitioner shall have completed the following training:

( 1 ) instruction by the laboratory director, or by a person who qualifies
as a technical consultant or a technical supervisor under CLIA, depend-
ing on the type and complexity of the tests being performed, in:

(A) the operation of each instrument to be used for simultaneous or
concurrent blood gas analysis and blood electrolyte analysis by the Re-
spiratory Care Practitioner, including the following:

1 . Equipment maintenance and calibration;

2. Method performance including the normal ranges and critical val-
ues for each test protocol;

3. Quality Control and Assurance requirements including remedial ac-
tion and reagent and specimen handling and integrity; and,

4. Clinical significance of test results and clinical applications for si-
multaneous or concurrent blood gas analysis and blood electrolyte analy-
sis.

NOTE: Authority cited: Section 1224, Business and Professions Code. Reference:
Sections 1209, 1220 and 1265, Business and Professions Code.

History

1 . New section filed 12-27-94 as an emergency: operative 12-27-94 (Register 94,
No. 52). A Certificate of Compliance must be transmitted to OAL 4-26-95 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 5-5-95 as an emergency; operative 5-5-95 (Register 95,
No. 18). A Certificate of Compliance must be transmitted to OAL by 9-4-95
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 9-15-95 as an emergency; operative 9-15-95 (Register
95, No. 37). A Certificate of Compliance must be transmitted to OAL by
1-15-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

4. Repealed by operation of Government Code section 1 1346.1(g) (Register 96,
No. 4).

5. New secfion filed 1-22-96 as an emergency; operafive 1-22-96 (Register 96,
No. 4). A Certificate of Compliance must be transmitted to OAL by 5-21-96
or emergency language will be repealed by operation of law on the following
day.

6. Certificate of Compliance as to 1-22-96 order including amendment of NOTE
transmitted to OAL 5-21-96 and filed 6-18-96 (Register 96, No. 25).

Article 5.5. Use of Point-of-Care

Laboratory Testing Devices by Registered

Nurses

§ 1 054.5. Conditions for Performance.

NOTE: Authority cited: Sections 1220(a) and 1224, Business and Professions
Code. Reference: Secfions 1206, 1209, 1220(a), 1265, 1282 and 1285, Business
and Professions Code.

History

1. New Article 5.5 (sections 1054.5 - 1054.6) and secfion filed 12-27-94 as an
emergency; operative 12-27-94 (Register 94, No. 52). A Certificate of Com-
pliance must be transmitted to OAL 4-26-95 or emergency language will be re-
pealed by operation of law on the following day.

2. New article 5.5 (secdons 1054.5-1 054.6) and secfion refiled 5-5-95 as an emer-
gency; operafive 5-5-95 (Register 95, No. 18). A Certificate of Compliance
must be transmitted to OAL by 9-4-95 or emergency language will be repealed
by operation of law on the following day.

3. New article 5.5 and secfion refiled 9-15-95 as an emergency; operafive
9-1 5-95 (Register 95, No. 37). A Certificate of Compliance must be transmitted
to OAL by 1-15-96 or emergency language will be repealed by operation of law
on the following day.

4. Repealed by operafion of Government Code secfion 11346.1(g) (Register 96,
No. 4).

Page 22.4

Title 17

State Department of Health Services

§1057

Article 5.6. Moderately Complex Laboratory

Testing by Licensed Psychiatric

Technicians, Licensed Vocational Nurses,

Licensed Midwives, Certified Nurse

Assistants, and Certified Home Health Aides

§ 1054.6. Testing Authority for Licensed Psychiatric
Technicians, Licensed Vocational Nurses,
Licensed IVIidwives, Certified Nurse Assistants,
and Certified Home Health Aides.

NOTH: Authority cited: Section 1224 Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1 206.5, and 1209, Business
and Professions Code.

History

1 . New section filed 1 2-27-94 as an emergency ; operati ve 1 2-27-94 ( Register 94,
No. 52). A Ceilificate of Compliance must be transmitted to OAL 4-26-95 or
emergency language will be repealed by operation of law on the following day.

3. New section refiled 9-15-95 as an emergency; operative 9-15-95 (Register
95, No. 37). A Certificate of Compliance must be transmitted to OAL by
I-l 5-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

4. Repealed by operation of Government Code secfion 11346.1(g) (Register 96,

No. 4).

5. New article 5.6 (sections 1054.6-1054.7), section heading, section, and Note
filed 5-28-96 as an emergency; operative 5-28-96 (Register 96, No. 22). A
Certificate of Compliance must be transmitted to OAL by 9-25-96 or emergen-
cy language will be repealed by operation of law on the following day.

6. New article 5.6 (sections 1054.6-1054.7) and section refiled 10-7-96 as an
emergency; operative 10-7-96 (Register 96. No. 41). A Certificate of Com-
pliance must be transmitted to OAL by 2-4-97 or emergency language will be
repealed by operafion of law on the following day.

7. Certificate of Compliance as to 10-7-96 order, including repealer of secfion,
transmitted to OAL 2-3-97 and filed 3-19-97 (Register 97, No. 12).

§ 1054.7. Preceptor Program Requirements for Licensed
Psychiatric Technicians, Licensed Vocational
Nurses, Licensed Midwives, Certified
Emergency Medical Technicians 11,
Paramedics, Certified Nurse Assistants, and
Certified Home Health Aides Performing
Moderate Complexity Testing on Point-of-Care
Laboratory Testing Devices.
(a) Prior to the performance of any clinical laboratory test or examina-
tion authorized in Business and Professions Code Section 1206.5(b)(ll),
a licensed psychiatric technician, licensed vocational nurse, licensed
midwife, certified emergency medical technician II, paramedic, certified
nurse assistant or certified home health aide shall have been trained by
a preceptor in:

( 1 ) The operation of each instrument to be used by the licensed psy-
chiatric technician, licensed vocation nurse, licensed midwife, certified
emergency medical technician II, paramedic, certified nurse assistant or
certified home health aide including:

(A) Each instrument's requirements for maintenance and calibration
which shall include training regarding all manufacturer's instructions;

(B) Each instrument's performance criteria including the reference
ranges, critical values for each test method, and actions to be taken for
values outside the analytical range; and

(C) Each instrument's quality control and quality assurance protocols,
including remedial action and reagent and specimen handling and integ-
rity; and,

(2) The clinical significance of test results for each instrument and the
clinical application for use of the instruments by licensed psychiatric
technicians, licensed vocational nurses, licensed midwives, certified

emergency medical technicians II, paramedics, certified nurse assistants
or certified home health aides; and,

(3) The common physiological conditions of patients that may impact
specimen integrity and cause inaccurate test results; and

(4) Principles of good laboratory practice including laboratory safety
and universal precautions.

(b) Prior to the utilization, for patient care, prognosis, monitoring,
treatment, or disease prevention, of any clinical laboratory test or exami-
nation performed by him or her, a licensed psychiatric technician. li-
censed vocational nurse, licensed midwife, certified einergency medical
technician II, paramedic, certified nurse assistant, certified home health
aide shall have the following experience and shall have been determined
to be coiTipetent to perform moderate complexity tests by the laboratory
director or a person who qualifies as a technical consultant pursuant to
Business and Professions Code Section 1209:

( 1 ) He or she shall participate in a preceptor program until such time
as he or she is able to perform clinical laboratory tests or examinations
with results that are consistent with the preceptor's results 907f of the
time over 20 separate testing events which taken together, cover the en-
tire range of expected values for the instalment.

(2) The experience requirement in subsection (b)(1) shall be met for
each instrument to be used by the licensed psychiatric technician, li-
censed vocaUonal nurse, licensed midwife, certified emergency medical
technician II, paramedic, certified nurse assistant or certified home
health aide.

NOTE: Authority cited: Section 1 224, Business and Professions Code; and Section
100275, Health and Safety Code. Reference: Sections 1206.5, 1209, and 1220,
Business and Professions Code.

History

1. New secfion filed 5-28-96 as an emergency; operative 5-28-96 (Register 96,
No. 22). A Certificate of Compliance must be transmitted to OAL by 9-25-96
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 1 0-7-96 as an emergency; operative 1 0-7-96 (Register 96,
No. 41 ). A Certificate of Compliance must be transmitted to OAL by 2-4-97
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 1 0-7-96 order, including amendment of .section
heading and section, transmitted to OAL 2-3-97 and filed 3-19-97 (Register
97, No. 12).

Article 6. Laboratory Reports

§1055. Reports.

Any report of results issuing from a clinical laboratory operating under
the provisions of Chapter 3, Division 2, Business and Professions Code
shall show clearly the name of a director of said laboratory.
Note: Authority cited: Sections 102 and 208. Health and Safety Code. Reference:
Sections 1220, 1225, 1284 and 1285, Health and Safety Code.

History
1. New secfion filed 9-30-60; effecfive thirtieth day thereafter (Register 60. No.

21).

§ 1056. Prenatal and Neonatal Blood Typing.

For purposes of compUance with Sections 29 1 and 304 of the Califor-
nia Health and Safety Code, rhesus (Rh) blood typing (as defined in Title
17, California Administrative Code, Chapter 2, Subchapter 1, Group 1,
Secfion 1002, Number 3, [DeterminaUon of Rh type]) shall con.sist of D
and if this is negafive, D" typing.

NOTE: Addifional authority cited: Sections 290-293 and 304-305. Health and
Safety Code.

History

1. New Sections 1056 and 1057 filed 3-16-70; effective thirtieth day thereafter
(Register 70, No. 12).

2. Amendment filed 2-2-7 1 ; effecfive thirtieth day thereafter ( Register 7 1 . No. 6 ).

3. Editorial correction (Register 72, No. 31 ).

§ 1057. Prenatal Blood Typing Reports.

Licensed clinical laboratories or approved public health laboratories
performing tests on pregnant women as required by Sections 290 and 29 1

Page 22.4(a)

§1060

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

of the California Health and Safety Code shall provide the requesting
physician with a copy of the report to be stamped or imprinted as follows:
"State law requires that the woman tested be informed as to the rhesus
(Rh) typing test results."

Every licensed physician and surgeon or other person engaged in the
prenatal care of a pregnant woman, or attending such woman at time of
delivery after receiving such report, shall be responsible for notifying the
woman tested of the results of the test.

History

1 . Amendment filed 2-2-7 1 ; effective thirtieth day thereafter (Register 71, No. 6).

Article 7. Cytotechnology

§ 1060. Definitions: Cytotechnologist License.

(a) The definitions in subsections (b) though (i) shall govern the inter-
pretation of this article.

(b) "Competency testing service or program" means an organization
that has been approved by the Department pursuant to section 1270 of the
California Business and Professions Code to administer a cytotechnolo-
gy competency examination.

(cj "Cytotechnologist competency examination" means an examina-
tion which evaluates a person's entry level skills and abilities in cytotech-
nology, including his or her understanding of: ( 1 ) the underlying scientif-
ic principles, technical and procedural aspects of cytotechnology; (2) the
identification of cellular changes in gynecological and non-gynecolog-
ical specimens through both a written and visual component; (3) cytopre-
paratory techniques; and (4) cytology laboratory operations; and which
include the following subject areas in the following ratios: 48% to 52%
female reproductive system (to include both the genital system and
breast); 1 3% to 1 7% respiratory system; 9% to 1 2% male and female gen-
itourinary systems; 6% to 10% alimentary system; and 13% to 17% body
cavity fluids and other body sites.

(d) "Entry Level Skills" means the following skills and abilities ex-
pected at career entry:

( 1 ) Knowledge and understanding of:

(A) the underlying scientific principles as well as the technical and
procedural aspects of the examination of cytology specimens;

(B) the physiological, biochemical, microbiological, and genetic fac-
tors which affect cell health and disease, and the importance of cytology
laboratory examinations to medical care;

(D) the introduction and implementation of new procedures and the
evaluation of new instruments;

(E) basic management theory and functions.

(2) Technical skills so that the examinee is capable of:

(A) performing examinations on cytology specimens;

(B) exercising initiative and independent judgment in deaUng with the
broad scope of procedural and technical j^roblems;

(C) participating in, or being delegated, the responsibility for deci-
sions involving quality control programs, or reagent purchases;

(D) communicating technical or general information to medical, para-
medical, or lay individuals;

(E) participating in and developing responsibility for the establish-
ment of technical and administrative procedures;

(F) supervising technicians, aides, and clerical personnel, as directed;
and,

(G) providing instruction in the basic theory, technical skills, and
application of cytology laboratory procedures.

(e) "Examinee" means an individual who meets the following require-
ments:

( 1 ) Has a baccalaureate degree from a college or university accredited
by the Western Association of Schools and Colleges or its equivalent
with 20 semester hours (30 quarter hours) of biological science, 8 semes-

ter hours (12 quarter hours) of chemistry and 3 semester hours (4 quarter
hours) of mathematics; and
(2) Has completed:

(A) A 12-month cytotechnology program accredited by the Council
on Accreditation of Allied Health Educational Program (CAAHEP) or its
equivalent; or

(B) Five years, of at least 40 hours a week, clinical laboratory experi-
ence in cytopreparatory techniques, microscopic analysis and evaluation
of the body systems within the last ten years. At least two of these years
must be subsequent to the completion of the academic component and at
least two years must be under the supervision of a licensed physician who
is a pathologist certified or eligible for certification by the American
Board of Pathology in Anatomic Pathology or has other qualifications
acceptable to the competency testing service or program.

(f) "Evidence of Satisfactory Performance" means (1 ) a copy of a doc-
ument issued to an examinee after January 1, 1993 by a cytotechnology
competency testing service or program indicating satisfactory perform-
ance by the examinee on a cytotechnologist competency examination; or
(2) a copy of a document issued to an individual by the American Society
of Clinical Pathologists (ASCP) Board of Registry (BOR) indicating sat-
isfactory performance by the individual on an ASCP Cytotechnology Ex-
amination taken prior to the approval of a competency testing service or
program under the provisions of this article.

(g) "Satisfactory performance" means ( 1 ) receipt of a passing score on
a cytotechnologist competency examination given after January 1 , 1 993;
or (2) passage of an ASCP Cytotechnology Examination prior to the ap-
proval of a competency testing service or program under the provisions
of this article.

(h) "Passing score" means a score determined by a cytotechnologist
competency testing service or program utilizing the criteria approved by
the Department pursuant to section 1062.

(i) "Owner(s)" means any person who is a sole proprietor, or holds a
partnership interest in, or who is an officer, director, or 5% (five percent)
or more shareholder in a corporation which owns an organization that is
applying for approval as a cytotechnologist testing service or program.

Note: Authority cited: Sections 1224 and 1270, Business and Professions Code.
Reference: Section 1270, Business and Professions Code.

History

1 . New article 7 and section filed 1 1-1 8-93 as an emergency; operative 1 1-1 8-93
(Register 93, No. 47). A Certificate of Compliance must be transmitted to OAL
by 3-1 8-94 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 11-18-93 order transmitted with amendment
of subsections (e)(2)(A) and (f) to OAL 3-18-94 and filed 4-29-94 (Register
94, No. 17).

§ 1 061 . Cytotechnology Licensure.

(a) A cytotechnologist Hcense shall be issued to an individual who sub-
mits the following to the Department:

(1 ) A verified and complete application as described in subsection (b);

(2) Evidence of satisfactory performance;

(3) The application fee required under Business and Professions Code
Section 1300 and Health and Safety Code Section 116.

(b) A complete application for a cytotechnologist license shall include
the following verified information on a form. Application for Cytotech-
nologist License (LAB 124, Rev. 1 1/93), provided by the Department:

(1 ) Name, address, social security number (optional), and ASCP regis-
tration number, if any, of the applicant; and

(2) The applicant's education, training and experience in gynecologi-
cal and non-gynecological cytology including:

(A) An official copy of any and all college credits including a state-
ment of any degrees conferred; and

(B) Documentation of each of the following, if completed or obtained
by the applicant:

1. The completion of a 12 month training program approved by
CAAHEP or its equvalent, or

2. The completion of five years of full-time, of at least 40 hours a
week, clinical laboratory experience in cytology;

Page 22.4(b)

Title 17

State Department of Health Services

§1061

3. ASCP registration certificate;

4. Licensure by tlie Department under Business and Professions Code
section 1270 subsection (c) or subsection (d); and

(3) The name and address of the applicant's current laboratory em-
ployer(s), and the number of hours employed (by each) and the time de-
voted, and volume of types of specimens examined at each location.

(c) Within 30 calendar days of receipt of an application for a cytotech-
nologist license, the Department shall inform the applicant in writing that
the application is either complete and accepted for filing or that it is in-
complete and what specific information is required before the application
may be accepted for filing.

(d) Within 90 calendar days from the date the Department receives the
information and documentation required in subdivision (a), it shall in-
form the applicant in writing whether a cytotechnologist license shall be
issued or denied. If a license is denied, the Department shall indicate the
reasons therefor.

(e) The Department's time periods for processing an application for
cytotechnologist license, from receipt of the initial application to the final
decision regarding the license, are as follows:

( 1 ) The median time for processing is 240 calendar days.

(2) The minimum time for processing is 120 calendar days.

[The next page is 22.5.

Page 22.4(c)

•

Title 17

State Department of Health Services

§1065

(3) The maximum time for processing is 360 calendar days.

(f) Eacli licensed cytotechnologist shall notify the Department within
30 calendar days of any and all changes in his or her employment, includ-
ing any changes in the name and address of his or her employer(s), the
hours employed by each, and the information specified in subsection
(b)(3) above.

NOTl-:: Authority cited: Sections 1224, 1270 and 1271(f), Business and Profes-
sions Code. Reference; Sections 1270, 1271 and 1300, Business and Professions
Code; Section 15376, Government Code; and Section 116, Health and Safety
Code.

History

1 . New section filed 1 1-18-93 as an emergency; operative 1 1-18-93 (Register93.
No. 47). A Certificate of Compliance must be transmitted to OAL by 3-18-94
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 1 1-18-93 order transmitted with amendment
of subsection (b)(2)(B) 1 to OAL 3-18-94 and filed 4-29-94 (Register 94, No.
17).

§ 1 062. Cytotechnologist Competency Testing Services Or
Programs.

(a) Any organization seeking approval by the Department as a cyto-
technologist competency testing service or program shall submit an
application to the Department which shall include documentation of the
following:

(1) The organization's name, address, and owner(s);

(2) The organization's mechanism for assuring that each individual for
whom a cytotechnologist competency testing examination is adminis-
tered meets the criteria as an examinee;

(3) The organization's mechanism for assuring that each cytotechnol-
ogist competency examination administered by the organization shall
test each examinee on his or her entry level skills and understanding of:

(A) The underlying scientific principles and the technical and proce-
dural aspects of cytology;

(B) The identification of cellular changes in gynecologic and non-gy-
necologic specimens through both a written and visual component;

(D) Cytology laboratory operations, and that each test shall include the
following subject areas in the following ratios: 487c to 52% female repro-
ductive system (to include both genital system and breast); 1 3%-l 7% re-
spiratory system; 9%-12% male and/or female genitourinary system;
6%-10% alimentary system; and 13%-17% body cavity fluids and other
body sites;

(4) The organization's mechanism for determining the validity and
passing score for each cytotechnologist competency examination admin-
istered by the organization in order that there is a consistency between
and among all testing events as to entry level skills that must be demon-
strated in order for an examinee to pass the examination; and,

(5) The organization' s mechanism for assuring the security of each cy-
totechnologist competency examination administered by it.

(b) Upon receipt of the above, and the determination by the Depart-
ment that the documentation provides assurances of the following, the
Department shall approve the organization as a cytotechnologist compe-
tency testing service or program and shall issue an approval document
indicating the terms of the organization's approval:

(1) The organization shall only administer cytotechnologist compe-
tency examinations to persons who qualify as an examinee;

(2) Each cytotechnologist competency examination administered by
the organization shall challenge each examinee on his or her entry level
skills and understanding of the subjects, and shall contain the subject
matter in the ratios identified in subsection (a) (3), above;

(3) Each cytotechnologist competency examination administered by
the organization shall be validly constructed and have a passing score
that fosters a consistency between and among all testing events as to entry
level skills that must be demonstrated in order for an examinee to pass
the examination; and,

(4) Each cytotechnologist competency examination shall be adminis-
tered in a secure fashion.

(c) Within 15 days of receipt of an application by an organization for
approval as a cytotechnologist competency testing service, the Depart-
ment shall inform the organization in writing that the application is com-
plete and accepted for review or deficient and what specific information
or documentation is required to complete the application.

(d) Within 30 calendar days from the date of filing of a completed
application, the Department shall inform the applicant organization in
writing whether the organization has been approved as a cytotechnolo-
gist competency testing service or program.

(e) The Department's time periods for processing an application for
approval as a cytotechnologist competency testing service or program,
from the receipt of the initial application to the final decision regarding
the approval, are as follows:

(1) The median time for processing is 90 calendar days.

(2) The minimum time for processing is 45 calendar days.

(3) The maximum time for processing is 135 calendar days.

(f) Cytotechnologist competency testing services or programs shall is-
sue a document to each examinee who obtains a passing score on each
cytotechnologist competency examination administered by the service
or program.

(g) Cytotechnologist competency testing services or programs shall
maintain, for a minimum of five years, and .shall make available to the
Department, records showing the validation, content, passing score, date
and place of each competency testing examinafion administered by it,
and a record of each examinee tested.

(h) A cytotechnologist competency testing service or program shall be
subject to review by the Department to determine adherence to the re-
quirements of this article and its approval. Failure of a cytotechnologist
competency tesdng service or program to meet the requirements of this
article or its terms of approval shall constitute good cause for revocation
of approval by the Department.

NOTE: Authority cited; Sections 1224 and 1270, Business and Professions Code.
Reference; Section 1270, Business and Professions Code; and Section 15376,
Government Code.

History

1. New section filed 1 1-18-93 as an emergency; operative 1 1-18-93 (Register 93,
No. 47). A Certificate of Compliance must be transmitted to OAL by 3-1 8-94
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 1 1-18-93 order transmitted with amendment
of subsection (a)(3)(D) to OAL 3-18-94 and filed 4-29-94 (Register 94, No.
17).

Article 8. Enforcement

§1065. Imposition of Sanctions.

(a) The department may impose, as applicable, one or more of the fol-
lowing sanctions on a clinical laboratory, a public health laboratory or a
provider of service:

(1) Principal sanctions.

(2) Intermediate sanctions.

(3) Altemafive sanctions.

(4) Automafic suspension of a license or registrafion based on federal
exclusion from the Medicare or Medicaid program or revocation of
CLIA certificate.

(5) State-initiated exclusions from the Medicaid and Medi-Cal pro-
grams.

(6) Exclusion from ownership or operation for two years following li-
cense or registration revocation.

(7) Civil suit to enjoin statutory or regulatory violations.

(8) Criminal sanctions for unlawful activity.

(9) Automatic revocation of license/registration or other approval
based on intentional referral of proficiency testing samples for analysis.

(10) Suspension of Medi-Cal and Medicaid payments for failure to
permit an inspection.

(b) The department's decision to impose sanctions shall be based on
one or more of the following:

Page 22.5

§ 1065.5

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

( 1 ) Deficiencies found by the department or its agents in tlie conduct
of inspections or through review of materials submitted by a laboratory
(e.g., personnel qualifications).

(2) Unsuccessful participation in proficiency testing.

(c) The department shall base its choice of sanction or sanctions to im-
pose on consideration of one or more factors that include, but are not lim-
ited to. the following, as assessed by the department or its agents:

(1) Whether the deficiencies pose immediate jeopardy.

(2) The nature, incidence, severity, and duration of the deficiencies or
noncompliance.

(3) Whether the same condition level deficiencies have been identified
repeatedly.

(4) The accuracy and extent of laboratory records (e.g.. of remedial ac-
tion) in regard to the noncompliance, and their availability to the depart-
ment, to its agents, or to the United States Health Care Financing Admin-
istration and its agents.

(5) The relationship of one deficiency (ir group of deficiencies to other
deficiencies.

(6) The overall compliance history of the laboratory.

(7) The corrective and long-term compliance outcomes that the de-
partment hopes to achieve through application of the sanction.

(8) Whether the laboratory has made any progress toward improve-
ment following a reasonable opportunity to correct deficiencies.

(d) The department shall impose a separate sanction for each condition
level deficiency or a single sanction for all condition level deficiencies
that are interrelated and subject to correction by a single course of action.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Healthand Safety Code; Stats. 1995,c.510, Section 1; and Section 14105,
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283,
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326, Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42
United States Code, Section 1 395w-2 [Section 1 846 of the federal Social Security
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a{a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1 902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFR Section 493.1840.

History

1. New article 8 (sections 1065-1067.15) and section filed 8-28-97 as an emer-
gency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance
must be transmitted to OAL by 1 2-26-97 or emergency language will be re-
pealed by operation of law on the following day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§1065.5. Principal Sanctions.

(a) The department may impose on a clinical laboratory the principal
sanctions of denial, revocation or suspension of a registration or license
issued under chapter 3 of division 2 of the liusiness and Professions Code
whenever it determines that any of the grounds identified in Business and
Professions Code section 1320 exist and it has complied with the require-
ments of Business and Professions Code sections 1267 and 1322. Aclini-
cal laboratory that has had a Statement ol Issues or an Accusation filed
against it for the denial, revocation or suspension of its license or registra-
tion may defend itself, its owner(s) and director(s) by filing a notice of
defense in accordance with section 1 150() of the Government Code. A
clinical laboratory that is dissatisfied with a final decision regarding a de-
nial, revocation or suspension may seek judicial review in accordance
with section 11523 of the Government Code.

(b) The department may impose on a public health laboratory the prin-
cipal sanctions of denial, revocation or suspension of the approval to op-
erate a public health laboratory granted under article 5 (commencing
with section 101 150) of the Health and Safety Code whenever it deter-
mines that the requirements identified in 17 CCR section 1078 are not be-
ing met and it has complied with chapter 5 (commencing with section
11 500) of part 1 of division 3 of title 2 of the Government Code. A public
health laboratory that has had a Statement of Issues or an Accusation filed

against it for the denial, revocation or suspension of its approval to oper-
ate may defend itself by filing a notice of defense in accordance with sec-
tion 1 1506 of the Government Code. A public health laboratory that is
dissatisfied with a final decision regarding a denial, revocation or suspen-
sion may seek judicial review in accordance with section 1 1523 of the
Government Code.

(c) The department may impose on a provider of service the principal
sanction of suspension from further participation in, including reim-
bursement from, the Medi-Cal and Medicaid programs whenever it de-
termines that any of the grounds identified in Welfare and Institutions
Code section 141 23 exist and it has complied with chapter 5 (commenc-
ing with section 1 1500) of part 1 of division 3 of title 2 of the Government
Code, except that hearings may be conducted by departmental hearing
officers appointed by the director. A provider of service that has had an
Accusation filed against it for its suspension from further participation
in the Medi-Cal program may defend itself its owner(s) or director(s) by
filing a notice of defense in accordance with section 1 1506 of the Gov-
ernment Code. A provider of service that is dissatisfied with a final deci-
sion regarding suspension from further participation in the Medi-Cal
program may seek judicial review in accordance with section 1 1523 of
the Government Code.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1 995, c.5 10, Section 1; and Section 14105,
Welfare and Institutions Code. Reference: Stats. 1995, c.5 10, Section 1; Section
101160, Health and Safety Code; Sections 1265, 1267, 1280. 1281, 1282, 1283,
1284, 1285, 1286, 1287, 1288.5. 1289, 1310, 1320. 1323, 1324and 1326,Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42
United States Code, Section 1395w-2 [Section 1846 of the federal Social Security
Act] ; 42 United States Code, Section 1 396a(a)(9)(C) [Section 1 902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFR Section 493.1840.

History

1. New section filed 8-28-97 as an emergency; operafive 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec-
tion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§ 1 065.1 0. Intermediate Sanctions.

(a) The department may impose on a cUnical laboratory the intermedi-
ate sanction of temporary suspension of a registration or license issued
under chapter 3 of division 2 of the Business and Professions Code based
on a departmental finding of immediate jeopardy or other grounds identi-
fied in Business and Professions Code secfion 1323. The intermediate
sanction becomes effective upon the serving of an Accusation. A clinical
laboratory that has had an Accusation filed against it for temporary sus-
pension of its license or registration may defend itself its owner(s) and
director(s) by filing a notice of defense in accordance with section 1 323
of the Business and Professions Code. Regardless of a notice of defense
being filed, the temporary suspension remains in effect at least until the
hearing is completed and the department has made a final determination
on the merits. A clinical laboratory that is dissaUsfied with a final deter-
mination on the merits may seek judicial review in accordance with sec-
tion 1 1523 of the Government Code.

(b) The department may impose on a public health laboratory the inter-
mediate sanction of temporary suspension of the approval to operate a
public health laboratory granted under article 5 (commencing with sec-
tion 101 150) of the Health and Safety Code based on a departmental find-
ing of immediate jeopardy. The intermediate sanction becomes effective
upon the serving of an Accusation. A public health laboratory that has had
an Accusation filed against it for temporary suspension of its approval
may defend itself, its owner(s) and director(s) by filing a notice of defense
in accordance with section 1 1506 of the Government Code. Regardless
of a nodce of defense being filed, the temporary suspension remains in
effect at least until the hearing is completed and the department

Page 22.6

Title 17

State Department of Health Services

§ 1065.30

has made a final determination on the merits. A public health laboratory
that is dissatisfied with a final determination on the merits may seek judi-
cial review in accordance with section 1 1523 of the Government Code,
(c) The department may impose on a provider of service the intermedi-
ate sanction of temporary suspension from participation in, including re-
imbursement from, the Medi-Cal and Medicaid programs based on a de-
partmental finding of immediate jeopardy or condition level deficiencies
and when in the opinion of the director of the department such action is
necessary to protect the public welfare or the interests of the Medi-Cal
program. The intermediate sanction becomes effective upon the serving
of an Accusation. A provider of service that has had an Accusation filed
against it for temporary suspension from participation in the Medi-Cal
program may defend itself, its owner(s) and director(s) by filing a notice
of defense in accordance with section 1 1506 of the Government Code.
Regardless of a notice of defense being filed, the temporary suspension
remains in effect at least until the hearing is completed and the depart-
ment has made a final determination on the merits. A provider of service
that is dissatisfied with a final determination on the merits may seek judi-
cial review in accordance with section 1 1523 of the Government Code.
NOTIi; Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1995,c.510, Section l;and Section 14105,
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section
1011 60, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282. 1283,
1284, 1285, 1286. 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326, Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42
United States Code, Section 1 395 w-2 [Section 1 846 of the federal Social Security
Act];42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFR Section 493.1840.

History

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec-
tion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§ 1 065.1 5. Alternative Sanctions.

(a) The department may impose on a clinical laboratory one or more
of the following alternative sanctions in lieu of or in addition to imposing
a principal sanction:

(1) Directed plans of correction, as set forth in section 1067.

(2) Onsite monitoring, as set forth in section 1067.10.

(3) Civil money penalties, as set forth in section 1067.5.

(b) Prior to the imposition of an alternative sanction a clinical laborato-
ry shall be given a Notice of Intent and an opportunity to respond. A clini-
cal laboratory that is dissatisfied with the imposition of an alternative
sanction may seek judicial review by filing a petition for writ of mandate
in accordance with the provisions of the Code of Civil Procedure.
Note: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1995, c.5 10, Section 1; and Section 14105,
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283,
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323. 1324and 1326, Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC, Section 1395x(s) [Section 186I(s) of the Social Security Act]; 42
United States Code, Section 1 395 w-2 [Section 1 846 of the federal Soci;il Security
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1 902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFH Section 493.1840.

History

1. New section filed 8-28-97 as an emergency; operadve 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24--97
and filed 2-9-98 (Register 98. No. 7).

§1065.20. Automatic Suspension.

The department shall automatically suspend a clinical laboratory li-
cense or registration based on federal exclusion from the Medicare or
Medicaid program or revocation of CLIA certificate. A clinical laborato-
ry that is dissatisfied with the imposition of an automaUc suspension may
seek judicial review by filing a petition for writ of mandate in accordance
with the provisions of the Code of Civil Procedure.
NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Heahh and Safety Code; Stats. 1 995. c.5 10, Section 1; and Section 14105.
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section
101 160, Health and Safety Code; Sections 1265, 1267, 1280. 1281, 1282. 1283.
1284, 1285, 1286, 1287. 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326. Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC, Secfion 1395x(s) [Section 1861(s) of the Social Security Actj; 42
United States Code, Secfion 1 395w-2 [Section 1846 of the federal Social Security
Act]; 42 United States Code, Section I396a(a)(9)(Cj [Section 1902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Secfion 1902(p) of the Social Security Act); 42 CFR Section 1002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFR Section 493.1840.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35 ). A Certificate of Compliance must be transmitted to OAL by 1 2-2(>-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1065.25. State-initiated Exclusions from Medicaid and
IVIedi-Cal.

The department may initiate exclusions from Medicaid and Medi-Cal
when the grounds for taking a permissive exclusion under 42 CFR part
1002 exist. The department shall initiate exclusions from Medicaid and
Medi-Cal when the grounds for taking a mandatory exclusion under 42
CFR part 1002 exist. Before imposing an exclusion, the department shall
give a provider of service an opportunity to submit documents and writ-
ten argument against the exclusion. A provider of service that is dissatis-
fied with the imposition of an exclusion may seek judicial review by fil-
ing a petition for writ of mandate in accordance with the provisions of the
Code of Civil Procedure.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1995, c.510. Section l;and Section 1410.5.
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section
101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283,
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326,Bu.siness
and Professions Code; Sections 11503, 11504, 11506 and 11523, Govemment
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42
United States Code. Secfion 1 395w-2 [Section 1 846 of the federal Social Security
Act]; 42 United States Code, Secfion 1396a(a)(9)(C) [Secfion 1902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1 902(p) of the Social Security Act] ; 42 CFH Section 1 002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFR Section 493.1840.

History

1. New secfion filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 1 2-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1065.30. Exclusion from Ownership or Operation.

The department shall exclude for a period of two years following revo-
caUon any person or entity from owning, operating, or directing a labora-
tory, whenever the person or entity has been the owner, operator or labo-
ratory director of a clinical laboratory that has had its clinical laboratory
license or registration revoked. A person or entity that is dissatisfied with
the imposition of an exclusion from owning or operating a clinical labo-
ratory may seek judicial review by filing a petition for writ of mandate
in accordance with the provisions of the Code of Civil Procedure.
NOTE: Authority cited: Secfion 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1995, c.510. Section 1; and .Section

Page 22.7

§ 1065.35

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

14103, Welfaie and Institutions Code. Reference: Stats. 1995, c.510. Section 1;
Section 101 160, Health and Salety Code; Sections 1265. 1267, 1280, 1281, 1282,

1283, 1284, 1285, 1286. 1287. 1288.5, 1289, 1310. 1320. 1323, 1324 and 1326,
Business and Professions Code; Sections 1 1503, 1 1504, 1 1506 and 1 1523, Gov-
ernment Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security
Act]; 42 United States Code, Section 1 395w-2 [Section 1846 of the federal Social
Security ActJ; 42 United States Code. Section 1396a(a)(9)(C) [Section
1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section
1396a(a)(30) [Section 1902(a)(30) of the federal Social Secunty Act]; 42 USC
Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section
1002.2; 42 CFR Sections 1001.201 thiough 1001.1701; Section 14123. Welfare
and Institutions Code; and 42 CFR Section 493.1840.

History

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 oider transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1065.35. Civil Suit to Enjoin Violations.

The department shall initiate a civil suit whenever such suit is neces-
sary to enjoin the violation or threatened violation of chapter 3 (com-
mencing with section 1 200) of the Business and Professions Code or the
regulations adopted thereunder. A person or entity against whom a civil
suit is filed shall have all the rights of defense afforded by California civil
law.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1 995, c.510, Section 1; and Section 14105,
Welfare and InstituUons Code. Reference: Stats. 1995. c.510. Section 1; Section
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283,
1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326,Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC, Section 1395x(s) [Section I861(s) of the Social Security Act]; 42
United States Code, Section 1 395w-2 [Section 1 846 of the federal Social Security
Act]; 42 United States Code, Section 1 396a(a)(9)(C) [Section 1902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFR Section 493.1840.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1065.40. Criminal Sanctions for Unlawful Activity.

The department may refer for prosecution to the Attorney General's
office or a District Attorney' s office, when appropriate, any person or en-
tity it has reason to believe has engaged in any of the unlawful activities
identified in sections 1280 through 1287, inclusive of the Business and
Professions Code. A person or entity against whom a criminal action is
filed shall have all the rights of defense afforded by California criminal
law.

NoTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105,
Welfare and Institutions Code. Reference: Stats. 1995, c.510. Section 1; Section
101 160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283,

1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326,Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC , Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42
United States Code, Section 1395w-2 [Section 1 846 of the federal Social Security
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the
federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1 902(p) of the Social Security Act] ; 42 CFR Section 1 002.2; 42 CFR Sec-
tions 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code;
and 42 CFR Section 493.1840.

History
1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-
and filed 2-9-98 (Register 98, No. 7).

order transmitted to OAL 12-24-97

§ 1065.45. Revocation for Referral of Proficiency Testing
Samples.

If the department determines that a laboratory has intentionally re-
ferred proficiency testing samples to another laboratory for analysis, it
shall take action to revoke the license/registration or other approval for
at least one year and may take action to impose any other available sanc-
tion.

NOTE: Authority cited: Section 1224. Business and Professions Code; Section
100275. Health and Safety Code; Stats. 1 995, c.510. Section 1; and Section 14105,
Welfare and InsUtutions Code. Reference: Stats. 1995. c.510. Section 1; Section
101160, Health and Safety Code; Secnons 1265, 1267, 1280, 1281, 1282, 1283,
1284. 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324and 1326. Business
and Professions Code; Sections 11503, 11504, 11506 and 11523, Government
Code; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42
United States Code, Section 1395w-2 [Section 1846 of the federal Social Security
Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the
federal Social Security Act); 42 United States Code, Section 1396a(a)(30) [Sec-
tion 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p)
[Section 1 902(p) of the Social Security Act]; 42 CFR Section 1 002.2; 42 CFR Sec-
tions 1001.201 through 1001. 1701; Section 14123, Welfare and Institutions Code;
and 42 CFR SecUon 493.1840.

History

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97.
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1066. Condition Level Requirements.

(a) Any requirement specified in subsections (b) through (i) shall con-
stitute a condition level requirement.

(b) Each clinical laboratory performing clinical laboratory tests or ex-
aminations classified as of moderate or of high complexity under CLIA
shall obtain and maintain a valid clinical laboratory license issued pur-
suant to section 1 265 of the Business and Professions Code.

(1) A sufficient number of laboratory personnel with the appropriate
education and either experience or training to:

(A) Provide appropriate direction, supervision and consultation;

(B) Accurately perform tests; and

(2) Laboratory personnel who meet the personnel qualifications, du-
ties, and responsibilities required in CLIA and sections 1203, 1204,
1206.5, 1207, 1209, 1209.1, 1210, 1270 and 1271 of the Business and
Professions Code.

(d) Each clinical laboratory shall:

( 1 ) Enroll in a proficiency testing program approved by the department
or by the United States Health Care Financing Administration if required
to enroll under Business and Professions Code section 1220(a)(2)(A);
and if required to enroll, demonstrate successful participation, as defined
under CLIA, for each specialty and subspecialty in which it performs
clinical laboratory tests or examinations, to the same extent as required
under CLIA,

(2) Authorize its proficiency test results to be reported to the depart-
ment in an electronic format that is compatible with the department' s pro-
ficiency testing data monitoring system, and

(3) Authorize the release of proficiency tests results to the public to the
same extent required by CLIA.

(e) Each clinical laboratory required to do so under Business and Pro-
fessions Code secfion 1220(d)(2)(A) shall establish and maintain a pa-
tient test management system that meets the standards of CLIA;

(f) Each clinical laboratory required to do so under Business and Pro-
fessions Code section 1220(d)(2)(B) shall:

(1) Establish and maintain a quality control program that meets the re-
quirements of CLIA,

(2) Perform all clinical laboratory tests or examinaUons classified as
waived under CLIA in conformity with the manufacturer's instructions.

(g) Each clinical laboratory required to do so under Business and Pro-
fessions Code section 1220(d)(2)(C) shall:

Page 22.8

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State Department of Health Services

§ 1067.5

•

( 1 ) Establish and maintain a comprehensive quaHty assurance pro-
gram that meets the standards of CLIA,

(2) Maintain records, equipment, and facilities that are adequate and
appropriate for the services rendered.

(3) Be conducted, maintained and operated without injury to the public
health, and

(4) If providing cytology services and its licensee ceases operation,
preserve

(A) Records,

(B) Reports,

(D) Cell blocks as prescribed in subdivision (g) of section 1271 and
section 1 274 of the Business and Professions Code.

(h) Each licensed or registered clinical laboratory shall submit to the
inspections identified in Business and Professions Code section 1220,
which inspections may be conducted by department employees or con-
tractors, or the United States Health Care Financing Administration
(HCFA), or HCFA agents. The department may conduct announced or
unannounced inspections of any premises, building, equipment, materi-
als, records, or information at any reasonable time to secure compliance
with, or prevent a violation of chapter 3 of division 2 of the B&P Code.
A clinical laboratory shall permit, as part of this inspection, the depart-
ment or its contractors or agents to:

( 1 ) Inspect, photograph, or copy any records, reports, test results, test
specimens, or other information related to the requirements of chapter 3
of division 2 of the Business and Professions Code or the regulations
adopted pursuant thereto. (The laboratory shall make all records and data
accessible and retrievable within a reasonable time frame during the
course of the inspection.);

(2) Secure any sample, photograph, or other evidence from any build-
ing or premises for the purpose of enforcing chapter 3 of division 2 of the
Business and Professions Code or the regulations adopted pursuant
thereto;

(3) Observe laboratory personnel performing tests (including profi-
ciency testing), data analysis and reporting;

(4) Interview all personnel of the clinical laboratory concerning com-
pliance with chapter 3 of division 2 of the Business and Professions Code
and the regulations adopted thereunder;

(5) Upon request, review all information and data necessary to:

(A) Determine that testing is being performed or the laboratory is be-
ing operated in a manner that does not constitute an imminent and serious
risk to public health;

(B) Evaluate complaints from the pubhc; and

(C) Determine whether or not the laboratory is performing tests with-
out a license or registration applicable to the category of tests or examina-
tions being performed; and

(6) Provide copies to the department or its contractors or agents of all
records and data required under chapter 3 of division 2 of the Business
and Professions Code and the regulations adopted thereunder.

(i) Each laboratory shall comply with the requirements identified as
"conditions" in subparts G through P of CLIA.

NOTH: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Stats. 1995, Chapter 510, Section 1. Refer-
ence: Statutes 1995, Chapter 510, Section 1; and Sections 1203, 1204, 1206.5,
1207, 1209, 1209.1, 1210, 1220, 1223, 1225 and 1265, Business and Professions
Code.

History

1 . New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

§ 1067. Procedures for the Imposition of Directed Plans of
Correction.

(a) The department may impose a directed plan of correction as an al-
ternative sanction for any clinical laboratory that has condition level defi-
ciencies.

(b) If the department is imposing a directed plan of correction, the fol-
lowing procedures shall apply:

( 1 ) The department shall give the laboratory a written Notice of Intent
to impose a directed plan of correction. The Notice of Intent shall include
the following:

(A) The condition level deficiency that has been identified,

(B) The sanction or sanctions that the department proposes to impose
against the laboratory,

(D) The projected effective date and duration of the proposed sanction
or sanctions,

(E) The authority for the proposed sanction or sanctions, and

(F) The time allowed for the laboratory to respond to the notice. (Dur-
ing the period specified, the laboratory may submit to the department
written evidence or other information against the imposition of the pro-
posed sanction or sanctions.)

(2) After the period specified in (b)( 1 )(F) has elapsed, the department
shall give the laboratory a written Notice of Sanction to impose a Di-
rected Plan of Correcfion that acknowledges any evidence or information
received from the laboratory and specifies the following:

(A) The sanction or sancfions to be imposed against the laboratory.

(B) The authority and rationale for imposing the sancfion or sanctions,

(D) A direction to the laboratory to take specific corrective action
within specific time frames in order to achieve compliance.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275. Health and Safety Code; and Stats. 1995, c.510. Section 1. Reference:
Stats. 1995, c.510. Section 1; Section 1310, Business and Professions Code; and
Sections 11503, 11505 and 11506, Government Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec-
tion (b)( 1 )(F), transmitted to OAL 1 2-24-97 and filed 2-9-98 (Register 98, No.
7).

§ 1067.5. Procedures for the Imposition of Civil Money
Penalties.

(a) The department may impose civil money penalties as an alternative
sanction for any clinical laboratory that has condition level deficiencies.

(b) If the department is imposing civil money penalties, the following
procedures apply:

(1 ) In determining the amount of the penalty, the department shall take
into account the following factors:

(A) The nature, scope, severity, and duration of the deficiency or non-
compliance.

(B) Whether the same condition level deficiencies have been identi-
fied during prior inspections.

(D) The accuracy and extent of laboratory records and their availabil-
ity to the department or its contractors or agents.

(2) For a condition level deficiency that does not pose immediate jeop-
ardy, the range of the penalty amount shall be $50-$3,000 per day of non-
compliance or per violation. The department may, before any hearing,
propose to increase the penalty amount into the range specified in (b)(3)
for a laboratory that has deficiencies which, after imposition of a lower
penalty amount, become sufficientiy serious to pose immediate jeopardy.

Page 22.9

§ 1067.10

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(3) For a condition level deficiency that poses immediate jeopardy, the
range of the penalty shall be $3,050-$ 10,000 per day of noncompliance
or per violation. If the immediate jeopardy is removed, but the deficiency
continues, the department shall shift the penalty amount to the range spe-
cified in (b)(2).

(4) The department shall send the laboratory written notice of intent
to impose a civil money penalty. The notice shall include the following
information:

(A) The statutory basis for the penalty,

(B) The proposed daily or per violation amount of the penalty.

(D) The time allowed for the laboratory to respond to the notice. (Dur-
ing the period specified, the laboratory may submit to the department
written evidence or other information against the imposition of the pro-
posed sanction or sanctions.)

(5) After the period specified in (b)(4)(D) has elapsed, the department
shall give the laboratory a written Notice of Sanction that acknowledges
any evidence or information received from the laboratory and specifies
the following:

(A) The sanction or sanctions to be imposed against the laboratory,

(B) The authority and rationale for imposing the sanction or sanctions,

(D) A specific statement regarding the laboratory's appeal rights and
a Notice of Defense in the following form: Unless a written request for
a hearing signed by the laboratory owner(s) or director(s) is delivered or
mailed to the department within 15 days after the Notice of Sanction was
mailed, the department may proceed upon imposition of the sanctions
identified in the Notice of Sanction without a hearing. A request for a
hearing may be made by delivering or mailing the enclosed form entitled
Notice of Defense, or by delivering or mailing a notice of defense as pro-
vided by section 1 1506 of the Government Code to: The Department of
Health Services at the address noted on the Notice of Sanction. The labo-
ratory may, but need not, be represented by counsel at any or all stages
of the proceedings.

(6) The laboratory shall have 15 days from the date of receipt of the
Notice of Sanction to request a hearing by delivering or mailing a Notice
of Defense. Hearings shall be conducted in accordance with chapter 5
(commencing with section 11500) of part 1 of division 3 of title 2 of the
Government Code, except that hearings may be conducted by depart-
mental hearing officers appointed by the director.

(7) The effective date of an alternative sanction of a civil money penal-
ty shall be delayed if the laboratory has appealed and the hearing or the
hearing decision is pending.

Note. Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Stats. 1995, c.510. Section 1. Reference:
Stats. 1995, c.510. Section 1; Section 1310, Business and Professions Code; and
Section 1 1505, Government Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec-
tion (b)(4)(D), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98,

No. 7).

§ 1 067.1 0. Procedures for the Imposition of On-site
Monitoring.

(a) The department may require continuous or intermittent monitoring
of a plan of correction to ensure that the laboratory makes the improve-
ments necessary to bring it into compliance with the condition level re-
quirements.

(b) The laboratory shall pay the costs of on-site monitoring by the de-
partment.

(1) The department shall provide written notice of the following:

(A) The condition level noncompliance that it has identified,

(B) The sanction or sanctions that the department proposes to impose
against the laboratory,

(D) The projected effective date and duration of the proposed sanction
or sanctions,

(E) The authority for the proposed sanction or sanctions, and

(F) The time allowed for the laboratory to respond to the notice. [Dur-
ing the period specified, the laboratory may submit to the department
written evidence or other information against the imposition of the pro-
posed sanction or sanctions.]

(2) After the period specified in (c)(1)(F) has elapsed, the department
shall give the laboratory written notice that acknowledges any evidence
or information received from the laboratory and specifies the following:

(A) The sanction or sanctions to be imposed against the laboratory,

(B) The authority and rationale for imposing the sanction or sanctions,
and

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Stats. 1995, c.510. Section 1. Reference:
Stats. 1995, c.510. Section 1; Section 1310, Business and Professions Code; and
Sections 1 1503, 1 1505 and 1 1506, Government Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order, including amendment of subsec-
fion (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

§ 1 067.1 5. Procedures for the Imposition of a Temporary
Suspension of a Laboratory or Clinical
Laboratory under the Medi-Cal Program.

(a) The department may impose a Temporary Suspension on a provid-
er of laboratory services prior to hearing if the laboratory has condition
level deficiencies or there is immediate jeopardy and in the director's
opinion such action is necessary to protect the public welfare or the inter-
ests of the Medi-Cal program.

(b) If the department is imposing a Temporary Suspension on a provid-
er of service, the following procedures apply:

( 1 ) The department shall serve the laboratory with a Notice of Sanction
which includes the following information:

(A) The sanction or sanctions to be imposed against the laboratory,
and

(B) The effective date and duration of sanction.

(2) At the same time as the Notice of Sanction is served, the department
shall serve the laboratory with an Accusation. Included with the Accusa-
tion is a Notice of Defense in the following form: Unless a written request
for a hearing signed by the owner(s) or director(s) of the laboratory is de-
livered or mailed to the department within 15 days after the Notice of
Sanction and Accusation were served, no hearing shall be held regarding
the imposition of the sanctions identified in the Notice of Sanction. A re-
quest for a hearing may be made by delivering or mailing the enclosed
form entitled Notice of Defense, or by delivering or mailing a notice of
defense as provided by section 1 1506 of the Government Code to: The
Department of Health Services at the address noted on the Notice of
Sanction. The laboratory may, but need not, be represented by counsel
at any or all stages of these proceedings.

(3) The laboratory shall have 15 days from the date of receipt of the
Notice of Sanction to request a hearing by delivering or mailing a Notice
of Defense. Hearings shall be conducted in accordance with chapter 5
(commencing with section 1 1500) of part 1 of division 3 of title 2 of the
Government Code, except that hearings may be conducted by depart-
mental hearing officers appointed by the director.

(4) The effective date of a Temporary Suspension of a clinical labora-
tory or laboratory under the Medi-Cal program shall not be delayed be-
cause the laboratory has appealed the sanction under (b)(3), above, and
the hearing or the hearing decision is pending.

Page 22.10

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State Department of Health Services

§1079

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
100275, Health and Safety Code; and Section 14105, Welfare and Institutions
Code. Reference: Stats. 1995, c.510. Section 1; Section 1265, Business and Pro-
fessions Code; Section 14123, Welfare and Institutions Code; 42 United States
Code, Section 1395w-2 (Section 1846 of the federal Social Security Act); 42
United States Code, Section 1396a(a)(9) (Section 1902(a)(9)(C) of the federal So-
cial Security Act); and Sections 1 1503, 1 1505 and 1 1506, Government Code.

History

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97,
No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 8-28-98 order transiriitted to OAL 12-24-97
and filed 2-9-98 (Register 98, No. 7).

Group 3. County and Municipal
Laboratories

Article 1

Official Public Health Laboratory
Service Required

§ 1075. Local Health Departments.

Each local health department shall have available the services of an of-
ficial public health laboratory. The laboratory of the State Department of
Health is hereby designated as the official laboratory for all local health
department jurisdictions not covered by local laboratory service.
Note: Authority cited for Article 1 : Sections 208, 1000, and 1002 of the Health
and Safety Code. Reference: Sections 1000 and 1 002, Health and Safety Code. Is-
suing agency: State Department of Public Health.

History

1. Article 1 (§§ 1075 to 1085, inclusive) originally published 8-15-45 (Title 17).

2. Revised Article 1 (§§ 1075 to 1084, inclusive) filed 10-26-49 (Register 18, No.
4).

3. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.

4).

§ 1076. Certificates of Approval Required.

A certificate of approval issued after inspection by the Department
shall be required to be in the possession of and be on display in every prin-
cipal and branch public health laboratory and no such laboratory shall
continue to operate following receipt of notice of cancellation of any ex-
isting certificate, or of refusal of the Department to issue a certificate.

History

1. Amendment filed 8-16-71 ; effective thirtieth day thereafter (Register 71, No.
34).

2. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.
4).

§ 1 076.1 . Public Health Laboratory.

The official public health laboratory shall consist of a principal public
health laboratory and may include branch public health laboratories.

(a) The principal public health laboratory is the laboratory facility that
provides the major or total laboratory services to a public health depart-
ment.

(b) A branch public health laboratory is any laboratory facility that
provides minor or auxiliary laboratory services.

NOTE: Authority cited: Sections 208, 1000 and 1002, Health and Safety Code.
Reference: Sections 1000 and 1002, Health and Safety Code.

History
1. New section filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.
4).

§ 1077. Reports Required.

The following reports shall be transmitted to the Department by all
laboratories approved under Section 1076. Standard forms shall be used
if provided by the Department.

(a) A report shall be made semiannually during the months of January
and July, of work load data and personnel information as requested by the
Department.

(b) A report shall be given within 30 days:

(1 ) Of any change in the directorship of the laboratory.

(2) Of any proposed expansion, reduction or shift in laboratory ser-
vices.

(3) Of any change in the location of the laboratory.

Note; Authority cited: Sections 208 and 1 130, Health and Safety Code. Refer-
ence: Section 1130, Health and Safety Code.

History

1. Amendment filed 8-3-67; effecfive thirtieth day thereafter (Register 67, No.
31).

2. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No.
34).

3. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.
4).

4. Editorial con-ecfion of NOTE filed 1 1-5-84 (Register 84, No. 45).

§ 1078. Minimum Requirements Specified.

Any laboratory approved under Section 1076 shall meet the following
minimum requirements:

(a) Maintain adequate equipment and facilities and sufficient person-
nel to carry on dependable public health laboratory work.

(b) Employ procedures, technics, and reporting practices approved by
the Department.

(d) Conduct, maintain, and operate programs, acceptable to the De-
partment, for controlling the quality of test performance.

(e) Demonstrate satisfactory performance in a proficiency testing pro-
gram approved by the Department.

(f) Maintain and conduct the laboratory in a manner approved by the
Department.

(g) Employ personnel as provided in this article.

(h) Accept specimens for examination as an aid to patient management
only from, and issue reports only to, persons licensed under the provi-
sions of the law relating to the healing arts or their representatives.

(i) Employ procedures and precautions to provide for the safety and
health protection of all persons in the laboratory.

History

1. Amendment filed 8-16-71; effecfive thirtieth day thereafter (Register 71, No.
34).

2. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.
4).

§ 1079. Professional Personnel to Be Certified.

(a) No person may act as a Public Health Microbiologist in any labora-
tory certified under Section 1076 who is not in possession of a Public
Health Microbiologist's Certificate issued by the Department.

(b) The Department may issue temporary certificates to applicants
who meet the requirements for admission to the next scheduled examina-
tion when this is deemed to be reasonably necessary for the provision of
public health laboratory services. Temporary certificates may not be is-
sued to applicants who have failed to pass certification examinations.

(c) Examinations, either written or oral, or both, for the certificate of
Public Health Microbiologist shall be held as needed and where desig-
nated by the Department. Such examinations shall be under the supervi-
sion of the Department.

(d) The minimum requirements for admission to the examinations for
a certificate as Public Health Microbiologist shall be as follows:

( 1 ) Holds an earned doctoral degree from an accredited institution with
a chemical, physical or biological science as a major, and has completed
at least one year of postdoctoral laboratory training in medical and public
health microbiology approved by the Department; or

(2) A baccalaureate or higher degree with a major in Medical or Public
Health Microbiology, or equivalent major as determined by the Depart-
ment, with courses acceptable to the Department, from a college or uni-
versity accredited by the Western Association of Schools and Colleges
or an essentially equivalent accrediting agency, as determined by the De-
partment; and experience represented by at least six months as a Public

Page 22.11

§1079

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Health Microbiologist-trainee in a public health laboratory approved by
the Department for such training; or experience equivalent to this train-
ing as determined by the Department in a laboratory acceptable to the De-
partment.

(e) No person shaH perform any test or make any examination in any
laboratory certified under Section 1076 unless he is in possession of a
valid Public Health Microbiologist's certificate or is otherwise approved
by the Department to perform specified laboratory procedures.

(f) Every person certified as a Public Health Microbiologist shall re-
port to the Department within 30 days any change of name or mailing ad-
dress giving both the old and new names and addresses.

(g) Certificates may be denied, revoked or suspended for any of the
following reasons:

( 1 ) Conviction of a felony or of any misdemeanor involving moral tur-
pitude, under laws of any State or of the United States, arising out of or
in connection with public health laboratory practice. The record of con-
viction or a certified copy thereof shall be conclusive evidence of such
conviction.

(2) Violation of any provision of the Business and Professions Code
governing the practice of medicine and surgery.

(3) Violation of these regulations.

(4) Knowingly making a false statement concerning a material matter
on an application for certification, or on an application for approval as a
trainee.

(5) The use of any degree, certificate or title in any manner, which has
been purchased or procured by barter or any unlawful means or obtained
from any institution which at the time said degree, certificate or title was
obtained was not recognized or accredited by the proper authorities of the
state where said institution was located to give training in the field of
study in which the degree, certificate or title is claimed.

(6) The use of drugs or alcoholic beverages to the extent, or in such a
manner, that such use impairs the ability of the certified person to practice
his profession with safety to other persons in the laboratory or to the pub-
lic.

(h) Proceedings under paragraph (g) above shall be conducted in ac-
cordance with Chapter 5, Part I, Division 3 of Title 2 of the Government
Code.

NOTE: Authority cited: Section 1224, Business and Professions Code; Section
208, Health and Safety Code. Reference: Section 1270, Business and Professions
Code; Section 1002, Health and Safety Code.

History

1 . Amendment of subsection (d) filed 1 2-12-78; effective thirtieth day thereafter
(Register 78, No. 50). For prior history, see Register 77, No. 4.

[The next page is 23.]

Page 22.12

Title 17

State Department of Health Services

§1126

2. Amendment of subsection (d)(2) filed 10-24-80; effective thirtieth day thereaf-
ter (Register 80, No. 43).

§1080, Professional Training,

(a) For purposes of this section a person receiving professional train-
ing required for certification as a Public Health Microbiologist shall be
designated as a Public Health Microbiologist-trainee.

(b) The credentials of a Public Health Microbiologist-trainee shall be
approved by the Department prior to appointment.

(c) The appointment or separation of a Public Health Microbiologist-
trainee shall be reported within 5 days to the Department giving the date
of appointment or separation.

(d) Laboratories which accept personnel for training as Public Health
Microbiol ogist-trainees shall be specifically approved for such training
by the Department. The minimum requirements for approval as training
laboratories shall be established by the Department.

(e) A Public Health Microbiologist-trainee shall not be entrusted with
any microbiological examination except under the supervision of quali-
fied personnel, nor shall he issue or sign a laboratory report for any test
which he is scheduled for training for certification as a Public Health Mi-
crobiologist.

History

1. Amendment filed 3-25-57; effective thirtieth day thereafter (Register 57, No.
5).

2. Renumbering of Section 1 08 1 and amendment filed 8-16-7 1 ; effective thirtieth
day thereafter (Register 71, No. 34).

3. Amendment of subsecdon (e) filed 1-21-77; effecfive thirtieth day thereafter
(Register 77, No. 4).

§ 1081, Certain Cultures and Specimens to Be Sent to the
State Laboratory,

(a) All laboratories making examinations for identification of typhoid
carriers shall, in all positive cases, forward to the Department a culture
of the organism, the isolation of which established the diagnosis.

(b) Whenever a laboratory receives a specimen for the laboratory diag-
nosis of suspected human cases of plague or botulism such laboratory
shall communicate immediately by telephone or telegraph with the De-
partment for instructions.

(c) Any other specimens or cultures shall be submitted as required by
the communicable disease regulations. Sections 2500 to 2699.

History

1 . Renumbering of Section 1079 and amendment filed 8-16-7 1 ; effective thirtieth
day thereafter (Register 71, No. 34).

2. Amendment of subsection (c) filed 1-21-77; effective thirtieth day thereafter
(Register 77, No. 4).

§ 1082, Certain Specimens to Be Sent to Approved
Laboratories,

Whenever specimens are taken for laboratory diagnosis of rabies or
botulism, or for release from isolation of cases of diphtheria, typhoid fe-
ver, salmonellosis, or shigellosis, they shall be sent by the physician to
a Public Health Laboratory approved for such work by the Department
in accordance with Section 1076.

History

1 . Amendment filed 3-25-57; effective thirtieth day thereafter (Register 57, No.
5).

2. Amendment filed 8-16-71; effecfive thirtieth day thereafter (Register 71, No.

34).

3. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.
4).

§ 1083, Inspections to Be Made.

Laboratories approved under Section 1 076 shall be inspected by a duly
authorized representative of the Department, for maintenance and con-
duct in conformity with these regulations. When deemed advisable, the
Department may send check specimens to local laboratories to evaluate
the accuracy and precision of specific test performance.

History

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No.

34).

§ 1084, Health Departments May Contract with Private
Laboratories.

A health officer of a municipality or county may designate any labora-
tory as an official public health laboratory to perform any of the basic ser-
vices, as defined under Section 1276(f). Any such laboratory shall be
subject to the same requirements as an official public health laboratory
as heretofore provided under Sections 1075 to 1083. inclusive.

History

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No.
34).

2. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.
4).

Group 4. Tests for Syphilis Under the
Premarital and Prenatal Laws

Article 1. Serologic Tests

§ 1125, Application Required,

The director of any laboratory in which performance of serologic tests
is planned in connection with premarital and prenatal examinations, as
required by Sections 4300-4309 of the Civil Code and Sections
3220-3229 of the Health and Safety Code, shall apply to the State De-
partment of Health for approval to perform these tests. The laboratory di-
rector shall submit to the State Department of Health, on forms provided
by the department, such information as may be required by the depart-
ment to satisfactorily evaluate the personnel, equipment, and scope of ac-
tivity in relation to these tests.

NOTE; §§ 11 25 to 1134, inclusive, originally issued under authority contained in
Section 79.04, Civil Code, and Deering's General Laws, Act 6265. Source of
§§ 1 125 to 1134, inclusive, is the Rules and Regulations issued by State Depart-
ment of Health. Additional authority cited for revision of Article 1: Sections 102
and 208, Health and Safety Code. Reference: Sections 3180-3199 and
3220-3229, Health and Safety Code.

History

1. Amendment filed 10-5-71 as procedural and organizational; effective upon fil-
ing (Register 71, No. 41). For prior history, see Register 60, No. 19.

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.
26).

§ 1 1 26, Approved Tests,

The serologic tests for syphilis approved by the Department for use in
connection with legally required premarital and prenatal examinations
are as follows: VDRL slide. Automated Reagin, Fluorescent Treponemal
Antibody (absorption), Reagin Screen, and the Rapid Plasma Reagin
(circle) Card. Any one of these tests shall constitute the "standard test"
as required by the California Civil Code and California Health and Safety
Code.

The serologic tests for rubella approved by the department for use in
connection with legally required premarital examinations shall be the he-
magglutination-inhibition (HI) test performed according to the standard
method of the U.S. Public Health Service, Center for Disease Control, or
modifications thereof approved by the Center for Disease Control and the
Department, and such other tests approved by the Center for Disease
Control and Food and Drug Administration, U.S. Public Health Service,
as the Department may evaluate and determine to be equal in reliability
and specificity to the approved hemagglutination-inhibition test.

Commercially prepared antigens and diagnostic kits utilized for the
approved rubella tests shall have been evaluated by, and shown to meet
specifications of the U.S. Public Health Service and such evaluation shall
be evidenced by a statement on the label of, or accompanying, the prod-
uct.

NOTE: Authority cited: Secfion 11426, Government Code; Sections 4300. 4301 ,
4302 and 4304, Cahfornia Civil Code; Sections 102 and 208, Health and Safety
Code. Reference: Secfions 3180-3199 and 3220-3229, Health and Safety Code.

Page 23

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§1127

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.
26). For prior history, see Register 71, No. 34.

2. Amendment filed 8-17-78; effective thirtietli day thereafter (Register 78, No.

33).

§ 1 1 27. Method of Conducting Tests.

All tests for syphilis must be conducted exactly as outlined by the au-
thor of the test. All equipment recommended by the author of the test
must be available in the laboratory before approval can be granted.

For syphilis serology, the latest United States Department of Health,
Education and Welfare, Public Health Service publication pertaining to
the performance of these tests, or its replacement, shall be the reference
on equipment and methods.

All tests for rubella must be conducted exactly according to the proto-
cols for each method or modification that has been approved by the Cen-
ter for Disease Control and the Department. All necessary equipment for
the approved rubella test to be performed must be available in the labora-
tory before approval to perform legally required tests can be granted.

The references for approved rubella test methods and equipment shall
be protocols issued by the Center for Disease Control, or the Department,
or provided by manufacturers for use with commercially distributed
diagnostic kits or components which have been approved by the Center
for Disease Control and the Department.

History

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No.
19). See history note to Section 1 125.

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.
26).

3. Amendment filed 8-17-78; effective thirtieth day thereafter (Register 78, No.

33).

§ 11 28. Evaluation Sera.

Any laboratory approved to perform premarital and prenatal serologic
tests must accept and test, evaluation sera provided by the department or
a proficiency testing service approved by the department, and report test
results to the department. Any laboratory showing unsatisfactory per-
formance shall make changes as recommended by the department or dis-
continue the testing of legally required premarital and prenatal blood
specimens, and return all outstanding "Marriage Health Certificates."

History

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No.
19). See history note to Section 1 125.

2. Amendment filed 3-15-66; effective thirtieth day thereafter (Register 71, No.
7).

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 66, No.
34).

§ 1 1 29. Marriage Health Certificates.

"Marriage Health Certificates" shall be assigned by the State Depart-
ment of Public Health to an individual laboratory at a specified location,
and shall be used by no other. These certificates must not be transmitted
to the physician until the tests have been }ierformed.

History
1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.

26). For prior history, see Register 66, No. 7

§ 1 1 30. Persons Permitted to Perform Tests.

Only a person who is duly licensed as a physician and surgeon pur-
suant to Sections 2000-2497 of the Business and Professions Code, or
duly authorized under the provisions of Chapter 3, Division 2 (commenc-
ing with Section 1200) of the Business and Professions Code, or who is
certified under the provisions of Sections 1075-1084 of Title 17 of the
California Administrative Code, shall be permitted to conduct premarital
and prenatal serologic tests.

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Sections 3220, 4300 and 4302, Health and Safety Code.

History
1. Amendment filed 2-18-58; effective thirtietli day thereafter (Register 58, No.
3). See history note to Section 11 25.

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.
26).

§ 1 1 31 . Change of Personnel.

Within 30 days after new personnel are employed to perform legally
required prenatal and premarital serologic tests, their names shall be
transmitted to the State Department of Health. This rule does not apply
to the rotation of staff members from one phase of laboratory work to
another.

History

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No.
19). See history note to Section 1 125.

2. Amendment filed 6-28-73; effecfive thirtieth day thereafter (Register 73, No.
26).

§ 11 32. Change of Director or Location.

Reapplication for approval to perform legally required premarital and
prenatal serologic tests shall be made when there is a change of laborato-
ry director or location.

History
1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.

26).

§1133. Advertising Prohibited.

Laboratories shall not be approved to perform premarital and prenatal
serologic tests if they advertise the performance of these tests to the lay
public.

§ 1134. Withdrawal of Approval.

Approval granted under this article may be withdrawn following vio-
lation of any of the provisions of Sections 1125-1 134 of Title 17 of the
California Administrative Code, Sections 3220-3229 of the Health and
Safety Code, Sections 4300-4309 of the Civil Code pertaining to the per-
formance of premarital and prenatal serologic tests and all outstanding
"marriage health certificates" shall be returned to the State Department
of Public Health.

History

1. Amendment filed 8-24-60; effective thirtieth day thereafter (Register 60, No.
19). See history note to Section 1 125.

2. Amendment filed 3-15-66; effective thirtieth day thereafter (Register 66, No.
7).

3. Amendment filed 10-5-71 as procedural and organizational; effective upon fil-
ing (Register 71, No. 41).

Group 5. Care of Laboratory Animals

Article 1. Definitions

§1150. Definitions.

(a) For purposes of these regulations, "person" includes: laboratory,
firm, association, corporation, copartnership, and educational institu-
tion.

(b) For purposes of these regulations, "board" means: the State De-
partment of Health Services.

(d) For purposes of these regulations, "animal" means: any live,
warm-blooded animal kept or used by any person for the purposes de-
fined herein.

(e) For purposes of these regulations, "individual" means: the one
whom the laboratory, firm, association, corporation, copartnership or
educational institution designates as being responsible for proper care of
the animals kept or used for experimentation, demonstration, or test; the
propriety of the procedures used; and the scientific justification for the
use of the animals in experiments, demonstrations, or tests.

History
1. New Group 5 (§§ 1150 through 1159) filed 3-28-52; effecfive thirtieth day
thereafter (Register 28, No. 1 ). For history of previous Group 5, see Register 26,
No. 7.

Page 24

(4-1-90)

Title 17

State Department of Health Services

§1158

Article 2. Certification Requirements

§1151. Issuance of the Certificate of Approval.

(a) All persons desiring to keep or use animals for the study, diagnosis,
and treatment of human and animal diseases, for education or research
in the advancement of veterinary, dental, medical, and biological
sciences for education and research in animal and human nutrition, and
for the testing and diagnosis, improvement and standardization of labora-
tory specimens, biologic products, pharmaceuticals and drugs shall make
application to the department on the forms provided by the department
for a certification of approval for such activities. They shall supply such
other information as may be required by the department for the establish-
ment, and its physical facilities with respect to the care of animals as re-
lated to the intent and purpose of this law.

(b) Certificates of approval shall not be issued to any person unless he
is at the time of application prepared and equipped to keep and use the
animals in accordance with the provisions of this law, and rules and regu-
lations of the board adopted in accordance thereof. The department will
provide anyone contemplating keeping or using animals information
concerning the requirements and conditions for the compliance with the
law.

(c) Each applicant for certification shall designate an individual who
will be directly responsible for the use and care of animals and for making
appropriate reports thereof. Such individuals shall occupy a responsible
position of authority in the applicant organization. A certified institution
which transfers such responsibility shall immediately notify the depart-
ment of such fact. The department may deny any application unless it is
satisfied that the responsible individual so designated is qualified and
will require that the animals kept or used by the applicant be used and
cared for in a humane manner acceptable to this department.

(d) A certificate of approval must be obtained for each address or cam-
pus where animals are kept or used for the purposes specified in this law.

(e) A new application or amendment to existing and approved applica-
tion must be made for any change of the responsible individual, or change
in location of the laboratory or animal quarters.

(0 Any major change in equipment or methods of management must
be approved in advance by the department.

(g) The certificate of approval or duplicate thereof as supplied by the
department shall be displayed in a prominent place in the approved ani-
mal quarters or approved laboratory.

(h) A certificate of approval shall not be issued unless the conditions
of the establishment and facilities are such as to reasonably insure that the
animals kept or used receive humane care and treatment.

(i) Denial, revocaUon, or suspension of certificates of approval must
be in accordance with the provisions of the Administrative Procedure
Act.

§1152. Fees.

(a) The application and renewal fees must be in accordance with the
provisions of Article 5 of Chapter 5 of Division 2 of the Health and Safety
Code.

(b) For the purpose of these regulations the fiscal year shall be from
January 1st to December 3 1 st.

§ 1 153. Application for Renewal of Certificate of Approval.

(a) Application for renewal of certificates of approval shall be on
forms provided by the department.

(b) Each holder of a certificate applying for renewal of his certificate
of approval shall be subject to a review of his activities during the pre-
vious licensing period and to such inspections of his records, premises,
equipment, and animals as may be determined by the department for con-
sideration by the board in passing upon the application for renewal.

§1154. Records.

Holders of certificates of approval shall keep the following records:

(a) Monthly census of animals kept according to type;

(b) Total number of animals used per month according to type;

Such records may be open to inspection by authorized agents of the
department during the normal working hours of operation.

Article 3. Minimum Standards

§ 1 1 55. Care and Treatment of Animals.

(a) Careful considerafion shall be given to the bodily comfort of such
animals. They shall be kindly treated, properly fed, and their quarters
shall be clean, properly lighted and maintained at the proper temperature.
Excepfion may be made to this rule only with expressed permission of
the responsible individual. This permission may be granted only when
the foregoing considerations would defeat the purpose of the work.

(b) Any operation likely to cause greater discomfort than the attending
anesthetization shall not be undertaken unul the animal be first rendered
incapable of perceiving pain. The animals shall be maintained in that
condifion until the operafion is completed. Exceptions to this rule may be
made only when provisions for maximum comfort including anesthesia
would defeat the object of the experiment, and then only with the ex-
pressed permission of the responsible individual.

(c) At the conclusion of experiments, the animals must be killed pain-
lessly or given care to minimize discomfort which is essentially equiva-
lent, as determined by the department, to that rendered human beings fol-
lowing an operafion. In any event, animals which have been used for any
purpose described herein shall not be disposed of as pets, except with the
expressed permission of the responsible individual. Due consideration in
this master shall be given to public health and to the animal's welfare.

§1156. Quarters.

The animal quarters shall be provided with proper lighting, ventila-
tion, and heating to maintain comfort of the animal except where the pro-
visions of Section II 55 otherwise provide. Equipment must be adequate
for the proper care and treatment of all animals kept or used. Cages, or
other enclosures, shall be large enough to permit reasonable freedom of
movement. Adequate facilities shall be provided for keeping animal
quarters and equipment clean. Overcrowding must be avoided in order
to limit the transmission of animal diseases. The animals shall be main-
tained in a room separate from any other activity of the establishment, or
under other physical conditions satisfactory to the department.

§1157. Personnel.

Capable personnel shall be employed for the adequate care and feed-
ing of the animals. In small, as well as in extensive animal facilities, one
individual shall be in complete charge of, and therefore, responsible for,
the entire operation of the unit. Selection of animal caretakers shall be
made with care. Nonprofessional personnel shall be chosen for their de-
pendabihty and their liking for animals. The training should include a
knowledge of the means of transmission of disease and an understanding
of the precautions necessary to prevent this. Caretakers should be trained
in recognizing early symptoms of the common diseases of the animals
under their care.

§1158. Feeding.

(a) The animals shall be well fed and shall receive wholesome food
suitable to the species and shall receive sufficient clean water except
where special studies require specified diet for the animal.

(b) Rules and regulations adopted by the board with reference to shel-
ter, food, sanitation, and the care and treatment of animals shall be promi-
nently displayed in all animal rooms.

Page 25

§1159

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 4. Filing of Complaint

§ 11 59. Filing of a Complaint.

Anyone who files a complaint to the department against an individual,
or person, violating this law shall supply in writing specific information
regarding the alleged violation, or violations. Such complaint shall in-
clude the time, date, place, individual, or person involved; and the names
of other witnesses who may be called to testify. This statement must be
in the form of a sworn affidavit and must be notarized.

Group 5.5. Methadone Drug Analysis
Laboratories

Article 1. Application

§ 1 1 60. Application of Subchapter.

Group 5.5 shall apply to all laboratories performing urine testing or
other body fluids analysis for methadone programs operating in Califor-
nia.

NOTE; Authority cited: Sections 208, 1 1881 and 11885, Health and Safety Code.
Reference: Section 11 885, Health and Safety ("ode.

History

1. New Group 5.5 (Articles 1-8, Sections 116(^-1196) filed 11-30-81; effective
thirtieth day thereafter (Register 81, No. 49).

2. Editorial coirection of NOTE filed 1 1-6-84 (Register 84, No. 45).

Article 2. Definitions

§1161. Methadone Drug Analysis.

"Methadone drug analysis" means the practical apphcation of special-
ized devices, instruments and methods by trained laboratory personnel
to detect the presence of chemical substances named in Section 11 86 in
samples of urine or other body fluids obtained from persons receiving
treatment from a methadone program.

NOTE: Authority cited: Sections 208, 11881 and 1 1885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety C'ode.

History

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1162. Methadone Drug Analysis Laboratory.

"Methadone drug analysis laboratory" means a place at which special-
ized apparatus, instruments and methods are used by trained laboratory
personnel to detect the presence of chemical substances named in Section
11 86 in urine or other body fluids obtained from persons receiving treat-
ment from a methadone program.

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1 885, Health and Safety Code.
Reference: Section 11885, Health and Safety C'ode.

History
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 63. Methadone Drug Analysis Supervisor.

"Methadone drug analysis supervisor" means a person, employed by
a methadone drug analysis laboratory, who is directly responsible for all
aspects of the performance of methadone drug analysis and for the super-
vision of personnel who perform such analysis.

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History

1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45).

§1164. Method.

"Method" means the steps used by a trained person to determine the
presence of drugs in urine or other body iluids.

NOTE: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code.
Reference: Section 11885, Health and Safety C'ode.

History

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 65. Instrument or Device.

"Instrument" or "device" means any item or combination of items of
equipment used to determine the presence of drugs; simple and complex
devices are included in this meaning.

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code.
Reference: Section 11 885, Health and Safety Code.

History

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 66. Sample or Specimen.

"Sample" or "specimen" means a representative portion of urine or
other body fluid or of an artificially constituted material, taken for the
purpose of determining the presence of drugs.

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History
1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 67. Department.

"Department" means the State Department of Health Services.
NOTE; Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History

1. Editorial correcfion of NOTE filed 11-6-84 (Register 84, No. 45).

§1168. May, Shall.

"May" is permissive; "Shall" is mandatory.
NOTE: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety Code.

History
1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45).

§1169. Methadone.

"Methadone" means the substance that can be described as 6-dime-

thyl-amino-4, 4-diphenyl-3-heptanone. Methadone doses are usually

administered as methadone chloride.

Note: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History

1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§ 1 1 70. Primary Metabolite of Methadone.

"Primary Metabolite of Methadone" means: 2-ethylidene-l, 5-dime-
thyl-3, 3-diphenylpyrrolidine.

NOTE: Authority cited: Secfions 208, 1 1 881 and 1 1885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety Code.

History
1. Editorial correcfion of NOTE filed 11-6-84 (Register 84, No. 45).

Article 3. Requirements for Methadone
Drug Analysis Laboratories

§ 1 1 71 . Licensing Requirement.

Every methadone drug analysis laboratory performing urine testing or
other body fluid analysis for any methadone program operating in Cali-
fornia shall have a valid license issued by the Department in accordance
with these regulations.

NOTE: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Sections 1 1886 and 1 1887, Health and Safety Code.

History
1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 72. Qualifications for Licensing.

A methadone drug analysis laboratory meets the qualifications for li-
censing if it:

(a) Employs at least one methadone drug analysis supervisor.

(b) Furnishes the Department with detailed, written descriptions of
each method it uses for drug analysis. Such description shall clearly de-
scribe the initial test and confirmatory test methods.

•

Page 26

Title 17

State Department of Health Services

§1183

(d) Demonstrates satisfactory performance in an initial proficiency
testing program conducted by the Department.

(e) Demonstrates satisfactory performance in a continuing external
proficiency testing program conducted by or approved by the Depart-
ment.

(t") Passes such on-site inspections as the Department may require.

(g) Demonstrates an ability to meet the requirements of these regula-
tions.

NOTE: Authority cited: Sections 208, 11 881 and 1 1885, Health and Safety Code.
Reference: Sections 1 1885, 1 1886 and 1 1890, Health and Safety Code.

History
]. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1173. Qualifications of Methadone Drug Analysis
Supervisor.

A methadone drug analysis supervisor shall have the following quali-
fications:

(a) Possesses a baccalaureate or higher degree, or an equivalent in
chemistry, biochemistry, or other appropriate discipline as determined
by the Department.

(b) Has two years practical experience in performing drug analysis on
biological fluids or tissues, such experience to include experience in in-
terpretation of chromatographic, spectrophotometric and immunochem-
ical testing results.

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 11 885, Health and Safety Code.

History
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 74. Use or Access of Patients.

A methadone drug analysis laboratory shall not employ or utilize the
services of a patient of any methadone program in, nor permit any such
patient access to, any of its activities involving urinalysis or other body
fluids testing for any methadone program.

NOTE: Authority cited: Sections 208, 1 1 88 1 and 11 885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety Code.

History

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

Article 4. Licensing Procedures

§ 1 1 75. Qualifying for License.

Upon receipt of a completed application and upon payment of the re-
quired fee, the Department shall submit such proficiency test samples
and perform such examinations as are required for that laboratory to com-
plete the qualifications. Upon the laboratory's successfully completing
all the qualifications, the Department shall issue to the applicant labora-
tory a methadone drug analyses laboratory license.
NOTE: Authority cited: Secfions 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Sections 11885, 11886 and 11887, Health and Safety Code.

History
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 76. Renewal of Licenses.

A license issued under these regulations shall be renewed annually as
long as the activity requiring licensure continues. Renewal shall be con-
tingent upon the laboratory continuing to fulfill the qualifications as set
forth in these regulations, and is further subject to the following:

(a) A methadone drug analysis laboratory license shall be vahd from
July 1 to June 30 of the next succeeding calendar year. Applications for
renewal and all applicable fees shall be submitted to the Department on
or before April 1 of each year.

(b) Failure to apply for renewal shall result in forfeiture after a period
of three months from the day on which the application for renewal should
have been submitted, with the exception that the Department may grant
a temporary extension under special circumstances.

NOTE: Authority cited: Sections 208, 11 881 and 1 1 885, Health and Safety Code.
Reference: Section 11887, Health and Safety Code.

History

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1177. Application Forms.

Application for a license and a renewal thereof, shall be made on forms
furnished by the Department. The applicant shall set forth all pertinent
information called for by the form. Application forms may be obtained
from, and shall be sent to: Clinical Chemistry Laboratory, Department of
Health Services, 2151 Berkeley Way, Berkeley, CA 94704.

NOTE; Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 11887, Health and Safety Code.

History

1. Editorial conection of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 78. Report of Change or Discontinuance.

The person responsible for the operation of a methadone drug analysis
laboratory shall report to the Department in writing within 30 days any
change in ownership, change in supervisorial personnel, changes in
methods of analysis, change of address or discontinuance of an activity
authorized under these regulations.

NOTE: Authority cited: Sections 208, 1 1 881 and 11 885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History
1. Editorial con-ection of NOTE filed 11-6-84 (Register 84, No. 45).

§ 1 1 79. License Implications.

Licenses issued under these regulations shall not imply approval of
anything carried out by a laboratory other than what is specified on the
Hcense.

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1 885, Health and Safety Code.
Reference: Sections 1 1885, 1 1886 and 1 1887, Health and Safety Code.

History

1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 80. Display of Licenses.

Licenses issued under these regulations shall be displayed on request
to representatives of the Department.

NOTE; Authority cited: Secdons 208, 1 1 881 and 1 1 885, Health and Safety Code.
Reference: Sections 1 1885 and 1 1887, Health and Safety Code.

History
1. Editorial con-ecfion of NOTE filed 1 1-6-84 (Register 84, No. 45).

§1181. Fees.

The annual application fee for a methadone drug analysis laboratory
license or its renewal shall be $ 100.00. A laboratory operated by the state,
a county, a city, a city and county, other public agency or a clinical labo-
ratory licensed pursuant to subdivision (f) of Section 1300 of the Busi-
ness and Professions Code shall be exempt from the fee.
NOTE; Authority cited: Secfions 208, 1 1881 and 1 1 885, Health and Safety Code.
Reference: Section 11 887, Health and Safety Code.

History

1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45).

Article 5. Substances Approved for

Analysis, Requirements for Collection and

Handling of Samples

§1182. Urine.

The only presently approved body fluid which may be tested for a
methadone program is urine.

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Sections 1 1885 and 1 1886, Health and Safety Code.

History
1. Editorial correcfion of NOTE filed 1 1-6-84 (Register 84, No. 45).

§1183. General.

Urine samples taken for methadone drug analysis shall be collected
and handled in a manner subject to the approval of the Department. The
identity and the integrity of the sample shall be maintained through col-

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§1184

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

lection to analysis and reporting. The only approved urine sample shall
be one which has been collected under direct observation by a staff mem-
ber of the methadone program. The sample shall be deposited in a clean
container.

NOTE: Authority cited: Sections 208, 11 881 and 1 1885, Health and Safety Code.
Reference: Section 1 1885. Health and Safety Code.

History

1. Editorial coiTection of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 84. Sample Preservation.

While not in transit to a laboratory, or being analyzed, any urine sam-
ple not containing a preservative shall be refrigerated.
NOTE: Authority cited: Sections 208, 11 881 and 1 1 885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety Code.

History

I. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

shall not be expressed in equivocal terms, such as "possible traces" or
"plus-minus."

NOTE; Authority cited: Sections 208, 11 881 and 1 1885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History
1. Editorial con-ection of NOTE filed 1 1-6-84 (Register 84, No. 45).

Article 6. Methods of Analysis and
Standards of Performance

§1185. General.

All methods used for methadone drug analysis shall be subject to the
standards as set forth in these regulations. Each licensed methadone drug
analysis laboratory shall have on file with the Department detailed, cur-
rent written descriptions of each method it uses for drug screening. Such
descriptions shall be immediately available to the person performing an
analysis and shall be available for inspection by the Department on re-
quest.

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety Code.

History

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 86. Standards of Performance.

The methods of analysis used by a laboratory shall be able to detect the
following drugs, and at least at the following concentrations, in urine:

Methadone

Primary Metabolite of Methadone

Morphine (total of free and conjugated)

Codeine

Amphetamine

Methamphetamine

Phenobarbital

Pentobarbital

Secobarbital

2 micrograms per milliliter
1 microgram per milliliter
1 microgram per milliliter

1 microgram per milliliter

2 micrograms per milliliter
5 micrograms per milliliter
1 microgram per milliliter

1 microgram per milliliter
1 microgram per milliliter

NOTE: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety Code.

History
1. Editorial correction of NOTE filed 11-6-84 (Register 84, No. 45).

§1187. Specificity.

In order to insure adequate specificity, all positive findings, with the
exception of methadone, shall be confirmed using an alternate method of
analysis, fundamentally different from that used in the initial test.
NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code.
Reference: Section 1 1885, Health and Safety Code.

History
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 88. Evaluation of Standards of Performance.

The ability of methods to meet the standards of performance, as con-
tained in this Article, shall be subject to evaluation by the Department us-
ing either a laboratory's internal quality control or external proficiency
testing results, or both.

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 89. Expression of Analytical Results.

All analytical results shall be expressed in terms of the generic or
chemical name of any drug found to be present, and analytical results

Article 7. Inspections, Quality Control,
Proficiency Testing

§ 1 190. Inspections and Proficiency Testing.

Licensed methadone drug analysis laboratories and laboratories ap-
plying for licensure shall be subject to on-site inspections by representa-
tives of the Department, and shall cooperate in the quality control profi-
ciency testing program conducted by or approved by the Department.
These tests shall be used by the Department to evaluate the accuracy of
the analyses performed by the laboratory.

Note: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Sections 1 1888 and 1 1890. Health and Safety Code.

History
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 91 . Access to Premises.

The Department may enter any methadone drug analysis laboratory at
any reasonable time for the purpose of determining whether or not the
laboratory is complying with the provisions of these regulations.
NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code.
Reference: Sections 1 1888 and 1 1890, Health and Safety Code.

History
1. Editorial correction of NOTE filed 1 1-6-84 (Register 84, No 45).

§ 1 192. Quality Control Program and Proficiency Testing.

Methods for methadone drug analysis shall be performed in accor-
dance with the following quality control program:

(a) Each laboratory shall have its own internal quality control program
and shall analyze a suitable control sample with each set of 50 samples.

(b) Each laboratory shall demonstrate acceptable performance in an
external proficiency testing program. The Department shall submit blind
proficiency test samples on a random basis to each methadone program
director; at least 12 samples per quarter shall be submitted. The metha-
done program director shall, in turn, submit this sample to the methadone
drug analysis laboratory in a container which is normally used by the pro-
gram. Each container shall bear identifying numbers and letters that are
indistinguishable from those used by patients in that program. The profi-
ciency test samples shall arrive at the laboratory intermingled with other
regular specimens. When the analysis is completed, the methadone pro-
gram director shall forward the results of the analysis to the Department.
The Department shall notify both the methadone program director and
the director of the methadone drug analysis laboratory of the results of
the proficiency test at the end of each month.

NOTE: Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Section 11885, Health and Safety Code.

History

1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1193. Standard of Performance in Proficiency Testing
Program.

Whenever a laboratory fails to correctly analyze at least 90 percent of
the external proficiency test samples, the Department may take such ac-
tion as it deems necessary or desirable to correct the source of error. Such
action may include, but is not limited to, the removal of the laboratory
from the List of Certified Methadone Laboratories, and, concurrently or
separately, the commencement of disciplinary proceedings to suspend or
revoke the license of the laboratory.

NOTE: Authority cited: Sections 208, 1 1 881 and 1 1885, Health and Safety Code.
Reference: Sections 11885, 11889 and 11893, Health and Safety Code.

Page 28

Title 17

State Department of Health Services

§1204

History
1 . Editorial coirection of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1 1 94. List of Certified Methadone Laboratories.

The Department shall compile, maintain and publish a current List of
Certified Methadone Laboratories, which shall contain all licensed meth-
adone drug analysis laboratories which are currently able to meet the ac-
ceptable level of performance required by the provisions of this sub-
chapter. Whenever the Department determines that any licensed
laboratory is presently unable to meet the acceptable level of perform-
ance, the Department shall remove the name of the laboratory from said
list and notify all programs in the State of such removal. A laboratory so
removed from the list shall not be restored to the list unless and until the
laboratory demonstrates to the satisfaction of the Department that it is
able to meet the acceptable level of performance.

NOTE: Authority cited: Sections 208, 11881 and 11885, Health and Safety Code.
Reference: Section 1 1889, Health and Safety Code.

History
1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

Group 7. Human Tissue Preservation

Article 8. Records

§1195. General.

Methadone dnig analysis laboratories shall maintain records which
clearly describe their activities under these regulations. Such records
shall be available for inspection by the Department upon request.
NOTE; Authority cited: Sections 208, 1 1881 and 1 1885, Health and Safety Code.
Reference: Sections 11885 and 11 890, Health and Safety Code.

History
] . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

§ 1196. Methadone Drug Analysis Laboratory Records.

Each licensed methadone drug analysis laboratory shall keep and pre-
serve, for at least three years, the following records:

(a) A record, which is kept current, of persons in its employ who are
qualified as methadone drug analysis supervisors. This record shall in-
clude the qualifications of each such person, including education, experi-
ence, training and performance in examinations and tests conducted by
the Department.

(b) A detailed, current written description of each method it uses for
drug screening.

(c) Complete records of samples analyzed under these regulations,
which shall include sample number, date sample received, date sample
analyzed, results and date results sent to methadone program director.

(d) Records of the internal quality control program.

(e) Records of laboratory performance as shown by results in the exter-
nal proficiency testing program.

NOTE: Authority cited: Sections 208, 11881 and 1 1885, Health and Safety Code.
Reference: Section 11 885, Health and Safety Code.

History
1 . Editorial correction of NOTE filed 1 1-6-84 (Register 84, No. 45).

Group 6. Water Laboratories

Note: Authority cited: Sections 208 and 4025, Health and Safety Code. Refer-
ence Section 4025, Health and Safety Code.

History

1. New Group 6 (§§ 1 174-11 84) filed 7-27-5 1 ; effective thirtieth day thereafter
(Register 25, No. 2).

2. Repealer of Group 6 (Sections 1174-1184) filed 10-22-79; effecfive thirtieth
day thereafter (Register 79, No. 43).

Article 1 . Approval

§1200. Definitions.

(a) As used in this group, "person" includes teaching institution, uni-
versity, college, legally licensed hospital, nonprofit blood bank, artery
bank, eye bank, or other therapeutic service operated by any agency ap-
proved by the State Director of Health Services.

(b) As used in this group, "department" means State of California De-
partment of Health.

Note: Authority cited for Group 7: Sections 102 and 208, Health and Safety Code

History

1. New Group 7 (Sections 1200 through 1205) filed 4-30-59; effective thirtieth
day thereafter (register 59, No. 7).

2. Editorial Correction (Register 73, No. 26).

§ 1201. Approval Required for Tissue Preservation.

No person shall collect, process, store, or distribute human tissues ob-
tained in accordance with Sections 7 1 00 or 7 1 1 5 of the Health and Safety
Code, or Section 20 of the Probate Code, unless such person shall have
received approval from the departinent.

§ 1 202. Provisions for Approval.

(a) An application for approval shall be made to the department, which
shall include the following items.

( 1 ) Complete and detailed description of the methods, equipment, and
technics used in relation to each tissue which is to be processed.

(2) The name and address of the person owning the place, establish-
ment, or institution, in which the processing is to be carried on.

(3) The name and address of the director v/ho shall be a duly licen.sed
physician and surgeon in the State of California.

(4) Kinds of tissues to be processed.

(5) Such additional information as the department may require in order
to determine compliance with these regulations.

(b) The operation of the tissue bank shall be under the direct supervi-
sion of a physician and surgeon duly licensed in this State.

(d) Application will be approved only when establishment and the
methods used are such that the tissues processed will not be contami-
nated, dangerous, or harmful.

(1) Representative samples shall be provided for the department of
each lot of tissues, if requested by the department, for the purpose of
checking sterility, quality, or other factor.

(2) Any duly authorized representative of the department shall have
free access to the establishment and the records thereof at all reasonable
hours for the purpose of ascertaining compliance with these regulations.

(e) Approval may be granted only for the processing of tissues for
which there is scientific evidence of therapeutic value and for which
methods of preservation have been developed.

(f) Renewal of Approval.

(1) The department shall issue renewal notices annually prior to the
end of each calendar year.

(2) Each person on applying for renewal shall review his activities in
the field for the preceding year if requested to do so by the department.

(g) There is no fee required in connection with this approval, or with
renewal of approval.

§ 1203. Exemptions from Approval.

This group does not apply to autogenous tissue grafting, or to homo-
grafts where tissues are obtained from living donors, or to other biologic
products as defined in Section 1601 of the Health and Safety Code.

§1204. Records.

(a) The director or supervisor of approved tissue processing programs
shall keep records of all tissues processed.

Page 29

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) Records may be designated by number (instead of by name of do-
nor) to conform with individual specimens or lots of tissue.

( 1 ) Name and address of institution from which material was obtained,
also name of physician responsible for procurement.

(2) Date and hour of death of donor.

(3) Cause of death and age of donor and. when available, pathologic
results including autopsy reports.

(4) Date and hour of obtaining tissue. If more than four hours post mor-
tem, state whether refrigeration was used and, if so, give length of time
and temperature.

(5) Date and method of processing tissue, if applicable.

(6) Date final storage begins.

(7) Date and place of use.

(8) Results of tests for contamination and other examinations.

(9) Pertinent laboratory data, including serologic tests for syphilis,
from donor. Prospective donors with histories of hepatitis shall not be ac-
cepted.

(10) Information relating to consent or authorization.

(d) Unless otherwise required by other provisions of law, all records
and information shall be retained for not less than two (2) years.

§1205. Labels.

(a) A method which will positively identify each specimen during the
period from procurement to the beginning of final storage shall be placed
in effect by each person.

(b) The final label shall show:

( 1 ) The name of the product, and method used in processing.

(2) A number which will identify the processing information related
to the specimen.

(3) A date prior to which use must be made of the product, or prior to
which use of the product is recommended, whichever is applicable.

(4) Name and address of the processor.

(5) If temperature is a factor in preservation, the temperature range
within which deterioration is avoided shall be specified.

(6) Other data descriptive of the product may also be included in the
label.

(7) Directions for reconstitution of the product, and preparation for its
use may be included in the label or in an accompanying circular.

(8) Altered or supplementary labels shall not be used.

Group 8. Forensic Alcohol Analysis and
Breath Alcohol Analysis

Article 1 . General

§1215. Authority.

Chapter 5 Sections 436.50-436.63 of Part 1 of Division 1 of the Health
and Safety Code.

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code.

History

1. New Group 8 (Sections 1215, 1215.1, 1216, 1216.1, 1217, 1217.1 through
1217.8, 1218, 1218.1 and 1218.2) filed 8-1 0-70; effective thirtieth day thereaf-
ter (Register 70, No. 33).

§1215.1. Definitions.

(a) 'Alcohol" means the unique chemical compound, ethyl alcohol,
with the exception that reference in these regulations to compounds to be
avoided as skin antiseptics includes the generic class of organic com-
pounds known as alcohols.

(b) "Forensic Alcohol Analysis" means the practical application of
specialized devices, instruments, and methods by trained laboratory per-
sonnel to measure the concentration of ethyl alcohol in samples of blood,
breath, urine, or tissue of persons involved in traffic accidents or traffic
violadons.

(c) "'Breath Alcohol Analysis" means analysis of a sample of a per-
son's expired breath, using a breath testing instrument designed for this
purpose, in order to determine the concentration of ethyl alcohol in the
person's blood.

(d) "Concentration" means the weight amount of alcohol contained in
a unit volume of liquid or a unit volume of gas under specified conditions
of temperature and pressure; in the case of a solid fissue specimen, "con-
centrafion" means the weight amount of alcohol contained in a unit
weight of specimen.

(e) "Forensic Alcohol Laboratory" means a place at which specialized
apparatus, instruments, and methods are used by trained laboratory per-
sonnel to measure the concentration of alcohol in samples of blood,
breath, urine, or tissue of persons involved in traffic accidents or in traffic
violations; this may be an activity of a laboratory engaged in activities
other than alcohol analysis.

(f) "Forensic Alcohol Supervisor" means a person employed by a fo-
rensic alcohol laboratory who can be responsible for all aspects of the
performance of forensic alcohol analysis and for the supervision of per-
sonnel who perform such analysis.

(g) "Forensic Alcohol Analyst" means a person employed by a foren-
sic alcohol laboratory who performs the technical procedures of forensic
alcohol analysis.

(h) "Forensic Alcohol Analyst Trainee" means a person employed by
a forensic alcohol laboratory for the purpose of receiving comprehensive
practical experience and instruction in the technical procedures of foren-
sic alcohol analysis under the supervision of a forensic alcohol supervi-
sor or forensic alcohol analyst.

(i) "Method" means the steps used by a trained person to make a mea-
surement of alcohol concentrafion.

(j) "Instrument" or "Device" means any item or combinafion of items
of equipment used to make a measurement of alcohol concentration; sim-
ple and complex devices are included in this meaning.

(k) "License" means a document issued by the State Department of
Health to a laboratory to perform the tests referred to in the Health and
Safety Code, Sections 436.51 and 436.52.

(/) "Sample" or "Specimen" means a representative portion of breath,
blood, urine, or tissue or of an arfificially constituted material, taken for
the purpose of measuring its alcohol concentration.

(m) "Alveolar" refers to the smallest air sacs in the lungs and to that
portion of the expired breath which is in equilibrium with respect to alco-
hol with the immediately adjacent pulmonary blood.

(n) "Department" means the California State Department of Health
and its duly authorized representatives.

History

1 . Amendment of subsections (b), (c), (d) and (e) filed 1 0-9-70; effective thiitieth
day thereafter (Register 70, No. 41).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

Article 2. Requirements for Forensic
Alcohol Laboratories

§ 1216. Authorization Requirement.

(a) Every laboratory performing forensic alcohol analysis shall have
a valid license issued in accordance with the provisions of these regula-
tions.

(1) Forensic alcohol analysis shall be performed only by persons who
meet the qualifications set forth in these regulations for forensic alcohol
supervisors, forensic alcohol analysts, or forensic alcohol analyst train-
ees.

(A) A trainee may perform forensic alcohol analysis only under the su-
pervision of a forensic alcohol supervisor or forensic alcohol analyst.

(2) The Department shall not be limited by these regulations in per-
forming functions in administration of the alcohol analysis and licensing
program.

Page 30

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Title 17

State Department of Health Services

§ 1217.1

History
1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.

§ 1 21 6.1 . Qualifications for Licensing.

(a) A laboratory meets the qualifications for licensing by:

( 1 ) Employing at least one forensic alcohol supervisor. If forensic al-
cohol analysis is performed by persons other than forensic alcohol super-
visors, such persons shall meet the qualifications set forth in these regula-
tions for forensic alcohol analysts or forensic alcohol analyst trainees;

(2) Maintaining a quality control program in forensic alcohol analysis
procedures;

(3) Demonstrating satisfactory performance in a proficiency testing
program conducted by or approved by the Department;

(4) Passing such on-site inspections as the Department may require;

(5) Showing ability to meet the requirements set forth in these regula-
tions.

(b) These qualifications shall be maintained at all times by each li-
censed laboratory.

(c) The Department may deny a license or renewal thereof, or take dis-
ciplinary action against a licensee, for failure to maintain these qualifica-
tions in a manner which meets the Department's standards for approval.

(d) Whenever a licensed laboratory employing only one forensic alco-
hol supervisor loses that person, the Department may upon petition of the
laboratory extend the license for a period not exceeding 90 days during
which time the laboratory shall hire another forensic alcohol supervisor.

(1) Such an extension shall be contingent on the laboratory's having
in its employ at least one forensic alcohol analyst and upon the laborato-
ry's successfully demonstrating to the Department continued compe-
tence in forensic alcohol analysis through such proficiency tests, exami-
nations, and on-site inspections as the Department may require.

(e) A forensic alcohol supervisor is a person who meets the following
qualifications:

(1) Possesses a baccalaureate or higher degree, or an equivalent, in
chemistry, biochemistry, or other appropriate discipline as determined
by the Department;

(2) Has two years of experience in performing forensic alcohol analy-
sis, such experience to include experience in interpretation and correla-
tion of alcohol analyses with subjective observations of the demeanor
and behavior of persons who have ingested known amounts of ethyl alco-
hol; or, in lieu of such two years of experience, satisfactorily completes
a training course approved by the Department, such training course to in-
clude at minimum the following schedule of subjects:

(A) Value and purpose of forensic alcohol analysis, including breath
alcohol analysis;

(B) Physiological action of alcohol;

(D) Laboratory methods of alcohol analysis;

(E) Instruments and procedures for breath alcohol analysis;

(F) Practical laboratory demonstration of the student's ability to per-
form alcohol analysis;

(G) Interpretation of results of alcohol analysis, including correlation
of alcohol analyses with subjective observations of the demeanor and be-
havior of persons who have ingested known amounts of alcohol;

(H) Court testimony;

(I) Court decisions regarding chemical tests of alcohol to determine al-
cohol influence; and

(J) Requirements of these regulations;

(3) Successfully demonstrates accuracy in the analysis of proficiency
test samples submitted by the Department, and successfully passes ex-
aminations prescribed by the Department;

(4) Demonstrates the ability to adhere to the provisions of these regula-
tions; or (in lieu of ( 1 ) and (2) above)

(5) Either is a person who, prior to January 1,1971, qualified as direc-
tor of a clinical laboratory operating under the provisions of the Califor-
nia Business and Professions Code, or is a person who, for a period of one

year prior to January 1 , 1 97 1 , has been employed in the activities of a fo-
rensic alcohol supervisor.

(f) A forensic alcohol analyst is a person who meets the following
quaHfications:

( 1 ) Successfully completes at least 60 semester-hours, or their equiva-
lent in quarter-hours, of college level courses, including 8 hours of gen-
eral chemistry and 3 hours of quantitative analysis;

(2) Successfully completes a training period in alcohol analysis on fo-
rensic or clinical specimens in a forensic alcohol laboratory or in a clini-
cal laboratory;

(3) Performs during the training period a minimum of 25 analyses of
alcohol concentration in blood samples, at least half of which contain al-
cohol;

(4) Successfully demonstrates accuracy in the analysis of proficiency
test samples submitted by the Department, and successfully passes ex-
aminations prescribed by the Department;

(5) Demonstrates ability to adhere to the provisions of these regula-
tions; or (in lieu of (1), (2), and (3) above)

(6) Either is a person who, prior to January 1 , 1 97 1 , was a clinical labo-
ratory technologist licensed under the provisions of the California Busi-
ness and Professions Code, or is a person who, for a period of one year
prior to January 1 , 1 97 1 , has been employed in the activities of a forensic
alcohol analyst.

(g) A forensic alcohol analyst trainee is a person who meets the follow-
ing qualifications:

(1) Meets the educational quahfication set forth as (1) for a forensic
alcohol analyst;

(2) Is employed by a licensed forensic alcohol laboratory.

History

1 . Amendment of subsection (c)( 1 ) filed 1 0-9-70; effective thirtieth day thereafter
(Register70, No. 41).

2. Amendment of subsection (b)(2) filed 8-2-72; effective thirtieth day thereafter
(Register 72, No. 32).

3. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

4. Editorial correction (Register 76, No. 24).

Article 3. Licensing Procedures

§ 1217. Forensic Alcohol Laboratory License.

(a) Upon receipt of a completed application which shows ability to
meet the requirernents set forth in these regulations, and upon payment
of any required fee, the Department shall submit such proficiency test
samples and perform such examinations as are required for that laborato-
ry to complete the qualifications.

(b) Upon the laboratory's successfully completing all the qualifica-
tions, the Department shall issue to the applicant laboratory a forensic al-
cohol laboratory license.

History
1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§ 1 21 7.1 . Renewal of Licenses.

(a) Licenses under these regulations shall be renewed as required by
the Department as long as the activity requiring authorization continues.
Renewal shall be contingent upon the laboratory continuing in the quali-
fications set forth in these regulafions.

(1) A forensic alcohol laboratory license shall be valid from January
1 to December 3 1 of a calendar year. Applicafions for renewal and appli-
cable fees shall be submitted to the Department on or before October 1
of each year.

(2) Failure to apply for renewal shall result in forfeiture after a period
of three months from the day on which the applicadon for renewal should
have been submitted, with the exception that the Department may grant
a temporary extension under special circumstances.

(3) An application for renewal shall not list as a forensic alcohol ana-
lyst trainee any person who fails to comply with the requirements of Sec-

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§ 1217.2

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

tion 1 2 1 6. 1 (f) (4) within a period of one year after he was first listed with
the Department as a trainee. The Department may extend this period for
a justifiable reason, such as illness.

History

1 . New subsection (c) filed 4-7-71 ; effective thirtieth day thereafter (Reeister 71 ,
No. 15).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§1217.2. Application Forms.

Application for a license and renewal thereof, shall be made on forms
furnished by the Department. The applicant shall set forth all pertinent
information called for by the form.

§ 1 21 7.3. Report of Change or Discontinuance.

(a) A person responsible for the operation of a forensic alcohol labora-
tory shall report to the Department in writing within 30 days any change
in qualified personnel who may be performing forensic alcohol analysis,
change of ownership, change of address or change or discontinuance of
an activity authorized under these regulations.

(b) Such reports shall be made on forms furnished by the Department
and shall set forth all pertinent information called for by the form.

(c) Persons who formerly qualified as forensic alcohol supervisors or
forensic alcohol analysts in another laboratory may be required to dem-
onstrate again their ability to meet the requirement of Section 1216.1 (e)
(3) or 1216.1 (f) (4) using the method, apparatus and facilities of the fo-
rensic alcohol laboratory which newly lists them in such a Report of
Change or Discontinuance.

History

1. Amendment filed 10-9-70; effective thirtieth day thereafter (Register 70, No.
41).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

3. Editorial conection (Register 76, No. 24).

§ 1217.4. License Implications.

Licenses issued under these regulations shall not imply approval of
anything carried out by a laboratory other than what is specified on the
document.

§1217.5. Licensing Records.

Forensic Alcohol Laboratory Licenses shall become part of permanent
records available to the courts for legal proceedings or to the Department.

§ 1217.6. Inspection and Additional Requirements.

(a) Display of Licenses. Licenses issued under these regulations shall
be displayed on request to representatives of the Department.

(b) Access to Premises. The Department may enter at all reasonable
times upon any laboratory for the purpose of determining whether or not
there is compliance with the provisions of these regulations.

§ 1 217.7. Surveys and Proficiency Tests.

(a) Laboratories having been licensed or applying for licensing as fo-
rensic alcohol laboratories shall be subject to on-site surveys by repre-
sentatives of the Department, the results of which must meet the require-
ments of these regulations, and shall accept periodic evaluation samples,
perform analyses and report the results of such analyses to the Depart-
ment.

(b) These analytical results shall be used by the Department to evaluate
the accuracy of the forensic alcohol analyses performed by the laborato-
ry, and the results must meet the requirements of these regulations.

History
1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§ 1 21 7.8. Fees and Other Procedures.

The annual application fee for a Forensic Alcohol Laboratory License
or its renewal shall be one hundred dollars ($100). A laboratory operated
by the state, city or county or other public organization shall be exempt
from the annual application fee requirement. Other procedures in the ad-

ministration of these regulations shall be carried out as set forth in Chap-
ter 5 (commencing with section 436.50) of Part 1 of Division 1 of the
Health and Safety Code. Such other procedures include suspension or re-
vocation of license, denial of license, and disciplinary action.

Article 4. Training of Personnel

§1218. Training Program Approval.

Any organization, laboratory, institution, school, or college conduct-
ing a course of instruction for persons to qualify under these regulations
shall submit a course summary and list of instructors and their qualifica-
tions to the Department for approval.

§1218.1. Additional Requirements.

At the discretion of the Department, any phase or portion of a training
program shall be subject to alteration in an effort to update the program
as technological advances are made or if a portion has been judged inap-
propriate.

§1218.2. Contracts.

The Department may contract with persons it deems qualified to ad-
minister such practical tests and written or oral examinations as may be
required under these regulations. This section shall not be construed to
authorize the delegation of any discretionary functions conferred on the
Department by law, including, but not limited to, the evaluation of tests
and examinations.

•

Article 5.

Collection and Handling of
Samples

§1219. General.

Samples taken for forensic alcohol analysis and breath alcohol analy-
sis shall be collected and handled in a manner approved by the Depart-
ment. The identity and integrity of the samples shall be maintained
through collection to analysis and reporting.

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Section 436.50, Health and Safety Code.

History

1. New Article5( 1219, 1219. 1,1219.2, 1219.3), filed 10-9-70; effective thirtieth

day thereafter (Register 70, No. 41).
2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.

48).

§ 1219.1. Blood Collection and Retention.

(a) Blood samples shall be collected by venipuncture from living indi-
viduals as soon as feasible after an alleged offense and only by persons
authorized by Section 13354 of the Vehicle Code.

(b) Sufficient blood shall be collected to permit duplicate determina-
tions.

(c) Alcohol or other volatile organic disinfectant shall not be used to
clean the skin where a specimen is to be collected. Aqueous benzalko-
nium chloride (zephiran), aqueous merthiolate or other suitable aqueous
disinfectant shall be used.

(d) Blood samples shall be collected using sterile, dry hypodermic
needles and syringes, or using clean, dry vacuum type containers with
sterile needles. Reusable equipment,if used, shall not be cleaned or kept
in alcohol or other volatile organic solvent.

(e) The blood sample shall be deposited into a clean, dry container
which is closed with an inert stopper.

( 1 ) Alcohol or other volatile organic solvent shall not be used to clean
the container.

(2) The blood shall be mixed with an anticoagulant and a preservative.

(f) When blood samples for forensic alcohol analysis are collected
post-mortem, all practical precautions to insure an uncontaminated sam-
ple shall be employed, such as:

(1) Samples shall be obtained prior to the start of any embalming pro-
cedure. Blood samples shall not be collected from the circulatory system

Page 32

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Title 17

State Department of Health Services

§ 1220.3

effluent during arterial injection of embalming fluid. Coroner's samples
do not need a preservative added if stored under refrigeration.

(2) Care shall be taken to avoid contamination by alcohol from the gas-
trointestinal tract directly or by diffusion therefrom. The sample shall be
taken from a major vein or the heart.

(g) In order to allow for analysis by the defendant, the remaining por-
tion of the sample shall be retained for one year after the date of collec-
tion.

(1) In coroner's cases, blood samples shall be retained for at least 90
days after date of collection.

(2)Whenever a sample is requested by the defendant for analysis and
a sufficient sample remains, the forensic alcohol laboratory or law en-
forcement agency in possession of the original sample shall continue
such possession, but shall provide the defendant with a portion of the re-
maining sample in a clean container together with a copy or transcript of
the identifying information carried on the original sample container.

History

1 . Amendment of subsection (d) filed 4-7-7 1 ; effective thirtieth day thereafter
(Register 71, No. 15).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§ 1219.2. Urine Collection and Retention.

(a) The only approved urine sample shall be a sample collected no
sooner than twenty minutes after first voiding the bladder.

(b) The specimen shall be deposited in a clean, dry container which
also contains a preservative.

(c) In order to allow for analysis by the defendant, the remaining por-
tion of the sample shall be retained for one year after the date of collec-
tion.

( 1 ) Whenever a sample is requested by the defendant for analysis and
a sufficient sample remains, the forensic alcohol laboratory or law en-
forcement agency in possession of the original sample shall continue
such possession, but shall provide the defendant with a portion of the re-
maining sample in a clean container together with a copy or transcript of
the identifying information carried by the original sample container.

History

1 . Amendment of subsection (a) filed 4-7-7 1 ; effective thirtieth day thereafter
(Register 71, No. 15).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§ 1 21 9.3. Breath Collection.

A breath sample shall be expired breath which is essentially alveolar
in composition. The quantity of the breath sample shall be established by
direct volumetric measurement. The breath sample shall be collected
only after the subject has been under continuous observation for at least
fifteen minutes prior to collection of the breath sample, during which
time the subject must not have ingested alcoholic beverages or other
fluids, regurgitated, vomited, eaten, or smoked.

History
1. Amendment filed 4-7-71; effective thirtieth day thereafter (Register 71, No.

15).

Article 6.

Methods of Forensic Alcohol
Analysis

§1220. General.

(a) All laboratory methods used for forensic alcohol analysis shall be
subject to standards set forth in this Article.

(b) Each licensed forensic alcohol laboratory shall have on file with
the Department detailed, up-to-date written descriptions of each method
it uses for forensic alcohol analysis.

( 1 ) Such descriptions shall be immediately available to the person per-
forming an analysis and shall be available for inspection by the Depart-
ment on request.

(2) Each such description shall include the calibration procedures and
the quality control program for the method.

NOTE: Authority cited: Sections 102 and 208. Health and Safety Code. Reference:
Section 436.50. Health and Safety Code.

History

1. New Anicle 6 ( 1220, 1220.1 through 1220.4) filed 10-9-70; effective thirtieth
day thereafter (Register 70, No. 41).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§ 1 220.1 . Standards of Performance.

(a) Methods for forensic alcohol analysis shall meet the following
standards of performance:

(1) The method shall be capable of the analysis of a reference sample
of known alcohol concentration within accuracy and precision limits of
plus or minus 5 percent of the value; these limits shall be applied to alco-
hol concentrations which are 0.10 grams per 100 milliliters or higher;

(2) The method shall be capable of the analysis of ethyl alcohol with
a specificity which is adequate and appropriate for traffic law enforce-
ment.

(3) The method should be free from interference from anticoagulants
and preservatives added to the sample;

(4) Blood alcohol results on post-mortem samples shall not be re-
ported unless the oxidizable substance is identified as ethyl alcohol by
qualitative test;

(5) The method shall give a test result which is always less than 0.01
grams of alcohol per 100 milliliters of blood when living subjects free of
alcohol are tested.

(b) The ability of methods to meet the standards of performance set
forth in this Section shall be evaluated by the Department using a labora-
tory's proficiency test results and such ability must meet the require-
ments of these regulations.

History
I . Amendment filed 1 1-24-75; effecfive thirtieth day thereafter (Register 75, No.
48).

§ 1 220.2. Standards of Procedure.

(a) Methods for forensic alcohol analysis shall meet the following
standards of procedure:

( 1 ) The method shall be calibrated with standards which are water so-
ludons of alcohol.

(A) Such alcohol solutions are secondary standards.

(B) Each forensic alcohol laboratory shall establish the concentration
of each lot of secondary alcohol standards it uses, whether prepared or
acquired, by an oxidimetric method which employs a primary standard,
such as United States National Bureau of Standards potassium dichro-
mate;

(2) The procedure shall include blank and secondary alcohol standard
samples at least once each day that samples are subjected to forensic alco-
hol analysis.

(A) The blank and secondary alcohol standard samples shall be taken
through all steps of the method used for forensic alcohol analysis of sam-
ples.

(3) The procedure shall also include analysis of quality control refer-
ence samples as described in Section 1220.3 and shall include at least du-
plicate analyses of samples for forensic alcohol analysis.

(A) A quality control reference sample shall not be taken from the
same lot of alcohol solution which is used as a secondary alcohol stan-
dard.

(4) Alcohols or other volatile organic solvents shall not be used to
wash or rinse glassware and instruments used for alcohol analysis;

(5) All instruments used for alcohol analysis shall be in good working
order and routinely checked for accuracy and precision.

History

1. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75. No.

48).

§1220.3. Quality Control Program.

(a) Methods for forensic alcohol analysis shall be performed in accor-
dance with the following quality control program:

Page 33

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§ 1220.4

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

( 1 ) For each method of forensic alcohol analysis it performs, each fo-
rensic alcohol laboratory shall make or acquire a suitable quality control
reference material containing alcohol, a sample of which it shall analyze
along with each set of samples; the alcohol concentration in the reference
material shall be between 0.10 and 0.20 grams per 100 milliliters of liq-
uid;

(2) For each lot of quality control reference material, the laboratory
shall determine a mean value of at least 20 replicate analyses, at a rate of
no more than 2 analyses per day, with the method used for analysis of
samples for forensic alcohol analysis;

(3) Acceptable limits of variation for the method shall be set as fol-
lows:

(A) The lower limit shall be calculated by subtracting, from the mean
value, 0.01 grams per 100 milliliters;

(B) The higher limit shall be calculated by adding, to the mean value,
0.01 grams per 100 milliUters;

(4) At least one sample of the quality control reference material shall
be analyzed with each set of samples analyzed for the purpose of forensic
alcohol analysis;

(5) Whenever analysis of the quality control reference material is out-
side the acceptable limits, the method shall be regarded to be in error, and
a forensic alcohol supervisor shall take remedial action to investigate and
correct the source of error;

(6) Until such time as the error has been corrected, as shown by return
of the analysis of the quality control reference material to values within
the acceptable limits, no samples shall be analyzed for the purpose of fo-
rensic alcohol analysis.

History

I . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§ 1220.4. Expression of Analytical Results.

(a) With the exception of tissue analysis, all analytical results shall be
expressed in terms of the alcohol concentration in blood, based on the
number of grams of alcohol per 100 milliliters of blood.

(1 ) The symbols, grams %, %, and % (W/V), shall be regarded as ac-
ceptable abbreviations of the phrase, grams per 100 milliliters of liquid.

(b) Analytical results shall be reported to the second decimal place, de-
leting the digit in the third decimal place when it is present.

(d) Blood alcohol concentrations less than 0.02% on post-mortem
blood samples may be reported as negative.

(e) A urine alcohol concentration shall be converted to an equivalent
blood alcohol concentration by a calculation based on the relationship:
the amount of alcohol in 1 .3 milliliters of blood is equivalent to the
amount of alcohol in 1 milliliter of urine.

(0 A breath alcohol concentration shall be converted to an equivalent
blood alcohol concentration by a calculation based on the relationship:
the amount of alcohol in 2,100 milliliters of alveolar breath is equivalent
to the amount of alcohol in 1 millihter of blood.

(g) Tissue analysis results shall be expressed in terms of a weight
amount of alcohol in a unit weight of the specimen.

History

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

2. Editorial correction (Register 76, No. 24).

Article 7.

Requirements for Breath Alcohol
Analysis

§1221. General.

Breath alcohol analysis shall be performed in accordance with stan-
dards set forth in this Article.

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Section 436.50, Health and Safety Code.

History

1. New Article 7 (Sections 1221, 1221.1 through 122I.5)filed 10-9-70; effective
thirtieth day thereafter (Register 70, No. 41).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

§ 1 221 .1 . Authorized Procedures.

(a) Breath alcohol analysis shall be performed only with instruments
and related accessories which meet the standards of performance set
forth in these regulations.

(b) Such instruments may be used for the analysis of breath samples
in places other than licensed forensic alcohol laboratories and by persons
other than forensic alcohol supervisors, forensic alcohol analysts and fo-
rensic alcohol analyst trainees only if such places and persons are under
the direct jurisdiction of a governmental agency or licensed forensic al-
cohol laboratory.

(1) Breath alcohol analysis by persons other than forensic alcohol su-
pervisors, forensic alcohol analysts and forensic alcohol analyst trainees
shall be restricted to the immediate analysis of breath samples collected
by direct expiration by the subject into the instrument in which the mea-
surement of alcohol concentration is performed.

(2) Except for the requirements of Section 1220.4, such immediate
analysis shall not be subject to the requirements of Article 6.

NOTE: Authority cited: SecUons 208 and 436.50, Health and Safety Code. Refer-
ence: Secfion 436.52, Health and Safety Code.

History

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

2. Repealer of subsecfion (c) filed 12-20-85 as an emergency; effective upon fil-
ing (Register 85, No. 52). A Certificate of Compliance must be transmitted to
OAL within 120 days or emergency language will be repealed on 4—21-86.

3. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Regis-
ter 86, No. 19).

§ 1 221 .2. Standard of Performance.

(a) Instruments for breath alcohol analysis shall meet the following
standard:

( 1 ) The instrument and any related accessories shall be capable of con-
forming to the "Model Specifications for Evidential Breath Testing De-
vices" of the National Highway Traffic Safety Administration of the U.S.
Department of Transportation, which were published in the Federal Reg-
ister, Vol. 49, No. 242, Pages 48854-48872, December 14, 1984, and are
hereby adopted and incorporated.

(b) The ability of instruments and any related accessories to conform
to the standard of performance set forth in this section shall be tested by
the U.S. Department of Transportation.

NOTE: Authority cited: Sections 208 and 436.50, Health and Safety Code. Refer-
ence: Section 436.52, Health and Safety Code.

History

1. Repealer of subsection (b) and relettering of (c), (d), (e), (f) and (g) to (b), (c),
(d), (e) and (f) filed 4-7-71 ; effective thirtieth day thereafter (Register 71, No.
15).

2. Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

3. Amendment filed 12-20-85 as an emergency; effective upon filing (Register
85, No. 52). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-21-86.

4. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Regis-
ter 86, No. 19).

§1221.3. Approved Instruments.

(a) Only such types and models of instruments and related accessories
as are named in the "Conforming Products List" published in the Federal
Register by the National Highway Traffic and Safety Administration of
the U.S. Department of Transportation shall be used for breath alcohol
analysis in this State.

NOTE: Authority cited: Sections 208 and 436.50, Health and Safety Code. Refer-
ence: Section 436.52, Health and Safety Code.

History

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

2. Editorial correction (Register 76, No. 24).

Page 34

(4-1-90)

Title 17

State Department of Health Services

§ 1230

3. Amendment filed 12-20-85 as an emergency; effective upon filing (Register
S5, No. 52). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed on 4-21-86.

4. Certificate of Compliance transmitted to OAL 4-8-86 and filed 5-8-86 (Regis-
ter 86, No. 19).

§ 1 221 .4. Standards of Procedure.

(a) Procedures for breath alcohol analysis shall meet the following
standards:

( 1 ) For each person tested, breath alcohol analysis shall include analy-
sis of 2 separate breath samples which result in determinations of blood
alcohol concentrations which do not differ from each other by more than
0.02 grams per 100 milliliters.

(2) The accuracy of instruments shall be determined.

(A) Such determination of accuracy shall consist, at a minimum, of pe-
riodic analysis of a reference sample of known alcohol concentration
within accuracy and precision limits of plus or minus 0.01 grams % of the
true value; these limits shall be applied to alcohol concentrations from
0. 1 0 to 0.30 grams %. The reference sample shall be provided by a foren-
sic alcohol laboratory.

1 . Such analysis shall be performed by an operator as defined in Sec-
tion 1 22 1 .4 (a)(5). and the results shall be used by a forensic alcohol labo-
ratory to determine if the instrument continues to meet the accuracy set
forth in Section 1221.4 (a)(2)(A).

(B) For the purposes of such determinations of accuracy, "periodic"
means either a period of time not exceeding 1 0 days or following the test-
ing of every 150 subjects, whichever comes sooner.

(3) Breath alcohol analysis shall be performed only with instruments
for which the operators have received training, such training to include
at minimum the following schedule of subjects:

(A) Theory of operation;

(B) Detailed procedure of operation;

(D) Precautionary checklist;

(E) Written and/or practical examination.

(4) Training in the procedures of breath alcohol analysis shall be under
the supervision of persons who quaUfy as forensic alcohol supervisors,
forensic alcohol analysts or forensic alcohol analyst trainees in a licensed
forensic alcohol laboratory.

(A) After approval as set forth in Section 1218, the forensic alcohol
laboratory is responsible for the training and qualifying of its instructors.

(5) An operator shall be a forensic alcohol supervisor, forensic alcohol
analyst, forensic alcohol analyst trainee or a person who has completed
successfully the training described under Section 1221.4 (a) (3) and who
may be called upon to operate a breath testing instrument in the perform-
ance of his duties.

(6) Records shall be kept for each instrument to show the frequency
of determination of accuracy and the identity of the person performing
the determination of accuracy.

(A) Records shall be kept for each instrument at a licensed forensic al-
cohol laboratory showing compliance with this Section.
NOTE: Authority cited: Section 436.50, Health and Safety Code. Reference: Sec-
tion 436.50, Health and Safety Code.

History

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

2. Amendment filed 12-20-85 as an emergency; effective upon filing (Register
85, No. 52). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed on 4-21-86.

3. Certificate of Compliance including amendment of subsection (a)(2)(A) L
transmitted to OAL 4-8-86 and filed 5-8-86 (Register 86, No. 19).

§ 1221.5. Expression of Analytical Results.

Results of breath alcohol analysis shall be expressed as set forth in Sec-
tion 1220.4.

Article 8. Records

§1222. General.

Forensic alcohol laboratories and law enforcement agencies shall
maintain records which clearly represent their activities which are cov-
ered by these regulations. Such records shall be available for inspection
by the Department on request.

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Section 436.50. Health and Safety Code.

History

1. New Article 8 (§§ 1222, 1222.1, 1222.2) filed 10-9-70; effective thirtieth day
thereafter (Register 70, No. 41).

§ 1222.1. Forensic Alcohol Laboratory Records.

(a) Each laboratory which is licensed to perform forensic alcohol anal-
ysis shall keep the following records for a period of at least three years:

( 1 ) An up-to-date record of persons in its employ who are qualified
as forensic alcohol supervisors and forensic alcohol analysts; the record
shall include the qualifications of each such person, including education,
experience, training and performance in proficiency tests and examina-
tions;

(2) A list of persons in its employ who are forensic alcohol analyst
trainees, the date on which each such person began his training period
and the number and results of analyses performed during the training pe-
riod;

(3) Records of samples analyzed by that laboratory under these regula-
tions, their results and the identity of persons performing the analyses;

(4) Records of the quality control program;

(5) Records of laboratory performance evaluation in alcohol analysis
as shown by results of proficiency tests;

(6) Records of such determinations of accuracy of breath testing in-
struments as a laboratory may perform for law enforcement agencies;

(7) Records of such training as a laboratory may provide to persons
who operate breath testing instruments for law enforcement agencies.

History
1 . Amendment filed 1 1-24-75; effecfive thirtieth day thereafter (Register 75, No.
48).

§ 1222.2. Breath Alcohol Analysis Records.

(a) Each agency shall keep the following records for breath testing in-
struments which are under its jurisdiction:

(1) Records of instrument determinations of accuracy;

(2) Records of analyses performed, results and identities of the persons
performing analyses;

(3) At the location of each instrument, the precautionary checklist to
be used by operators of the instrument.

History

1 . Amendment filed 1 1-24-75; effective thirtieth day thereafter (Register 75, No.
48).

2. Editorial correcfion (Register 76, No. 24).

Group 9. HIV Antibody Testing
Article 1 . Approval of Laboratories

§ 1230. Approval of Laboratories for Use of HIV Antibody
Test.

(a) No person or entity shall perform tests to detect antibodies to HIV
in California, or on specimens originating in California, unless that per-
son or entity is

(1) licensed or certified:

(A) to engage in the production of biologies in accordance with chap-
ter 4, division 2 of the Health and SafetyCode, or

(B) as a clinical laboratory in accordance with chapter 3, division 2 of
the Business and Professions Code, or

Page 35

§1250

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(D) as a blood bank by the United States Food and Drug Administra-
tion in accordance with 42 U.S.C., section 262(a), or

(E) as a clinical laboratory licensed in serology to engage in interstate
commerce in accordance with the Chnical Laboratory Improvement Act
of 1967 (CLIA-67). 42 U.S.C. section 263a. and

(2) Enrolled in a proficiency testing program approved by the Depart-
ment in accordance with Title 1 7, section 1 05 1 of the California Code of
Regulations for each HIV screening and confirmatory procedure offered
by the laboratory.

(b) An application for approval shall be submitted for each separate
location where tests are performed using j'orms provided by the Depart-
ment and providing information as required by the Department. Within
1 5 days of receipt of an application, the Department shall notify the appli-
cant in writing that the application is complete or shall specifically identi-
fy what additional information is required.

Within 60 days from the receipt of a completed application, the De-
partment shall notify the applicant that thcapplication is either approved
or disapproved.

(c) An approved laboratory shall perform screening for evidence of
human immunodeficiency virus (HIV) antibody utilizing only Food and
Drug Administration (USFDA) approved kits. In addition, screening as-
says shall be performed in strict accordance with a kit's package insert
and any other manufacturers' instructions or guidelines.

(d) A specimen shall not be reported as positive on the basis of a
screening result. Approved laboratories shall perform confirmatory test-
ing on all specimens tested which give a repeatedly-reactive HIV screen-
ing result using an additional more specific test prior to reporting the re-
sult.

(e) Whenever a confirmatory test gives an indeterminate result, the
specimen giving such an indeterminate result shall be evaluated further,
either by additional local testing or by referral to another laboratory. If,
upon further evaluafion the specimen continues to give an indeterminate
result, the laboratory shall notify the submitter of the specimen that the
result is inconclusive.

(f) An approved laboratory shall maintain records of tests and test re-
sults in a manner to ensure the patient's confidentiality.

(g) Approved laboratories which are blood banks or plasma centers
shall report to the Department at the conclusion of each month and all oth-
er approved laboratories shall report to the Department at the conclusion
of each quarter the number and results of the tests performed.

(h) Approval for performing the tests to detect antibodies to HIV may
be denied or terminated for failure to comply with the requirements of
this section or with requirements set forth in law, or for conduct inimical
to the public health, morals, welfare, or safety of the people of the State
of California in the maintenance and operation of the facility or services
for which approval is granted.

NOTE: Authority cited: Sections 208 and 1603. 1 (h). Health and Safety Code. Ref-
erence: Section 5, Statutes of 1985, Chapter 23; and Sections 1603.1 and 1632,
Health and Safety Code.

History

1 . New section filed 1-21-86 as an emergency, effecfive upon filing (Register 86,
No. 6). A certificate of Compliance must be transmitted to OAL within 120 days
or emergency language will be repealed on 5-21-86.

2. Change without regulatory effect of group 9 and article 1 heading filed 2-7-86;
effecfive upon filing (Register 86, No. 6).

3. Certificate of Compliance as to 1-2 1-86 order including amendment of section
heading and subsections (b) and (f) transmitted to OAL 5-15-86 and filed
6-12-86 (Register 86, No. 24).

4. Amendment filed 1-8-90 as an emergency; operative 1-8-90 (Register 90, No.
4). A Certificate of Compliance must be transmitted to OAL within 120 days or
emergency language will be repealed by operation of law on 5-8-90.

5. Amendment filed 5-1 1-90 as an emergency; operative 5-1 1-90 (Register 90,
No. 25). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 9-8-90.

6. Amendment filed 9-12-90 as an emergency; operative 9-12-90 (Register 90.
No. 43). A Certificate of Compliance must be transmitted to OAL by 1-10-91
or the emergency language will be repealed by operation of law on the following
day.

7. Certificate of Compliance including amendment transmitted to OAL 1-9-91
and filed 2-8-91 (Register 91 . No. 1 1 ).

Chapter 3. Local Health Service

Subchapter 1. Standards for State Aid for
Local Health Administration

(Originally Printed 11-1-47)

Article 1. Organization

§1250. Health Officer.

The health department shall be under the direction of the health officer
devoting full fime to official dufies and these duties shall constitute his
primary responsibility and no other acdvities shall interfere with per-
formance of his official dufies.

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Sections 454 and 1 130, Health and Safety Code.

History
l.NewSecdons 1250 to 1 329, inclusive, filed 10-1^7 as an emergency (Register

10, No. 1).

2. Amendment filed 9-24-71 ; effective thirtieth day thereafter (Register 71, No.
39).

3. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correcfion
of Section 1250 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 9-24-7 1 remains in effect uninterrupted (Register 85, No.
30).

4. Editorial correcfion of NOTE filed 8-19-85; effecfive thirtieth day thereafter
(Register 85, No. 34).

§1251. Office.

The health department shall maintain and operate a central office and
headquarters on a full-time basis during the normal work week of the lo-
cal government.

NOTE; Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Section 1130, Health and Safety Code.

History

1. OAL Nodce of Erroneous Filing filed 7-18-85; purported editorial correcfion
of Section 1251 filed in error on 7-1-85 is null and void and text as filed with
Secretai7 of State on 10-1-47 remains in effect uninterrupted (Register 85, No.
30).

2. New NOTE filed 8-19-85; effecfive thirtieth day thereafter (Register 85, No.
34).

§1252. Clerical Staff.

There shall be a clerical staff under proper supervision, adequate to
meet local needs.

Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Secfion 1130, Health and Safety Code.

History

1. OAL Notice of Erroneous Fifing filed 7-18-85; purported editorial correcfion
of Section 1252 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No.
30).

2. New NOTE filed 8-19-85; effecfive thirtieth day thereafter (Register 85, No.

34).

§ 1 253. Public Health Nursing Staff.

(a) There shall be a public health nursing staff under the supervision
of a director of public health nursing, and such additional supervisors,
who are necessary to provide effecfive service. Public health nurses shall
be qualified and knowledgeable in matters pertaining to health, safety
and sanitafion within a local health jurisdiction which shall include but
not be limited to:

( 1 ) The control and prevention of communicable and chronic disease;

(2) The promofion of maternal, child and adolescent health;

(3) The prevenfion of abuse and neglect of children, spouses and elder-
ly adults within the home environment;

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(4) The case management of California Children Services or handi-
capped children;

(5) The assessment and prevention of accidents within the home envi-
ronment;

(6) The provision of services for populations at risk; and,

(b) All members of the public health nursing staff who are employed
as public health nurses including supervisory personnel shall be certified.
Note: Authority cited: Section 1130, Health and Safety Code. Reference: Sec-
tions 600-603, Health and Safety Code.

History

1. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No.
23).

2. Amendment filed 3-9-87; effective thirtieth day thereafter (Register 87, No.
11).

§ 1254. Environmental Health Staff.

There shall be an adequate staff of Registered Sanitarians under the di-
rection of a Director of Environmental Health. In addition, the staff shall
include such other support personnel as are required to carry out the envi-
ronmental health program.

NOTE: Authority cited: Sections 208, 1111 and 11 30, Health and Safety Code.
Reference: Sections 1111 and 1 130, Health and Safety Code.

History

1. Amendment filed 5-7-75; effective thirtieth day thereafter (Register 75, No.
19).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1254 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 5-7-75 remains in effect uninterrupted (Register 85, No.
.30).

3. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No.
34).

§1255. Public Health Laboratory.

The principal public health laboratory shall be under the direction of
a public health laboratory director. A branch public health laboratory
shall be under the direction of a branch public health laboratory director
who shall be directly responsible to the director of the principal public
health laboratory.

NOTE; Authority cited: Secfions 208, 1111 and 1130, Health and Safety Code.
Reference: Sections 1000, 1001, 1002, 1111 and 1130, Health and Safety Code.

History

1. Amendment filed 5-19-49 (Register 16, No. 4).

2. Repealer and new secfion filed 1-28-59; effective thirtieth day thereafter (Reg-
ister 59, No. 3).

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No.

34).

4. Amendment filed 1-21-77; effecfive thirtieth day thereafter (Register 77, No.

4).

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1255 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No.
30).

6. Editorial correction of NOTE filed 8-19-85; effecfive thirtieth day thereafter
(Register 85, No. 34).

§ 1256. Provisional Approval of Health Departments.

The Director of Health Services, after thorough investigation of geo-
graphic, transportation, economic, or other conditions, may grant provi-
sional approval to health departments which serve all of the incorporated,
as well as the unincorporated, area of the county and which are under the
direction of a part-time county health officer; provided, however, that
such counties shall have a population of less than 25,000, as determined
pursuant to Section 1 101, Chapter 8, Part 2, Division 1 of the Health and
Safety Code. Such health departments, however, shall meet all standards
established for local health departments by the Department except Sec-
tion 1250 of this article. Such provisional approval shall terminate on
June 30, 1948, but may be renewed annually at the discretion of the Di-
rector.

NOTE: Authority cited: Secfions 208, 1111 and 1130, Health and Safety Code.
Reference: Secfions 1 101, 1 102 and 1 130, Health and Safety Code.

History

1. New section filed 1-28-59; effective thirtieth day thereafter (Register 59, No.
3).

2. OAL Notice of Erroneous Filing filed 7-18-85: purported editorial correction
of Secfion 1256 filed in error on 7-1-85 is null and void and text as filed with
Secretary of Slate on 1-28-59 remains in effect uninterrupted (Reeister 85, No.
30).

3. Editorial correcfion filed 8-19-85; effecfive thirtieth day thereafter (Register
85, No. 34).

Article 2. Program

§ 1275. Duties and Functions.

A local health department, in order to qualify for funds pursuant to Di-
vision I, Part 2, Chapter 8, of the Health and Safety Code, shall perform
all of the duties and functions imposed upon it by the Health and Safety
Code and other statutes of the State of California, and by the rules, regula-
tions and orders of the Department of Health Services.
NOTE; Authority cited: Sections 208, 1 111 and 1 130. Health and Safety Code.
Reference: Sections 1 130 and 1 155. Health and Safety Code.

History

1. OAL Nofice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1275 filed in ertor on 7-1-85 is null and void and text as filed with
Secretary of State on 10-1-47 remains in effect unintertupted (Register 85, No.
30).

2. Editorial correction filed 8-19-85; effecfive thirtieth day thereafter (Register
85, No. 34).

§1276. Basic Services.

The health department shall offer at least the following basic services
to the health jurisdiction which it serves:

(a) Collection, tabulation and analysis of all public health statistics, in-
cluding population data, natality, mortality and morbidity records, as
well as evaluation of service records.

(b) Health education programs including, but not necessarily limited
to, staff education, consultation, community organizadon, public infor-
mation, and individual and group teaching, such programs to be planned
and coordinated within the department and with schools, public and vol-
untary agencies, professional societies, and civic groups and individuals.

(c) Communicable disease control, including availability of adequate
isolation facilities, the control of the acute communicable diseases, and
the control of tuberculosis and the venereal diseases, based on provision
of diagnostic consultative services, epidemiologic investigation and ap-
propriate preventive measures for the particular communicable disease
hazards in the community.

(d) Medical, nursing, educational, and other services to promote ma-
ternal and child health, planned to provide a comprehensive program to
meet community needs in these fields.

(e) Environmental health and sanitation services and programs in ac-
cordance with an annual plan and program outline as required in Title 1 7,
Section 1328, and approved by the State Department of Health and the
applicable services and program standards as specified in the State De-
partment of Health "Services in a Local Environmental Health and Sani-
tation Program," September 1976. The required services and programs
shall be as follows:

(l)Food.

(2) Housing and institutions.

(3) Radiological health in local jurisdictions contracting with the State
Department of Health to enforce the Radiadon Control Law pursuant to
Secdon 25600-25654 and Secdons 25800-25876, Health and Safety
Code.

(4) Milk and dairy products in local jurisdictions maintaining an ap-
proved milk inspecdon service pursuant to Secdon 32503, Food and
Agricultural Code.

(5) Water oriented recreation.

(6) Safety.

(7) Vector control.

(8) Wastes management.

(9) Water supply.

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(10) Air sanitation.

(1 J ) Additional environmentally related services and programs as re-
quired by the County Board of Supervisors, City Council, or Health Dis-
trict Board.

(12) And may include land development and use.

(f) Laboratory services, provided by an approved public health labora-
tory in health departments serving a population of 50,000 or more. Such
laboratories shall provide:

( 1 ) Services necessary for the various programs of the health depart-
ment.

(2) Consultation and reference services to further the development of
improved procedures and practices in laboratories employing such pro-
cedures related to the prevention and control of human disease.

(g) Services in nutrition, including appropriate activities in education
and consultation for the promotion of positive health, the prevention of
ill health, and the dietary control of disease.

(h) Services in chronic disease, which may include case finding, com-
munity education, consultation, or rehabilitation, for the prevention or
mitigation of any chronic disease.

(i) Services directed to the social factors affecting health, and which
may include community planning, counseling, consultation, education,
and special studies.

(j) Services in occupational health to promote the health of employed
persons and a healthful work environment, including educational, con-
sultative and other activities appropriate to local needs. Where the popu-
lation of a health jurisdiction exceeds 500 thousand, the program in occu-
pational health shall include a planned and organized service with trained
staff.

( 1 ) "Services in occupational health" shall mean, as a minimum, a pro-
gram of industrial sanitation and surveillance of occupational health haz-
ards to insure that places of employment are maintained in a healthful and
sanitary condition. For the purpose of this section, "sanitary condition"
is defined as equivalent to that described in the "Recommended Stan-
dards of Sanitation in Places of Employment" issued by the California
State Department of Health Services. Such services shall be provided by
at least one Occupational Health Sanitarian as defined in Section 1307,
or any one of the occupational health disciplines in Section 1306, with
medical, sanitation, and public health nursing support available.

(2) "Planned and organized service" shall include services in occupa-
tional health as defined above, and in addition the prevention of work-in-
duced illness and disability by recognizing, evaluating and preventing
unhealthful environmental conditions and practices in places of work.

(3) "Trained staff shall be defined as follows:

(A) When the health jurisdiction includes a population of 500,000 to
1 ,000,000, at least 1 , and after July 1 , 1 968, 2 full-time health profession-
als representing 1 or 2, respectively, of the disciplines listed in part (4)
hereof shall be employed.

(B) When health jurisdictions include more than 1 ,000,000 population
at least 2. and after July 1, 1968, 3 full-time health professionals repre-
senting 2 or 3, respectively, of the 5 disciplines listed in part (4) hereof
shall be employed.

(C) When health jurisdictions include more than 5,000,000 popula-
tion, at least 10 full-time health professionals including all 5 of the disci-
plines listed in part (4) hereof shall be employed.

(4) Occupational health disciplines include: Occupational Health Phy-
sician; Occupational Health Nursing Consultant; Industrial Hygiene En-
gineer; Industrial Hygienist (including sanitarians with appropriate train-
ing); and Industrial Hygiene Chemist as defined in Section 1306.

(k) Appropriate services in the field of family planning, which may in-
clude:

(1) Promotion of availability of program elements such as:

(A) Assembling knowledge about family planning, attitudes, values,
and information held by population groups.

(B) Public and professional educational services about the health
benefits of family planning and fertility control methods.

(C) Professional services for sterility correction,fertility control and
genetic counseling for all segments of the population, making available
methods acceptable to families of any religious persuasion.

(D) Evaluation of the adequacy of the community's family planning
efforts.

(2) Provision of program elements which are not otherwise likely to
be made available, including family planning services for those groups
who cannot reasonably obtain them.

(1) Public health nursing services to provide for the preventive and
therapeutic care of the population served.

NOTE: Authority cited: Sections 208, 1111 and 11 30, Health and Safety Code.
Reference: Sections 1 11 1, 1 112, 1 113, 11 30, 1 155, 1555.5 and 1 155.6, Health and
Safety Code.

History

1 . Amendment of subsection (j)(l ) filed 6-24-68; effective thirtieth day thereafter
(Register 68, No. 24). For prior history, see Register 67, No. 50.

2. Amendment of subsection (f) filed 8-16-71; effective thirtieth day thereafter
(Register 71, No. 34).

3. New subsection (1) filed 6-7-74; effective thirtieth day thereafter (Register 74,

No. 23).

4. Amendment of subsection (e) filed 12-9-77; effective thirtieth day thereafter
(Register 77, No. 50).

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial cortection
of Section 1276 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 12-9-77 remains in effect uninterrupted (Register 85, No.
30).

6. Editorial cortection filed 8-19-85; effective thirtieth day thereafter (Reeister
85, No. 34).

Article 3. Personnel

§1300. Health Officer.

The health officer shall be a graduate of a medical school of good
standing and repute and shall be eligible for a license to practice medicine
and surgery in the State of California; provided however that those health
officers on a full-time basis as of September 19, 1947, shall be consid-
ered as meeting the requirements of this section.

NOTE; Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Sections 454 and 1 130, Health and Safety Code.

History

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial cortection
of Section 1300 filed in ertor on 7-1-85 is null and void and text as filed with
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No.
30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No.
34).

§ 1 301 . Director of Public Health Nursing.

(a) A director of public health nursing shall be a public health nurse
who has:

( 1 ) Completed a baccalaureate program of study in public health nurs-
ing accredited by the National League for Nursing and has had three
years of progressively responsible experience in public health nursing or

(2) A Masters Degree with preparation in Nursing Administration, Su-
pervision or Consultation from a program accredited by the National
League for Nursing or the American Public Health Association and at
least three years of progressively responsible experience in public health
nursing.

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Sections 600, 601, 602, 603, 604 and 11 30, Health and Safety Code.

History

1. Amendment filed 2-6-51 as an emergency; designated to be effective 3-1-51
(Register 23, No. 3).

2. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No.
23).

3. OAL Notice of Ertoneous FiUng filed 7-18-85; purported editorial cortection
of Section 1301 filed in ertor on 7-1-85 is null and void and text as filed with
Secretary of State on 6-7-74 remains in effect uninterrupted (Register 85, No.
30).

4. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No.
34).

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§ 1302. Director of the Public Health Laboratory.

The director of a principal public health laboratory shall be a certified
Public Health Microbiologist whose qualifications conform with the
specifications for this position as established by the Department, pur-
suant to the provisions of the Health and Safety Code. The director shall
have had four or more years of experience in public health laboratory
work. The quality, variety and currency of this experience shall be satis-
factory to the Department.

NOTK: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Sections 1000, 1002 and 1 130, Health and Safety Code.

History

1. New section filed 2-6-51 as an emergency; designated to be effective 3-1-51
(Register 23, No. 3).

2. Repealer and new section filed 1-28-59; effective thirtieth day thereafter (Reg-
ister 59, No. 3).

3. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No.
34).

4. Amendment filed 1-21-77; effective thirtieth day thereafter (Register 77, No.
4).

5. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1302 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No.
30).

6. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register
85, No. 34).

§ 1302.1. Director of a Branch Public Health Laboratory.

The director of a branch public health laboratory shall be a certified
Public Health Microbiologist whose qualificafions conform with the
specifications for this position as established by the Department, pur-
suant to the provisions of the Health and Safety Code. The director shall
have had two or more years experience in public health laboratory work.
The quality, variety and currency of this experience shall be satisfactory
to the Department.

NOTE: Authority cited: Sections 208, 1111 and 1130. Health and Safety Code.
Reference: Secdons 1000, 1002 and 1130, Health and Safety Code.

History

1 . New section filed 1-21-77; effective thirtieth day thereafter (Register 77, No.
4).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1 302. 1 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 1-21-77 remains in effect uninterrupted (Register 85, No.
30).

3. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register
85, No. 34).

§ 1303. Health Educator.

A health educator shall hold a master's degree with specialization in
public or community health education awarded upon completion of a
program of study accredited by the American Public Health Association.
NOTE; Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Secfion 1 130, Health and Safety Code.

History

1 . New section filed 1-28-59; effective thirtieth day thereafter (Register 59, No.
3).

2. Amendment filed 10-1-62; effective thirtieth day thereafter (Register 62, No.
21).

3. Amendment filed 8-10-70; effective thirtieth day thereafter (Register 70, No.
33).

4. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1303 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 8-10-70 remains in effect uninterrupted (Register 85, No.
30).

5. Editorial correcfion of NOTE filed 8-19-85; effective thirtieth day thereafter
(Register 85, No. 34).

§ 1304. Director of Health Education.

A director of health education appointed after November 1, 1962 who
is responsible for the supervision of other professional staff shall have
had, in addition to the professional training specified above, three or
more years full-time paid experience in public health education, prefer-
ably in a local public health department.

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Secdon 1 130, Health and Safety Code.

History

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No.
21).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1304 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 10-1-62 remains in effect unintemjpted (Recister 85, No.
30).

3. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter
(Register 85, No. 34).

§1305. Public Health Nurse.

(a) A public health nurse shall be currently licensed to pracfice as a reg-
istered nurse in California and shall:

(1) Possess a CaHfomia Public Health Nurse Certificate issued prior
to March 5, 1954, or a Public Health Nurse Ceruficate issued under the
provisions of Secfion 4500 et seq: and

(2) By October 1, 1987 acquire training in the detecfion, prevention,
reporting requirements and treatment of child abuse and neglect in accor-
dance with Secfion 4501 of this chapter of working for a local health ju-
risdicfion on or after January 1, 1981.

(A) Directors of Public Health Nursing as defined in Section 1301
shall have the responsibility for veiifying that all members of their Public
Health Nursing Staff who have received Public Health Nurse Certificates
prior to October 1, 1987, have received training which satisfies the re-
quirement in Section 4501(a)(4).

(B) The Department of Health Services shall have the responsibility
for verifying that all nurses who receive a Public Health Nurse Certificate
after October 1, 1987 have received training which satisfies the require-
ments in Secfion 4501(a)(4).

Note: Authority cited: Sections 208, 600, 602 and 1 1 30, Health and Safety Code.
Reference: Section 600, 602, 605 and 1 130, Health and Safety Code.

History

1. New secdon filed 10-1-62; effecdve thirtieth day thereafter (Register 62, No.
21).

2. Amendment filed 8-16-71; effecdve thirtieth day thereafter (Register 71, No.

34).

3. Repealer and new secdon filed 6-7-74; effective thirtieth day thereafter (Regis-
ter 74, No. 23).

4. Amendment filed 3-9-87; effecdve thirtieth day thereafter (Register 87, No.
11).

§ 1306. Occupational Health Trained Staff.

Qualificafions for each discipline included in the definition of trained
staff shall conform to the following specifications:

(a) Occupational Health Physician. M.D. degree and license to prac-
fice medicine in California, and either:

(1) a master's degree in public health or occupational medicine and
two years' experience in the full-fime practice of occupational medicine,
or

(2) four years' experience in the full-time practice of occupational
medicine, at least one year of which shall have been in a public health
program.

(b) Occupafional Health Nursing Consultant. Baccalaureate degree
and possession of a vafid license as a registered nurse and a valid Califor-
nia Public Health Nurse certificate, and, either:

(1 ) a master' s degree in pubUc health and two years' experience in the
full-fime pracfice of occupafional health nursing, or

(2) four years' experience m the full-time pracfice of occupational
health nursing, and two years in a generalized public health nursing pro-
gram.

(1) a master's degree in pubHc health or industrial hygiene and two
years' experience in the full-time practice of industrial hygiene engi-
neering, or

(2) four years' experience in the full-time practice of industrial hy-
giene engineering, at least one year of which shall have been in a public
health program.

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(d) Industrial Hygienist. Baccalaureate degree with major in a physical
or biological science, and, either:

(1) a master's degree in public health or industrial hygiene and two
years' experience in the fill-time practice of industrial hygiene, or

(2) four years' experience in the full-time practice of industrial hy-
giene, at least one year of which shall have been in a public health pro-
gram, or

(3) registration as a sanitarian in California with four years' experience
in a local health department, three years of which shall have been in the
full-time practice of industrial hygiene.

(e) Industrial Hygiene Chemist. Baccalaureate degree with major in
chemistry or biochemistry, and, either:

( 1) a master's degree in chemistry, biochemistry, or a related field of
environmental chemistry and two years' experience as a professional
chemist doing increasingly complex analytical procedures, or

(2) four years' experience as a professional chemist doing increasingly
complex analytical procedures.

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Section 1130, Health and Safety Code.

History

1 . New section filed 1 2-1 5-67; effective thirtieth day thereafter. (Register 67, No.
50).

2. Amendment of subsection (d) filed 6-24—68; effective thirtieth day thereafter
(Register 68, No. 24).

3. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1306 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 6-24—68 remains in effect uninterrupted (Register 85, No.
30).

4. Editorial correction of NOTE filed 8-19-85; effective thirtieth day thereafter
(Register 85, No. 34).

§ 1307. Occupational Health Sanitarian.

(a) Qualifications for an Occupational Health Sanitarian shall conform
to the following specifications:

(1) Registration as a sanitarian in California;

(2) Three years' full-time experience in environmental sanitation;

(3) One year of experience in an occupational health program of a local
health department under direct supervision of an Industrial Hygiene En-
gineer or Industrial Hygienist as defined in Section 1306, or satisfactory
completion of a two-week intensive training course in the recognition of
occupational health hazards conducted by the California State Depart-
ment of Public Health, or the equivalent of such a course conducted by
an institution acceptable to the Department.

(b) An Occupational Health Sanitarian with two years' full-time expe-
rience in that classification may qualify as an Industrial Hygienist for the
purposes of Section 1 276(j)(4) of this Code by completing two additional
years of full-time experience in industrial hygiene under the direct super-
vision of an Industrial Hygiene Engineer or Industrial Hygienist quali-
fied under Section 1306 above.

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Secfions519, 1111 and 1130, Health and Safety Code.

History

1. New secfion filed 6-24-68; effecfive thirtieth day thereafter (Register 68, No.
24).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Secfion 1307 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 6-24-68 remains in effect uninterrupted (Register 85, No.
30).

3. Editorial correcdon of NOTE filed 8-19-85: effecfive thirtieth day thereafter
(Register 85, No. 34).

§ 1308. Director of Environmental Health.

A director of Environmental Health shall hold a valid certificate of
registration as a Sanitarian in the State of California and shall have had
three or more years' experience in an environmental health agency (a
Master's Degree in Public Health, Health Science, Public Administra-
tion, or related field may be substituted for one year of the required expe-
rience).

Note: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Sections 1130 and 1155, Health and Safety Code.

History

1 . New section filed 5-7-75; effective thirtieth day thereafter (Register 75, No.
19).

2. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial coiTcction
of Section 1308 filed in enor on 7-1-85 is null and void and text as filed with
Secretary of State on .5-7-75 remains in effect uninterrupted (Register 85, No.
30).

3. Editorial correction of NOTE filed 8-19-85; effecfive thirtieth day thereafter
(Register 85, No. 34).

Article 4. Finance

§1325. Use of Funds.

Funds available to local health departments under Chapter 8, Part 2,
Division 1 of the Health and Safety Code may be expended for personnel,
including but not limited to new or additional personnel and adjustments
of salaries of existing personnel, maintenance and operation, equipment,
and for capital expenditures. The funds may be used only to augment lo-
cal appropriations provided for public health purposes, through the local
public health department, including those functions listed in Article 2,
but not including any of the following:

(a) Medical, hospital and therapeutic care of physically handicapped
children.

(b) Maintenance of hospitals (including emergency hospitals and first
aid stations), sanatoria and homes.

(d) Street cleaning.

(e) Inspection of building construction.

(f) Inspection of plumbing.

(g) Maintenance of dog or animal pounds,
(h) Inspection of cemeteries.

Note: Authority cited: Sections 100275, 100295 and 100950, Health and Safety
Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code.

History

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Secfion 1325 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No.
30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No.
34).

3. Change without regulatory effect amending Note filed 10-13-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 42).

§ 1326. Restrictions on Matching Funds.

For matching purposes as specified in Section 101255 of the Health
and Safety Code, local health departments shall not include funds appro-
priated for functions listed under subsections (a) to (h), inclusive of Sec-
tion 1325 above.

Note; Authority cited: Sections 100275, 100295 and 100950, Health and Safety
Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code.

History

1. OAL Notice of Erroneous Filing filed 7-18-85; purported editorial correction
of Section 1326 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on lC^-1-47 remains in effect uninterrupted (Register 85, No.
30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No.

34)

3. Change without regulatory effect amending section and Note filed 10-13-98
pursuant to section 1 00, title 1 , Cahfornia Code of Regulations (Register 98, No.

42).

§ 1327. Deposit and Expenditure of Funds.

The governing body of each local health department shall set up a spe-
cial fund or account as approved by the State Department and all pay-
ments received from the State by the governing body shall be deposited
in that fund or account. No money shall be expended from such fund or
account except for public health purposes in accordance with Division
1 , Part 2, Chapter 8, of the Health and Safety Code, and the rules and reg-
ulations adopted by the State Department of Health Services pursuant
thereto.

NOTE: Authority cited: Sections 100275, 100295 and 100950, Health and Safety
Code. Reference: Sections 100295, 101250 and 101255, Health and Safety Code.

Page 40

Title 17

State Department of Health Services

§ 1363

History

1. Amendment filed 7-2-64; effective thirtieth day thereafter (Register 64, No.
14).

2. OAL Notice of EiToneous Filing filed 7-18-85; purported editorial conection
of Section 1 327 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 7-2-64 remains in effect uninten-upted (Register 85, No.
30).

3. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85. No.
34).

4. Change without regulatory effect amending Notf; filed 10-13-98 pursuant to
section 100. title 1, California Code of Regulations (Register 98, No. 42).

§ 1328. Budget and Program.

Local health departments shall submit a budget each year, showing a
total plan for the expenditure of public health funds during the year, to-
gether with an outline of the program contemplated. The appropriation
made in support of such budget shall also be reported.
NOTI-:: Authority cited; Sections 100275, 100295 and 100950, Health and Safety
Code. Reference: Sections 100295, 101250 and 101255. Health and Safety Code.

History

1. OAL Nofice of Erroneous Fihng filed 7-18-85; purported editorial correction
of Section 1328 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 10-1-47 remains in effect uninteiTupted (Register 85, No.
30).

2. New NOTE filed 8-19-85; effective thirtieth day thereafter (Register 85, No.
34.)

3. Change without regulatory effect amending NOTii filed 10-13-98 pursuant to
section 100, title 1, California Code of Regulafions (Register 98, No. 42).

§1329. Reports.

Local health departments shall report their expenditures, and shall
submit reports of services and operations, upon forms provided for that
purpose, at such times as the State Department of Health Services may
require.

NOTE: Authority cited: Sections 208, 1111 and 1130, Health and Safety Code.
Reference: Sections II 30, 1 153 and 1 154. Health and Safety Code.

History

1. OAL Notice of Erroneous Fihng filed 7-18-85; purported editorial correction
of Section 1329 filed in error on 7-1-85 is null and void and text as filed with
Secretary of State on 10-1-47 remains in effect uninterrupted (Register 85, No.
30).

2. Editorial correction filed 8-19-85; effective thirtieth day thereafter (Register
85, No. 34).

Note: Authority cited: Sections 208, 1 11 1 and 1 155.6, Health and Safety Code.
Reference: Section 1 155.5, Health and Safety Code.

History
1. New NOTE filed 5-8-84 (Register 84, No. 19).

Subchapter 2. Standards for State Aid for
Comprehensive Environmental Agencies

Article 1. Definitions

§ 1351. Comprehensive Environmental Agency.

"Comprehensive Environmental Agency" means an agency responsi-
ble to the board of supervisors which has been assigned the total function
of providing environmental health and sanitation services and programs
and other related environmental management functions which the board
of supervisors may choose to delegate to the agency.
NOTE: Authority cited: Sections 208, 1 11 1 and 1 155.6, Health and Safety Code.
Reference: Section 1 155.5, Health and Safety Code.

History

1. New Subchapter 2 (Sections 1351-1375, not consecufive) filed 12-9-77; effec-
tive thirtieth day thereafter (Register 77, No. 50).

2. Editorial con-ection of NOTE filed 5-8-84 (Register 84, No. 19).

§ 1353. Environmental Health and Sanitation Services and
Programs.

"Environmental Health and Sanitation Services and Programs" means
those agency provided services and programs which are required by the
Director of the State Department of Health to meet local environmental
health and sanitation needs. The term shall include additional environ-
mentally related services and programs for which responsibility has been
delegated to the agency by the county Board of Supervisors or Health
District Board.

Article 2. Agency Personnel and Facilities

§ 1355. Director of Environmental Health.

(a) There shall be a full-time Director of Environmental Health who
shall be responsible for the administration of environmental health and
sanitation services and programs.

(b) The Director shall meet the following minimum qualifications:

( 1 ) Possession of a valid certificate of registration as a sanitarian in the
State of California.

(2) Three or more years' experience in an environmental health
agency. A Master's Degree in Public Health, Health Science, Public Ad-
ministration, or a related field may be substituted for one year of the re-
quired experience.

Note: Authority cited: Sections 208, 1 1 1 1 and 1 155.6, Health and Safety Code.
Reference: Secuons 1 155.5 and 1 155.6, Health and Safety Code.

History
1 . New NOTE filed 5-8-84 (Register 84, No. 19).

§1357. Environmental Health staff.

There shall be an adequate staff of Registered Sanitarians meeting the
qualifications established by the State Department of Health pursuant to
provisions of the Health and Safety Code and other support personnel
necessary to implement agency services and programs. Staffing units
shall be equal to or greater than those levels provided by the environmen-
tal health unit of the health department prior to the transfer.
Note: Authority cited: Sections 208, 1 11 1 and 1 L55.6, Health and Safety Code.
Reference: Sections 1 155.5 and 1 155.6. Health and Safety Code.

History
1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1359. Clerical staff.

There shall be sufficient, properly supervised clerical staff to meet
agency needs. Staffing levels shall be equal to or greater than those levels
provided by the environmental health unit of the health department prior
to the transfer.

Note: Authority cited: Secfions 208, 1 1 1 1 and 1 155.6. Health and Safety Code.
Reference: Secfions 1 155.5 and 1 155.6, Health and Safety Code.

History
1. New NOTE filed 5-8-84 (Register 84, No. 19).

§1361. Office Facilities.

There shall be provided publicly accessible office faciUties which
shall be in operation full time during the normal county government work
week.

Note: Authority cited: Sections 208, 11 1 1 and 1 155.6, Health and Safety Code.
Reference: Secfions 1 155.5 and 1155.6, Health and Safety Code.

History
1. New NOTE filed 5-8-84 (Register 84, No. 19).

Article 3. Organization

§ 1 363. Conditions of Transfer.

(a) Prior to transferring environmental health and sanitation services
and programs from a local health department to an agency, the following
shall be met:

(1) The county board of supervisors or health district board shall au-
thorize the total environmental health and sanitation services and pro-
grams to be transferred and maintained as a single organizational unit.

(2) The Director of the State Department of Health shall give written
approval for the transfer.

(3) The proposed agency shall have a State Department of Health ap-
proved annual program plan.

Page 41

§1365

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTH; Authority cited: Sections 208, 1111 anil 1 153.6, Health and Safety Code.
Reference: Sections 1 155.5 and 1 155.6, Heahli and Safety Code.

History
1. New NOTE fded 5-8-84 (Register 84, No. 19).

§ 1 365. Powers and Duties of the County Health Officer.

The county health officer shall retain powers, duties, and responsibili-
ties relating to the protection of public health as set forth in Section 452
of the Health and Safety Code.

NOTE: Authority cited: Sections 208, 1111 and 1 155.6, Health and Safety Code.
Reference: Sections 452, 1 155.5 and 1 155.6, Health and Safety Code.

History
1 . New NOTE filed 5-8-84 (Register 84, No. 19).

§ 1 367. Powers and Duties of the District Health Officer.

The district health officer shall retain powers, duties, and responsibili-
ties relating to the protection of public health as set forth in Division 1,
Part 2, Chapter 6 (commencing with Section 880) of the Health and Safe-
ty Code.

NOTE: Authority cited: Sections 208, 1 II 1 and 1 155.6, Health and Safety Code.
Reference: Division 1, Part 2, Chapter 6 (commencing with Section 880) (Pur-
suant to the Savings Clause in Statutes 1959, Chapter 380, Page 2305, Section 3,
as amended by Statutes 1961, Chapter 1362, Page 3137, Section 1; Statutes 1968,
Chapter 468, Page 1099, Section 1) and Sections 1 155.5 and 1 155.6, Heahh and
Safety Code.

History
1. New NOTE filed 5-8-84 (Register 84, No. 19).

§ 1369. Powers and Duties of the Director of
Environmental Health.

(a) The Director of Environmental Health shall have powers and duties
relating to environmental health and sanitation services and programs.

(b) The powers and duties shall be clearly delineated in writing and
shall provide for well-defined, direct lines of communication with the
county or district health officer to assure coordination of pubhc health
programs and environmental health and sanitation services and pro-
grams.

(c) These regulations shall not be deemed to diminish or impede any
additional powers and duties of the Director of Environmental Health
specified by statute, rule, regulation, resolution or order, or which may
have been delegated to him by the county or district health officer.
NOTE: Authority cited: Sections 208, 1111 and 1 155.6, Health and Safety Code.
Reference: Sections 11 55.5 and 11 55.6, Health and Safety Code.

History

I. New NOTE filed 5-8-84 (Register 84, No. 19).

Article 4. Program

§1371. Basic Program.

(a) Environmental health and sanitation services and programs shall
be offered in accordance with an annual program plan approved by the
State Department of Health and the applicable services and program
standards an specified in the State Department of Health "Services in a
Local Environmental Health and Sanitation Program," September 1976.
The required services and programs shall be as follows:

(l)Food.

(2) Housing and institutions.

(3) Radiological health in local jurisdictions contracting with the State
Department of Health to enforce the Radiation Control Law pursuant to
Sections 25600-25654 and Sections 25800-25876, Health and Safety
Code.

(4) Land development and uses.

(5) Milk and dairy products in local jurisdictions maintaining an ap-
proved milk inspection service pursuant to Section 32503, Food and
Agricultural Code.

(6) Occupational health.

(7) Water oriented recreation.

(8) Safety.

(9) Vector control.

(10) Wastes management.

(11) Water supply.

(12) Additional environmentally related services and programs as re-
quired by the County Board of Supervisors, City Council, or Health Dis-
trict Board.

(13) Air sanitation.

NOTE: Authority cited: Sections 208, 1 1 1 1 and 1 155.6, Health and Safety Code.
Reference: Sections 1 155.5 and 11 55.6, Health and Safety Code.

History
1. New NOTE filed 5-8-84 (Register 84, No. 19).

§ 1373. Annual Program Plans.

(a) Each county or district shall submit to the State Department of
Health, annually for approval, program plans in each of the categories
specified in Section 1371.

(b) The annual program plans shall contain information pertaining to
comiTiunity needs, authority, goals, objectives, activities, personnel, and
program evaluation as may be required by the State Department of
Health.

Note: Authority cited: Secdons 208, 1 1 1 1 and 1 155.6, Health and Safety Code.
Reference: Secfions 1 155.5 and 1 155.6, Health and Safety Code.

History
I. New NOTE filed 5-8-84 (Register 84, No. 19).

§1375. State Financial Aid.

County or district eligibility for funds pursuant to Division 1, Part 2,
Chapter 8 (commencing with Section 1 100) of the Health and Safety
Code shall be contingent upon fulfillment by the agency of all environ-
mental health and sanitation requirements imposed upon county or dis-
trict health departments by state statutes, rules, regulations and orders,
and by local ordinances.

NOTE: Authority cited: Secfions 208, 1 11 1 and 11 55.6, Health and Safety Code.
Reference: Sections 1 155.5 and 1 155.6, Health and Safety Code.

History
1. New NOTE filed 5-8-84 (Register 84, No. 19).

Subchapter 3. Standards for Maintaining
County Health Services

Article 1. Application

§ 1 401 . Application of Subchapter.

Subchapter 3 shall apply to local jurisdictions that elect to apply for
State funds under the provisions of Part 4.5 of Division 9 of the Welfare
and Institutions Code.

NOTE: Authority cited: Section 16712, Welfare and InstituUons Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16702,
Welfare and Institutions Code.

History

1 . New Subchapter 3 (Secfions 1401-1463, not consecufive) filed 10-18-78 as an
emergency; effective upon filing (Register 78, No. 42).

2. Certificate of Compliance filed 2-6-79 (Register 79, No. 6).

3. Repealer of Subchapter 3 (Sections 1401-1463, not consecutive) and new Sub-
chapter 3 (Secfions 1401-1497, not consecufive) filed 8-29-80 as an emergen-
cy; designated effective 8-29-80 (Register 80, No. 35). A Certificate of Com-
pliance must be transmitted to OAL within 120 days or emergency language
will be repealed on 12-29-80.

4. Certificate of Compliance transmitted to OAL 12-5-80 and filed 1-14-81
(Register 81, No. 3).

5. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

6. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§ 1403. Section Headings.

Section headings contained herein shall not be deemed to govern, lim-
it, or modify the provisions of any section.

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code. Reference:
Secfion 16712, Welfare and Institufions Code.

Page 42

Title 17

State Department of Health Services

§ 1420.1

Article 2. Definitions

§1405. Addendum.

NOTH: Authority cited: Section 16812, Welfare and Institutions Code. Reference:

Section 16990, Welfare and Institutions Code.

History

1. Change without regulatory effect repealing section and amending NoTi; filed
1 0-13-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg-
ister 98, No. 42).

§1407. Agreement,

"Agreement" means the Standard Agreement for County Health Ser-
vices entered into and signed by the governing body of each local juris-
diction and the Director of the State Department of Health Services
which specifies the conditions under which monies shall be transferred
to each local jurisdiction from the County Health Services Fund pursuant
to Part 4.5 of Division 9 of the Welfare and Institutions Code.
Note: Authority cited: Section 1 67 1 2. Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and
16704(b), Welfare and Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1409. Allocation.

NOTE: Authority cited: Section 16712, Welfare and Institutions Code. Reference
cited: Sections 16702 and 16704, Welfare and Institutions Code.

History

1. Renumbering and amendment of Section 1409 to Secfion 1418 filed 12-31-82
as an emergency; effective upon filing (Register 83, No. 2). A Certificate of
Compliance must be transmitted to OAL within 120 days or emergency lan-
guage will be repealed on 4-30-83.

2. Certificate of Compliance transmitted to OAL 4-29-83 and filed 6-9-83 (Reg-
ister 83, No. 24).

§ 1411. Annual Local Jurisdiction Budget.

"Annual Local Jurisdiction Budget" means the official local jurisdic-
tion budget adopted each year by the governing body of the local jurisdic-
tion.

NOTE: Authority cited: Secfion 16812, Welfare and Insfitufions Code; and Stat-
utes of 1982, Chapter 1594, Secfion 87(c). Reference: Secfion 16990, Welfare and
Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effecfive upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correcdon of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect amending Note filed 10-13-98 pursuant to
section 100, Ufie 1, California Code of Regulations (Register 98, No. 42).

§1411.1. Benefits Chart.

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Secfion
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Secfion
87(c). Reference: Section 16709, Welfare and Insfitufions Code.

History

1. New section filed 12-31-82 as an emergency; effecfive upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of Note transmitted to
OAL 4^29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending section head-
ing and Note filed 9-7-2005 pursuant to section 100, title 1, California Code
of Regulations (Register 2005, No. 36).

§1413. Budget.

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code. Reference
cited: Section 16700, Welfare and Insfitufions Code.

History
1. Renumbering and amendment of Section 1413 to Section 1430.3 filed
12-31-82 as an emergency; effecfive upon filing (Register 83, No. 2). A Certifi-

cate of Compliance must be transmitted to OAL within 1 20 days or emergency
language will be repealed on 4-30-83.

2. Certificate of Compliance transmitted to OAL 4-29-83 and filed 6-9-83 (Reg-
ister 83. No. 24).

§ 1 41 5. City Health Services.

"City health services" means public health services, outpatient health
services, and inpatient health services provided directly by a city or fi-
nanced or purchased by a city through grants, contracts, or agreements,
but not including services provided pursuant to Division 5, Welfare and
Institutions Code, or Division 10.5, Health and Safety Code.
NOTE: Authority cited: Section 167 1 2, Welfare and Institutions Code. Reference:
Section 16701(c), Welfare and Institutions Code.

§ 1417. County Health Services.

"County health services" means public health services, outpatient
health services, and inpatient health services provided directly by a local
jurisdiction or financed or purchased by a local jurisdiction through
grants, contracts, or agreements but not including services provided:

(1) Pursuant to Division 5, Welfare and Institutions Code.

(2) Pursuant to Division 10.5, Health and Safety Code.

(3) In Fiscal Year 1977-78 which are not part of the reported net
county costs for Fiscal Year 1 977-78.

NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and
16701(a), Welfare and Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§ 1418. County Health Services Allocation.

"County Health Services Allocation" means monies disbursed from
the County Health Services Fund established pursuant to subdivision (a)
of Section 16703, Welfare and Institutions Code, in an amount specified
in the Standard Agreement for County Health Services entered into and
signed by duly authorized local jurisdiction officials and the Director of
Health Services. The "County Health Services Allocation" consists of an
amount based on county population, in the case of a county, and may in-
clude an amount based on net costs budgeted by a local jurisdiction for
the provision of health services.

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Secfion 87(c). Reference: Sections 16700, 16702 and
16704, Welfare and Insfitufions Code.

History

1 . Renumbering and amendment of Secfion 1409 to Section 1418 filed 12-31-82
as an emergency; effecfive upon filing (Register 83, No. 2). A Certificate of
Compliance must be transmitted to OAL within 120 days or emergency lan-
guage will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correcfion transmitted to OAL
4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1419. County Health Services Fund.

"County Health Services Fund" means the fund created by Section
16703, subdivision (a). Welfare and Institutions Code, for deposit of
monies appropriated for distribution to the local jurisdictions pursuant to
Part 4.5 of Division 9 of the Welfare and Institutions Code.
NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Secfion 87(c). Reference: Sections 16700 and 16703,
Welfare and Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§ 1420.1. County Medical Services Program.

NOTE: Authority cited: Secfion 10725, Welfare and Institutions Code; Section
100275, Health and Safety Code; and StaUites of 1982, Chapter 1594, Section
87(c). Reference: Secfion 16709, Welfare and Institutions Code.

Page 43

§ 1420.2

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1. New section filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial conection of Note transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatoiy effect repealing section and amending NOTi-; filed
9-7-2005 pursuant to section 100, title 1 , California Code of Resulations (Reg-
ister 2005, No. 36).

§ 1420.2. County Medical Services Program Account.

NOTH: Authority cited: Section 10725, Welfare and Insututions Code; Section
100275. Heahh and Safety Code; and Statutes of 1982, Chapter 1594, Section
87(c). Reference: Section 16709(d), Welfare and Institutions Code.

History

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100, fitle 1, California Code of Regulations (Reg-
ister 2005, No. 36).

§ 1420.3. County Medical Services Program Contract.

Note: Authority cited: Section 10725, Welfare and Institutions Code; Section
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Secfion
87(c). Reference: Section 16709, Welfare and Institutions Code.

History

1. New section filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20
days or einergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correcUon of Note transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to secfion 100, title \, California Code of Regulations (Reg-
ister 2005, No. 36).

§ 1420.4. Declaration of Intent to Enter into Contract.

NOTE: Authority cited: Secfion 10725, Welfare and Institutions Code; Section
100275. Health and Safety Code; and Statutes of 1982, Chapter 1594, Section
87(c). Reference: Section 16709, Welfare and Insututions Code.

History

2. Certificate of Compliance including editorial correcdon of Note transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100, title I, California Code of Regulations (Reg-
ister 2005, No. 36).

§ 1420.5. County Medical Services Program Reserve
Account.

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; and Section
100275, Health and Safety Code. Reference: Section 16709(g), Welfare and Insti-
tutions Code.

History

1 . New section filed 4-4-86 effective thirtieth day thereafter (Register 86, No. 1 4).

2. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to secfion 100, fitle 1, California Code of Regulations (Reg-
ister 2005, No. 36).

§1421. Department.

"Department" means the State Department of Health Services.
NOTE: Authority cited: Section 16712, Welfare and Insfitutions Code. Reference
cited: Secfion 16702, Welfare and Insfitufions Code.

§1422. Director.

"Director" means the Director of the State Department of Health Ser-
vices.

NOTE; Authority cited: Section 16712, Welfare and Institutions Code. Reference
cited: Section 16700, Welfare and Institutions Code.

§ 1 422.1 . Eligible Contract County,

"EHgible Contract County" means a county which has requested the
transfer of funding pursuant to Section 11 57.5 of the Health and Safety
Code.

NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1 982. Chapter 1594, Section 87(c). Reference: Section 16704, Welfare and
Institutions Code.

History

1. New section filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No.^24).

§ 1422.3. Eligibility Manual.

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section
87(c). Reference: Section 16709, Welfare and Institutions Code.

History

2. Certificate of Compliance including editorial correction of Note transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Reg-
ister 2005, No. 36).

§1423. Expenditures.

"Expenditures" means funds budgeted or expended to support health
program operations and includes:

( 1 ) Health services supplied or provided for through purchase or con-
tract.

(2) Salaries and employee benefits.

(3) Operation and maintenance costs.

(4) Depreciation of facilities owned by a local jurisdiction.

(5) Administrative costs.

(6) Federal Revenue Sharing Funds budgeted or expended for these

health activities.

NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16708, Welfare and
Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial cortection of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§ 1425. Fixed Assets, Fixtures, Structures and
Improvements.

NOTE: Authority cited: Section 16812, Welfare and Institutions Code. Reference:

Section 16708, Welfare and Institutions Code.

History

1 . Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to section 100, title 1 , California Code of Regulations (Reg-
ister 98, No. 42).

§ 1427. Inpatient/Outpatient Services.

"Inpatient/outpatient services" means those medical care services pro-
vided directly by a local jurisdiction or purchased or provided through
contracts with other providers which may include but not be limited to:

(1) General acute inpatient hospital services.

(2) Outpatient services administered by hospital staff, non-hospital
based county clinics, and community clinics funded by a local jurisdic-
tion.

(3) Skilled nursing facilities.

(4) Licensed home health agencies.

(5) Rehabilitation facility services.

(6) Inpatient/outpatient services for criminal justice inmates.

(7) Ambulance and related emergency services.

NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and
16701(a), Welfare and Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

Page 44

Title 17

State Department of Health Services

§ 1437

§1428. Local Jurisdiction.

"Local Jurisdiction" means a county, the San Joaquin Local Health
District, a city which has not transferred to the county enforcement au-
thority of applicable health statutes and regulations, or a city which pro-
vides public health services pursuant to a contract with a county through
an organized health department recognized by the Department.
NOTf': Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1 594, Section 87(c). Reference: Section 16700, Welfare and
Institutions Code.

History

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No.^24).

§ 1429. Maximum Allocation.

NOTK: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16705, Welfare and
Institutions Code.

History

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg-
ister 98, No. 42).

§1430. May, Shall, Should.

"May" means permissible. "Shall" means mandatory. "Should"
means desirable.

NOTE: Authority cited: Section 16712, Welfare and Institutions Code. Reference:
Section 16712, Welfare and Insfitutions Code.

§ 1 430.1 . Medically Indigent Services Account.

NOTE: Authority cited: Section 16812, Welfare and Institufions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803(b), Welfare
and Institutions Code.

History

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to section 100, title 1, Cahfomia Code of Regulations (Reg-
ister 98, No. 42).

§ 1430.2. Medically Indigent Services Allocation.

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and
Institutions Code.

History

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
1 0- 1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg-
ister 98, No. 42).

§ 1 430.3. Multi-Year Budget.

NoTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16990, Welfare and
Institutions Code.

History
1. Renumbering and amendment of Section 1413 to Section 1430.3 filed
1 2-3 1 -82 as an emergency; effective upon filing (Register 83, No. 2). A Certifi-

cate of Compliance must be transmitted to OAL within 1 20 days or emergency
language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial conection of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83. No. 24).

3. Change without regulatory effect repealing section and amending NoTi-; filed
10- 13-98 pursuant to secfion 100, title 1, California Code of Regulations (Reg-
ister 98, No. 42).

§ 1430.4. Multi-Year Plan.

"Multi-Year Plan" means the County Health Services three-year plan
which describes proposed county health services in a format specified by
the Department and submitted by a local jurisdiction pursuant to Part 4.5
of Division 9 of the Welfare and Institutions Code.
NOTE: Authority cited: Secfion 16712, Welfare and In.stitutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16700, Welfare and
Institutions Code.

History

1. Renumbering and amendment of Section 1433 to Section 1430.4 filed
12-31-82 as an emergency; effective upon filing (Register 83, No. 2). A Certifi-
cate of Compliance must be transmitted to OAL within 120 days or emergency
language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial coirection of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§ 1 431 . Net City Costs for Health Services.

NOTE: Authority cited: Section 1681 2, Welfare and Institutions Code. Reference:

Section 16801(e), Welfare and Institutions Code.

History

1 . Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to secfion 100, fitle 1, California Code of Reguladons (Reg-
ister 98, No. 42).

§ 1432. Net County Costs for Health Services.

"Net county costs for health services" means expenditures for county

health services less revenues received for county health services plus

Federal Revenue Sharing funds budgeted or expended for county health

services.

NOTE: Authority cited: Secfion 16712, Welfare and Institutions Code. Reference:
Section 16701(b), Welfare and Insfitufions Code.

§ 1433. Plan.

NOTE: Authority cited: Section 16712, Welfare and Insfitutions Code. Reference:

Secfion 16700, Welfare and Institutions Code.

History

1. Renumbering and amendment of Section 1433 to Section 1430.4 filed
1 2-3 1-82 as an emergency; effective upon filing (Register 83, No. 2). A Certifi-
cate of Compliance must be transmitted to OAL within 1 20 days or emergency
language will be repealed on 4-30-83.

§1435. Public Health Services.

"Public health services" means those health promotion, surveillance,
and disease prevention services designed to protect the health of the pub-
lic, population groups, and individuals.

NOTE: Authority cited: Section 1 6812, Welfare and Institufions Code. Reference:
Secfion 16801, Welfare and Insfitutions Code.

History
1. Change without regulatory effect amending Noti-; filed 10-13-98 pursuant to

section 100, fitie 1, California Code of Regulations (Register 98, No. 42).

§ 1 437. Reported Net County Costs for Fiscal Year
1977-78.

"Reported net county costs for Fiscal Year 1977-78" means those net
county costs for health services for Fiscal Year 1977-78 which were
originally reported to the Department pursuant to Section 20 of Chapter
292 of the Statutes of 1978 or amended pursuant to County Health Ser-
vices Bulletin #2-1 979. These costs are those exact amounts listed below
by county except that the amount listed for Alameda County does not in-
clude the net costs for Berkeley and the amount listed for San Joaquin
County does not include the net costs for the San Joaquin Local Health
District:

Page 45

§1439

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Alameda

$22,649,584

C)range

$21,552,624

Alpine

$23,704

Placer

$812,227

Amador

$491,123

Plumas

$115,890

Butte

$1,179,463

Riverside

$10,248,905

Calaveras

$35,861

Sacramento

$9,646,438

Colusa

$273,457

San Benito

$80,536

Contra Costa

$11,924,448

San Bernardino

$7,920,785

Del Norte

$106,435

San Diego

$10,797,538

El Dorado

$1,015,867

San Francisco

$40,124,175

Fresno

$11,853,293

San .loaquin

$3,006,398

Glenn

$121,505

San Luis Obispo

$1,889,127

Humboldt

$1,238,729

San Mateo

$8,280,966

Imperial

$1,035,813

Santa Barbara

$4,647,590

Inyo

$593,006

Santa Clara

$16,715,698

Kern

$8,830,127

Santa Cruz

$2,592,658

Kings

$718,199

Shasta

$563,682

Lake

$64,719

Sierra

$15,916

Lassen

$401,705

Siskiyou

$285,207

Los Angeles

$177,838,404

Solano

$1,006,584

Madera

$311,721

Sonoma

$1,439,658

Marin

$1,760,674

Stanislaus

$4,384,380

Mariposa

$24,291

Sutter

$999,607

Mendocino

$547,607

Tehama

$474,072

Merced

$1,301,322

Trinity

$318,281

Modoc

$164,312

Tulare

$2,317,423

Mono

$424,737

Tuolumne

$328,064

Monterey

$4,200,837

Ventura

$5,803,840

Napa

$820,398

Yolo

$1,419,400

Nevada

$171,556

Yuba

$334,214

NOTE: Authority cited: Section 16812.

, Welfare and Institutions Code. Reference:

Section 16990,

Welfare and Institutions Code.

History

1. Change without regulatory effect amending Note filed 10-13-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 42).

§ 1439. Revenues.

"Revenues" means income budgeted or received for health services
from fees, fines, grants, subventions, and/or monetary aid from govern-
ment agencies but excluding property taxes, Federal Revenue Sharing,
and monies provided pursuant to Part 4.5 of Division 9 of the Welfare and
Institutions Code.

NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1 594, Section 87(c). Reference: Section 16700, Welfare and
Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Comphance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

§1440. "Update."

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1 594, Section 87(c). Reference: Section 16936, Welfare and
Institutions Code.

History

1. New section filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
1 0- 1 3-98 pursuant to section 1 00, dtle 1 , Calilomia Code of Regulations (Reg-
ister 98, No. 42).

Article 3. County Health Services
Multi-Year Plan and Budget

§ 1445. Multi-Year Plan and Budget Submission.

(a) Beginning in 1983, and each third subsequent year thereafter, the
governing body of each county, the Cities of Berkeley, Long Beach, and
Pasadena, and the San Joaquin Local Health District shall adopt and shall
submit a Multi-Year Plan and Budget to the Director in the form and in
accordance with procedures specified in this Article on or before Sep-
tember 15.

(b) Beginning in 1984, and each year thereafter, the governing body
of each county, the Cities of Berkeley, Long Beach, and Pasadena, and
the San Joaquin Local Health District shall adopt and shall submit an up-
date of its adopted Multi-Year Plan and Budget to the Director in the
form and in accordance with procedures specified in this Article on or be-
fore September 15.

(c) Copies of the Multi-Year Plan and Budget and Update shall be sub-
mitted to the appropriate area health planning agency simultaneously to
submission to the Department.

(d) Submission of a Multi-Year Plan and Budget or Update shall not:

( 1 ) Relieve any county of its indigent health care obligation under Sec-
tion 17000, Welfare and Institutions Code.

(2) Restrict the ability of the State or any interested person or persons
to obtain any judicial relief to which there is entitlement. NOTE: Author-
ity cited: Section 16712, Welfare and Institutions Code; and Statutes of
1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and
1671 1, Welfare and Institutions Code.

History

1. Amendment of subsection (b) filed 5-21-81; effective thirtieth day thereafter
(Register 81, No. 21).

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

3. Certificate of Compliance including editorial correction transmitted to OAL
4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Amendment of Article 3 heading and Section 1445 filed 4-4-86; effective thir-
tieth day thereafter (Register 86, No. 14).

§ 1451. Multi-Year Plan and Budget and Update Content.

(a) The Multi-Year Plan and Budget submitted by each local jurisdic-
tion shall contain but not be limited to a:

(1) Narrative section which provides a description of public health,
and inpatient and outpatient services be provided or contracted for by the
local jurisdiction.

(2) Budget section which details proposed expenditures, revenues and
net county costs for county health services.

(3) Certification section containing signatures necessary for the for-
mal transfer of State and/or Federal monies to the local jurisdiction pur-
suant to the Multi-Year Plan and Budget.

(b) The Multi-Year Plan and Budget shall include only health pro-
grams, services, and administrative support that are part of the reported
net county costs for Fiscal Year 1 977-78 and may include any new health
programs which have been instituted since Fiscal Year 1977-78.

(c) Health programs and associated costs which existed during Fiscal
Year 1977-78 and which are not part of the reported net county costs for
Fiscal Year 1977-78 shall be excluded from the Multi-Year Plan and
Budget, but may be in the Addendum identified in (d).

(d) The Multi-Year Plan and Budget may contain an Addendum
which includes narrative descriptions and estimated expenditures, reve-
nues, and net county costs for health services, exclusive of mental health,
alcohol, and drug abuse treatment, not reported in the Plan and Budget.

(e) In those counties, except the County of Alameda, where the gov-
erning body of a city has not transferred to the county enforcement au-
thority of applicable public health statutes and regulations or where pub-
lic health services are provided b a city pursuant to a contract with a
county, such a county shall, in the Multi-Year Plan and Budget, Update,
and Agreement, provide for continuation and funding of such services.

(f) The Multi-Year Plan and Budget shall include only fiscal informa-
tion which is consistent with the regulations on capital expenditures, de-
preciation, and administrative overhead as listed below:

(1) Capital expenditures for local jurisdiction structures and fixtures,
and improvements to local jurisdiction structures and fixtures shall not
be considered allowable costs.

(2) Depreciation for local jurisdiction structures and fixtures, and im-
provements to local jurisdiction structures and fixtures shall be an allow-
able expense for purposes of applying for monies pursuant to 1466. De-
preciation also shall be an allowable expense for purposes of applying for
monies pursuant to 1465(a) only if the:

Page 46

Title 17

State Department of Health Services

§1466

(A) Reported net county costs for Fiscal Year 1977-78 included de-
preciation expenses for such local jurisdiction staictures and fixtures, or
improvements to local jurisdiction structures and fixtures; or.

(B) Reported net county costs for Fiscal Year 1977-78 included capi-
tal expenditures for such local jurisdiction structures and fixtures, or im-
provements to local jurisdiction structures and fixtures; or,

(C) Capital expense was incurred after June 30, 1978 and was for an
allowable expense as determined by Department guidelines and regula-
tions.

(3) Expenditures for fixed assets involving inpatient or outpatient
health services for persons certified eligible pursuant to Section 17000
of the Welfare and Institutions Code shall be depreciated and all other ex-
penditures for fixed assets may be either expensed or depreciated, but not
both.

(4) Administrative overhead shall be listed as a single line item or dis-
tributed across all programs, but not both.

(5) The Multi-Year Plan and Budget and Update shall include the Cost
Allocation Summary presented annually to the State Controller's Office
for the determination of indirect costs for Federal grants and contracts.

(g) The Multi-Year Plan and Budget and Update shall include infor-
mation pertaining to medical services provided to indigent county resi-
dents. Specifically the Plan and Budget and Update shall include but not
be limited to:

( 1 ) The eligibility criteria the county uses to determine whether a per-
son is certified as eUgible for health services under Section 17000 of the
Welfare and Institutions Code.

(2) A description of the county's eligibility process used to determine
whether a person is eligible for services under Section 17000 of the Wel-
fare and Institutions Code.

(3) A description of how county residents are notified or informed of
the availability of county financed services pursuant to Section 17000 of
the Welfare and Institutions Code.

(4) A listing of services or benefits which are provided.

(5) A listing of the location of services and how the county ensures rea-
sonable accessibility of such services.

(6) A description of the county's fee collection policies, fee schedules,
procedures and expected revenues for persons covered by Section 17000
of the Welfare and Institutions Code.

(7) An estimate of the Section 1 7000 target population size and an esti-
mate of the number of persons who will use the services/benefits.

(8) A projection of the estimated costs of serving the medically indi-
gent population under Section 17000 of the Welfare and Institutions
Code.

(h) The annual Update of the Multi-Year Plan and Budget submitted
by the local jurisdiction shall contain but not be limited to:

( 1 ) The requirements specified in subdivisions (a) through (g), and any
other instructions, forms, and guidelines developed by the Department
pertaining to the annual Update.

(2) The Update shall not duplicate any of the material in the Multi-
Year Plan and Budget.

(3) The Update also shall serve as a progress report evaluating what
has been accomplished over the past year and shall provide specific ti-
me-limited measurable objectives in relation to each of the elements in
the Multi-Year Plan and Budget during the apphcable fiscal year.
NoTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700, 16709,
16710 and 1671 1, Welfare and Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

3. Amendment of Subsections (a)(1), (a)(2), (f)(5) and (g) filed 4-4-86; effective
thirtieth day thereafter (Register 86, No. 14).

§ 1457. Plan and Budget Review.

(a) The Department shall review the County Health Services Multi-
Year Plan and Budget or Update submitted by each local jurisdiction to
ensure as a minimum that the Multi-Year Plan and Budget or Update:

(1) Have been submitted in accordance with the procedures specified
by the Director.

(2) Are in the format and cover the content specified by the Director.

(3) Contain the necessary signatures and certifications as specified by
the Director.

(4) Contain budgeted financial data by budget unit as specified in the
Annual County Budget and are presented in the format specified by the
Department.

(5) Include copies of revenue and appropriations pages from the An-
nual County Budget for each budget unit listed pursuant to (4). Interim
documentation may be submitted until an official Annual County Budget
has been printed.

(6) Are in conformance with:

(A) Uniform accounting standards and procedures.

(B) Fiscal policies stated in these regulations.

(b) Based on the review of the Multi-Year Plan and Budget or Update,
the Department may require a local jurisdiction to submit additional data
or information in a format specified by the Department.

( 1 ) The data or information shall be requested to augment an incom-
plete or inaccurate submission.

(2) Any local jurisdiction which does not comply with the request shall
be considered as not having submitted a Multi-Year Plan and Budget or
Update in conformance with Department guidelines and regulations and
shall not receive per capita monies from the County Health Services
Fund.

(c) All fiscal information submitted as part of the Multi-Year Budget
or Update shall be verifiable and shall be subject to State audit.
NOTE: Authority cited: Section 16712. Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16700 and 16704,
Welfare and Institutions Code.

History

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

Article 4. Allocations, Agreement,

Disbursement, Reporting and Recoupment

Procedures

§ 1465. County Health Services Allocation.

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16705,
Welfare and Institutions Code.

History

1. Amendment of subsection (b)(3) filed 5-21-81: effective thirtieth day thereaf-
ter (Register 81, No. 21).

3. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending NoTi-. filed
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg-
ister 98, No. 42).

§ 1466. Medically Indigent Services Allocation.

(a) The Department shall compute each county's Medically Indigent
Services Allocation in accordance with Subdivision (d) of Section 1 6703
of the Welfare and Institutions Code.

(b) A county may apply for all or a portion of its total allocation pur-
suant to 1473(c). If the County chooses to apply for these funds, it shall

Page 47

§1467

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

be bound by conditions and limitations contained in paragraph ( 1) of sub-
division (c) of Section 16704 of the Welfare and Institutions Code on the
use of such funds.

NOTE: Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982. Chapter 1594, Section 87(c). Reference: Sections 16703(b),
16704(c) and 16709(a), Welfare and Institutions Code.

History

1. New section filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2), A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial coiTection of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

§ 1467. Medically Indigent Services Application.

(a) In order to apply for the Medically Indigent Services Allocation,
a county shall submit to the Department an Application adopted by the
County Board of Supervisors prior to the disbursement of funds from the
Medically Indigent Services Account. The Application shall be in a form
and in accordance with procedures specified by the Director and shall
contain but not be limited to the following:

( 1 ) Unless a county has contracted with the Department pursuant to
Article 6, an assurance by the County that it will incur no less in net costs
of county funds for county health services in any fiscal year than the
amount required to obtain the maximum allocation as specified in
1465(a).

(2) An assurance by the county that funds allocated pursuant to 1466
shall be expended only for health services included in Sections 14132
and 14021 of the Welfare and Institutions Code for persons certified eli-
gible pursuant to Section 17000 of the Welfare and Institutions Code. A
county shall not be bound by utilization control provisions which are spe-
cified within Sections 14132 and 14021.

(3) An assurance by the county that funds allocated pursuant to 1466
shall not be expended for costs of services specified in county Short-
Doyle plans which are in excess of the 125 percent limitation specified
in Section 5705.1 of the Welfare and Institutions Code.

Note: Authority cited: Section 16712, Welfare and Institution Code; and Statutes
of 1982, Chapter 1594, Section 8(c). Reference: Sections 16704(c) and 16706,
Welfare and Institutions Code.

History
1. New section filed 4-4-86; effective thirtieth day thereafter (Register 86, No.
14).

§ 1469. Agreement.

(a) Upon completion of the Departmental review of a local jurisdic-
tion's Multi-Year Plan and Budget or Update, the Department shall issue
an Agreement for review and signature by appropriate officials repre-
senting the local jurisdicfion. The agreement shall include, as appropri-
ate, but shall not be limited to:

(1) The total funds to be allocated to the county based on population
as specified in 1465(a)(1).

(2) The total funds to be allocated to the county based on budgeted al-
lowable expenditures, revenues, and net costs as specified in 1465(a)(2).

(3) The total funds to be allocated to an Eligible Contract County sole-
ly for public health services as specified in 1465(a)(3).

(4) The total funds to be allocated to the City of Berkeley as specified
in 1465 (a)(5).

(5) The total funds to be allocated to the San Joaquin Local Health Dis-
trict solely for pubUc health services as specified in 1465(a)(6).

(6) The net costs of local jurisdiction funds for health services that
must be incurred by the local jurisdiction in order to receive the total allo-
cation specified in 1465(a).

(7) The sharing ratio of State funds as specified in (2), (3), (4) and (5)
to the local jurisdiction funds as specified in (6). The sharing ratios shall
not exceed those specified in 1465(h), as applicable.

(8) An assurance by the local jurisdiction that it agrees to expend local
jurisdiction funds for net county costs for county health services in the
amounts specified in 1465(c), (d), (e), and (f), as applicable.

(9) An assurance by the local jurisdiction that the health services pro-
vided by the Agreement will be in general accordance with the local juris-
diction's Multi-Year Plan and Budget or Update.

( 1 0) An assurance by the local jurisdiction that monies provided by the
State under the terms of this Agreement will be used to finance health ser-
vices as described in the Multi-Year Plan and Budget or Update and for
no other purpose.

(1 1 ) An assurance by the local jurisdiction that sufficient records, files
and documentation will be maintained for State review concerning pro-
gram activity and expenditures made under this Agreement and will be
accessible for a period of at least four years from the expiration of this
Agreement, or in the event of a State audit, until the audit has been re-
solved.

(12) An assurance by the local jurisdiction that access will be provided
during normal working hours to authorize representatives of the Depart-
ment and of other State agencies to all records, files, and documentation
related to the Agreement.

(13) An assurance by the local jurisdiction that reports will be pro-
vided as required by the Department.

(b) The Agreement shall also include provisions pertaining to medi-
cally indigent services funds received pursuant to 1466. The provisions
shall include but not be limited to:

( 1 ) The total funds to be allocated to the county based on the allocation
specified in 1466.

(2) The net costs for health services that must be incurred by the county
in order to receive the allocafion specified in 1466.

(3) An assurance by the county that it will incur no less in net costs of
county funds for county health services in any fiscal year than the amount
required to obtain the maximum allocafion specified in 1465.

(4) An assurance by the county that funds allocated pursuant to 1466
shall be expended only for health services included in Secdons 14132
and 14021 of the Welfare and Insfitutions Code for persons certified eli-
gible pursuant to Secfion 17000 of the Welfare and Insfitudons Code. A
county shall not be bound by utilization control provisions which are spe-
cified within Secdons 14132 and 14021.

(5) An assurance by the county that funds allocated pursuant to 1466
shall not be expended for costs of services specified in county Short-
Doyle plans which are in excess of the 125 percent limitadon specified
in Secdon 5705.1 of the Welfare and Insdtutions Code.

(6) The total funds to be provided by the State as specified in (a) and
in (b)( 1 ) above, under the terms of the Agreement.

(d) A local jurisdicdon that has not submitted a signed Agreement to
the Department by the end of a current fiscal year shall be subject to re-
coupment of any funds disbursed pursuant to (b)(1).

(e) A local jurisdicdon that does not conform with any or all of the
terms of the Agreement may be subject to recoupment of funds disbursed
to that local jurisdicdon.

Note: Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16704 and 16706,
Welfare and Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction transmitted to OAL
4-29-83 and filed 6-9-83 (Register 83, No. 24).

§1473. Disbursement.

Note: Authority cited: Section 16812, Welfare and Institufions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16803, Welfare and
Institutions Code.

History

1 . Amendment of subsection (a)(2) filed 5-21-81 ; effective thirtieth day thereafter
(Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

Page 48

Title 17

State Department of Health Services

§1477

4. Amendment filed 4-4-86; effective thirtieth day thereafter (Register 86, No.

14).

5. Change without regulatory effect repealing section and amending Note filed
10-1 3-98 pursuant to section 100, fitle 1, California Code of Reaufations (Reg-
ister 98, No. 42).

§1475. Reports.

(a) For Fiscal Year 1979-80 and annually thereafter, each local juris-
diction shall submit to the Department a report of estimated actual expen-
ditures, revenues, and net county costs for services provided in accor-
dance with the Multi-Year Plan and Budget or Update.

( 1 ) The report shall be submitted in a form and in accordance with pro-
cedures specified by the Department.

(2) The report shall be due on November 15 in the year following the
fiscal year for which data s being reported.

(b) For Fiscal Year 1979-80 and annually thereafter, each local juris-
diction shall submit to the Department a report of actual expenditures,
revenues and net county costs for services provided in accordance with
the Multi-Year Plan and Budget or Update.

( 1 ) The report shall be submitted in accordance with the format and
procedures as specified by the Department.

(2) The report shall be due on November 15 in the second year follow-
ing the fiscal year for which data is being reported.

(c) Beginning on November 15, 198 hand annually thereafter each lo-
cal jurisdiction shall prepare and submit to the Department a report de-
scribing health services provided by the local jurisdiction pursuant to
Part 5 (commencing with SecUon 17000) of Division 9 of the Welfare
and Institutions Code.

(1) The report shall be submitted in accordance with the procedures
and Umetable as established by the Department.

(2) The report shall include but not be limited to information covering
the following:

(A) Eligibility standards

(B) Services provided

(D) Fees collected

(E) Target population size

(F) Costs

(d) The Director shall withhold part or all payment of County Health
Services Funds to a local jurisdiction, unless the reports specified in (a)
through (c) have been received by the Department.

Note: Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Sections 16706 and 16716,
Welfare and Institutions Code.

History

2. Certificate of Compliance includina editorial correction transmitted to OAL
4-29-83 and filed 6-9-83 (Register'83, No. 24).

§1477. Recoupment.

(a) For Fiscal Year 1979-80 and annually thereafter, the Department
shall review the report specified in 1475(a), which shall serve as the ini-
fial basis for the recovery of funds not expended in accordance with the
Agreement described in 1469.

( 1 ) The Department:

(A) Shall determine whether or not the county has reported only net
costs specifically allowed pursuant to Department guidelines and regula-
tions.

(B) May disallow reported costs that are inaccurate or are not allow-
able costs for county health services or for health services provided to
persons eligible pursuant to Section 1 7000 of the Welfare and Institu-
fions Code.

(2) The Department shall notify the local jurisdicfion in wrifing of its
determinations and allowances made pursuant to (1).

(3) Notification shall be sent to the local jurisdiction's governing
body, Auditor-Controller, Administrative Officer, and the Health

Agency Director, Health Officer, and Hospital Administrator, as applica-
ble.

(4) The notification for the fiscal year shall list:

(A) Aggregate net county costs specified in the Agreement.

(B) Estimated actual net county costs as reported pursuant to 1475(a).

(5) If the estimated actual net county costs are less than the aggregate
net county costs specified in the Agreement, the notificafion shall declare
the Department's intent to do one or a combination of the following in
order to recoup the State porfion of the funds specified in (4)(C):

(A) Adjust subsequent payments to the local jurisdiction from the
County Health Services Fund.

(B) Negotiate a repayment plan for the local jurisdiction.

(b) For Fiscal Year 1979-80 and annually thereafter, the Department
shall review the report specified in 1475(b) which shall serve as the final
basis for recoupment of funds not expended in accordance with the
Agreement described in 1469, unless the report is modified by actual au-
dit findings officially adopted by the State.

( 1 ) The Department:

(A) Shall determine whether or not the local jurisdiction has reported
only net costs specifically allowed pursuant to Department guidelines
and regulations.

(B) May disallow reported costs that are inaccurate or are not allow-
able after verifying the information with the local jurisdiction and notify-
ing them of the proposed disallowance.

(2) The Department shall notify the local jurisdiction in writing of its
determinations and disallowances made pursuant to ( 1 ) and of any differ-
ence between the actual net county costs reported pursuant to 1475(b)
and the estimated actual net county costs reported pursuant to 1475(a).

(3) Notification shall be sent to the local jurisdiction's governing
body, Auditor-Controller, Administrative Officer, and the Health
Agency Director, Health Officer, and Hospital Administrator, as applica-
ble.

(4) The notification for the fiscal year shall list the:

(A) Actual net county costs as reported pursuant to 1475(b).

(B) Estimated actual net county costs as reported pursuant to 1475(a).

(5) If the actual net county costs are less than the estimated actual net
county costs the notification shall declare the Department's intent to do
one or a combination of the following in order to recoup the State portion
of the funds specified in (4)(c):

(A) Adjust subsequent payments to the local jurisdiction from the
County Health Services Fund.

(B) Negotiate a repayment plan for the local jurisdiction.

(c) The governing body of the local jurisdiction shall have twenty-one
(21) working days, following receipt of notification pursuant to (a)(2) or
(b)(2) to appeal the Department's decision. The appeal shall be in accor-
dance with the format and procedures specified by the Department.

(d) Tlie Department may adjust the monthly payments made to a
county pursuant to an Agreement as specified in 1469(b) if the county
fails to expend such funds as specified in the Agreement.

(e) The Department shall recover any unexpended funds disbursed to
county as specified in 1473(b) for medically indigent services in accor-
dance with the procedures specified in the Agreement.

(f) The Department shall recover any funds not expended pursuant to
1469(b) in accordance with the procedures specified in the Agreement.
NOTE; Authority cited: Section 16712, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16706, Welfare and
Institutions Code.

History
I. Amendment of subsections (d)(B) and (e) filed 5-21-81 ; effective thirtieth day
thereafter (Register 81, No. 21).

Page 49

§1481

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed on 4-30-83.

3. Certificate of Compliance including editorial correction transmitted to OAL
4-29-83 and filed 6-9-83 (Register 83, No. 24).

§ 1481. Special Needs and Priorities.

NOTE: Authority cited: Section 16812, Welfare and histitutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Section 16707, Welfare and
Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effective upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

3. Amendment filed 4^1-86; effective thirtieth day thereafter (Register 86, No.

14).

4. Change without regulatory effect repealing section and amending Note filed
1 0-1 3-98 pursuant to section 1 00, fitle 1 , California Code of Regulations (Reg-
ister 98, No. 42).

Article 5. Public Hearing Procedures

§1485. Purpose.

Note: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Secdon 87(c). Reference: SecUons 16705 and
16705.5, Welfare and Institutions Code.

History
\. Amendment filed 12-31-82 as an emergency; effective upon filing (Register

83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120

days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No.'24).

3. Change without regulatory effect repealing section and amending NOTE filed
10-13-98 pursuant to secdon 100, title 1, California Code of Reguladons (Reg-
ister 98, No. 42).

§1486. Conditions.

NOTE: Authority cited: Secdon 16812, Welfare and Insdtutions Code; and Stat-
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdons 16705 and
16705.5, Welfare and Institudons Code.

History

1. Amendment filed 12-31-82 as an emergency; effecdve upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to secdon 100, title 1, California Code of Reguladons (Reg-
ister 98, No. 42).

§1487. Scheduling.

NOTE: Authority cited: Secdon 16812, Welfare and Institudons Code; and Stat-
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdons 16705 and
16705.5, Welfare and Institutions Code.

History

1. Amendment filed 12-31-82 as an emergency; effecdve upon filing (Register
83, No. 2). A Certificate of Compliance must be d-ansraitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

2. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

3. Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg-
ister 98, No. 42).

§1489. Notification.

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdons 16705 and
16705.5, Welfare and Institutions Code.

History

1. Amendment of subsections (a)(1) and (a)(2) filed 5-21-81; effecdve thirtieth
day thereafter (Register 81, No. 21).

2. Amendment filed 12-31-82 as an emergency; effecdve upon filing (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

3. Certificate of Compliance including editorial conection of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to section 100, title 1, California Code of Regulations (Reg-
ister 98, No. 42).

§1491. Conduct.

NOTE; Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Secdons 16705 and
16705.5, Welfare and Institutions Code.

History

1. Amendment of subsections (b) and (d) filed 5-21-81; effective thirtieth day
thereafter (Register 81, No. 21).

3. Certificate of Compliance includine editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing secdon and amending Note filed
10-13-98 pursuant to section 100, tide 1 , California Code of Regulations (Reg-
ister 98, No. 42).

§1493. Findings.

NOTE: Authority cited: Section 16812. Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Secdon 87(c). Reference: Secdon 16705, Welfai-e and
Institutions Code.

History

1. Amendment of subsection (a) filed 5-21-81; effective thirtieth day thereafter
(Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed
1 0-1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg-
ister 98, No. 42).

§1495. Transmittal.

NOTE: Authority cited: Section 16812, Welfare and Institudons Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Secdons 16705 and
16705.5, Welfare and Institudons Code.

History

1. Amendment of subsection (a) filed 5-21-81; effective thirtieth day thereafter
(Register 81, No. 21).

2. Amendment filed 12-31-82 as an emergency; effective upon fihng (Register
83, No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-30-83.

3. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed
10-13-98 pursuant to secdon 100, tide 1, California Code of Regulations (Reg-
ister 98, No. 42).

§1497. Determinations.

NOTE: Authority cited: Section 16812, Welfare and Institutions Code; and Stat-
utes of 1982, Chapter 1594, Section 87(c). Reference: Secdons 16705 and
16705.5, Welfare and Institudons Code.

History

1. Amendment of subsections (b) and (c) and new subsection (f) filed 5-21-81;
effective thirtieth day thereafter (Register 81, No. 21).

3. Certificate of Compliance including editorial correction of NOTE transmitted
to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

4. Change without regulatory effect repealing section and amending Note filed
1 0- 1 3-98 pursuant to section 1 00, title 1 , California Code of Regulations (Reg-
ister 98, No. 42).

Article 6.

County Medical Services
Program

§ 1498. County Medical Services Program.

Page 50

Title 17

State Department of Health Services

§1501

History

1. New Article 6 (Sections 1498-1498.9) filed 12-31-82 as an emergency; effec-
tive upon filing (Register 83, No. 2). A Certificate of Compliance iriust be trans-
mitted to OAL within 120 days or emergency lanauase will be repealed on
4-30-83.

2. Certificate of Compliance including amendments and editorial con-ections
transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83. No. 24).

3. Amendment of subsection (f) filed 4^-86; effective thirtieth day thereafter
(Register 86, No. 14).

4. Change without regulatory effect repealing section and ainending Note filed
9-7-2005 pursuant to section 100. fitle 1 , California Code of Regulations (Reg-
ister 2005, No. 36).

§ 1 498.1 . Declaration of intent to Contract.

History

1 . Certificate of Compliance including editorial conection of NoTi-: transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83. No. 24).

2. Amendment of subsecUons (a) and (c) filed 4-4-86; effective thirtieth day
thereafter (Register 86, No. 14).

3. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100, title I, California Code of Regulations (Reg-
ister 2005, No. 36).

§ 1498.2. Small County Advisory Committee.

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Secdon
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section
87(c). Reference: Section 16709, Welfare and Institutions Code.

History

1 . Certificate of Compliance including editorial correction of Note transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100. title 1, California Code of Regulations (Reg-
ister 2005, No. 36).

§1498.3. Contract.

History

1. Certificate of Compliance including amendment of subsection (a)(1) and Note
transmitted to OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Amendment of subsections (c), (d) and (e) filed 4-4-86; effective thirtieth day
thereafter (Register 86, No. 14).

3. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Reg-
ister 2005, No. 36).

§1498.4. Eligibility.

NOTE: Authority cited: Section 10725, Welfare and Institutions Code; Section
100275, Health and Safety Code; and Statutes of 1982, Chapter 159, Section 87(c).
Reference: Sections 16703, 16706 and 16709, Welfare and Insfitutions Code.

History

1. Certificate of CompHance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

2. Amendment of subsecfions (b), (d), (e) and (f) filed 4-4-86; effective thirtieth
day thereafter (Register 86, No. 14).

3. Change without regulatory effect repealing secfion and amending Note filed
9-7-2005 pursuant to section 1 00, title 1 , California Code of Regulations (Reg-
ister 2005, No. 36).

§ 1498.5. Benefits.

NOTE: Authority cited: Secfion 10725, Welfare and Insdtufions Code; Secfion
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section
87(c). Reference: Secfion 16709, Welfare and Insfitutions Code.

History

1. Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100, title 1, California Code of Regulations (Reg-
ister 2005, No. 36).

§ 1498.6. Administration.

Note: Authority cited: Secfion 10725, Welfare and Institutions Code; Secfion
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section
87(c). Reference: Sections 16709 and 16717, Welfare and Institutions Code.

History

1. Certificate of Compliance including editoiial correction of Ncm-: transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending NoTi-. filed
9-7-2005 pursuant to section 1 00, fitie 1 , California Code of Regulations ( Reg-
ister 2005, No. 36).

§1498.7. Fiscal.

History

1. Certificate of Compliance including editorial con-ection of Note; transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Amendment filed 4^t-86; effective thirtieth day thereafter (Register 86, No.
14).

3. Change without regulatory effect repealing section and amending Noti-. filed
9-7-2005 pursuant to section 100, fitle 1 , California Code of Regulations (Reg-
ister 2005, No. 36).

§1498.8. Liabilities.

NOTE: Authority cited: Secfion 10725, Welfare and Institutions Code; Section
100275, Health and Safety Code; and Statutes of 1982, Chapter 1594, Section
87(c). Reference: Section 16709, Welfare and Institutions Code.

History

1 . Certificate of Compliance including editorial correcfion of Note transmitted to
OAL 4-29-83 and filed 6-9-83 (Register 83, No. 24).

2. Change without regulatory effect repealing section and amending Not?; filed
9-7-2005 pursuant to section 100, tide 1 , California Code of Regulations (Reg-
ister 2005, No. 36).

§1498.9. Reporting.

History

1 . Certificate of Compliance including amendment transmitted to OAL 4-29-83
and filed 6-9-83 (Register 83. No. 24)

2. Change without regulatory effect repealing section and amending Note filed
9-7-2005 pursuant to section 100. title 1. California Code of Regulations (Reg-
ister 2005, No. 36).

Chapter 3.1. Indian Health

Article 1. Definitions

§1500. Indian.

"Indian" means any person who is:

(a) Identified as an Indian on the rolls maintained by the Bureau of In-
dian Affairs,

(b) Identified as an Indian on the rolls maintained by an Indian tribe,
band, or other organized group of Indians, in any state,

(c) A descendant in the first or second degree of any person identified
at any time on a roll referred to in subsection (a) or (b),

(d) Declared to be a member of a tribe or a descendant in the first or
second degree of a member of a tribe by the tribal council of his or her
tribe, or

(e) A descendant in any degree from a member of a tribe which has
been declared to be terminated by the United States government. Howev-
er, any person qualifying under this subsection must be at least one quar-
ter Indian blood.

NOTE: Authority cited: Sections 102 and 208, Health and Safetv Code. Reference:
Sections 429.30, 429.31 and 429.32, Article 14, Chapter 2, Part 1, Division 1,
Health and Safety Code.

History

1. New Chapter 3.1, Articles 1-4 (Sections 1500-1541, not consecutive) filed
4-1-76 as an emergency; effective upon filing (Register 76, No. 14).

2. Certificate of Compliance filed 7-14-6 (Register 76, No. 29).

§1501. Indian Tribe.

"Indian Tribe" means any Indian tribe, band, nation or other organized
group or community, which is determined to be ehgible for the special
programs and services provided by the United States or State of Califor-
nia, to Indians because of their status as Indians.

Page 51

§1502

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 1502. Existing Indian Health Programs.

"Existing Indian Health Programs" means any program which pro-
vided, as of September 8, 1975, direct health services as defined in Sec-
tion 1503 under the supervision of a licensed physician and surgeon, den-
tist, optometrist, or nurse.

§ 1 503. Direct Health Services.

"Direct Health Services" means one or more of the following services
provided under the supervision of a licensed provider of health services
acting within the scope of his or her license:

(a) Primary health care consisting of diagnostic, treatment and health
maintenance services.

(b) Outreach, education, referral, follow-up services and assistance to
the individual in obtaining services from other agencies to which he is
entitled (health advocacy).

(1) Screening and disease detection services.

(2) Alcohol and drug abuse detoxification services.

(3) Dental health services.

(4) Services leading to the prevention of vision and hearing loss and
the restoration of vision and hearing.

(5) Family planning services.

(6) Maternal and child health services.

(7) Medical care of chronic conditions.

§ 1504. Licensed Provider of Health Services.

"Licensed Provider of Health Services" for the purposes of Section
1503 means:

(a) A provider practicing in Cahfomia licensed by the appropriate
healing arts board.

(b) An individual employed by the Federal government in the practice
of the healing arts on tribal lands.

§1505. Department.

"Department" means the State Department of Health Services.
NOTE: Authority cited: Sections 208 and 11 82.2(d), Health and Safety Code. Ref-
erence: Section 1 182.2, Health and Safety Code.

History
1. Editorial correction filed 12-7-84 (Register 84, No. 49.

§1506. Director.

"Director" means the Director of the State Department of Health Ser-
vices.

NOTE: Authority cited: Sections 208 and 1 1 82.2(d), Health and Safety Code. Ref-
erence: Section 1182.2, Health and Safety Code.

History
1. Editorial correction filed 12-7-84 (Register 84, No. 49).

§ 1507. Indian Medicine and Traditional Health Practices.

"Indian Medicine and Traditional Health Practices" means traditional
practices of Indian medicine which are native to an Indian community,
which are accepted by that Indian community as handed down through
the generations and which can be established through the collective
knowledge of the elders of that Indian community.
NOTE: Authority cited: Sections 208 and 1 182.2(d), Health and Safety Code. Ref-
erence: Section 1182.2, Health and Safety Code.

History
1. New NOTE filed 12-7-84 (Register 84, No. 49).

tor. The representatives of the California Urban Indian Health Council
and the California Rural Indian Health Board shall be appointed by the
Council and the Board.

Article 3.

Article 2. Indian Health Policy Panel

§ 1520. Indian Health Policy Panel.

An Indian Health Policy Panel established by the Director shall advise
the Director regarding policy for Indian health.

§ 1521. Panel Membership.

Panel membership shall consist of four representatives of the Califor-
nia Rural Indian Health Board, four representatives of the California Ur-
ban Indian Health Council, and two individuals appointed by the Direc-

Assistance to Indian Health
Programs

§ 1530. Financial Assistance to Indian Health Programs.

Monies available under Chapter 606, Statutes of 1975, and any funds
available to carry out provisions of Article 14 (commencing with Section
429.30) ofChapter 2 of Part 1 of Division 1 of the Health and Safety Code
shall be allotted for the following purposes:

(a) Direct health services as defined under Section 1 503 of these regu-
lations.

(b) Technical assistance by individuals experienced in the delivery of
health services including, but not limited to, health professionals, econo-
mists, sociologists, accountants, legal advisors, midwives (to the extent
otherwise permitted by law), and other experts in Indian medicine and
traditional health practices. Technical assistance may be provided by
State staff, by consultants under contract with the State, or through con-
tracts with local public and voluntary health organizations or existing In-
dian health programs.

(1) On the job training using workers in the program or individuals
from other projects or agencies as instructors.

(2) Short term training sponsored by an educational facility not to ex-
ceed two weeks duration at any one time or one day per week over a
three-month period.

(3) Tuition for the course work required by a staff member for the
A. A., B.A. degree or advanced degree.

(d) Studies concerning the health needs, resources and practices of
California Indians. Special emphasis shall be placed on the area of Indian
medicine and traditional health practices.

§ 1531. Allocation of Financial Assistance to Indian Health
Programs.

(a) Funds shall be allocated for health services which are supplemental
to those available from the Federal or State government. State funds
available for the purposes of the Indian Health Service Program (Article
14 (commencing with Section 429.30) ofChapter 2 of Part 1 of Division
1 of the Health and Safety Code) shall not duplicate or replace any com-
mitment made by the Federal government.

(b) No funds shall be provided from those appropriated for the pur-
poses of the Indian Health Service Program for types of services for
which Indians are eligible under other programs and for which other
funds are available, including but not limited to the following types of
services:

(1) Family planning.

(2) Supplemental Feeding for Women, Infants and Children (WIC).

(3) Alcoholism or substance abuse services.

(4) Hospitalization other than for emergency services, if an individual
is eligible for medical care under Title XVIII or XIX of the Federal Social
Security Act, under the Workmen's Compensation Statutes of Califor-
nia, from the Veteran's Administration or other similar programs or
when a public health service hospital is accessible or if an individual has
private health insurance.

(5) Maternal and Child Health.

(6) Crippled Childrens Services.

(7) Community Mental Health Services Program (Short-Doyle).

(8) Developmental Disability Program (Regional Centers).

§ 1532. Allocation Formula.

(a) In the determination of the allocation of State funds the following
factors shall be considered:
(1) Need as demonstrated by:
(A) The number of individuals to be served.

Page 52

Title 17

State Department of Health Services

§1540

(B) The availability of other resources in the service area.

(D) Higher costs of providing health services in the areas served.

(2) The ability of the proposed program to meet that need, as deter-
mined by:

(A) Adequate personal services.

(B) Sufficient operating expenses.

(3) Compliance with statewide plan for Indian health services and ex-
isting priorities for services.

(4) Compliance with local Indian health plan.

(5) The demonstrated ability of the Indian health program to carry out
the proposed services.

§ 1533. Reimbursement for Service.

(a) The programs shall maximize utilization of reimbursement from
third-party payors.

(b) Where an Indian is eligible for health benefits from third-party
payors and the service is provided by an existing Indian health program,
the revenue collected from third-party payors shall be used to increase
the services offered by the program.

§ 1534. To Qualify for Funding.

(a) To qualify for funding an existing Indian health program shall be
administered by a nonprofit corporation organized under the laws of this
State or by an Indian tribe as defined in Section 1501. The board of direc-

tors or trustees of such corporation shall be composed of a majority of
Indians as defined in Section 1500.

NOTE: Authority cited: Sections 208 and 1 1 82.2(d), Health and Safety Code. Ref-
erence: Sections 11 82 and 11 82.2, Health and Safety Code.

History

1. New NOTE filed 12-7-84 (Register 84, No. 49).

§ 1535. Criteria for Reimbursement of Direct Services.

(a) Salaries, travel expenses, and per diein rates for employees of exist-
ing Indian health programs shall be no greater than the rate set for State
employees in like circumstances. Exceptions shall be granted only when
no provider of services is available to the program at the rate set for State
einployees.

(b) Rates for reimbursement of services provided on a fee-for-service
basis shall be no greater than the prevailing rates in the community in
which the provider of services offers services.

Article 4. Standards of Service

§ 1 540. Confidentiality of Information.

(a) All patient files and information maintained or possessed by an ex-
isting Indian health program shall be treated as privileged communica-
tion, shall be held confidential, and shall not be divulged without the writ-
ten consent of the individual or his personal representative, (or the parent
or guardian, in the case of a minor), except as may be necessary to provide
emergency services to the individual, to file a claim for benefits on behalf

[The next page is 59.]

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§2500

of the individual, or as required by the Department to administer this pro-
gram. Information may be disclosed in summary, statistical, or other
form which does not identify the particular individual.

(b) Services shall be provided in a manner that respects the privacy and
dignity of the individual.

§ 1 541 . Informed Consent.

(a) No individual shall be denied benefits available under the Indian
Health Service Program for failure to accept any form of offered treat-
ment. In the case of any medical treatment offered or given to an individ-
ual under the Indian Health Services Program, a signed consent form
shall be obtained indicating that the individual has been informed of all
known risks, benefits, and alternatives to the proposed treatment. This re-
quirement may be waived in the case of emergencies. In the case of mi-
nors, the consent form shall be signed by the parent or guardian.

Chapter 3.5. Joint Regulations for
Handicapped Children

Subchapter 1. Interagency Responsibilities

for Providing Services to Handicapped

Children

§ 2000. Joint Regulations for Handicapped Children.

CROSS-REFERENCE: See Title 2, Division 9, Chapter 1, Articles
1-9, Sections 60000-60610, not consecutive.

History
1 . New Chapter 3.5 (Subchapter 1, Section 2000) printed as cross-reference only

(Register 86, No. 21).

Chapter 4. Preventive Medical Service

(Originally Printed 8-15-45)

Subchapter 1. Reportable Diseases and
Conditions

Article 1. Reporting

§ 2500. Reporting to the Local Health Authority.

(a) The following definitions shall govern the interpretation of this
Subchapter.

(1) 'CDC means the Centers for Disease Control and Prevention,
United States Department of Health and Human Services.

(2) 'CSTE' means the Council of State and Territorial Epidemiolo-
gists.

(3) 'MMWR' means the Morbidity and Mortality Weekly Report.

(4) 'Case' means (A) a person who has been diagnosed by a health care
provider, who is lawfully authorized to diagnose, using clinical judgment
or laboratory evidence, to have a particular disease or condition listed in
subsection (j); or (B) a person who meets the definifion of a case in Sec-
tion 2564 - Diarrhea of the Newborn, Section 2574 - Food Poisoning,
Section 26 1 2 Salmonella Infections (Other than Typhoid Fever), Section
2628 - Typhoid Fever, or Section 2636 - Venereal Disease; or (C) a per-
son who is considered a case of a disease or condition that satisfies the
most recent communicable disease surveillance case definitions estab-
lished by the CDC and published in the Morbidity and Mortality Weekly
Report (MMWR) or its supplements; or (D) an animal that has been de-
termined, by a person authorized to do so, to have rabies or plague.

(5) 'Clinical signs' means the objective evidence of disease.

(6) 'Clinical symptoms' means the subjective sensation of disease felt
by the patient.

(7) 'Communicable disease' means an illness due to a specific micro-
biological or parasitic agent or its toxic products which arises through
transmission of that agent or its products from an infected person, animal,
or inanimate reservoir to a susceptible host, either directly or indirectly
through an intermediate plant or animal host, vector, or the inanimate en-
vironment.

(8) 'Director' means State Director of Public Health.

(9) 'Drug susceptibility testing' means the process where at least one
isolate from a culture of a patient's specimen is subjected to antimicrobial
testing to determine if growth is inhibited by drugs commonly used to
treat such infections.

(10) 'Epidemiological risk factors' means those attributes, behaviors,
exposures, or other factors that alter the probability of disease.

(11) 'Epidemiologically linked case' means a case in which the patient
has/has had contact with one or more persons who have/had the disease,
and transmission of the agent by the usual modes of transmission is plau-
sible.

( 1 2) 'Foodborne disease' means illness suspected by a health care pro-
vider to have resulted from consuming a contaminated food.

( 1 3) 'Foodborne disease outbreak' means an incident in which two or
more persons experience a similar illness after ingestion of a common
food, and epidemiologic analysis implicates the food as the source of the
illness. There are two exceptions: even one case of botulism or chemical
poisoning constitutes an outbreak if laboratory studies identify the caus-
ative agent in the food.

(14) 'Health care provider' means a physician and surgeon, a veteri-
narian, a podiatrist, a nurse practitioner, a physician assistant, a regis-
tered nurse, a nurse midwife, a school nurse, an infection control practi-
tioner, a medical examiner, a coroner, or a dentist.

(15) 'Health officer' and 'local health officer' as used in this subchap-
ter includes county, city, and district health officers.

(16) 'In attendance' means the existence of the relationship whereby
a health care provider renders those services which are authorized by the
health care provider's licensure or certification.

(17) 'Infection control practitioner' means any person designated by
a hospital, nursing home, clinic, or other health care facility as having re-
sponsibilities which include the detection, reporting, control and preven-
tion of infections within the institution.

(18) 'Laboratory findings' means (A) the results of a laboratory ex-
amination of any specimen derived from the human body which yields
microscopical, cultural, immunological, serological, or other evidence
suggesuve of a disease or condition made reportable by these regula-
tions; or (B) the results of a laboratory examination of any specimen
derived from an animal which yields evidence of rabies or plague.

(19) 'Multidrug-resistantM>ro&6fr/^nM/n tuberculosis' means a labo-
ratory culture or subculture of Mycobacterium tuberculosis which is de-
termined by antimicrobial susceptibility testing to be resistant to at least
isoniazid and rifampin.

(20) 'Outbreak' means the occurrence of cases of a disease (illness)
above the expected or baseline level, usually over a given period of time,
in a geographic area or facility, or in a specific population group. The
number of cases indicating the presence of an outbreak will vary accord-
ing to the disease agent, size and type of population exposed, previous
exposure to the agent, and the time and place of occurrence. Thus, the
designation of an outbreak is relafive to the usual frequency of the disease
in the same facility or community, among the specified population, over
a comparable period of fime. A single case of a communicable disease
long absent from a population or the first invasion by a disease not pre-
viously recognized requires immediate reporting and epidemiologic in-
vestigation.

(21) 'Personal informafion' means any information that identifies or
describes a person, including, but not limited to, his or her name, social
security number, date of birth, physical description, home address, home
telephone number, and medical or employment history.

(22) 'Sexually Transmitted Diseases' means Chancroid. Lymphogra-
nuloma Venereum, Granuloma Inguinale, Syphilis, Gonorrhea, Chlamy-
dia, Pelvic Inflammatory Disease, and Nongonococcal Urethritis.

Page 59

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B VRCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(23) 'Suspected case' means (A) a persi)n whom a health care provider
believes, after weighing signs, symptoms, and/or laboratory evidence, to
probably have a particular disease or condition listed in subsection (j); or
(B) a person who is considered a probable case, or an epidemiologically-
linked case, or who has supportive laboratory findings under the most re-
cent communicable disease surveillance case definition established by
CDC and published in the Morbidity and Mortality Weekly Report
(MMWR) or its supplements; or (C) an animal which has been deter-
mined by a veterinarian to exhibit clinical signs or which has laboratory
findings suggestive of rabies or plague.

(24) 'Unusual disease' means a rare disease or a newly apparent or
emerging disease or syndrome of uncertain etiology which a health care
provider has reason to believe could possibly be caused by a transmissi-
ble infectious agent or microbial toxin.

(25) 'Water-associated disease' means an illness in which there is evi-
dence to suggest that the illness could possibly have resulted from physi-
cal contact with or swallowing water from a microbiologically or chemi-
cally contaminated source. Examples of such potentially contaminated
water sources are lakes, rivers, streams, irrigation water, wells, public
and private drinking water, bottled water, reclaimed water, ocean and bay
waters, hot springs, hot tubs, whirlpool spas, and swimming pools. Epi-
demiologic investigation by public health authorifies is required to dem-
onstrate that a suspected water-associated illness was likely to have been
waterborne and related to the suspected source.

(26) 'Waterborne disease outbreak' means an incident in which two
or more persons experienced a similar illness after consumption or use
of the same water intended for drinking or after water contact such as by
immersion, and epidemiologic invesfigation by public health authorifies
implicates the same water as the source of the waterborne illness. There
is one exception: a single case of waterborne chemical poisoning consti-
tutes an outbreak if laboratory studies indicate that the source water is
contaminated by the chemical.

(b) It shall be the duty of every health care provider, knowing of or in
attendance on a case or suspected case of any of the diseases or conditions
listed in subsecfion (j) of this secfion, to report to the local health officer
for the jurisdiction where the patient resides as required in subsection (h)
of this section. Where no health care provider is in attendance, any indi-
vidual having knowledge of a person who is suspected to be suffering
from one of the diseases or conditions fisted in subsecfion (j) of this sec-
fion may make such a report to the local health officer for the jurisdicfion
where the pafient resides.

(c) The administrator of each health facility, clinic or other setfing
where more than one health care provider may know of a case, a sus-
pected case or an outbreak of disease within the facility shall establish
and be responsible for administrafive procedures to assure that reports
are made to the local health officer.

(d) Each report made pursuant to subsection (b) shall include all of the
following informafion if known:

(1) name of the disease or condition being reported; the date of onset;
the date of diagnosis; the name, address, telephone number, occupation,
race/ethnic group, Social Security numbei', sex, age, and date of birth for
the case or suspected case; the date of death if death has occurred; and
the name, address and telephone number of the person making the report.

(2) If the disease reported pursuant to subsecfion (b) is hepafifis, a sex-
ually transmitted disease or tuberculosis, then the report shall include the
following applicable informafion, if known: (A) hepafifis information as
to the type of hepafifis, type-specific laboratory findings, and sources of
exposure, (B) sexually transmitted disease informafion as to the specific
causative agent, syphilis-specific laboratory findings, and any compfica-
fions of gonorrhea or chlamydia infecfions, or (C) tuberculosis informa-
fion on the diagnosfic status of the case or suspected case, bacteriologic,
radiologic and tuberculin skin test findings, informafion regarding the
risk of transmission of the disease to other persons, and a list of the anti-
tuberculosis medications administered to the patient.

(e) Confidential Morbidity Report forms, PM 1 10 (1/90), are available
from the local health department for reporting as required by this section.

(f) Information reported pursuant to this section is acquired in confi-
dence and shall not be disclosed by the local health officer except as au-

thorized by these regulations, as required by state or federal law, or with
the written consent of the individual to whom the information pertains or
the legal representative of the individual.

(g) Upon the State Department of Pubhc Health's request, a local
health department shall provide to the Department the information re-
ported pursuant to this section. Absent the individual's written consent,
no information that would directly or indirectly identify the case or sus-
pected case as an individual who has applied for or been given services
for alcohol or other drug abuse by a federally assisted drug or alcohol
abuse treatment program (as defined in federal law at 42 C.F.R. Secfion
2.11) shall be included.

(h) The urgency of reporting is idenfified by symbols in the list of dis-
eases and condifions in subsecfion (j) of this secfion. Those diseases with
a diamond ( ♦ ) are considered emergencies and shall be reported imme-
diately by telephone. Those diseases and conditions with a cross {+) shall
be reported by mailing, telephoning or electronically transmitfing a re-
port within one (1) working day of idenfification of the case or suspected
case. Those diseases and condifions not otherwise identified by a dia-
mond or a cross shall be reported by mailing a written report, telephon-
ing, or electronically transmitting a report within seven (7) calendar days
of the time of identification.

(i) For foodborne disease, the bullet (•) symbol indicates that, when
two (2) or more cases or suspected cases of foodborne disease from sepa-
rate households are suspected to have the same source of illness, they
shall be reported immediately by telephone.

(j) Health care providers shall submit reports for the following dis-
eases or conditions.

Acquired Immune Deficiency Syndrome (AIDS)

+ Amebiasis

♦ Anthrax

♦ Avian Influenza (human)
+ Babesiosis

♦ Botulism (Infant, Foodborne, Wound, Other)

♦ Brucellosis

+ Campylobacteriosis

Chancroid
-I- Chickenpox (only hospitalization and deaths)

Chlamydial Infections, including lymphogranuloma venereum
(LGV)

♦ Cholera

♦ Ciguatera Fish Poisoning
Coccidioidomycosis

-I- Colorado Tick Fever

+ Conjunctivitis, Acute Infectious of the Newborn, Specify
Etiology
Creutzfeldt-Jakob Disease (CJD) and other Transmissible
Spongiform Encephalopathies (TSE)
-t- Cryptosporidiosis

Cysticercosis or taeniasis

♦ Dengue

♦ Diarrhea of the Newborn, Outbreaks

♦ Diphtheria

♦ Domoic Acid Poisoning (Amnesic Shellfish Poisoning)
Ehrlichiosis

-I- Encephafifis, Specify Etiology: Viral, Bacterial, Fungal,
Parasific

♦ Escherichia coli: shiga toxin producing (STEC) including

£. CO// 0157
-I- • Foodborne Disease
Giardiasis

Gonococcal Infecfions
-I- Haemophilus influenzae, invasive disease (report an incident of
less than 15 years of age)

♦ Hantavirus Infections

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State Department of Health Services

§2500

•

♦ Hemolytic Uremic Syndrome
Hepatitis, Viral

+ Hepatitis A

Hepatitis B (specify acute case or chronic)
Hepatitis, C (specify acute case or chronic)
Hepatitis D (Delta)
Hepatitis, other, acute

Influenza deaths (report an incident of less than 1 8 years of age)
Kawasaki Syndrome (Mucocutaneous Lymph Node

Syndrome)
Legionellosis
Leprosy (Hansen Disease)
Leptospirosis
+ Listeriosis

Lyme Disease
+ Malaria

♦ Measles (Rubeola)

+ Meningitis, Specify Etiology: Viral, Bacterial, Fungal,
Parasitic

♦ Meningococcal Infections
Mumps

♦ Paralytic Shellfish Poisoning
Pelvic Inflammatory Disease (PID)

+ Pertussis (Whooping Cough)

♦ Plague, Human or Animal
+ Poliomyelitis, Paralytic

+ Psittacosis
+ Q Fever

♦ Rabies, Human or Animal
+ Relapsing Fever

Rheumatic Fever, Acute
Rocky Mountain Spotted Fever
Rubella (German JVdeasles)
Rubella Syndrome, Congenital
+ Salmonellosis (Other than Typhoid Fever)

♦ Scombroid Fish Poisoning

♦ Severe Acute Respiratory Infection (SARS)

♦ Shiga toxin (detected in feces)
+ Shigellosis

♦ Smallpox (Variola)

♦ Staphylococcus aureus infection (only a case resulting in death

or admission to an intensive care unit of a person who has not
been hospitalized or had surgery, dialysis, or residency in a
long-term care facility in the past year, and did not have an
indwelling catheter or percutaneous medical device at the
time of culture.)
+ Streptococcal Infections (Outbreaks of Any Type and

Individual Cases in Food Handlers and Dairy Workers Only)
+ Syphilis
Tetanus

Toxic Shock Syndrome
Toxoplasmosis
+ Trichinosis
+ Tuberculosis

♦ Tularemia

+ Typhoid Fever, Cases and Carriers

Typhus Fever
+ Vibrio Infections

♦ Viral Hemorrhagic Fevers (e.g., Crimean-Congo, Ebola, Lassa

and Marburg viruses)
+ Water-Associated Disease (e.g.. Swimmer's Itch and Hot Tub

Rash)
+ West Nile virus infection

♦ Yellow Fever
+ Yersiniosis

♦ OCCURRENCE of ANY UNUSUAL DISEASE

♦ OUTBREAKS of ANY DISEASE (Including diseases not
listed in Section 2500). Specify if institutional and/or open
community.

( ♦ ) - to be reported immediately by telephone.

(+) = to be reported by mailing a report, telephoning, or electronically

transmitting a report within one ( 1 ) working day of identification of
the case or suspected case.

(No diamond or cross symbol) = to be reported within seven (7) calendar days by
mail, telephone, or electronic report from the time of identification.

(•) = when two (2) or more cases or suspected cases of foodbome disease
from sepaiate households are suspected to have the same source of ill-
ness, they should be reported immediately by telephone.
NOTE: Authority cited: Sections 120130, 131080 and 131200, Health and Safety
Code. Reference: Sections 1603.1. 100325, 103925, 113150, 113155, 120125,
120130, 120140, 120175, 120245. 120250, 131050, 131051 and 131080. Health
and Safety Code; Sections 551, 554 and 555, Business and Professions Code; Sec-
tion 1798.3, Civil Code; 42 C.F.R. Sections 2. 1 1 and 2.12; Cal. Const., art. 1 , Sec-
tion 1; and Section 1040, Evidence Code.

History

1. Originally published 8-15-1945 (Title 17).

2. Amendment filed 12-22-69; effective thirtieth day thereafter (Register 69, No.
52). For prior history, see Register 66, No. 39.

3. Amendment filed 1 2-14-79; effective thirtieth day thereafter (Register 79, No.
50).

4. Amendment of subsection (a) and new subsections (b)-(h) filed 3-30-89; op-
erative 3-30-89 (Register 89, No. 14).

5. Editorial correction of History No. 4 printing error (Register 89, No. 23).

6. Editorial correction of subsection (g)(1) printing error (Register 90, No. 4).

7. Editorial con-ection of printing errors in subsection (g) (Register 91, No. 46).

8. Amendment of section and Note filed 5-1-95 as an emergency; operative
5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted
to O AL by 8-29-95 or emergency language will be repealed by operation of law
on the following day.

9. Amendment of section and Note, including amendment of subsection (i)(l)
"Diphtheria", refiled 8-21-95 as an emergency; operative 8-21-95 (Register
95, No. 34). A Certificate of Compliance must be transmitted to OAL by
12-19-95 or emergency language will be repealed by operation of law on the
following day.

10. Certificate of Compliance as to 5-1-95 order, including amendment of section,
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

11. Editorial correction of subsections (j)(l) and (j)(2) (Register 97, No. 12).

12. Amendment of subsection (j), repealer of subsection (j)(l) designator and ini-
tial text, repealer of subsection (j)(2) and amendment of Note filed 5-17-2000;
operative 10-2-2000 (Register 2000, No. 20).

13. Editorial correction restoring inadvertently deleted footnote (Register 2000,
No. 33).

14. Amendment of subsection (j) and amendment of Note filed 1 1-5-2001 as an
emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of
Compliance must be transmitted to OAL by 3-5-2002 or emergency language
will be repealed by operation of law on the following day.

15. Amendment of subsection (j) and amendment of Note refiled 3-1-2002 as an
emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Com-
pliance must be transmitted to OAL by 7-1-2002 or emergency language will
be repealed by operation of law on the following day.

16. Certificate of Compliance as to 3-1-2002 order, including amendment of
Note, transmitted to OAL 6-26-2002 and filed 7-1 6-2002 (Register 2002, No.
29).

17. Amendment of subsection (j) filed 6-30-2005; operative 6-30-2005. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
120130 (Register 2005, No. 32).

18. Amendment of subsection (j) filed 10-26-2006; operative 10-26-2006. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
120130(a) and (d) (Register 2006, No. 43).

19. Amendment of subsection (j) filed 6-12-2007; operative 6-12-2007. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
120130 (Register 2007, No. 31).

20. Amendment of subsection (j) filed 7-30-2007; operative 7-30-2007. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code .section
120130 (Register 2007, No. 31).

21. Amendment of subsections (a)(8), (g) and (j) and amendment of Note filed
2-1 3-2008; operative 2-1 3-2008. Submitted to OAL for printing only pursuant
to Health and Safety Code section 120130(a) and (d) (Register 2008, No. 7).

Page 61

§2501

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 2501. Investigation of a Reported Case, Unusual
Disease, or Outbreak of Disease.

(a) Upon receiving a report made pursuant to Section 2500 or 2505,
the local health officer shall take whatever steps deemed necessary for
the investigation and control of the disease, condition or outbreak re-
ported. If the health officer finds that the nature of the disease and the cir-
cumstances of the case, unusual disease, or outbreak warrant such action,
the health officer shall make or cause to be made an examination of any
person who or animal which has been reported pursuant to Sections 2500
or 2505 in order to verify the diagnosis, or the existence of an unusual
disease, or outbreak, make an investigation to determine the source of in-
fection, and take appropriate steps to prevent or control the spread of the
disease. Whenever requested to do so by the Department, the health offi-
cer shall conduct a special morbidity and mortality study under Health
and Safety Code Section 2 1 1 for any of the diseases made reportable by
these regulations.

(b) If a disease is one in which the local health officer determines iden-
tification of the source of infection is important, and the source of infec-
tion is believed to be outside the local jurisdiction, the health officer shall
notify the Director or the health officer under whose jurisdiction the in-
fection was probably contracted if known. Similar notification shall be
given if there are believed to be exposed persons, living outside the juris-
diction of the health officer, who should be quarantined or evaluated for
evidence of the disease.

Note: Authority cited: Sections 207, 208 and 3123, Health and Safety Code; and
Section 555(b), Business and Professions Code. Reference: Sections 7, 200, 207,
211. 211.5, 304.5, 410, 1603.1, 3051, 3053, 31 10. 3122, 3123, 3124, 3125, 3131
and 3132, Health and Safety Code; Sections 551, 554 and 555, Business and Pro-
fessions Code.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment filed 3-30-89; operafive 3-30-89 (Register 89, No. 14).

3. Amendment of section and Note, including renumbering and amendment of
former section 2512 to subsecUon 2501(b)(l )-(2), filed 5-1-95 as an emergen-
cy; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must
be transmitted to OAL by 8-29-95 or emergency language will be repealed by
operation of law on the following day.

4. Amendment of section and Note refiled 8-21-95 as an emergency; operative
8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted
to OAL by 12-19-95 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 5-1-95 order, including repealer and new sec-
tion heading, and amendment of section and Note transmitted to OAL
12-19-95 and filed 2-2-96 (Register 96, No. 5).

§ 2502. Reports by Local Health Officer to State
Department of Public Health.

(a) Summary Reports: Each local health officer shall report at least
weekly, on the Weekly Morbidity by Place of Report form (DHS 8245
(1 1/95)) to the Director the number of cases of those diseases, conditions,
unusual diseases or outbreaks of disease reported pursuant to Section
2500. Copies of the form are available from the Department's Division
of Communicable Disease Control.

(b) Individual Case and Outbreak Reports: For the diseases listed be-
low, the local health officer shall prepare and send to the Department
along with the summary report described in (a) above an individual case
or outbreak report for each individual case/outbreak of those diseases
which the Department has identified as requiring epidemiological analy-
sis reported pursuant to Section 2500. At the discretion of the Director,
the required individual case/outbreak report may be either a Confidential
Morbidity Report (PM-1 10 1/90), its electronic equivalent or a hard copy
8.5x1 1 inch individual case/outbreak report form. The Weekly Morbid-
ity by Place of Report form (DHS 8245 1 1/95)) indicates which format
to use. Each individual case report shall include the following: (1) verifi-
cation of information reported pursuant to Section 2500; (2) information
on the probable source of infection, if known; (3) laboratory or radiologic
findings, if any; (4) clinical signs and/or symptoms, if applicable; and (5)
any known epidemiological risk factors. The Department or CDC has
prepared forms that may be used for many of the diseases requiring indi-
vidual case reports. Where a form exists, its identification number is

listed in parentheses next to the diseases listed below. Copies of these
case report forms are available from the Department's Division of Com-
municable Disease Control. An individual case report is required for the
following diseases:

Acquired Immune Deficiency Syndrome (AIDS) (CDC 50.42B)

Anthrax (ACD-152)

Avian Influenza (human) (pending)

Botulism (Infant, Foodbome, Wound, Other) (ACD-153)

Brucellosis (262-101)

Chickenpox (Varicella) deaths (separate reporting form required)

Chickenpox (Varicella) hospitalizations (separate reporting form
required)

Cholera (CDC 52.79)

Creutzfeldt-Jakob Disease (CJD) and other Transmissible Spongi-
form Encephalopathies (TSE) (pending)

Cysticercosis (pending)

Diarrhea of the Newborn, Outbreaks (262-504)

Diptheria (262-505)

Escherichia coli: shiga toxin producing (STEC) including
E.coliOl51

Foodbome Disease Outbreak (CDC 52.13)

Haemophilus influenzae. Invasive Disease (DHS 8449)

Hantavirus Infections (pending)

Hemolytic Uremic Syndrome (pending)

Hepatitis A (CDC 53.1)

Hepatitis B, acute only (CDC 53.1)

Hepatitis C, acute only (CDC 53.1)

Hepatitis D (Delta), acute only (CDC 53.1)

Hepatitis, any other acute viral type (CDC 53.1)

Influenza deaths (report an incident of less than 1 8 years of age)
(pending)

Kawasaki Syndrome (Mucocutaneous Lymph Node Syndrome)
(DHS 8468)

Legionellosis (CDC 52.56)

Leprosy (Hansen Disease) (CDC 52.18)

Leptospirosis (262-102)

Listeriosis (DHS 8296)

Lyme Disease (DHS 8470)

Malaria (CDC 54.1)

Measles (Rubeola) (DHS 8345)

Meningoccal Infections (DHS 8469)

Outbreak of Disease Report (DHS 262-501)

Pelvic Inflammatory Disease (PID)

Pertussis (Whooping Cough) (DHS 8258)

Plague (CDC 56.37)

Poliomyelitis, Paralytic (DHS 8421)

Psittacosis (8023-005)

Q Fever (262-101)

Rabies, Human or Animal (Humans 262-105, Animals PM 102)

Relapsing Fever (262-107)

Rocky Mountain Spotted Fever (CDC 55.1)

Rubella (German Measles) (PM 358; for Congenital Rubella, CDC
71.17)

Severe Acute Respiratory Infection (SARS) (pending)

Shiga toxin (detected in feces)

Smallpox (pending)

Staphylococcus aureus infection (only a case resulting in death or ad-
mission to an intensive care unit of a person who has not been hospital-
ized or had surgery, dialysis, or residency in a long-term care facility in
the past year, and did not have an indwelling catheter or percutaneous
medical device at the time of culture.)

Streptococcal Outbreaks and Individual Cases in Food Handlers and
Dairy Workers Only

SyphiUs (for Congenital Syphilis, CDC 73.126)

Tetanus (CDC 71.15)

Toxic Shock Syndrome (CDC 52.3)

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•

Trichinosis (CDC 54.7)

Tuberculosis (CDC 72.9 A, B, and C)

Tularemia (262-101)

Typhoid Fever, Cases and Carriers (Cases, CDC 52.5; Carriers, CDC

4.383)
Typhus Fever (262-107)
Unusual Disease Report (DHS 262-501)
Vibrio Infections (CDC 52.79)
Viral Hemorrhagic Fevers (pending)
Waterbome Disease Outbreak (CDC 52.12)
West Nile virus infection (pending)
Yellow Fever

(c) Immediate Reports: Cases and suspect cases of anthrax, botulism,
brucellosis, cholera, dengue, diarrhea of the newborn (outbreaks), diph-
theria, plague, rabies (human only), smallpox (varoila), tularemia, vari-
cella deaths, viral hemorrhagic fevers, yellow fever, occurrence of any
unusual diseases, and outbreaks of any disease are to be reported by the
local health officer to the Director immediately by telephone.

(d) Upon request of the Department, the local health officer shall sub-
mit an individual case report for any disease not listed in subsection (b)
above.

(e) During any special morbidity and mortality study requested under
Section 2501 , the local health officer shall be the Director's agent for pur-
poses of carrying out the powers conferred under Government Code Sec-
tion 11181.

(f) Confidentiality. Information reported pursuant to this section is ac-
quired in confidence and shall not be disclosed by the local health officer
except as authorized by these regulations, as required by state or federal
law, or with the written consent of the individual to whom the informa-
tion pertains or to the legal representative of that individual.

( 1 ) A health officer shall disclose any information, including personal
information, contained in an individual case report to state, federal or lo-
cal public health officials in order to determine the existence of a disease,
its likely cause or the measures necessary to stop its spread.

(2) A health officer may for purposes of his or her investigation dis-
close any information contained in an individual case report, including
personal information, as may be necessary to prevent the spread of dis-
ease or occurrence of additional cases.

(3) A health officer may disclose any information contained in an indi-
vidual case report to any person or entity if the disclosure may occur with-
out linking the information disclosed to the individual to whom it per-
tains, and the purpose of the disclosure is to increase understanding of
disease patterns, to develop prevention and control programs, to commu-
nicate new knowledge about a disease to the community, or for research.

(4) Notwithstanding subsections (1), (2), and (3) above, no informa-
tion that would directly or indirectly identify an individual as one who
has applied for or been given services for alcohol or other drug abuse by
a federally assisted drug or alcohol abuse treatment program (as defined
in 42 C.F.R. § 2. 1 1 ) shall be included in an individual case report or other-
wise disclosed absent the individual's written consent.

(g) Whenever the health officer collects personal information in order
to prepare an individual case report required by subsection (b). the health
officer shall notify the individual from whom the information is collected
that: (1) supplying personal information related to the individual's dis-
ease is mandatory; (2) the only disclosure of personal information will
be pursuant to subsections 2502(f(l) and 2502(f)(2); and (3) non-perso-
nal information may be disclosed pursuant to subsection 2502(f)(3).
NOTli; Authority cited: Sections 120130, 131080 and 131200, Health and Safety
Code; and Section 555(b), Business and Professions Code. Reference: Sections 7,
1603.1, 100325. 100330, 103925, 113150, 113155, 120125, 120130, 120140,
120145, 120175, 120190, 120245, 120250, 131050, 131051 and 131080, Health
and Safety Code; and Sections 55 1 , 554 and 555, Business and Professions Code;
Section 1798.3, Civil Code; Sections 11181 and 11182, Government Code; 42
C.F.R. Sections 2.11 and 2.12.; Cal. Const., art. 1, Section 1; and Section 1040,
Evidence Code.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

3. Amendment filed 5-1-95 as an emergency; operative 5-1-95 (Register 95. No.
18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or
emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95,
No. 34). A Certificate of Compliance must be transmitted to OAL by 12 19 95
or emergency language will be repealed by operation of law on the following
day.

5. Certificate of Compliance as to 5-1-95 order, including repealer and new sec-
tion heading, section and Note transmitted to OAL 12-19-95 and filed 2-2-96
(Register 96, No. 5).

6. Editorial conection of subsection (c) (Register 97, No. 12).

7. Amendment of subsections (b)-(c) and amendment of NoTH filed 1 1-5-2001
as an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate
of Compliance must be transmitted to OAL by 3-5-2002 or emergency lan-
guage will be repealed by operation of law on the following day.

8. Amendment of subsections (b)-(c) and amendment of NoTi-. refiled 3-1-2002
as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of
Compliance must be transmitted to OAL by 7-1-2002 or emergency language
will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

10. Amendment of subsection (b) filed 6-30-2005; operative 6-30-2005. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
120130 (Register 2005, No. 32).

11. Amendment of subsection (b) 6-12-2007; operative 6-12-2007. Submitted
to OAL for printing only pursuant to Health and Safety Code section 120130
(Register2007, No. 31).

12. Amendment of subsection (b) filed 7-30-2007; operative 7-30-2007. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
120130 (Register 2007, No. 31).

13. Amendment of section heading, subsection (b) and Noth filed 2-1 3-2008; op-
erative 2-13-2008. Submitted to OAL for printing only pursuant to Health and
Safety Code secfion 120130(a) and (d) (Register 2008, No. 7).

§ 2503. Reporting Occurrence of Unusual Diseases.

Note.- Authority cited: Sections 207, 208 and 3 123, Health and Safety Code. Ref
erence: Sections 200, 207, 3053, 31 10, 3123, 3124 and 3125, Health and Safety
Code.

History

1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

3. Amendment of section heading and section filed 5-1-95 as an emergency; op-
erative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be
transmitted to OAL by 8-29-95 or emergency language will be repealed by op-
eration of law on the following day.

4. Amendment of section heading and section refiled 8-21-95 as an emergency;
operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be
transmitted to OAL by 12-19-95 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 5-1-95 order, including repealer of section
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

§ 2504. Report by Health Care Provider of Out-of-State
Laboratory Findings.

Whenever a health care provider' s identification of a case or suspected
case of tuberculosis includes laboratory findings from an out-of-state
laboratory, the health care provider shall include those findings with the
report made pursuant to SecUon 2500(b), and if the laboratory performed
drug susceptibility tesfing, the results of such testing shall also be so re-
ported.

Note: Authority cited: Sections 207, 208 and 3 123, Health and Safety Code. Ref
erence: Sections 200, 207, 3053, 3110, 3123, 3125 and 3285, Health and Safety
Code.

History

1 . Amendment of section heading, repealer and new section, and new NoTi filed
5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 1 8). A Certificate
of Compliance must be transmitted to OAL by 8-29-95 or emergency language
will be repealed by operation of law on the following day.

2. Repealer and new section refiled 8-2 1 -95 as an emergency; operative 8-2 1 -95
(Register 95, No. 34). A Certificate of Compliance must be tran.smitted to OAL

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

by 12-19-95 or emergency language will be repealed by operation of law on
the following day.
3. Certificate of Compliance as to 5-1-95 order transmitted to OAL 1 2-1 9-95 and
filed 2-2-96 (Register 96, No. 5).

§ 2505. Notification by Laboratories.

(a) To assist the local health officer, the laboratory director, or the lab-
oratory director's designee, of a clinical laboratory, an approved public
health laboratory or a veterinary laboratory in which a laboratory exami-
nation of any specimen derived from the human body (or from an animal,
in the case of rabies or plague testing) yields microscopical, cultural, im-
munological, serological, or other evidence suggestive of those diseases
listed in subsections (e)(1) and (e)(2) below, shall report such findings to
the health officer of the local health jurisdiction where the health care
provider who first submitted the specimen is located.

(1) For those diseases listed in subsection (e)(1), the report of such
findings shall be made within one hour after the laboratory notifies the
health care provider or other person authorized to receive the report. If
the laboratory that makes the positive finding received the specimen
from another laboratory, the laboratory making the positive finding shall
notify the health officer of the jurisdiction in which the health care pro-
vider is located within one hour from the time the laboratory notifies the
referring laboratory that submitted the specimen.

(2) For those diseases listed in subsection (e)(2), the report of such
findings shall be made within one working day from the time that the lab-
oratory notifies the health care provider or other person authorized to re-
ceive the report. If the laboratory that makes the positive finding received
the specimen from another laboratory, the laboratory making the positive
finding shall notify the health officer of the jurisdiction in which the
health care provider is located within one working day from the time the
laboratory notifies the referring laboratory that submitted the specimen.

(b) To permit local health officer follow-up of laboratory findings, all
specimens submitted for laboratory tests or examinations related to a dis-
ease or condition listed in subsections 25()5(e)(l) or 2502(e)(2) shall be
accompanied by a test requisition which includes the name, gender, and
age or date-of-birth of the person from whom the specimen was obtained
and the name, address and telephone number of the health care provider
or other authorized person who submitted the specimen. Whenever the
specimen, or an isolate therefrom, is transferred between laboratories, a
test requisition with the above patient and submitter information shall ac-
company the specimen. The laboratory that first receives a specimen
shall be responsible for obtaining the patient and submitter information
at the time the specimen is received by that laboratory.

(c) Each notification to the local health officer shall include the date
the specimen was obtained, the patient identification number, the speci-
men accession number or other unique specimen identifier, the laborato-
ry findings for the test performed, the date that any positive laboratory
findings were identified, the name, gender, address, telephone number (if
known) and age or date of birth of the person from whom the specimen
was obtained, and the name, address, and telephone number of the health
care provider for whom such examination or test was performed.

(d) The notification shall be submitted as specified in subsections
(e)(1) and (e)(2) of this Section to the local health officer in the jurisdic-
tion where the health care provider who submitted the specimen is lo-
cated. When the specimen is from an out-of-state submitter, the state
epidemiologist of the submitter shall be provided the same positive find-
ings per subsections (e)(1) and (e)(2) of thi s SecUon. If the laboratory that
finds evidence for any of those diseases listed in subsections (e)(1) and
(e)(2) is an out-of-state laboratory, the California clinical laboratory that
receives a report of such findings from the out-of-state laboratory shall
notify the local health officer in the same way as if the finding had been
made by the California laboratory.

(e) Laboratory reports to the local health officer shall include the in-
formadon as specified in (c) of this Section and laboratories shall submit
the reports within the following timeframes:

(1) The diseases specified shall be reported within one hour after the
health care provider or other person authorized to receive the report has

been notified. Laboratories shall make the initial reports to the local
health officer by telephone and follow the initial report within one work-
ing day by a report in writing submitted by electronic facsimile transmis-
sion or electronic mail to the local health officer. The diseases reported
pursuant to this requirement are:

Anthrax (see section 255 1 for additional reporting instmctions)

Avian Influenza (see (j) for additional reporting requirements)

Botulism (see section 2552 for additional reporting instructions)

Brucellosis, by isolation of Brucella species from a clinical specimen,
or demonstration by immunofluorescence of Brucella species in a clini-
cal specimen, or fourfold or greater rise in antibody titer to Brucella anti-
gen between acute and convalescent phase seiTim specimens obtained
two or more weeks apart and studied at the same laboratory, or elevated
serum antibody to Brucella antigen at a titer of 1 : 1 60 or greater in a single
serum specimen, (see section 2553 for special reporting instructions)

Burkholderia pseudomallei and B. mallei

Plague, animal or human (see section 2596 for additional reporting
instructions)

Smallpox (Variola) (see section 2614 for additional reporting instruc-
tions)

Tularemia, by isolation of Francisella tularensis in a clinical speci-
men, or demonstration by immunofluorescence of F. tularensis in a clini-
cal specimen, or fourfold or greater rise in antibody titers to F. tularensis
antigen between acute and convalescent phase serum specimens ob-
tained two or more weeks apart and studied at the same laboratory, or ele-
vated antibody to F. tularensis antigen at a titer of 1:160 or greater in a
single serum specimen, (see section 2626 for additional reporting
instructions)

Viral Hemorrhagic Fever agents, e.g., Crimean-Congo, Ebola, Lassa,
and Marburg viruses (see section 2638 for additional reporting instruc-
tions)

(2) The diseases specified shall be reported within one working day
after the health care provider or other person authorized to receive the re-
port has been notified. Laboratories shall transmit these reports to the lo-
cal health officer by courier, mail, electronic facsimile or electronic mail.
The diseases reported pursuant to this requirement are:

Acid fast bacillus (AFB) (see (g) for additional reporting require-
ments)

Bordetella pertusis acute infection, by culture or molecular identifica-
tion

Borrelia burgdorferi infection

Chlamydial infections, including lymphogranuloma venereum (LGV)

Cryptosporidiosis

Cyclospora cayetanensis

Diphtheria

Encephalitis, arboviral

Escherichia coli: shiga toxin producing (STEC) including E. coli
0157

Gonorrhea

Haemophilus influenzae (report an incident of less than 15 yers of age,
sterile site)

Hepatitis A, acute infection, by IgM anitbody test or positive viral anti-
gen test

Hepatitis B, acute infection, by IgM anti-HBc anitbody test

Hepatitis B surface antigen positively (specify gender)

Hepatitis C (see (i) for additional reporting requirements)

Legionella (antigen or culture)

Listeria

Malaria (see (h) for additional reporting requirements)

Measles (Rubeola), acute infection, by IgM anitbody test or positive
viral antigen test

Mycobacterium tuberculosis (see (f) for additional reporting require-
ments)

Neisseria meningitidis (sterile site isolate)

Rabies, animal or human

Rubella, acute infection by IgM antibody test or culture

Page 64

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§2505

Salmonella sp.

Shiga toxin (detected in feces)

Shigella sp.

Syphilis

Tuberculosis

Typhoid

Vibrio species infections

West Nile virus infection

(f) In addition to notifying the local health officer pursuant to subsec-
tion (a), any clinical laboratory or approved public health laboratory that
isolates Mycobacterium tuberculosis from a patient specimen shall:

(1) Submit a culture as soon as available from the primary isolate on

which a diagnosis of tuberculosis was established. Such a culture shall
be submitted to the public health laboratory designated in Title 17 Cali-
fornia Code of Regulations, Section 1075 for the local jurisdiction where
the health care provider's office is located. The following information
shall be submitted with the culture: the name, address, and the date of
birth of the person from whom the specimen was obtained, the patient
identification number, the specimen accession number or other unique
specimen identifier, the date the specimen was obtained from the patient,
and the name, address, and telephone number of the health care provider
for whom such examination or test was performed. The public health lab-
oratory shall retain the culture received (one culture from each culture-
positive patient) in a viable condition for at least six months.

[The next page is 65.]

•

Page 64.1

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Title 17

State Department of Health Services

§2508

(2) Unless drug susceptibility testing has been performed by the clini-
cal laboratory on a strain obtained from the same patient within the pre-
vious three months or the health care provider who submitted the speci-
men for laboratory examination informs the laboratory that such drug
susceptibility testing has been performed by another laboratory on a cul-
ture obtained from that patient within the previous three months, the clin-
ical laboratory shall:

(A) Perform or refer for drug susceptibility testing on at least one iso-
late from each patient from whom Mycobacterium tuberculosis was iso-
lated; and

(B) Report the results of drug susceptibility testing to the local health
officer of the city or county where the submitting physician's office is lo-
cated within one working day from the time the health care provider or
other authorized person who submitted the specimen is notified; and

(C) If the drug susceptibility testing determines the culture to be resis-
tant to at least isoniazid and rifampin, in addition, submit one culture or
subculture from each patient from whom multidrug-resistant Mycobac-
terium tuberculosis was isolated to the official public health laboratory
designated in Title 17 California Code of Regulations Section 1075 for
the local health jurisdiction in which the health care provider's office is
located. The local public health laboratory shall forward such cultures to
the Department's Microbial Diseases Laboratory. The following infor-
mafion shall be submitted with the culture: the name, address, and the
date of birth of the person from whom the specimen was obtained, the pa-
tient identification number, the specimen accession number or other
unique specimen idendfier, the date the specimen was obtained from the
patient, and the name, address, and telephone number of the health care
provider for whom such examination or test was performed.

(g) Whenever a clinical laboratory finds that a specimen from a padent
with known or suspected tuberculosis tests positive for acid fast bacillus
(AFB) staining and the padent has not had a culture which idendfies that
acid fast organism within the past 30 days, the clinical laboratory shall
culture and idendfy the acid fast bacteria or refer a subculture to another
laboratory for those purposes.

(h) In addidon to notifying the local health officer pursuant to subsec-
tion (a), any clinical laboratory that makes a finding of malaria parasites
in the blood film of a patient shall immediately submit one or more such
blood film slides for confirmadon to the public health laboratory desig-
nated in Tide 1 7 California Code of Reguladons Secdon 1 075 for the lo-
cal health jurisdicdon where the health care provider is located. When re-
quested, all blood films shall be returned to the submitter.

(i) Any laboratory with a posidve hepatids C virus (HCV) test that
meets the CDC laboratory criteria for diagnosis of HCV infecdon in a
California resident shall report the positive test to the local health officer.

The following test results are reportable.

( 1 ) All HCV posidve recombinant immunoblot assay (RIBA) tests;

(2) All HCV RNA positive tests [e.g., nucleic acid tests (NAT)];

(3) All HCV genotype reports; and

(4) And-HCV reactive by a screening test (e.g., enzyme immunoassay
[EIA] or chemiluminescence immunoassay [CIA]) with either:

(A) The exact signal-to-cut-off (s/co) rado or index value; or

(B) A comment that indicates whether or not the screening test s/co ra-
do or index value is predictive of a true posidve as determined for the par-
dcular assay as defined by the CDC in the case definidon for "laboratory
criteria for diagnosis" of Hepadtis C virus infecdon, past or present. The
url for the s/co ratios that meet the CDC case definition is
http://www.cdc.gOv/ncidod/diseases/hepadds/c/sc_ratios.htm.

If a laboratory chooses to report a reactive anti-HCV screening test
(e.g., EIA or CIA test) with a s/co or index value that is lower than re-
quired to meet the CDC case definidons AND does not report the exact
s/co or index value (i.e., the laboratory report is posidve without a specif-
ic s/co or index value reported), then the laboratory report MUST include
a comment to indicate that the s/co or index value is low and that supple-
mental testing (e.g., RIBA or NAT) is recommended by the CDC.

(j) Whenever a laboratory receives a specimen for the laboratory diag-
nosis of avian influenza in a human such laboratory shall communicate
immediately by telephone with the Department's Viral and Rickettsial
Disease Laboratory for instrucdon.

(k) All laboratory notificadons herein required are acquired in confi-
dence and shall not be disclosed by the local health officer except (1 ) as
authorized by these reguladons; (2) as required by state or federal law ;
or (3) with the written consent of the individual to whom the information
pertains or the legal representative of that individual.

(/) The local health officer shall disclose any information, including
personal information, contained in a laboratory notification to state, fed-
eral or local public health officials in order to determine the existence of
the disease, its likely cause and the measures necessary to stop its spread.

NOTE; Authority cited: Sections 100180, 100275, 120130 and 125095. Health and
Safety Code. Reference: Sections 100180, 120125, 120130. 120140. 120175.
120575, 121365 and 125100, Health and Safety Code; Sections 1209. 1246.5 and
1288, Business and Professions Code; Cal. Const.., art. 1, Section 1; and Section
1040, Evidence Code.

History

1. New section fded 3-26-62; effective thirtieth day thereafter (Register 62,
No.6).

2. Amendment of subsections (a) and (b) filed 6-25-72 as an emergency; effective
upon filing (Register 72, No. 27).

3. Certificate of Compliance filed 10-24-72 (Register 72, No. 44).

4. Amendment of subsection (d) filed 3-30-89; operative 3-30-89 (Register 89.
No. 14).

5. Amendment of section and Notf; filed 5-1-95 as an emergency; operative
5-1 -95 (Register 95, No. 18). A Certificate of Compliance must be transmitted
to OAL by 8-29-95 or emergency language will be repealed by operation of law
on the following day.

6. Amendment of section and Note refiled 8-21-95 as an emergency; operative
8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted
to OAL by 12-19-95 or emergency language will be repealed by operation of
law on the following day.

7. Certificate of Compliance as to 5-1-95 order, including amendment of section,
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

8. Change without regulatory effect amending subsection (c) filed 7-15-97 pur-
suant to section 100, title 1, California Code of Regulations (Register 97, No.
29).

9. Amendment of subsections (a)-(d), repealer of subsection (e) and new subsec-
tions (e)-(e)(2) and amendment of Noth filed 1 1-5-2001 as an emergency; op-
erative 1 1-5-2001 (Register 2001, No. 45). A Certificate of Compliance must
be transmitted to OAL by 3-5-2002 or emergency language will be repealed by
operation of law on the following day.

10. Amendment of subsections (a)-(d), repealer of subsection (e), new subsections
(e)-(e)(2) and amendment of NoTi- refiled 3-1-2002 as an emergency; opera-
tive 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be
transmitted to OAL by 7-1-2002 or emergency language will be repealed by
operation of law on the following day.

1 1 . Certificate of Compliance as to 3-1-2002 order, including further amendment
of subsection (e)(1), transmitted to OAL 6-26-2002 and filed 7-1 6-2002 ( Reg-
ister 2002, No. 29).

12. Amendment of subsection (e)(2) filed 6-30-2005; operative 6-30-2005. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
120130 (Register 2005, No. 32).

13. Amendment of subsection (e)(2) filed 10-26-2006; operative 10-26-2006.
Submitted to OAL for printine only pursuant to Health and Safety Code section
120130(a) and (d) (Register 2006, No. 43).

14. Amendment of subsections (e)(l )-(2), new subsections (i)-(j) and subsection
relettering filed 6-12-2007; operative 6-12-2007. Submitted to OAL for print-
ing only pursuant to Health and Safety Code section 1 20 1 30 (Register 2007. No.
31).

15. Amendment of subsection (e)(2) filed 7-30-2007; operative 7-30-2007. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
120130 (Register 2007, No. 31).

§ 2508. Reporting by Schools.

It shall be the duty of anyone in charge of a public or private school,
kindergarten, boarding school, or day nursery to report at once to the lo-
cal health officer the presence or suspected presence of any of the com-
municable diseases.

Page 65

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Title 17

§ 2509. Records of Local Health Officer.

The local health officer shall maintain such records as he deems neces-
sary in the performance of his duties, or as requested by the State Depart-
ment of Health Services.

§ 2510. Outbreaks of Nonreportable Diseases.

History

1 . Repealer filed 7-29-55; effective thirtieth day thereafter (Register 55, No. 1 1 ).

§ 251 1 . Determination of Morbidity Level.

It shall be the duty of the local health officer to determine the amount
and kind of communicable disease occurring in his area by such methods
as he deems necessary in order to obtain knowledge of the general level
of morbidity in his jurisdiction.

History
1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

§2512.

Article 2. General Instructions

Investigation of the Case.

History

1. Renumbering and amendment of former section 2512 to subsection
2501(b)(l)-(2) filed 5-1-95 as an emergency; operative 5-1-95 (Register 95,
No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering and amendment of former section 2512 to subsection
2501(b)(l)-(2) refiled 8-21-95 as an emergency; operative 8-21-95 (Register
95, No. 34). A Certificate of CompUance must be transmitted to OAL by
12-19-95 or emergency language will be repealed by operafion of law on the
following day.

§ 2514. Instructions to Household.

It shall be the duty of the health care provider in attendance on a case
or suspected case of any disease or condition listed in Sections 2500, or
of any other disease considered to be communicable, to give detailed in-
structions to the members of the household in regard to precautionary
measures to be taken for preventing the spread of the disease or condi-
tion. Such instructions shall conform to these regulations and local ordi-
nances. It is the responsibility of each health care provider to be informed
as to these regulations and the local ordinances which are in effect in the
communities in which the health care provider practices.
Note-. Authority cited: Sections 207, 208 and 3 1 23, Health and Safety Code. Ref-
erence: Sections 207, 208, 3123 and 3285, Health and Safety Code.

History

1 . Amendment of section and new Note filed 5-1-95 as an emergency; operative
5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted
to OAL by 8-29-95 or emergency language will be repealed by operation of law
on the following day.

2. Amendment of section and Note refiled 8-21-95 as an emergency; operadve
8-2 1-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted
to OAL by 12-19-95 or emergency language will be repealed by operation of
law on the following day.

3. Certificate of Compliance as to 5-1-95 order, including amendment of section,
transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).

§2515. Definition of Isolation.

Isolation is defined as separation of infected persons from other per-
sons for the period of communicability in such places and under such
conditions as will prevent the transmission of the infectious agent. Isola-
tion will be applied as instructed below.

§2516. Strict Isolation.

If the disease is one requiring strict isolation, the health officer shall
insure that instructions are given to the patient and members of the house-
hold, defining the area within which the patient is to be isolated and stat-
ing the measures to be taken to prevent the spread of the disease.

Strict isolation shall include the following measures:

(a) The patient shall have a separate bed in a room protected against
flies.

(b) All persons, except those caring for the patient, shall be excluded
from the sick room.

(c) The persons caring for the patient shall avoid coming in contact
with any other persons within the household or elsewhere until every pre-
caution has been taken to prevent the spread of infectious material from
the patient's room.

(d) The persons caring for the patient shall wear a washable outer gar-
ment and shall thoroughly wash their hands with soap and hot water after
handling the patient or any object he may have contaminated. On leaving
the room in which the patient is isolated, the attendant shall take off the
washable outer garment and hang it in the room until disinfected.

(e) All discharges from the nose and mouth shall be burned or disin-
fected. The discharges should be received in pieces of soft tissue or cloth
and dropped into a paper bag which can be burned.

(f) Objects which may have been contaminated by the patient shall be
thoroughly cleansed before being removed from the contaminated area.

(g) The feces and urine of patients suffering from diseases in which the
infectious agent appears in the feces or urine shall be disposed of accord-
ing to instructions given be the local health officer.

§2518. Modified Isolation.

If the disease is one in which only a modified isolation is required, the
local health officer shall issue appropriate instructions, prescribing the
isolation technique to be followed. The isolation technique will depend
upon the disease.

§ 2520. Quarantine.

Quarantine is defined as the limitation of freedom of movement of per-
sons or animals that have been exposed to a communicable disease for
a period of time equal to the longest usual incubation period of the dis-
ease, in such manner as to prevent effective contact with those not so ex-
posed. If the disease is one requiring quarantine of the contacts in addi-
tion to isolation of the case, the local health officer shall determine the
contacts who are subject to quarantine, specify the place to which they
shall be quarantined, and issue instructions accordingly. He shall insure
that provisions are made for the medical observation of such contacts as
frequently as necessary during the quarantine period.

§ 2522. Observation.

For the purposes of definition, the term "observation," as used in these
regulations, shall refer to a frequent check upon the person under obser-
vation to determine whether such person is free of the disease for which
he has been placed under observation, or has contracted the disease. Un-
less otherwise specified, it does not mean the isolation or quarantine of
the individual.

§ 2524. Terminal Disinfection.

Each person released from quarantine or isolation shall bathe and wash
his hair with soap and hot water and put on clean clothes. The area of iso-
lation shall be disinfected according to the instructions of the local health
officer.

§ 2526. Exclusion and Readmission by School Authorities.

It shall be the duty of the principal or other person in charge of any pub-
lic, private or Sunday School to exclude therefrom any child or other per-
son affected with a disease presumably communicable, until the expira-
tion of the prescribed period of isolation for the particular communicable
disease. If the attending physician, school physician, or health officer
finds upon examination that the person is not suffering from a communi-
cable disease, he may submit a certificate to this effect to the school au-
thority who shall readmit the person.

NOTE: Authority cited: Sections 207, 208 and 3123. Health and Safety Code. Ref-
erence: Sections 200, 207, 3051, 3053, 3110, 3118 and 3123, Health and Safety
Code.

History
1. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

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•

§ 2528. Contamination by Pathogenic Organisms of IVIilk,
Milk Products or Products Resembling Milk
Products.

(a) The Slate Department of Health Services finds that the presence of
any of the following pathogenic organisms in milk, milk product, or
product resembling milk products make such product unsafe for human
consumption: Mycobacterium tuberculosis; Brucella spp.; Streptococ-
cus pyogenes, group A hemolytic; Corynebacterium diphtheria; Salmo-
nella paratyphi; Salmonella schottmuelleri; Salmonella hirschfeldi; Sal-
monella typhi; Salmoneela dublin; Salmonella typhimurium; Shigella
spp. Whenever a health officer finds that milk, milk product, or product
resembling milk products, is unsafe for human consumption because it
contains any of the above named organisms, he shall issue a written order
to the producer or distributor of the product ( 1 ) summarizing the labora-
tory findings, and (2) prohibiting the sale or disposal of such milk, milk
product, or product resembling milk products, except by a method ap-
proved by him, until such time as he finds the product or products to be
safe for human consumption.

(b) Whenever a health officer has evidence that milk, milk product, or
product resembling milk products has caused human illness or contains
toxins which make such product unsafe for human consumption, he may
issue a written order to the producer or distributor of the product ( 1 ) stat-
ing the facts upon which his conclusions are based, and (2) prohibiting
the use, sale, or disposal of such milk, milk product, or product resem-
bling milk products, except by a method approved by him, until such time
as he finds it to be safe for human consumption.

(c) The health officer shall immediately forward a copy of any order
issued pursuant to this section to the State Director of Health Services.

(d) Any producer or distributor of milk, milk product, or product re-
sembling milk products, subject to an order of a health officer pursuant
to this section may appeal to the State Department of Health Services
solely upon the question of whether such products are, in fact, safe for hu-
man consumption. Such appeal shall be made in writing, stating which
of the facts set forth in the order are admitted and denied. Upon receipt
of the written appeal, the State Director of Health Services, after such in-
vestigation of the matter as he deems necessary, may amend or rescind
the order, or set the matter for hearing before a hearing officer designated
by him. In the event the order is not rescinded or amended to the satisfac-
tion of the appellant, the matter shall be set for hearing. The hearing shall,
if possible, be set within 14 days from the date of receipt of the appeal,
unless additional time is required by the appellant. Insofar as is practica-
ble, the procedures of the Administrative Procedure Act (Ch. 5, Pt. 1 , Div.
3, Title 2, of the Government Code) shall apply. The hearing officer shall
submit a proposed decision to the State Department of Health Services
which shall issue its decision in accordance with Section 1 1 5 1 7 of the Ad-
ministrative Procedure Act. The decision shall be subject to judicial re-
view.

(e) The procedures of this section authorize a health officer to take im-
mediate action to protect the public health in the event he finds that milk,
milk products, or products resembling mifk products constitutes the ap-
plicability of other provisions of law pertaining to the regulation of such

products, including but not limited to, the provisions of the Agricultural
Code and the California Pure Foods Act (Ch. 3, Div. 2 1 , Health and Safe-
ty Code).

NOTE: Authority cited: Sections 102 and 208. Health and Safety Code. Reference:
Sections 3 11 0-3 125, Health and Safety Code.

History
1. Repealer and new section filed 12-22-69; effective thirtieth day thereafter
(Register69, No. 52).

§ 2530. Public Food Handlers.

No person known to be infected with a communicable disease or sus-
pected of being infected with a communicable disease shall engage in the
commercial handling of food, or be employed on a dairy or on premises
handling milk or milk products, until he is determined by the health offi-
cer to be free of such disease, or incapable of transmitting the infection.
(See Chapter 7, Article 1, Section 28295, Health and Safety Code.)
NOTE: Authority cited: Sections 207, 208 and 3 1 23, Health and Safety Code. Ref-
erence: Sections 200, 207, 305 1 , 3053, 3110, 3 123. 3131,31 32 and 28295. Health
and Safety Code

History

1. Amendment filed 3-30-89; operative 3-30-89 (Register 89, No. 14).

§ 2534. Laboratory Tests for the Release of Cases of
Carriers of Communicable Diseases.

Whenever laboratory tests are required for the release of cases or carri-
ers, the tests shall be taken by the health officer or his representatives and
shall be submitted to a public health officer or his representatives and
shall be submitted to a public health laboratory approved by the State De-
partment of Health Services. Specimens may be sent to laboratories not
so approved, provided the specimens are divided and a portion of the
specimens are sent to an approved laboratory. Release shall be consid-
ered on the basis of the report of the approved laboratory only.

§ 2536. Transportation of Communicable Disease Cases.

No person with a communicable disease subject to isolation not any
contact subject to quarantine shall travel or be transported from one place
to another within the local health jurisdiction, without the permissions of
the local health officer, and no such person shall travel or be transported
outside the area of jurisdiction of the health officer until the permission
of the health officer into whose jurisdiction the patient is to be brought
is obtained. An exception may be made in instances where the patient is
to be admitted directly to a hospital for the treatment of the communica-
ble disease,provided that the health officer from whose jurisdiction the
case to be transported shall insure that adequate precautions are taken to
prevent dissemination of the disease by the patient or his contacts en
route to the hospital.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55.

No. 8).

§ 2538. Funerals.

Funeral services for individuals who have died of a communicable dis-
ease shall be conducted in accordance with instructions of the health offi-
cer. In diseases requiring quarantine of contacts, a public funeral service
may be permitted only if the casket remains closed and those contacts

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•

subject to quarantine who attend the funeral are adequately segregated
from the public.

§ 2540. General Clause.

In addition to the requirements stipulated in these regulations, the local
health officer shall, after suitable investigation, take such additional steps
as he deems necessary to prevent the spread of communicable disease or
a disease suspected of being communicable in order to protect the public
health.

Article 3. Specific Diseases and Conditions

§ 2550. Amebiasis.

(a) Under ordinary circumstances, isolation of cases and quarantine of
contacts are not required.

(b) Persons who are found to be excreting Endamoeba histolytica in
the feces shall be prohibited from public food handling until three feces
specimens, taken at intervals of not less than three days, shall be proved
negative for the organism by a public health laboratory approved by the
State Department of Health Services.

§ 2551. Anthrax. Cases and Suspect Cases to Be Reported
by Telephone.

(See Section 2502(c).)

(a) Patient. The patient shall be isolated in accordance with Section
25 1 8. Wound isolation precautions shall be instituted until lesions are
free of anthrax bacilli. There are no restrictions on contacts.

(b) Laboratory. Whenever a laboratory receives a specimen for the
laboratory diagnosis of suspected human anthrax, such laboratory shall
communicate immediately by telephone with the Microbial Diseases
Laboratory of the State Department of Health Services for instruction.
Note: Authority cited: Sections 100180, 100275, 120L30and 120145, Health and
Safety Code. Reference: Sections 120130, 120175, 120190, 120195 and 120215,
Health and Safety Code.

History

1 . Amendment of section heading and section and new Note filed 1 1-5-2001 as
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of
Compliance must be transmitted to OAL by 3-5-2002 or emergency language
wiU be repealed by operation of law on the following day.

2. Amendment of section heading and section and new Note refiled 3-1-2002 as
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of
Compliance must be transmitted to OAL by 7-1-2002 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

§ 2552. Botulism. Cases and Suspect Cases to Be
Reported by Telephone.

(See Section 2502(c).) The health officer shall make an immediate in-
vestigation of every case or suspected case of botulism in an effort to es-
tablish the diagnosis and determine the source. In the event that a com-
mercial food product is suspected as the source, special instructions will
be given by the State Department of Health Services. The local health of-
ficer shall take all necessary steps to prevent distribution and consump-
tion of the suspected food. There are no restrictions on case or contacts.
Whenever a laboratory receives a specimen for the laboratory diagnosis
of suspected human botuUsm, such laboratory shall communicate im-
mediately by telephone with the Microbial Diseases Laboratory of the
Department of Health Services for instruction.

Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety
Code. Reference: Sections 100180, 100275, 120175, 120185 and 120190, Health
and Safety Code.

History

1 . Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment of secUon heading and section and new Note filed 1 1-5-2001 as
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of
Compliance must be transmitted to OAL by 3-5-2002 or emergency language
will be repealed by operation of law on the following day.

3. Amendment of section heading and section and new Note refiled 3-1-2002 as
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of

Compliance must be transmitted to OAL by 7-1-2002 or emergency language
will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

§ 2553. Brucellosis (Undulant Fever). Cases and Suspect
Cases to Be Reported by Telephone.

(See Section 2502(c).) There are no restrictions on case or contacts.
Whenever a laboratory receives a specimen for the laboratory diagnosis
of suspected human brucellosis, such laboratory shall communicate im-
mediately by telephone with the Microbial Diseases Laboratory of the
Department of Health Services for instruction.

NOTE: Authority cited: Sections 100180, 100275 and 120130. Health and Safety
Code. Reference: Sections 100180, 100275, 120185 and 120190, Health and Safe-
ty Code.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment of section heading and section and new Note filed 1 1-5-2001 as
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of
Compliance must be transmitted to OAL by 3-5-2002 or emergency language
will be repealed by operation of law on the following day.

3. Amendment of secdon heading and section and new Note refiled 3-1-2002 as
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of
Compliance must be transmitted to OAL by 7-1-2002 or emergency language
will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

§ 2554. Chancroid.

(See Section 2636 on Venereal Diseases.)

§ 2555. Chickenpox.

History
1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§ 2556. Cholera. Cases and Suspect Cases to Be Reported
by Telephone or Telegraph.

(See Section 2501(c).) The case shall be isolated in accordance with
Section 25 1 6 and the intimate contacts quarantined pending receipt of in-
structions from the State Health Services Department.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8).

§ 2558. Coccidioidomycosis.

Report active cases only primary (including cavitary) or disseminated.
There are no restrictions on case or contacts.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8).

§ 2560. Conjunctivitis, Acute Infectious of the Newborn.

(a) Acute infectious conjunctivitis of the newborn includes gonorrheal
ophthalmia and ophthalmia neonatorum.

(b) Prophylaxis for acute infectious conjunctivitis of the newborn shall
be administered to all infants within two hours after birth in accordance
with Sections 551-556 of the Business and Professions Code.

( 1 ) One percent silver nitrate in wax ampules administered without sa-
line irrigation.

(2) Ophthalmic ointments or drops containing tetracycline or erythro-
mycin.

(d) An infant with acute infectious conjunctivitis shall be isolated in
accordance with Section 25 16, Title 1 7, California Administrative Code,
until clinical recovery occurs and negative laboratory tests are obtained.
NotE: Authority cited: Section 555(b), Business and Professions Code. Refer-
ence: Sections 551 through 556, Business and Professions Code.

History

1. Amendment filed 5-28-53; effective thirt^ieth day thereafter (Register 53, No.
9).

2. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No.
20).

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Title 17

3. Amendment filed 12-15-79; effective thirtieth day thereafter (Resister 79, No.
50).

§ 2562. Dengue. Cases and Suspect Cases to Be Reported
by Telephone or Telegraph.

(See Section 2501(c).) The case shall be confined during the clinical
phase of the disease in a room or dwelling satisfactorily protected against
mosquitos. There are no restrictions on contacts.

History
1 . Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8).

§ 2564. Diarrhea of the Newborn.

(a) Any infant under 1 month of age in a hospital or institution, or any
infant hospitalized because of prematurity, who has two or more watery
or otherwise apparently abnormal stools within a 24-hour period, with
or without other signs of illness, shall be considered a suspicious case of
diarrhea of the newborn and immediately isolated. Any newborn, who
within four days after discharge from a hospital has two or more watery
or otherwise apparently abnormal stools within a 24-hour period, with
or without other signs of illness, shall be considered a suspicious case and
kept under close observation. If the diarrhea continues for more than two
days the infant shall be immediately reported as a case of diarrhea of the
newborn to the local health officer by telephone or other equally prompt
means. An exception may be made in the case of entirely breastfed in-
fants who show no signs of illness and are gaining weight.

(b) Isolation of Case. The case shall be placed in strict isolation until
discharged from the hospital.

(c) Quarantine of Infants in Nursery. If two or more cases occur, all
infants in the nursery shall be quarantined and no infants shall be ad-
mitted until all exposed infants have been discharged and the nursery
thoroughly cleaned, and personnel, equipment, and procedures involved
have been investigated by the health officer and found adequate.

(d) Care of Noncontacts. Infants bom subsequent to quarantine of in-
fants in the newborn nursery for diarrhea of the newborn shall be cared
for in a separate clean newborn nursery by a separate nursing staff.

(e) Closure of Hospital to Maternity Admissions. If cases of diarrhea
of the newborn as defined above occur also in the temporary clean nurs-
ery, the hospital shall be closed to maternity admissions until all cases
and contacts are discharged and all nursery rooms and equipment thor-
oughly cleaned.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

§ 2566. Diphtheria.

(a) Isolation of Patient. The patient shall be isolated in accordance with
Section 2516 until 2 cultures from the throat and 2 from the nose, taken
not less than 24 hours apart, fail to show the presence of diphtheria bacilli,
except that upon clinical recovery and where antibiotics have been used
as therapy, isolation may be modified in accordance with Section 2518.
Release cultures may not be taken less than seven days after discontinu-
ance of such therapy. Isolation may be terminated if the bacilli cultured
from the case are proved to be virulent.

(b) Control of Household Contacts. All household contacts shall be
kept under daily medical observation for clinical evidence of diphtheria
for seven days after last exposure. These contacts shall be isolated if they
are found to have sore throat or nasal discharge until proved by culture
not to have diphtheria. All household contacts under the age of 1 5 shall
be quarantined for at least seven days after the last exposure to the case.
Nose and throat cultures for diphtheria should then be taken and the con-
tacts may be released from quarantine if such cultures are negative. If the
contact has received an antibiotic, release cultures may not be taken less
than seven days after discontinuation of such medication.

(c) Release of Carriers From Isolation. Convalescent or healthy carri-
ers of diphtheria bacilli may be released from quarantine if the bacilli are
shown to be avirulent by appropriate laboratory tests. Any person who

has been free from the symptoms of diphtheria for four weeks or longer
and who harbors virulent diphtheria bacilli is defined as a chronic carrier.
Efforts should be made to eliminate the carrier state in such persons by
appropriate medical or surgical measures. If these measures are un-
successful or are refused the health officer may release the carrier from
isolation when, in his judgment, such release is not detrimental to the
public health, except that the carrier may not be permitted to engage in
any occupation which involves handling of foods of close association
with children outside his own family.

(d) Laboratory Tests for the Release of Cases or Carriers. Cultures or
virulence tests for the release of diphtheria cases or carriers shall be taken
not less than seven days after discontinuation of antibiotic therapy and
examined in accordance with the provisions of Section 2534.

(e) Cases on Dairies. When a case of diphtheria occurs or is confined
on the premises where milk or milk products are handled, the health offi-
cer shall prohibit the use, sale or disposal of such milk or milk product,
except by a method approved by him, until he is satisfied that such prod-
ucts are safe for human consumption.

(f) Immunization. The health officer shall take appropriate measures
to encourage and facilitate a continuing program of active immunization
against diphtheria for all children within his jurisdiction.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

§ 2570. Encephalitis, Acute (Including Arthropod-Borne
Viral, Post-Infectious, and Others).

The patient shall be isolated in accordance with Section 25 1 8 for seven
days from the onset of the infection. There are no restrictions on contacts.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8).

§ 2572. Disorders Characterized by Lapses of

Consciousness, Alzheimer's Disease and
Related Disorders.

NOTE: Authority cited: Sections 100275 and 103900, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No.
20).

2. Amendment filed 1 1-9-66; effective thirtieth day thereafter (Register 66, No.
39).

3. Amendment of subsection (a) and new subsections (b)-(d) filed 1-9-90; opera-
tive 1-9-90 pursuant to Government Code Secfion 11346.2(d) (Register 90,

No. 4).

4. Repealer of section and amendment of Note filed 5-17-2000; operadve
10-2-2000 (Register 2000, No. 20).

§ 2574. Food Poisoning.

(Excluding Botulism and Salmonella infections). A reportable case of
food poisoning is defined as follows: any person with symptoms of acute
gastroenteritis, vomiting, diarrhea, or neurologic symptoms whose ill-
ness occurs in association with a group of other persons who may have
consumed a common food or beverage. The etiologic agents include:

(a) Organic poisons present in normal animal or plant tissues, includ-
ing mushrooms, fish, and mussels.

(b) Mineral or organic poisons, including arsenic, lead, cadmium, and
fluorine, introduced into food by accident, or with the intent to improve
the appearance or as preservatives.

(c) Toxins preformed in food by the growth of microorganisms, in-
cluding staphylococci. (Botulism is reported separately. See Section
2552.)

Upon receiving the report, the health officer shall make or cause to be
made an investigation in an effort to determine the source and cause of
the outbreak. If the responsible food is one distributed outside the area
over which he has jurisdiction, he shall immediately report his findings
to the Director of the State Department of Health Services and to those
local health officers concerned. There are no restrictions on cases or con-
tacts.

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§ 2575. German Measles (Rubella).

The patient shall be isolated in accordance with Section 2518 until
clinically recovered. There are no restrictions on contacts.

History

1 . Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55. No. 8).

2. New section filed 10-25-66; effective thirtieth day thereafter Register 66, No.
.17). For history of former section see Register 55. No. 8.

§ 2577. Gonococcus Infection.

(See Section 2636 on Venereal Diseases.)

§ 2578. Granuloma Inguinale.

(See Section 2636 on Venereal Diseases.)

§ 2579. Hepatitis, Infectious.

(This term includes cases diagnosed as acute catarrhal jaundice, epi-
demic hepatitis and epidemic jaundice.) The patient shall be isolated in
accordance with Section 2518 during the acute symptoms. There are no
restrictions on contacts.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8).

§ 2580. Influenza, Epidemic.

History
1. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§ 2581. Hepatitis, Serum (Homologous Serum Jaundice).

The patient shall be isolated in accordance with Section 2518 during
the acute symptoms. There are no restrictions on contacts.

History
1. New section filed 5-24—55; effective thirtieth day thereafter (Register 55, No.

8).

§ 2582. Leprosy (Hansen's Disease).

The patient shall be isolated in accordance with Section 2518 if deter-
mined by clinical observation or by laboratory findings to be infectious.
The degree of isolation shall be determined by the local health officer,
who should, whenever possible, be advised by a physician specially qual-
ified in this disease. If isolation of the patient is required and cannot be
carried out at home or if adequate therapy is not available, the State De-
partment of PubHc Health shall be notified and shall designate a hospital
where the patient shall be isolated and treated. Apparently arrested or in-
active cases, and persons who have been in close contact with a case for
a prolonged period, shall be kept under observation as long as deemed
necessary by the local health officer to determine if they have become in-
fected or the disease reactivated.

All reports pertaining to cases of leprosy are confidential and the iden-
tity of patients shall not be divulged except as may be necessary for the
protection of the public health.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment filed 7-19-55, as an emergency; effective upon filing (Register 55,
No. 10).

§ 2584. Leptospirosis (Including Weil's Disease).

There are no restrictions on case or contacts.
History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

§ 2585. Lymphogranuloma Venereum.

(See Secfion 2636 on Venereal Diseases.)

§ 2586. Malaria.

The pafient shall be confined during the chnical phases of the disease
in a room or dwelling satisfactorily protected against mosquitoes.

§ 2588. Measles.

The patient shall be isolated in accordance with Section 2518 during
the period of catarrhal symptoms and for seven days after the appearance

of the rash. Restriction on contacts is not required, except at the discretion
of the local health officer.

§ 2590. Meningitis, Meningococcal or Menlngococcemia.

(a) The patient shall be isolated in accordance with Section 25 1 8 until
the end of the febrile period and until all acute symptoms have subsided.

(b) Contacts. Quarantine of contacts is not required, except at the dis-
cretion of the local health officer, but intimate contacts should be kept un-
der frequent medical observation for a minimum of three days subse-
quent to diagnosis of the case. Prophylactic treatment of household
contacts under medical supervision may be required by the health officer
prior to release.

History
1. Amendment filed 5-24-55; effective thirtieth dav thereafter (Register 55. No.
8).

§ 2592. Mumps.

The patient shall be isolated in accordance with Section 25 18 until the
swelling of the salivary glands has subsided. There are no restrictions on
contacts.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

§ 2593. Neoplasm, Cancer.

(a) Definifions.

(1) Department means Department of Health Services.

(2) Director means the Director of the Department of Health Services.

(3) Regional cancer registry means the organization authorized to re-
ceive and collect cancer data for a designated area of the state and which
maintains the system by which the collected information is reported to
the Department.

(4) Cancer means all malignant neoplasms, including carcinoa in situ,
which are specified in Volume I of the 1 986 California Cancer Reporting
System Standards and as set forth in the International Classification of
Diseases for Oncology Field Trial Edition 1986.

(5) Case means a cancer diagnosis for an individual who is either a res-
ident of the designated area of the regional cancer registry, regardless of
where the individual was treated or diagnosed, or seen at a cancer report-
ing facility, other facility or by a physician within the designated area of
the regional cancer registry, regardless of where the individual resides.

(6) Active follow-up program means a system for determining the vi-
tal status of each reported case no later than twelve months after the date
of the last reported contact. This date is defined in Volume I of the 1 986
California Cancer Reporting System Standards.

(7) Cancer reporting facility means a hospital or other facility which
treats or diagnoses cancer and is also one of the following:

(A) A facility currently licensed as a health facility under the provi-
sions of Chapter 2, commencing with Section 1250, of Division 2 of the
Health and Safety Code;

(B) A surgical clinic licensed under Chapter 1, Section 1204, of Divi-
sion 2 of the Health and Safety Code;

(C) A facility covered by the provisions of Section 1206, except for
subsection (f), of the Health and Safety Code which, while not licensed
as a clinic, is operated for the predominant purpose of diagnosing or treat-
ing cancer or where a minimum of 1 00 or more cancer cases are diag-
nosed or treated in a year.

(8) Quality Control System means operational procedures by which
the accuracy, completeness and timeliness of the information reported to
the Department can be determined and verified. These criteria are de-
fined in Volume I of the 1986 California Cancer Reporting System Stan-
dards.

(9) Certified Tumor Registrar (CTR) means the designation given to
individuals who pass the certification examination given by the National
Tumor Registrars Association (NTRA).

(10) Population-based means that all cases are drawn from a defined
population of known size and characteristics, usually one within a de-
fined geographic area.

Page 69

§2593

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(11) Cancer incidence data means information on new cases of cancer
including the required data listed in the 1 986 California Cancer Report-
ing System Standards and counts of these cases by their characteristics
such as age, sex and ethnicity, and by anatomic site and morphology.

(12) Instance of cancer means case of cancer as defined in subsection
(a)(5) above.

(13) Modeled after the Cancer Surveillance Program of Orange
County means a population-based registry that collects treatment data,
has a phased implementation, collects follow-up data, has a community
advisory component and receives data in a machine-readable format
from cancer reporting facilities as defined in subsection (a)(7) above.

(b) Reporting requirements. The Director shall designate cancer as a
disease to be mandatorily reported for all counties within the State. All
counties shall be assigned to a designated regional cancer registry. When
the Director designates cancer as a disease to be mandatorily reported
within an area, the Director shall designate the initial mandatory report-
ing period, which may be less than a full calendar year, for which the re-
gional registry will submit cases to the Department.

(DA regional cancer registry shall establish and maintain a cancer re-
porting system which is able to report 97 percent of the incident cases in
the initial designated reporting period and each calendar year.

(2) The regional cancer registry shall have suitable arrangements to
obtain data for reporting resident cases diagnosed or treated outside the
designated area of the regional cancer registry.

(3) The regional cancer registry shall report to the Department all cases
diagnosed or treated in a calendar year or initial reporting period within
twelve months after the close of that calendar year or initial reporting pe-
riod.

(4) The regional cancer registry shall submit, for each reportable case,
the required data specified in Volume I, Section 13, of the 1986 Califor-
nia Cancer Reporting System Standards.

(5) The regional cancer registry shall report to the Department all
follow-up information provided by cancer reporting facilities with an ac-
tive follow-up program no later than six months after the cancer report-
ing facility provides the information to the regional registry. In addition,
each regional registry shall implement within three years of the designa-
tion of mandatory cancer reporting for the region a program of active
follow-up for all resident cases not otherwise being followed by a cancer
reporting facility. The results of the active follow-up program of the re-
gional registry shall be reported to the Department quarterly.

(6) Data submitted to the Department by the regional cancer registry
shall be in machine-readable form. The format and codes used shall be

as specified by the Department.

(7) The regional cancer registry shall maintain a system of quality con-
trol in accordance with procedures approved by the Department.

(8) Representatives of the Department shall have access to the source
data and the stored data in the regional cancer registry for the purpose of
quality control assessments. This includes access to all cancer records
maintained by a reporting facility, physician, individual or agency pro-
viding diagnostic or treatment services to cancer patients within the re-
gion.

(9) The regional cancer registry shall maintain confidentiality of data
as required in Section 2 1 1 .5, Health and Safety Code, and shall maintain
a security system for records which contain identifying data. This system
shall be reviewed and approved by the Department.

(10) When cancer is designated a reportable disease in a region, the
corresponding regional cancer registry shall inform the public that cancer
has been designated as a disease required to be reported in that region and
that each patient diagnosed or treated with a Reportable Neoplasm will
be reported to the Department as required by law.

(11) Cancer reporting facilities within a reporting region shall report
to the regional cancer registry the required data as listed in Volumes I and
III of the 1986 California Cancer Reporting System Standards. These re-
ports shall conform to Volumes I, II and III of the 1986 California Cancer
Reporting System Standards. When a cancer reporting facility fails to
produce reports meeting the standards cited above, the regional cancer
registry may perform the data collection and collect compensation from
the facility for the activity at cost.

(12) Cancer reporting facilities shall report to their regional cancer
registry each reportable case within six months of the time the case comes
under the care of, or is admitted to, the facility.

(13) Cancer reporting facilities with an active follow-up program
shall report follow-up information to the regional cancer registry no less
frequently than quarterly.

(14) A facility not already defined as a cancer reporting facility under
these regulations which diagnoses or treats cancer and is a primary care
clinic as defined in Section 1 204, Health and Safety Code or an acute psy-
chiatric hospital as defined in Section 1 250, Health and Safety Code shall
report each cancer case to its regional cancer registry, or to the local
health department, the choice to be determined by the regional registry,
using the Confidential Morbidity Report (Form PM-1 10), shown below,
within 30 days of the date the patient is admitted to the facility or treated
in the facility for the first time. These reports shall conform to California
Cancer Reporting System Standards, Volume IV.

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(15) Physicians and surgeons caring for cancer patients not referred to
a facility defined as a cancer reporting facility under these regulations
shall report each cancer case to the regional cancer registry or to the local
health department, the choice to be determined by the regional registry,

using the Confidential Morbidity Report (PM-110), within 30 days of
seeing the patient for the cancer for the first time. These reports shall con-
form to California Cancer Reporting System Standards, Volume IV.

Page 70

Title 17

State Department of Health Services

§ 2603

(16) Cancer reporting facilities shall submit their cancer cases and
follow-up information to the regional cancer registry in machine-read-
able form. The format and codes used shall be as specified by the Depart-
ment in the 1986 California Cancer Reporting System Standards Vol-
ume II.

( 1 7) Cancer reporting facilities may elect to have the regional cancer
registry staff do the cancer data collection. They may do so by a contract
with the regional cancer registry to identify and report the cancer cases
with the facility reimbursing the regional registry for that registry's ex-
pense.

(18) Cancer reporting facilities and physicians shall employ a mecha-
nism to ensure that their patients are informed that cancer has been desig-
nated a reportable disease and that the facility will report each patient
with cancer to the Department as required by law. Patient information
sheets for this purpose will be supplied to physicians by the Department.

(c) Staffing. The identification and collection of cancer data in the re-
gional cancer registries and cancer reporting facilities shall be performed
by Certified Tumor Registrars (CTR) or staff eligible to take the certifica-
tion examination.

(d) Training and Credentialing Period. Reporting facilities so request-
ing upon application to the regional registry, may be granted a credential-
ing period of up to 24 months for the purpose of obtaining training to meet
the requirements set forth in subsection (c) above. No credentialing peri-
od may be granted to extend beyond 30 months from the effective date
of mandatory cancer reporting for the region or beyond July 1 , 1 990. Dur-
ing a credentialing period the reporting facility must meet the quality and
other reporting standards. It is the responsibility of the Department,
which may be carried out by the regional cancer registries, to assure that
adequate tumor registrar training resources are available for no less than
24 months following the initiation of mandatory reporting in a region.

(e) Designation of Agent. The Director may designate and contract
with any agency to act as the Department's agent for the maintenance of
the regional cancer registry. The designated agent shall comply with all
regulations for the regional cancer registry.

(f) Revocation of Designation. The Director shall have the authority
to revoke the designation as Departmental agent. Revocation shall be ef-
fective no sooner than 30 days after a written notice to revoke the desig-
nation has been served.

NOTE: Authority cited: Sections 208, 2 10 and 2 II .3, Health and Safety Code. Ref-
erence: Sections 210, 211.3 and 211.5, Health and Safety Code.

History

1. New section filed 3-20-81; effective thirtieth day thereafter (Register 81, No.
12).

2. Amendment filed 1 1-2-87; operative 12-2-87 (Register 87, No. 45).

§ 2594. Pertussis (Whooping Cough).

The patient shall be isolated in accordance with Section 2518 during
the early catarrhal period and for 21 days after the appearance of the typi-
cal paroxysmal cough. The isolation provisions shall be adequate to pre-
vent exposure of young children to the patient. Restrictions on contacts
not required.

§ 2595. Physically Handicapped Children

(See subchapter 3).

§ 2596. Plague. Cases and Suspect Cases to Be Reported
by Telephone.

(See Section 2502(c).)

(a) All laboratory specimens submitted for the purpose of establishing
a diagnosis shall be examined only in such laboratories as may be desig-
nated by the Director of the State Department of Health Services. When-
ever a laboratory receives a specimen for the laboratory diagnosis of sus-
pected human plague, such laboratory shall communicate immediately
by telephone with the State Department of Health Services Microbial
Diseases Laboratory for instruction.

(b) Isolation. The patient shall be confined in a dwelling free from ro-
dents and fleas and shall be isolated in accordance with Section 25 1 6. The
period of isolation shall not be terminated until two days after all symp-

toms have subsided. In cases of pneumonic plague, strict precautions
against respiratory transmission of the disease shall be enforced.

(c) Contacts. Contacts of cases of plague shall be kept under quaran-
tine until the health officer is satisfied that they have not contracted the
infection, except that contacts of cases of pneumonic plague shall be kept
in quarantine for a period of at least seven days after last exposure.
NOTE: Authority cited: Sections 100180, 100275, I20I30and 120145. Health and
SafetvCode. Reference: Sections 100180, 100275, 120145, 120190, 120215 and
120240. Health and Safety Code.

History

1 . Amendment filed 5-24-55; effective thirtieth dav thereafter (Reeister 55, No.
8).

2. Amendment of section heading and subsection (a) and new Nori-. filed
1 1-5-2001 as an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A
Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emer-
gency language will be repealed by operation of law on the following day.

3. Amendment of section heading and subsection (a) and new NoTi. refiled
3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9 ). A Cer-
tificate of Compliance must be transmitted to OAL by 7-1 -2002 or emergency
language will be repealed by operafion of law on the following day.

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

§2597. Q Fever.

No restrictions on cases or contacts.
History
1. New section filed 5-24-55; effective thirtieth day thereafter (Register 55. No.
8).

§ 2598. Pneumonia, Infectious (Except Pneumonic
Plague).

History
I. Repealer filed 5-24-55; effective thirtieth day thereafter (Register 55, No. 8).

§ 2600. Poliomyelitis, Acute Anterior.

The case shall be isolated in accordance with Section 25 1 8 for a period
of seven days from the onset of illness or for the duration of fever if long-
er. Restrictions on contacts is not required, except at the discretion of the
local health officer.

§ 2602. Psittacosis.

The patient shall be isolated in accordance with Section 2518 during
the acute stages. There are no restrictions on contacts.

§ 2603. Control of Pet Birds.

(a) The department or local health officers may quarantine any species
of pet birds imported into this State from states and countries where psit-
tacosis or other diseases transmitted by pet birds to human beings have
been reported by an official agency to be currently prevalent in pet birds.
Such quarantine shall remain in effect until removed by the department,
or local health officers, following proof that the quarantined birds are not
infected with psittacosis or other diseases transmissible by pet birds to
human beings.

(b) Whenever a pet bird or birds are suspected to be a source of human
disease or a pet bird or birds are infected with a disease which is a poten-
tial source of human disease and, in the opinion of the department or local
health officers, it is deemed necessary for the protection of the public, the
pet bird or birds shall be quarantined. Such quarantine shall remain in ef-
fect until the quarantine authority has evidence that the quarantined bird
or birds are not a hazard to the public's health. Such evidence may be ob-
tained by the following actions:

(1) A sufficient number of birds, such numbers to be specified by the
quarantine authority, are to be provided for laboratory testing in a labora-
tory approved by the department.

(2) If, upon completion of the necessary laboratory test no evidence is
found that the birds are infected with a disease hazardous to human
health, they may be released from quarantine. Such release shall be made
only by the quarantine authority.

(3) If upon completion of the necessary laboratory test there is evi-
dence that the bird or birds are infected with a disease hazardous to hu-
man health, the bird or birds shall remain under quarantine until the haz-
ard has been eliminated to the satisfaction of the quarantine authority.

Page 71

§ 2603.5

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(4) If, following treatment methods or other methods which may be
used to eliminate the hazard in the quarantined bird or birds, the quaran-
tine authority finds that the hazard to humans no longer exists, it may re-
lease the bird or birds from quarantine.

(5) The owner of the quarantined bird or birds shall have the option to
destroy the quarantined bird or birds if he so desires. In such case the
quarantine will be lifted following evidence that the infected premises
are thoroughly disinfected.

NOTE: Authority cited: Sections 100273 and 121745, Health and Safety Code.
Reference: Section 121745. Health and Safety Code.

History

1. Amendment of subsections (a)(3), (a)(4), (d) and (k) filed 12-15-67; effective
thirtieth day thereafter (Register 67, No. 50). For prior history, see Register 65,
No. 22.

2. Amendments of subsection (d) filed 8-10-70; effective thirtieth day thereafter
(Register 70, No. 33).

3. Amendment of subsections (a) and (f) filed 11 -20-85; effective upon filing pur-
suant to Government Code Section 1 1346.2(d) (Register 85, No. 47).

4. Change without regulatory effect of NOTE (Register 86, No. 32).

5. Change without regulatory effect repealing subsections (a)-(/), relettering sub-
sections, and amending NOTE filed 1-28-99 pursuant to section 100, title 1, Cal-
ifornia Code of Regulations (Register 99, No. 5).

§ 2603.5. Control of Psittacine Birds.

NOTE; Authority cited: Sections 208 and 2100, Health and Safety Code.

History

1. New section filed 11-2-55 as an emergency; effective upon filing (Register
55,No. 16).

2. Repealer filed 12-1 9-55; effective thirtieth day thereafter (Register 55, No. 1 8).

§ 2604. Rabies, Human.

The patient shall be isolated in accordance with Section 2518 during
the course of the disease. There are no restrictions on contacts of a human
case.

NOTE: Authority cited: Sections 102, 208 and 1900-2000, Health and Safety
Code.

History
1. Amendment filed 12-19-57; effective thirtieth day thereafter (Register 57, No.

22).

§ 2606. Rabies, Animal.

(a) Reporting. Any person having knowledge of the whereabouts of an
animal known to have or suspected of having rabies shall report the facts
immediately to the local health officer. The health officer shall likewise
be notified of any person or animal bitten by a rabid or suspected rabid
animal.

In those areas declared by the Director of the State Department of
Health Services to be rabies areas (See Section 1901.2, California Health
and Safety Code) the local health officer shall be notified when any per-
son is bitten by an animal of a species subject to rabies, whether or not
the animal is suspected of having rabies.

(b) Isolation. Any rabid animal, clinically suspected rabid animal, or
biting animal shall be isolated in strict confinement as follows:

(1) Isolation of Rabid Animals or Clinically Suspected Rabid Ani-
mals. Any rabid animal or clinically suspected rabid animal shall be iso-
lated in strict confinement under proper care and under the observation
of a licensed veterinarian, in a pound, veterinary hospital, or other ade-
quate facility in a manner approved by the local health officer, except
where such responsibility has been delegated to a comparable officer by
the governing body, and shall not be killed or released for at least 10 days
after the onset of symptoms suggestive of rabies, with the exception that
such animals may be sacrificed with permission of the local health officer
for the purpose of laboratory examination for rabies using the fluorescent
rabies antibody (FRA) test in an approved public health laboratory.

(2) Isolation of Biting Animals. At the discretion of the local health of-
ficer, any animal which bites or otherwise exposes a person shall be iso-
lated in strict confinement in a place and manner approved by the local
health officer and observed for at least 14 days (dogs and cats 10 days)
after the day of infliction of the bite, with the exception that the following
altemaUve to the 10 day isolation of dogs and cats is permitted — dogs or

cats which have been isolated in strict confinement under proper care and
under observation of a licensed veterinarian, in a pound, veterinary hos-
pital, or other adequate facility in a manner approved by the local health
officer, may be released from isolation by the local health officer after
five days of veterinary observation if upon conducting a thorough physi-
cal examination on the fifth day or more after infliction of the bite, the
observing veterinarian certifies that there are no clinical signs or symp-
toms of any disease. Notwithstanding the foregoing provisions, a local
health officer may authorize, with permission of the owner and other le-
gal restrictions permitting, the euthanasia of a biting animal for the pur-
pose of laboratory examination for rabies using the fluorescent rabies an-
tibody (FRA) test in an approved public health laboratory.

(3) Isolation of Biting Animals in Officially Declared Rabies Areas.
In officially declared rabies areas (see Section 1901 .2, California Health
and Safety Code) the isolation described in paragraph (2) above shall be
mandatory for any animal of a species subject to rabies that has bitten or
otherwise exposed a person, with the exception of rodents (members of
the order Rodentia) and rabbits and hares (members of the order Lago-
moi-pha).

(4) Laboratory Examination of Rabid Animals, Clinically Suspected
Rabid Animals or Bidng Animals Which Die or Have Been Killed. If any
rabid animal, clinically suspected rabid animal or biting animal dies or
has been killed, adequate specimens shall be obtained and examined in
a public health laboratory approved by the department. No person shall
destroy or allow to be destroyed the brain of an animal of a species subject
to rabies that has bitten or otherwise exposed a person before the destruc-
tion of such brain has been authorized by the local health department; pro-
vided, however, that the provisions of this paragraph (4) shall not apply
to rodents (members of the order Rodentia ) and rabbits or hares (mem-
bers of the order Lagomorpha ).

(c) Animal Contacts. Any animal of a species subject to rabies which
has been bitten by a known rabid or suspected rabid animal or has been
in intimate contact with a rabid or suspected rabid animal shall be quaran-
tined in a place and manner approved by the local health officer, except
where such responsibility has been delegated to a comparable officer by
the local governing body, for a period of six months or destroyed, with
the exception that the following alternatives are permitted in the case of
dogs and cats as follows:

(1 ) If a dog over one year of age has been vaccinated against rabies
within 36 months but not less than 30 days with a rabies vaccine of a type
approved by the Department for a maximum immunity duration of at
least 36 months, the dog may be revaccinated immediately (within 48
hours) in a manner prescribed by the Department and quarantined in a
place and manner approved by the local health officer for a period of 30
days following revaccination.

(2) If a dog under one year of age has been vaccinated against rabies
within 1 2 months but not less than 30 days with a rabies vaccine of a type
approved by the Department, the dog may be revaccinated immediately
(within 48 hours) in a manner prescribed by the Department and quaran-
tined in a place and a manner approved by the local health officer for a
period of 30 days.

(3) If a cat has been vaccinated within one year but not less than 30
days with an annual type feline rabies vaccine or if a cat has been vacci-
nated under one year of age with a 36-month type of feline rabies vaccine
within 12 months but not less than 30 days, the cat may be revaccinated
immediately (within 48 hours) in a manner prescribed by the Department
and quarantined in a place and manner approved by the local health offi-
cer for a period of 30 days following revaccination.

(4) If a cat over one year of age has been vaccinated against rabies and
has been vaccinated within 36 months and more than 30 days with a
36-month type feline rabies vaccine, the cat may be revaccinated imme-
diately (within 48 hours) in a manner prescribed by the Department and
quarantined in a place and manner approved by a local health officer for
a 30-day period following revaccination.

Page 72

Title 17

State Department of Health Services

§ 2606.6

NOTI-;; Authority cited: Sections 208. 1905 and 3123, Health and Safety Code.
Reference: Sections 1901. 1903. 1903. 1907 and 3123, Health and Safety Code.

History

1. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No.
19). For prior history see Register 65. No. 8.

2. Amendment of subsection (c) filed 5-20-77; effective thirtieth day thereafter
(Regi.ster77. No. 21).

3. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No.

5).

§ 2606.2. Rabies Quarantine.

If rabies i.s knov/n to exist within an area, the local health officer may
establish a rabies quarantine and shall define the boundaries of the quar-
antine area and specify the animals subject to quarantine, and all such ani-
mals within the quarantined area shall be kept in strict confinement upon
the private premises of the owner, keeper or harborer at all times until the
quarantine is terminated by the local health officer.
NOTE: Authority cited: Sections 102, 208 and 1900-2000, Health and Safety
Code.

History

1 . New section filed 1 2-19-57; effective thirtieth day thereafter (Register 57, No.
22).

2. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No.
19).

§ 2606.4. Officially Declared Rabies Areas.

(a) Administration and Enforcement. For purposes of administration
and enforcement of Section 1920, California Health and Safety Code, in
officially declared rabies areas, the following shall apply:

( 1 ) Licensing and Vaccination Procedure. The vaccination of dogs
four months of age or older as required by subdivision (b), Section 1920,
California Health and Safety Code, shall be held a requisite to licensing
as required under subdivision (a) therein. Completion of the licensing
procedure consists of issuance of a license tag or a vaccination tag bear-
ing the license data and shall be carried out only after presentation of a
current valid official vaccination certificate. Current copies of the Com-
pendium of Canine Rabies Vaccines approved by the Department, to-
gether with the maximum immunity duration periods prescribed by the
Department for each type product, are available upon request from the
Veterinary Public Health Unit, Infectious Disease Section, California
Department of Health Services, 2151 Berkeley Way, Berkeley, Califor-
nia, 94704, telephone (415) 540-2391.

(2) Vaccination Certificates. Official vaccination certificates must
show:

(A) the name, address and telephone number of the dog's owner;

(B) the description of the dog, including breed, color, age, and sex;

(D) the type of rabies vaccine administered;

(E) the name of the manufacturer; and

(F) the lot number of the vaccine used.

Such certificates shall bear the signature of the veterinarian adminis-
tering the vaccine or a signature authorized by him, and in addition such
certificate shall be stamped, printed, or typed with his name, address and
telephone number for legibility, with the exception that at dog vaccina-
tion clinics conducted pursuant to Section 1 920(f) of the Health and Safe-
ty Code, vaccination certificates approved by the local health officer may
be used provided that the specific clinic is identified upon the vaccination
certificate and records are maintained containing the information speci-
fied under items (E) and (F) above.

(3) Interval Permitted for Procurement of License. The vaccination of
dogs four months of age against rabies as required under subdivision (b).
Section 1920, California Health and Safety Code, and the license re-
quired by subdivision (a) of said section shall be procured not later than
30 days after the dog attains the age of four inonths. The license renewal
shall be procured not later than 60 days after expiration of the previously
issued license.

(4) Rabies Control Activities Reporting. During such time as a county
is under official declaration as a rabies area, each local official responsi-

ble for the various phases of local dog or rabies control within each city,
county and city or cities, or county shall make quarterly rabies control ac-
tivities reports to and on forms furnished by the Department. Such reports
shall be submitted to the Department by the local officials responsible for
the various phases of local dog or rabies control through the local health
officer so as to reach the Department not later than 30 days following
each quarter.

(b) Vaccination of Dogs Against Rabies. Dogs shall be considered to
be properly vaccinated for the purposes of Section 1920, California
Health and Safety Code, when injected at four months of age or older
with an approved canine rabies vaccine and rcvaccinated in accordance
with the following conditions:

(1) Primary Immunization. Primary immunization shall be defined as
the initial inoculation of an approved canine rabies vaccine administered
to young dogs between the ages of 4 to 12 months.

(2) Minimum Age for Rabies Vaccination. The minimum age for
which rabies immunization of dogs shall be accepted for purposes of
dog-owner compliance with requirements for rabies vaccination and for
purposes of issuance of dog licenses (See Section 2606.4(a)(1)) is 4
months.

(3) Revaccination Intervals. Dogs shall be rcvaccinated one year (12
months) after the primary immunization with an approved type of rabies
vaccine. Dogs receiving vaccination after primary immunization or any
dog receiving its initial rabies vaccination over 12 months of age shall be
re vaccinated thereafter at least once every three years (36 months) with
an approved type rabies vaccine.

(c) Issuance of Dog Licenses. In no instances shall a dog license be is-
sued for a period beyond the date upon which revaccination is due except,
following primary immunization in a local jurisdiction which is on a
fixed one-year licensing period, a license may be issued for a period be-
yond the revaccination date if early revaccination cannot be required in
accordance with subdivision (d).

(d) Notwithstanding the rabies revaccination intervals specified in
Section 2606.4(b)(3) above, local authorities may require revaccination
prior to issuance of a license provided that revaccination against rabies
in no instance shall be required sooner than one year ( 1 2 months) follow-
ing a primary immunization or sooner than 2 years (24 months) following
a vaccination of dogs vaccinated over one year (12 months) of age.
NOTE: Authority cited: Sections 208 and 1905. Health and Safety Code. Refer-
ence: Sections 1905 and 1920, Health and Safety Code.

History

1. New section filed 12-19-57; effective thirtieth day thereafter (Regi.stcr 57, No.

22).

2. Amendment filed 5-5-71; effective thirtieth day thereafter (Register 71, No.
19).

3. Amendment filed 5-20-77; effective thirtieth day thereafter (Register 77, No.

21).

4. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No.

5).

§ 2606.6. Importation of Dogs.

All dogs four months of age or older imported into this State for any
purpose shall be accompanied by a certificate issued by a licensed veteri-
narian, stating that the dog or dogs have been vaccinated against rabies
within 30 months of the date of importation for dogs vaccinated over 1 2
months of age or within 12 months for dogs vaccinated under 12 months
of age with a canine rabies vaccine of a type approved by the Department
for an immunity duration of at least 36 months.

NOTE: Authority cited: Sections 208 and 1905, Health and Safety Code. Refer-
ence: Sections 1905 and 1920(b), Health and Safety Code.

History

1 . New Section filed 12-19-57; effective thirtieth day thereafter (Register 57. No.

22).

2. Amendment filed 5-5-71; effective thirtieth dav thereafter (Register 71, No.
19).

3. Amendment filed 5-20-77; effective thirtieth day thereafter (Register 77, No.
21).

4. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No.
5).

Page 73

§ 2606.8

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 2606.8. Skunk Rabies.

(a) Due to the presence of rabies in skunks in California and in many
other states and the resultant hazard to the public health of rabies devel-
oping in skunks kept as pets, no person shall:

( 1 ) trap or capture skunks for pets.

(2) trap, capture or hold skunks in captivity for sale, barter, exchange
or gift,

(3) transport skunks from or into the state except as provided under (b)
below.

(b) The importation of skunks into (California or the exportation of
skunks from the State is prohibited except by permit from the California
State Department of Health Services to a recognized zoological garden
or a research institution.

NOTE: Authority cited: Sections 208 and 1905, Health and Safety Code. Refer-
ence: Section 1905, Health and Safety Code.

History

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No.
21).

2. Amendment filed 1-27-86; effective thirtieth day thereafter (Register 86, No.

5).

§ 2608. Relapsing Fever.

(a) (Tick-borne). There are no restrictions on case or contacts.

(b) (Louse-borne) Cases and Suspect Cases to Be Reported by Tele-
phone or Telegraph. (See Section 2501(c).) The patient shall be confined
during the clinical phase of the disease in a dwelling or room free of ro-
dents or lice. There are no restrictions on contacts. All lice and louse eggs
on the patient's body, hair, or clothing shall be destroyed. Household
contacts shall be louse-free.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

§2610. Rheumatic Fever, Acute.

There are no restrictions on case or contacts.
History
1. Amendment filed 5-24-55; effecdve thirtieth day thereafter (Register 55, No.
8).

§ 261 1 . Rocky IVIountain Spotted Fever.

There are no restrictions on case or contacts.
History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

§ 2612. Salmonella Infections (Other Than Typhoid Fever).

(a) Any illness in which organisms of the genus Salmonella (except the
typhoid bacillus) have been isolated from feces, blood, urine or patholog-
ical material shall be reported as a Salmonella infection. A culture of the
organisms on which the diagnosis is established shall be submitted first
to a local public health laboratory and then to the State Microbial Dis-
eases Laboratory for definitive identification. The period of isolation in
accordance with Section 25 1 8 shall be until clinical recovery. The patient
shall be subject to supervision by the local health officer who may re-
quire, at his discretion, release specimens of feces for testing in a labora-
tory approved by the State Department of Health Services.

However, no patient shall be released from supervision to engage in
any occupation involving the preparation, serving or handUng of food,
including milk, to be consumed by individuals other than his immediate
family, nor to engage in any occupation involving the direct care of chil-
dren or of the elderly or of patients in hospitals or other institutional set-
tings until two successive authentic specimens of feces taken at intervals
of not less than 24 hours, beginning at least 48 hours after cessation of
specific therapy, if any was administered, have been determined, by a
public health laboratory approved by the State Department of Health Ser-
vices to be negative for Salmonella organisms. (See Section 2534.)

(b) Carriers. Any person who harbors Salmonella organisms three
months after onset is defined as a convalescent carrier and may be re-
stricted at the discretion of the local health officer.

Any person continuing to harbor Salmonella organisms one year after
onset is a chronic carrier. Any person who gives no history of having had
Salmonellosis or who had the illness more than one year previously who
is found to harbor Salmonella organisms on two successive specimens
taken not less than 48 hours apart is also considered to be a chronic carri-
er.

Chronic carriers of Salmonella, other than S. typhosa, shall be re-
stricted at the discretion of the local health officer.

NOTE: Authority cited: Sections 208 and 3123, Health and Safety Code. Refer-
ence: Section 3123. Health and Safety Code.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment filed 10-1 8-61 ; effective thirtieth day thereafter (Register 61 , No.
21).

3. Amendment filed 1 1-25-83; effective thirtieth day thereafter (Register 83, No.
48).

§ 261 2.1 . Turtle Salmonellosis.

(a) Except as otherwise provided in this section, it shall be unlawful
to import, sell or offer for sale or distribution to the public any live
turtle(s) with a carapace length of less than 4 inches.

(b) The Department or any authorized representative thereof, or any
local health officer or his representative may order the humane destruc-
tion of any turtle(s) that are unlawful to import, sell or offer for sale or
distribution to the public under subsection (a) above.

(c) The Department or any authorized representative thereof, or any
local health officer or his representative may quarantine turtles, take sam-
ples of tank water or any other appropriate samples of or from turtles of-
fered for sale or distribution for the purpose of testing for Salmonella and
Arizona organisms. The Department or any local health officer may order
the immediate humane destruction of any lot of turtles found contami-
nated with Salmonella, Arizona, or other organisms which may cause or
have caused disease in humans.

(d) Shipments of turtles under 4 inches in carapace length are per-
mitted to a governmental agency, or to a recognized research or educa-
tional institution for research or teaching purposes or to a zoological gar-
den for display.

(e) The following warning shall be posted conspicuously for buyer in-
formadon at every display of turtles for retail sale or distribution or where
the public may come in contact with turtles:

CAUTION: Turtles may transmit bacteria causing disease in humans. It is im-
portant to wash the hands thoroughly after handling turtles or material that had
contact with turtles. Do not allow water or any other substance that had contact
with turtles to come in contact with food or areas where food is prepared. Make
sure that these precautions are followed by children and others handling turtles.

(f) For each sale of turtle(s) at retail, a sales slip shall be issued by the
seller to the purchaser at time of the sale. The sales slip shall include the
name, address and telephone number of the purchaser and the seller, and
the date of sale. The sales slip shall have printed legibly on its front the
warning statement contained in subsection (e) above. The seller shall
keep a copy of the sales slip, which shall include the name, address and
telephone number of the purchaser for not less than one year, and keep
a complete record of all purchases, losses and other dispositions of
turtles.

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Sections 205, 3051-3053, Health and Safety Code.

History

1. New section filed 10-5-72; effective thirtieth day thereafter (Register 72, No.
41).

2. Amendment filed 10-7-77; effective thirtieth day thereafter (Register 77, No.
41).

§ 2613. Shigella Infections (Dysentery, Bacillary).

(a) The period of isolation in accordance with Section 2518 shall be
until the acute symptoms have subsided.

Page 74

Title 17

State Department of Health Services

§2626

The palicnt shall be subject to supervision by the local health officer
who may require, at his discretion, release specimens of feces for testing
in a laboratory approved by the State Department of Health Services.
However, no patient shall be released from supervision to engage in any
occupation involving the preparation, serving or handling of food, in-
cluding milk, to be consumed by individuals other than his immediate
family, nor to engage in any occupation involving the direct care of chil-
dren or of the elderly or of patients in hospitals or other institutional set-
tings until two successive authentic specimens of feces or of rectal swabs,
taken at intervals of not less than 24 hours, beginning at least 48 hours
after cessation of specific therapy, if any was administered, have been de-
termined, by a public health laboratory approved by the State Department
of Health Services, to be negative for Shigella organisms. (See Section
2534.)

(b) Contacts. Restrictions on contacts shall be at the discretion of the
local health officer.

NOTE; Authority cited: Sections 208 and 3123, Health and Safety Code. Refer-
ence: Section 3123, Health and Safety Code.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

2. Amendment filed 10-18-61; effective thirtieth day thereafter (Register 61, No.
21).

3. Amendment filed 1 1-25-83; effective thirtieth day thereafter (Register 83, No.
48).

§ 2614. Smallpox (Variola). Cases and Suspect Cases to
Be Reported by Telephone.

(See Section 2502(c).)

(a) Patient. The patient shall be isolated in accordance with Section
25 1 6 until the scabs have separated and the scars have completely healed.

(b) Household Contacts. Household contacts shall be quarantined for
at least 17 days after last exposure, except that the local health officer
may, at his discretion, when the patient is properly isolated, release from
quarantine persons who shall submit to vaccination against smallpox and
prove to the satisfaction of the local health officer that the vaccination is
successful. Such persons shall remain in quarantine until released by the
local health officer.

(c) Casual Contacts. A person who has been exposed to the risk of con-
tracting the disease by proximity to a case or to a suspected case of small-
pox, shall be quarantined for a period not less than 17 days from the last
date of exposure. Such persons may be released from quarantine if evi-
dence of protection against smallpox is established to the satisfaction of
the local health officer.

(d) Vaccination. The local health officer shall provide at public ex-
pense, as available, smallpox vaccination for persons who have been ex-
posed to a case or suspected case of smallpox.

(e) Laboratory. Whenever a laboratory receives a specimen for the lab-
oratory diagnosis of smallpox (variola), such laboratory shall communi-
cate immediately by telephone with the State Department of Health Ser-
vices Viral Rickettsial Disease Laboratory for instruction.

NOTE: Authority cited : Sections 1 00 1 80, 1 00275, 1 20 1 30 and 1 201 45, Health and
Safety Code. Reference: Sections 100180, 100275, 120130, 120190, 120195 and
120215, Health and Safety Code.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment of section heading and section and new Note filed 1 1-5-2001 as
an emergency; operative 1 1-3-2001 (Register 2001, No. 45). A Certificate of
Compliance must be transmitted to OAL by 3-5-2002 or emergency language
will be repealed by operation of law on the following day.

3. Amendment of section heading and section and new Note refiled 3-1-2002 as
an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of
CompHance must be transmitted to OAL by 7-1-2002 or emergency language
will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

§ 2616. Streptococcal Infections, Hemolytic (Including

Scarlet Fever and Streptococcal Sore Throat).

(a) The patient shall be isolated in accordance with Section 2518 for
not less than seven days from onset. Patients treated with an effective an-
tibiotic may be released upon clinical recovery.

(b) Contacts. Household contacts should be kept under frequent medi-
cal observation for the development of streptococcal disease. Restriction
on contacts is not required, except at the discretion of the local health offi-
cer.

History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8).

§2617. Syphilis.

(See Section 2636 on Venereal Diseases.)

§2618. Tetanus.

There are no restrictions on case or contacts.
History

1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

§ 2620. Trachoma.

The patient shall be isolated in accordance with Section 2518 during
the acute stages and when not under medical treatment satisfactory to the
health officer. There are no restrictions on contacts.

§ 2622. Trichinosis.

The local health officer shall make an investigation to determine the
source of infection. If the suspected source is a commercial food product,
the health officer shall report the fact at once to the State Department of
Public Health. There are no restrictions on case or contacts.

§ 2624. Tuberculosis.

A person having or suspected of having tuberculosis in a communica-
ble stage shall be considered as fulfilling the requirements of modified
isolation as long as he is under adequate medical supervision and ob-
serves the instructions issued by the local health officer. The isolation
shall be adequate for the protection of persons residing within the house-
hold as well as the public.

A person having tuberculosis in a communicable stage, who refuses
to observe the instructions of the local health officer and thereby need-
lessly exposes others to infection, shall be placed in strict isolation at
home until such time as the local health officer feels that such isolafion
is no longer necessary for the protection of the public; and, in the event
that such household isolafion proves inadequate for the protection of
members of the household or community, the pafient shall be placed in
isolafion in quarters designated by the local health officer, until such time
as such isolafion is no longer necessary for the protecfion of the public.

The person officially in charge of a sanatorium or other place where
tuberculosis patients are cared for shall be responsible for immediately
nofifying the health officer in whose territory a patient resides whenever
such pafient having tuberculosis in a communicable stage leaves the in-
stitution.

In every case in which a non-communicable tuberculous pafient has
been placed in a nursing home the local health officer or his deputy shall
be responsible for the confinued surveillance of such a pafient to ensure
that he remains non-communicable.

History
1 . Amendment filed 12-22-69; effective thirtieth day thereafter (Register 69, No.

52).

§ 2626. Tularemia. Cases and Suspect Cases to Be
Reported by Telephone.

(See Section 2502(c).)

There are no restricfions on case or contacts. Whenever a laboratory
receives a specimen for the laboratory diagnosis of suspected human tu-
laremia, such laboratory shall communicate immediately by telephone
with the State Department of Health Services Microbial Diseases Labo-
ratory for instruction.

Page 75

§2628

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Note: Authority cited: Sections 100180, 100275 and 120130, Health and Safety
Code. Reference: Sections 100180, 100275, 120130 and 120190, Health and Safe-
ty Code.

History

1 . Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.
8).

2. Amendment of section heading and section and new NoTK filed 1 1-5-2001 as
an emergency; operative 1 1-5-2001 (Register 2001, No. 45). A Certificate of
Compliance must be transmitted to OAL by 3-5-2002 or emergency language
will be repealed by operation of law on the following day.

3. Amendment of section heading and section and new Nori. refiled 3-1-2002 as
an emergency; operative 3-1-2002 (Register 2002. No. 9). A Certificate of
Compliance must be transmitted to OAL by 7-1-2002 or emergency language
will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

§ 2628. Typhoid Fever.

(a) Case. A culture of the organism on which the diagnosis of typlioid
fever is established shall be submitted first to a local public health labora-
tory and then to the State Microbial Diseases Laboratory for phage typ-
ing. The patient shall be isolated in accordance with Section 2518 until
clinical recovery. The patient shall remain subject to supervision by the
local health officer until three successive specimens of feces and urine
taken at least 24 hours apart, beginning at least one week after disconti-
nuation of specific therapy and not earlier than one month after onset of
disease, have been found negafive for typhoid bacilli at a public health
laboratory approved by the State Department of Health Services. If any
one of this series is positive, cultures of both urine and feces shall be re-
peated at intervals of 1 month during the 12-month period following on-
set, until at least three sets of negative cultures are obtained. The padent
shall not take any part in the preparation, serving, or handling of milk or
other food to be consumed by individuals other than his immediate fami-
ly, or parficipate in the management of a dairy, milk distribuUng plant,
boarding house, restaurant, food store, or any place where food is pre-
pared or stored, or engage in any occupation involving the direct care of
young children or the elderly or of pafients in hospitals or other institu-
tional settings until release specimens have been obtained, as described
above, and are negative for typhoid organisms. (See Section 2534.)

(b) Contacts. There are no restrictions on contacts, except that any
member of the patient's household shall not take part in the preparauon,
serving, or handling of milk or other food to be consumed by individuals,
other than the immediate family except at the discretion and under the re-
strictions of the local health officer.

(c) Definition of Carriers. ( 1 ) Convalescent Carriers: Any person who
harbors typhoid bacilli for three or more months after onset is defined as
a convalescent carrier. Convalescent carriers may be released when three
consecutive negative specimens of feces and urine taken at intervals of
not less than one month, beginning at least one week after discontinua-
tion of specific therapy are obtained. Such release may be granted at any
time from 3-12 months after onset.

(2) Chronic Carriers: If the person continues to excrete typhoid bacilli
for more than 12 months after onset of typhoid fever, he is defined as a
chronic carrier. Any person who gives no history of having had typhoid
fever or who had the disease more than one year previously, and whose
feces or urine are found to contain typhoid bacilli on two separate exami-
nations at least 48 hours apart, confirmed by State Microbial Diseases
Laboratory, is also defined as a chronic carrier. All carriers shall be re-
ported to the local health officer. Such reports shall be kept confidential
and shall not be divulged to persons other than the carrier and his immedi-
ate family, except as may be required for the protection of the public
health.

(3) Other Carriers: A person should be held under surveillance if ty-
phoid bacilli are isolated from surgically removed tissues, organs, e.g.,
gallbladder, kidney, etc., or from draining lesions such as osteomyelitis.
If the person continues to excrete typhoid bacilli for more than 12 months
he is defined as a chronic carrier and may be released after safisfying the
criteria for other chronic carriers.

(d) Carrier Restricfions and Supervision. When any known or sus-
pected carrier of this disease is reported to the local health officer, he shall
make an investigation and submit a report to the State Department of
Health Services. He shall have performed laboratory work as defined in
subsecUon (e) below. Any known or suspected carrier of this disea.se
shall be subject to modified isolation and the provisions of this isolaUon
shall be considered as fulfilled during such period as he complies with
the instnictions issued by the State Department of Health Services and
the local health officer.

(1 ) Restrictions. Instructions shall be given to the carrier in writing by
the local health officer.

(2) Supervision. The local health officer or his representadve shall
communicate with each carrier living within his jurisdiction at least twice
a year to learn of any changes in the carrier's address, occupation or acti-
vifies and to determine whether all instructions are being carried out. The
local health officer shall submit a report to the State Department of Health
Services every six months on each carrier in his jurisdicUon. Any
changes of address shall be reported immediately.

(e) Laboratory Tests. Whenever laboratory tests are required for the
release of typhoid cases or carriers, the tests shall be taken by the local
health officer or his representatives under such conditions that he can cer-
tify as to their being authentic specimens of the individual, and shall be
submitted to a public health laboratory approved by the State Department
of Health Services. Cultures from release speciinens which are found
posifive by the approved laboratory shall be forwarded to the State Divi-
sion of Laboratories for phage typing.

(f) Requirements for Release of Chronic Carriers. Authority for Re-
lease of Carriers. Any person ascertained to be a chronic typhoid carrier
may be released from supervision by the Director of the State Department
of Health Services or his designated representative provided the carrier
applies for such release through his local health officer and fulfills the re-
quirements specified by the Director of the State Health Department or
his designated representadve.

(1 ) Fecal Carriers. A person who has been determined to be a chronic
fecal carrier may be released if six successive authendc stool and urine
specimens taken at intervals of not less than one month are determined
to be negative by a public health laboratory approved by the State Depart-
ment of Health Services. If any one of these specimens is posidve. he
shall not be released unless the carrier condition has been cured by chole-
cystectomy, or by such other methods as are acceptable to the State De-
partment of Health Services. The necessary requirements for such re-
lease will be submitted to the carrier and to the local health officer by the
State Department of Health Services when application for the release is
submitted.

(2) Cholecystectomy. The local health officer or, in areas not served
by a local health department, the Director of the State Department of
Health Services, shall be notified before a cholecystectomy is undertaken
unless a specimen of duodenal contents, containing bile, has been found
positive for typhoid bacilli, since in some cases the infection is not local-
ized in the gall bladder. The patient shall be released under the same con-
ditions as outiined for a fecal carrier.

(3) Urinary Carriers. A person who has been determined to be a chron-
ic urinary carrier may be released if six successive authentic urine speci-
mens taken at intervals of not less than one month are determined to be
negative by a public health laboratory approved by the State Department
of Health Services. If any one of these specimens is positive, he may be
released following the surgical removal of the infected kidney or by such
other methods as are acceptable to the State Department of Health Ser-
vices. The necessary requirements for such release will be submitted to
the carrier and to the local health officer by the State Department of
Health Services when apphcation for the release is submitted.

NOTE: Authority cited: Sections 208 and 3123, Health and Safety Code. Refer-
ence: Section 3123, Health and Safety Code.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

Page 76

Title 17

State Department of Health Services

§2636

2. Amendment filed 10-18-61; effective thirtieth day thereafter (Register 61, No.
21).

3. Amendment filed 1 1-25-83; effective thirtieth day thereafter (Register 83, No.

48).

§ 2630. Typhus Fever (Flea-Borne, Endemic Type).

The patient shall be confined during the clinical phase of the disease
in a dwelling or room free of rodents, fleas or lice. There are no restric-
tions on contacts.

History
1. Amendment filed 5-24-53; effective thirtieth day thereafter (Register 55, No.

8).

§ 2632. Typhus Fever (Louse-Borne, Epidemic Type).

Cases and Suspect Cases to Be Reported by
Telephone or Telegraph.

(See Section 250 1 (c). ) The patient shall be confined during the clinical
phase of the disease in a dwelling or room free of rodents or lice. All lice
and louse eggs on the patient's body, hair, or clothing shall be destroyed.
Household contacts shall be louse-free. There are no other restrictions
on contacts.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8.)

§ 2636. Venereal Diseases.

(a) Sections 2636 to 2636(m) inclusive pertain to the venereal diseases
and, unless otherwise specified, shall include syphilis, gonococcus infec-
tion, granuloma inguinale, lymphogranuloma venereum, and chancroid.
(See Chapter 765, Statutes 1947; also Section 21 100, Health and Safety
Code.)

(b) Reports Confidential. Reports of examinations, cases, investiga-
tions and all records thereof made under the regulations for the control
of venereal diseases shall be confidential and not open to public inspec-
tion and no part thereof divulged, except as may be necessary for the pres-
ervation of the public health.

(c) Report of Unusual Prevalence. When the local health officer,
through investigation, becomes aware of unusual prevalence of venereal
diseases, or of unusual local conditions favoring the spread of these dis-
eases, he shall report the fact at once to the State Department of Health
Services.

(d) Parents or Guardians Responsible for Compliance of Minors. The
parents or guardians of minors suffering from a venereal disease shall be
legally responsible for the compliance of such minors with the require-
ments of the regulations relating to the venereal diseases.

(e) Certification. Each local health officer shall take every proper
means of repressing prostitution, inasmuch as it is the most prolific
source of the venereal diseases. Health officers and physicians shall not
issue certificates of freedom from venereal diseases to known prostitutes,
as such certificates may be used for purposes of solicitation.

(0 Diagnosis. The local health officer may require the submission of
such specimens as may be designated from cases of venereal disease for
examination in a laboratory approved by the State Department of Health
Services. The local health officer may require any physician in atten-
dance on a person infected with a venereal disease or suspected of being
infected with a venereal disease to submit such specimens as approved
by the State Department of Health Services provided, however, nothing
shall prevent the physician or individual from having additional exami-
nation made elsewhere.

(g) Instruction to the Patient. It shall be the duty of the physician in at-
tendance on a person having a venereal disease, or suspected of having
a venereal disease, to instruct such patient in precautionary measures for
preventing the spread of the disease, the seriousness of the disease, and
the necessity for treatment and prolonged medical supervision, and the
physician shall, in addition, furnish approved literature on these subjects.
Approved literature for distribution to patients may be secured from the
State Department of Public Health and the local health departments free
of charge.

(h) Investigation. All city, county and other local health officers are
hereby directed to use every available means to ascertain the existence
of, and immediately to investigate, all reported or suspected cases of ve-
nereal disease in the infectious stages within their several territorial juris-
dictions, and to ascertain the sources of such infections. The attending
physician, in every case of venereal disease coming to him for treatment,
shall endeavor to discover the source of infection, as well as any sexual
or other intimate contacts which the patient was in the communicable
stage of the disease. The physician shall make an effort, through the
cooperation of the patient, to bring these cases in for examination and,
if necessary , treatment. If, within 10 days of identification, any such
source of infection or any such contact has not given satisfactory evi-
dence of being under the care of a physician, such person shall be re-
ported to the health officer, the physician's name being kept confidential
in any investigation by the health department. In cases in which prosti-
tutes are named as sources of infection, all obtainable information as to
name, description, residence, etc., shall be given to the health officer at
once.

In carrying out such investigations, all health officers are hereby in-
vested with full powers of inspection, examination and isolation of all
persons known to be infected with a venereal disease in an infectious
stage, or suspected of being infected with a venereal disease in an infec-
tious stage and are hereby directed:

(1) To make such examinations as are deemed necessary of persons
reasonably suspected of having a venereal disease in an infectious stage.

(2) When the individual to be examined is a woman, to provide the ser-
vices of a woman physician if such physician is available, when so re-
quested by the individual to be examined.

(3) To isolate such person, whenever deemed necessary for the protec-
tion of the public health. In establishing isolation the health officer shall
proceed as provided in Sections 2636(i), 2636(j), 2636(1) and 2636(m).

(4) Pursuant to Secfion 3 194.5 of the Health and Safety Code, a person
employed by a Public Health Department shall meet the following train-
ing requirements as a prerequisite to the performance of venipuncture or
skin puncture:

(A) Possess a statement signed by a licensed physician and surgeon
stating that the individual named in such statement has received adequate
training in the proper procedure to be employed in the performance of ve-
nipuncture and skin puncture.

(B) In order to receive such statement, the venereal disease case inves-
tigator shall be trained by a licensed physician and surgeon. The trainee
shall observe and receive sufficient instruction and demonstration of the
proper technique and procedure to be employed in the performance of ve-
nipunctures and skin punctures; in turn, the physician and surgeon shall
then observe the procedure and technique of the trainee.

(C) When such training has been completed by the trainee to the satis-
facfion of the physician and surgeon, such physician and surgeon shall
execute a statement that the venereal disease case investigator has re-
ceived adequate training in the proper procedure to be employed in the
performance of venipuncture and skin puncture.

Satisfacfion of these training requirements shall be in addifion to other
requirements of Section 3194.5 of the Health and Safety Code.

(i) Isolation. Any person who presents himself (or herself) to any phy-
sician or person for treatment or diagnosis of any venereal disease except
late syphilis shall be considered to be in modified isolation. The require-
ments of this isolation shall be considered fulfilled if the patient remains
under adequate and proper treatment until the completion of the course
of treatment, except in instances in which, because of occupation, suspi-
cion of prostitution, or other reason, the health officer deems more strict
isolation necessary to safeguard other persons.

(j) Violation of Isolation to be Reported. Whenever any person while
in the infectious or potentially infectious stage of a venereal disease,
lapses from treatment for a period of more than 1 0 days after the time ap-
pointed for such treatment, the said diseased person shall be deemed to
have violated the requirements of isolation, and the physician or person
in attendance upon such case shall report the same at once to the local

Page 76.1

§2638

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

health department, giving the person's name, address, and report num-
ber, together with such other information as requested on the card pro-
vided for this purpose, except that this sliall not be required in instances
in which a report has been received that the patient is under treatment
elsewhere.

(k) If any person has knowledge that a person infected with a venereal
disease is failing to observe adequate precautions to prevent spreading
infection, he shall report the facts at once to the local health officer.

(/) Gonorrhea. A case of gonococcus infection of the genitourinary
tract shall be regarded as subject to isolation until the local health officer
is reasonable satisfied that the disease is no longer communicable.

(m) Syphilis. A case of syphilis shall be regarded as subject to isolation
until, under treatment, all syphilitic lesions of the skin or mucous mem-
brane are completely healed and a competent clinical examination fails
to show the presence of any area from which infection may be spread.
Any patient who refuses or otherwise fails to receive a full course of a
currently accepted method of treatment, or who discontinues treatment
prematurely, may be subjected to strict isolation if the health officer
deems it necessary.

NOTE: Authority cited: Sections 102.208 and 3194.5, Health and Safety Code.
Reference: SecUon 3194.5, Health and Safety Code.

History

1 . New subsecdon (h)(4) filed 2-14-73; effective thirtieth day thereafter (Register
73, NO. 7).

§ 2638. Viral Hemorrhagic Fevers (e.g., Crimean-Congo,
Ebola, Lassa and Marburg Viruses). Cases and
Suspect Cases to Be Reported by Telephone.

(See Section 2502(c).)

(a) Patient. The patient shall be isolated in accordance with Section
25 1 6. Strict barrier isolation and patient blood, secretion and excreta pre-
cautions shall be enforced. The patient shall be instructed to refrain from
unprotected sexual activity until secretions are free of virus or for 3
months after illness onset.

(b) Laboratory. Whenever a laboratory receives a specimen for labora-
tory diagnosis of suspected viral hemorrhagic fevers, such laboratory
shall communicate immediately by telephone with the State Department
of Health Services Viral and Rickettsial Disease Laboratory for instruc-
tions.

NOTE: Authority cited: Sections 100180, 100275, 120130, 120145 and 120175,
Health and Safety Code. Reference: Sections 100180, 100275, 120130, 120185,
120190, 120195, 120215 and 120240, Health and Safety Code.

History

1 . New section filed 1 1-5-2001 as an emergency; operative 1 1-5-2001 (Register

2001, No. 45). A Certificate of Compliance must be transmitted to OAL by
3-5-2002 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register

2002, No. 9). A Certificate of Compliance must be transmitted to OAL by
7-1-2002 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 3-1-2002 order transmitted to OAL 6-26-2002
and filed 7-16-2002 (Register 2002, No. 29).

§ 2640. Yellow Fever Cases and Suspect Cases to Be
Reported by Telephone or Telegraph.

(See Section 2501(c).) The case shall be confined during the clinical
phase of the disease in a room satisfactorily protected against mosqui-
toes. Contacts shall be kept under observation for a period of seven days
after the date of last exposure.

History
1. Amendment filed 5-24-55; effective thirtieth day thereafter (Register 55, No.

8).

Article 3.5. Reporting of Human
Immunodeficiency Virus (HIV) Infection

Subarticlel. Definitions

§ 2641 .5. Alternative Testing Site.

"Alternative Testing Site" means an anonymous HIV testing site
funded by the California Department of Public Health, administered by
a county health department and operated pursuant to Health and Safety
Code, Sections 120890-120895.

Note. Authority cited: Sections 1 20 1 25, 1 201 30, 1 3 1 080 and 1 3 1 200, Health and
Safety Code. Reference: Sections 120175, 120775. 120885-120895, 121025,
131051, 131052, 131056 and 131080, Health and Safety Code.

History
l.Newarticle3.5(subarticles 1 and 4), subarticle 1 (sections 2641. 5-2641. 90) and

section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).
2. Amendment of section and Notf. filed 2-6-2008; operative 2-6-2008 (Register

2008, No. 6).

§ 2641 .1 0. Anonymous Counseling and Testing Program.

"Anonymous Counseling and Testing Program" means a program of-
fering HIV counseling and testing while maintaining anonymity of the
patient.

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and
121025, Health and Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641 .1 5. Anonymous HIV Test.

"Anonymous HIV Test" means an HIV test that maintains the ano-
nymity of the patient.

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and
121025, Health and Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641 .20. Biological Specimen.

"Biological specimen" means any material that is derived from the hu-
man body.

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and
Safety Code. Reference: Section 1206, Business and Professions Code; and Sec-
tions 100180, 101160, 120175, 120775, 120885-120895 and 121025, Health and
Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641 .25. Confidential HIV Test.

"Confidential HIV Test" means an HIV test that links the test results
to the patient in a restricted manner to protect against unauthorized dis-
closure of the identity of the patient.

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and
Safety Code. Reference: Sections 100180, 120175, 120775 and 121025, Health
and Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641 .30. Confirmed HIV Test.

"Confirmed HIV test" means:

(a) a procedure which verifies the presence of HIV infection as deter-
mined by any clinical laboratory test or HIV Test Algorithm or examina-
tion used to detect the presence of HIV, a component of HIV, or antibo-
dies to or antigens of HIV, including the HIV antibody (HIV-Ab), HIV
p-24 antigen, Western blot (Wb), and immunofluorescence antibody
tests; or

(b) for the purpose of this Article, all tests used to monitor HIV infec-
tion, including HIV nucleic acid detection.

Page 76.2

Title 17

State Department of Health Services

§ 2641.57

NOTE: Authority cited: Sections 120125, 120130, 121022, 131080 and 131200,
Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1265 and 1281,
Business and Professions Code; and Sections 101 150, 101 160, 120175, 120775,
120885-120895, 121025, 120917, 121022, 131051. 131052, 131056 and 131080,
Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of subsection (a) and NOTH filed 1-8-2007 as an emergency pur-
suant to Health and Safety Code section 121022, subdivision (c); operative
1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be trans-
mitted to OAL by 5-8-2007 or emergency language will be repealed by opera-
tion of law on the following day.

3. Amendment of subsection (a) and NOTi-; refiled 4-18-2007 as an emergency
pursuant to Health and Safety Code section 121022, subdivision (c); operative
5-9-2007 (Register 2007. No. 16). A Certificate of Compliance must be trans-
mitted to OAL by 9-6-2007 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment ofsubsection (a) and NoTH refiled with further amendment of Note
8-21-2007 as an emergency pursuant to Health and Safety Code section
12] 022. subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certifi-
cate of Compliance must be transmitted to OAL by 1-7-2008 or emergency lan-
guage will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including further amendment
of subsection (a), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Regis-
ter 2008. No. 6).

§ 2641 .35. Department.

"Department" means the California Department of Public Health, Of-
fice of AIDS.

NOTti: Authority cited: Sections 120125, 120130. 131080 and 13 1200, Health and
Safetv Code. Reference: Sections 120175, 120775, 120885-120895, 121025,
131051, 131052, 131056 and 131080, Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of section and Note filed 2-6-2008; operative 2-6-2008 (Register
2008, No. 6).

§ 2641 .45. Health Care Provider.

"Health care provider" means an individual who obtains the results of
an HIV test or HIV test algorithm or submits a biological specimen to a
laboratory for a test to detect the presence of HIV, a component of HIV
or antibodies to or antigens of HIV, receives the test results and is;

(a) licensed under the provisions of Business and Professions Code,
Division 2 (Healing Arts) and acting within his or her scope of practice,
or;

(b) a designee of a physician and surgeon acting under the general su-
pervision of that physician or surgeon, or;

(c) a person working in a pubHcly-funded confidential counseling and
testing program acting under the general supervision of, and following
the protocols approved by, the local Health Officer for the local health
department.

NOTE: Authority cited: Sections 101160, 120125, 120130, 121022, 131080 and
131200, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1281
and 1285, Business and Professions Code; and Sections 120175, 120775,
120885-120895, 120917, 121022, 121025, 131051, 131052, 131056 and 131080,
Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of first paragraph and Note filed 1-8-2007 as an emergency pur-
suant to Health and Safety Code section 121022, subdivision (c); operative
1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be trans-
mitted to OAL by 5-8-2007 or emergency language will be repealed by opera-
tion of law on the following day.

3. Amendment of first paragraph and Note refiled 4-18-2007 as an emergency
pursuant to Health and Safety Code secfion 121022, subdivision (c); operative
5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be trans-
mitted to OAL by 9-6-2007 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment of first paragraph and Note refiled with further amendment of
Note 8-21-2007 as an emergency pursuant to Health and Safety Code section
121022, subdivision (c); operafive 9-7-2007 (Register 2007, No. 35). A Certifi-
cate of Compliance must be transmitted to OAL by 1-7-2008 or emergency lan-
guage will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-2 1-2007 order, including further amendment
of first paragraph, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Resis-
ter 2008, No. 6).

§ 2641 .50. Health Officer and Local Health Officer.

"Health Officer and Local Health Officer" means the officer ap-
pointed by the local governing body (county, city, and district), as de-
fined in Section 2500.

NOTE: Authority cited: Sections 1 00 1 80, 1 00275, 1 20 1 25 and 1 20 1 30, Health and
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and
121025. Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002. No. 18).

§ 2641 .55. HIV/AIDS Case Report.

"HIV/AIDS Case Report" means California Departinent of Public
Health HIV/AIDS Confidential Case Report form. Adult (CDPH 8641 A
(05/07)) or Pediatric (CDPH 864 IP (05/07)), hereby incorporated by ref-
erence in this Article and available from the local health department or
the Department.

NOTE: Authority cited: Sections 120125, 120130, 121022, 131080 and 131200,
Health and Safety Code. Reference: Secfions 120175, 120775, 120885-120895,
121022, 121025, 121035, 131019, 131051, 131052, 131056 and 131080, Health
and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Amendment of section and Note filed 1-8-2007 as an emergency pursuant to
Health and Safety Code section 121022, subdivision (c); operative 1-8-2007
(Register 2007. No. 2). A Certificate of Compliance must be transmitted to OAL
by 5-8-2007 or emergency language will be repealed by operation of law on
the following day.

3. Amendment of section and Note refiled with further amendments 4-18-2007
as an emergency pursuant to Health and Safety Code section 121022. subdivi-
sion (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Com-
pliance must be transmitted to OAL by 9-6-2007 or emergency language will
be repealed by operation of law on the following day.

4. Amendment of section and Note refiled with further amendment of Note
4-18-2007 as an emergency pursuant to Health and Safety Code section
121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). ACertifi-
cate of Compliance must be transmitted to OAL by 1-7-2008 or emergency lan-
guage will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including further amendment
of section, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008,
No. 6).

§ 2641 .56. HIV/AIDS Confidentiality Agreement.

"HIV/AIDS Confidentiahty Agreement" means California Depart-
ment of Public Health HIV/AIDS Confidentiahty Agreement form
(CDPH 8689 (05/07)), hereby incorporated by reference and available
from the Department.

NOTE: Authority cited: Secfions 120125, 120130, 121022, 131080 and 131200,
Health and Safety Code. Reference: Secfions 120175, 120775, 120820,
120885-120895, 120975, 120980, 121022. 121025. 121035, 121110, 131019,
131051, 131052, 131056 and 131080, Health and Safety Code.

History

1 . New secdon filed 1 -8-2007 as an emergency pursuant to Health and Safety
Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No.
2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 4-1 8-2007 as an emergency pursuant to Health and Safety
Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007. No.
16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or
emergency language will be repealed by operation of law on the following day.

3. New section refiled with further amendment of NoTi-; 8-21-2007 as an emer-
gency pursuant to Health and Safety Code section 121022, subdivision (c): op-
erative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be
transmitted to OAL by 1-7-2008 or emergency language will be repealed by
operation of law on the following day.

4. Certificate of Compliance as to 8-21-2007 order, including further amendment
of section and Note, transmitted to OAL 1 2-2 1 -2007 and filed 2-6-2008 ( Reg-
ister 2008, No. 6).

§ 2641 .57. HIV Test Algorithm.

"HIV test algorithm" means any multi-test procedure that determines
the presence of HIV infection using confirmation protocols published in
the Centers for Disease Control and Prevenfion's Morbidity and Mortal-
ity Weekly Report (MMWR).

NOTE: Authority cited: Sections 120125, 120130. 121022. 131080 and 131200.
Health and Safety Code. Reference: Secfions 1206 and 1220. Business and Profes-
sions Code; and Sections 120917, 121022, 131051. 131052 and 131056. Health
and Safety Code.

Page 76.3

§ 2641.60

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1. New section filed 1-8-2007 as an emergency pursuant to Health and Safety
Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No.
2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 4-18-2007 as an eimergency pursuant to Health and Safety
Code section 121022. subdivision (c); operative 5-9-2007 (Register 2007, No.
16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or
emergency language will be repealed by operation of law on the following day.

3. New section refiled with further amendment of Notf 8-21-2007 as an emer-
gency pursuant to Health and Safety Code section 121022, subdivision (c): op-
erative 9-7-2007 (Register 2007. No. 35). A Certificate of Compliance must be
transmitted to OAL by 1-7-2008 or emergency language will be repealed by
operation of law on the following day.

4. Certificate of Compliance as to 8-2 1-2007 order, including further amendment
of section, transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008,
No. 6).

§ 2641 .60. Laboratory.

"Laboratory" means a 'clinical laboratory,' a 'physician office labora-
tory," or a 'public health laboratory,' as defined in Business and Profes-
sions Code. Section 1206, that is authorized to perform clinical laborato-
ry tests or examinations in California, or a clinical laboratory located
outside of the State of California that is licensed pursuant to Business and
Professions Code Section 1241(a) and that tests specimens originating in
California.

NOTE: Authority cited: Sections 1224 and 1288, Business and Professions Code;
and Sections 100180, 100275, 101160, 120125 and 120130, Health and Safety
Code. Reference: Sections 1206, 1220, 1241, 1265 and 1281, Business and Profes-
sions Code.

History
1. New section filed 5-2-2002: operafive 7-1 -2002 (Register 2002, No. 18).

§ 2641 .65. Laboratory Test.

"Laboratory test" means a clinical laboratory test or examination as
defined in Business and Professions Code, Section 1206(a)(4) and per-
formed by a laboratory as defined in this Article.

NOTE: Authority cited: Sections 1224 and 1288, Business and Professions Code;
and Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Ref-
erence: Sections 1202.5 and 1206. Business and Professions Code; and Section
101 160, Health and Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641.70. Local Health Department.

"Local health department" means the governing body providing pub-
lic health services to cities and/or counties, as identified in Health and
Safety Code, Section 101 185.

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and
121025, Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641 .75. Non-Name Code. [Repealed]

NOTE: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140,
Health and Safety Code. Reference: Sections 100180, 120175, 120775,
120885-120895 and 121025, Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. Repealer filed 1-8-2007 as an emergency pursuant to Health and Safety Code
section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A
Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emer-
gency language will be repealed by operation of law on the following day.

3. Repealer refiled 4-18-2007 as an emergency pursuant to Health and Safety
Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No.
16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or
emergency language will be repealed by operation of law on the following day.

4. Repealer refiled 8-21-2007 as an emergency pursuant to Health and Safety
Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No.
35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order transmitted to OAL
12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§ 2641 .77. Partial Non-Name Code. [Repealed]

NOTE: Authority cited: Sections 100180. 100275, 120125, 120130 and 120140
Health and Safety Code. Reference: Sections 100180, 120175, 120775,
120885-120895 and 121025. Health and Safety Code.

History

1 . New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

5. Certificate of Compliance as to 8-21-2007 order transmitted to OAL
12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§ 2641.80. Personal Information.

"Personal information" means an iBdividual's complete Social Secu-
rity Number, complete name or surname, home address, California driv-
er's license or identification number, electronic mail address or tele-
phone number.

NOTE: Authority cited: Sections 100180, 100275, 120125 and 120 130, Health and
Safety Code. Reference: Sections 100180, 120175. 120775, 120885-120895 and
121025, Health and Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641 .85. Publicly-Funded Confidential Counseling and
Testing Program.

"Publicly-funded Confidential Counseling and Testing Program"
means a program financed by federal, state or local governmental agen-
cies that provides confidential HIV tests to patients.
NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and
121025, Health and Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

§ 2641 .90. Soundex Code.

"Soundex code" means a phonetic, alphanumerical formula which is
used to convert the first letter and sequential consonants of an individu-
al's surname into an algorithm. The Soundex code instructions are identi-
fied by the Department as form DHS 8641 SC (9/01), hereby incorpo-
rated by reference in this Article.

NOTE: Authority cited : Sections 1 00 1 80, 1 00275, 1 20 1 25 and 1 201 30, Health and
Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and
121025, Health and Safety Code.

History
1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

Subarticle 4. Reporting Requirements

§ 2643.5. HIV Reporting by Health Care Providers.

(a) Each health care provider that orders a laboratory test used to iden-
tify HIV, a component of HIV, or antibodies to or antigens of HIV shall
submit to the laboratory performing the test a pre-printed laboratory req-
uisition form which includes all documentation as specified in 42 CFR
493. 11 05 (57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan.
19, 1993) and adopted in Business and Professions Code, Section 1220.

(b) The person authorized to order the laboratory test shall include the
following when submitting information to the laboratory:

(1) Complete name of patient; and

(2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and

(3) Patient gender (male, female, transgender male-to-female, or
transgender female-to-male); and

(4) Date biological specimen was collected; and

(5) Name, address, telephone number of the health care provider and
the facility where services were rendered, if different.

Page 76.4

Title 17

State Department of Health Services

§ 2643.10

(c) Each health care provider shall, within seven calendar days of re-
ceipt from a laboratory of a patient' s confirmed HIV test or determination
hy the health care provider of a patient's confirmed HIV test, report the
confirmed HIV test to the local Health Officer for the jurisdiction where
the health care provider facility is located. The report shall consist of a
completed copy of the HIV/AIDS Case Report form.

( 1 ) All reports containing personal information, including HIV/AIDS
Case Reports, shall be sent to the local Health Officer or his or her desig-
nee by:

(A) courier service, U.S. Postal Service Express or Registered mail, or
other traceable mail; or

(B) person-to-person transfer with the local Health Officer or his or
her designee.

(2) The health care provider shall not submit reports containing per-
sonal information to the local Health Officer or his or her designee by
electronic facsimile transmission or by electronic mail or by non-trace-
able mail.

(d) HIV reporting by name to the local Health Officer, via submission
of the HIV/AIDS Case Report, shall not supplant the reporting require-
ments in Article 1 of this Subchapter when a patient's medical condition
progresses from HIV infection to an Acquired Immunodeficiency Syn-
drome (AIDS) diagnosis.

(e) A health care provider who receives notification from an out-of-
state laboratory of a confirmed HIV test for a California patient shall re-
port the findings to the local Health Officer for the jurisdiction where the
health care provider facility is located.

(f) When a health care provider orders multiple HIV-related viral load
tests for a patient, or receives multiple laboratory reports of a confirmed
HIV test, the health care provider shall be required to submit only one
HIV/AIDS Case Report, per patient, to the local Health Officer.

(g) Nothing in this Subchapter shall prohibit the local health depart-
ment from assisting health care providers to report HIV cases.

(h) Information reported pursuant to this Article is acquired in confi-
dence and shall not be disclosed by the health care provider except as au-
thorized by this Article, other state or federal law, or with the written con-
sent of the individual to whom the information pertains or the legal
representative of that individual.

NOTE: Authority cited: Sections 120125, 120130, 120140, 121022, 131080 and
13 1200. Health and Safety Code. Reference: Sections 1202.5, 1206, 1206.5, 1220,
1241, 1265 and 1281, Business and Professions Code; and Sections 1603.1,
101160, 120175, 120250, 120775, 120885-120895, 120917, 120975, 120980,
121015, 121022, 121025, 121035, 121085, 131051, 131052, 131056 and 131080,
Health and Safety Code.

History

1 . New subarticle 4 (sections 2643.5-2643.20) and section filed 5-2-2002; opera-
tive 7-1-2002 (Register 2002, No. 18).

2. Amendment of section and Note filed 1-8-2007 as an emergency pursuant to
Health and Safety Code section 121022, subdivision (c); operative 1-8-2007
(Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL
by 5-8-2007 or emergency language will be repealed by operation of law on
the following day.

3. Amendment of section and Note refiled 4-18-2007 as an emergency pursuant
to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007
(Register 2007, No. 16). A Certificate of Compliance must be transmitted to
OAL by 9-6-2007 or emergency language will be repealed by operation of law
on the following day.

4. Amendment refiled 8-21-2007 with further amendment of Note as an emer-
gency pursuant to Health and Safety Code section 121022, subdivision (c); op-
erative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be
transmitted to OAL by 1-7-2008 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 8-21-2007 order, including redesignation of
former subsections (c)( 1 )A. and (c)( 1 )B. as subsections (c)( 1 )(A) and (c)(1)(B),
transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).

§ 2643.10. HIV Reporting by Laboratories.

(a) The laboratory director or authorized designee shall, within seven
calendar days of determining a confirmed HIV test, report the confirmed
HIV test to the Health Officer for the local health jurisdiction where the
health care provider facility is located. The report shall include the:

( 1 ) Complete name of patient; and

(2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and

(3) Patient gender (male, female, transgender male-to-female, or
transgender female-to-male); and

(4) Name, address, and telephone number of the health care provider
and the facility that submitted the biological specimen to the laboratory,
if different; and

(5) Name, address, and telephone number of the laboratory; and

(6) Laboratory report number as assigned by the laboratory; and

(7) Laboratory results of the test performed; and

(8) Date the biological specimen was tested in the laboratory; and

(9) Laboratory Clinical Laboratory Improvement Amendments
(CLIA) number.

(b)( 1 ) All reports containing personal information, including laborato-
ry reports, shall be sent to the local Health Officer or his or her designee
by:

(A) courier service, U.S. Postal Service Express or Registered mail, or
other traceable mail; or

(B) person-to-person transfer with the local Health Officer or his or
her designee.

(2) The laboratory shall not submit reports containing personal in-
formation to the local Health Officer or his or her designee by electronic
facsimile transmission or by electronic mail or by non-traceable mail.

(c) A laboratory that receives incomplete patient data from a health
care provider for a biological specimen with a confirmed HIV test, shall
contact the submitting health care provider to obtain the information re-
quired pursuant to Section 2643.5(b)(l )-(5), prior to reporting the con-
firmed HIV test to the local Health Officer.

(d) If a laboratory transfers a biological specimen to another laboratory
for testing, the laboratory that first receives the biological specimen from
the health care provider shall report confirmed HIV tests to the local
Health Officer.

(e) Laboratories shall not submit reports to the local health department
for confirmed HIV tests for patients of an Alternative Testing Site or oth-
er anonymous HIV testing program, a blood bank, a plasma center, or for
participants of a blinded and/or unlinked seroprevalence study.

(f) When a California laboratory receives a biological specimen for
testing from an out-of-state laboratory or health care provider, the
California director of the laboratory shall ensure that a confirmed HIV
test is reported to the state health department in the state where the biolog-
ical specimen originated.

(g) When a California laboratory receives a report from an out of state
laboratory that indicates evidence of a confirmed HIV test for a Califor-
nia patient, the California laboratory shall notify the local Health Officer
and health care provider in the same manner as if the findings had been
made by the California laboratory.

(h) Information reported pursuant to this Article is acquired in confi-
dence and shall not be disclosed by the laboratory except as authorized
by this Article, other state or federal law, or with the written consent of
the individual to whom the information pertains or the legal representa-
tive of the individual.

NOTE: Authority cited: Section 1224, Business and Professions Code; and Sec-
tions 120125, 120130, 120140, 121022. 131080 and 131200, Health and Safety
Code. Reference: Sections 1206, 1206.5. 1209, 1220, 1241, 1265, 1281 and 1288,
Business and Professions Code; and Sections 101150, 120175, 120775,
120885-120895, 120975, 120980. 121022, 121025, 121035, 131051, 1310.52,
131056 and 131080, Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

3. Amendment of section and Note refiled 4-18-2007 as an emergency pursuant
to Health and Safety Code section 121022, subdivision (c): operative 5-9-2007
(Register 2007, No. 16). A Certificate of Compliance must be transmiued to
OAL by 9-6-2007 or emergency language will be repealed by operation of law
on the following day.

4. Amendment refiled with further amendment of Note 8-21-2007 as an emer-
gency pursuant to Health and Safety Code section 121022, subdivision (c); op-

Page 76.5

§ 2643.15

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

crativc 9-7-2007 (Register 2007, No. ?5). A Certificate of Compliance must be
transmitted to OAL by 1-7-2008 or emergency language will be repealed by
operation of law on the following day.

3. Certificate of Compliance as to 8-21-2007 order, including redesignation of
former subsections (b)(l)A. and (b)(l iB. as subsections (b)(1)(A) and
(b)( 1 )(B), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Reaister 2008,
No. 6).

§ 2643.15. HIV Reporting by Local Health Officers.

(a) The local Health Officer or his or her authorized designee shall
match and unduplicate laboratory reports of confirmed HIV tests with the
local health department HIV/AIDS registry database and with HIV/
AIDS Case Reports received from health care providers and not entered
into the database.

(b) The Health Officer or his or her authorized designee shall, within
45 calendar days of receipt of a laboratory report of a confirmed HIV test,
submit unduplicated HIV/AIDS Case Reports to the Department.

( 1 ) HIV/AIDS Case Reports shall be sent by courier service, U.S. Post-
al Service Express or Registered mail, or other traceable mail to the
California Department of Public Health, Office of AIDS, HIV/AIDS
Case Registry.

(2) The local Health Officer or his or her authorized designee shall not
report confirmed HIV tests for patients of an Alternative Testing Site or
other anonymous counseling and testing program, a blood bank, a plasma
center, or for participants of a blinded and/or unlinked HIV seropreva-
lence study.

(c) The local Health Officer or his or her authorized designee shall not
submit an HIV/AIDS Case Report to the Department for an infant under
the age of 18 months, unless the infant's HIV infection is confirmed.

(d) All local health department employees and contractors shall sign
the HIV/AIDS Confidentiality Agreement prior to accessing confiden-
tial HIV-related public health records. All HIV/AIDS Confidentiality
Agreements shall be renewed at least once per year.

(e) Information reported pursuant to this Article is acquired in confi-
dence and shall not be disclosed by the local Health Officer or his or her
authorized designee except as authorized by this Article, other state or
federal law, or with the written consent of the individual to whom the in-
formation pertains or the legal representative of the individual.
NOTE; Authority cited: Sections 120125, 120130, 120140, 121022, 131080 and
131200, Health and Safety Code. Reference: Sections 120175, 120775, 120820,
120885-120895, 120975, 120980, 121015, 121022, 121025, 121035, 121085,
131019, 131051, 131052, 131056 and 131080, Health and Safety Code.

History

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

2. New subsection (d), subsection relettering and amendment of Note filed
1-8-2007 as an emergency pursuant to Health and Safety Code section 121022,
subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of
Compliance must be transmitted to OAL by 5-8-2007 or emergency language
will be repealed by operation of law on the following day.

3. New subsection (d), subsecfion relettering and amendment of NOTE refiled
4-18-2007 as an emergency pursuant to Health and Safety Code section
121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). ACertifi-
cate of Compliance must be transmitted to OAL by 9-6-2007 or emergency lan-
guage will be repealed by operation of law on the following day.

4. New subsection (d), subsection relettering and amendment of Note refiled with
further amendment of Note 8-21-2007 as an emergency pursuant to Health and
Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register
2007, No. 35). A Certificate of Compliance must be transmitted to OAL by
1-7-2008 or emergency language will be repealed by operation of law on the
following day.

5. Certificate of Compliance as to 8-21-2007 order, including further amendment
of subsection (b)(1), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Reg-
ister 2008, No. 6).

§ 2643.20. HIV Reporting Exemptions.

Alternative Testing Sites; other anonymous or unlinked HIV testing
programs; blood banks; plasma centers; and blinded and/or unlinked ser-
oprevalence studies are exempt from these HIV reporting regulations.
NOTE: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and
Safety Code. Reference: Secdons 100180, 120175, 120775, 120885-120895 and
121025, Health and Safety Code.

History
1. New secfion filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).

Article 4. Approval Procedures for Canine
Rabies Vaccines

§ 2650. Canine Rabies Vaccine Advisory Committee.

The Director shall appoint a Canine Rabies Vaccine Advisory Com-
mittee consisting of 6 to 8 members. The Committee's responsibility
shall be to assist the Department in evaluating the effectiveness of canine
rabies vaccines. Membership shall include individuals with recognized
professional expertise in at least one of the fields of immunology, virolo-
gy, epidemiology, public health and veterinary medicine. Committee
members shall serve without compensation but shall be reimbursed for
actual and necessary expenses incurred during service on the committee.
Canine rabies vaccines that have been approved by the Animal and Plant
Health Inspection Service (APHIS), U.S. Department of Agriculture,
shall be evaluated for the degree of effectiveness by the Canine Rabies
Vaccine Advisory Committee. In order to evaluate vaccine effectiveness
the committee shall:

(a) Review test data submitted by canine rabies vaccine manufacturing
firms, for approval of canine rabies vaccines.

(b) Make recommendations for Departmental approval or disapproval
of canine rabies vaccines.

(c) Make recommendations concerning approval of any variances
from the established standards for acceptance of canine rabies vaccines.
NOTE: Authority cited: Section 1920(b), Health and Safety Code. Reference: Sec-
tion 1920(b), Health and Safety Code.

History
1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

§ 2651 . Approval of Canine Rabies Vaccines.

(a) In order for a canine rabies vaccine to be approved for use in Cali-
fornia, it shall adhere to the following requirements:

(1) Meet Animal and Plant Health Inspection Service (APHIS) stan-
dards for sterility and safety. Evidence of product conformance to APHIS
Standards will be demonstrated by the United States Department of Agri-
culture (USDA) product licensing; and

(2) If an inactivated vaccine, it shall have a minimal relative potency
(RP) at vaccination of at least 2.0 as determined by the National Institute
of Health (NIH)Test for potency or if a modified live virus (MLV) vac-
cine it shall meet USDA potency Requirements; and

(3) Demonstrate an immunity duration of three or more years based on
an immunity duration challenge study conducted in conformity with sec-
tion 2652; and

(4) Comply with the origin and integrity of Rabies Vaccine Virus Re-
quirements in section 2653.

NOTE: Authority cited: Section 1920(b), Health and Safety Code. Reference: Sec-
tion 1920(b), Health and Safety Code.

History
1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

§ 2652. Immunity Duration-Challenge Studies.

(a) The demonstration of an acceptable immunity duration of three or
more years, as shown by adequate challenge studies in dogs, shall be re-
quired. However, the above challenge study shall not suffice for accep-
tance of a subsequent multiple vaccine product that contains the same ra-
bies vaccine as one of two or more component vaccines.

(b) Vaccine Trial Protocols. Vaccine trial protocols shall be submitted
to the Department by vaccine manufacturers prior to beginning the im-
munity duration challenge study. The protocol shall include animals, ma-
terials, methods and procedures. The protocol shall include the identifi-
cation number of each animal, its source and/or that of its mother, if
applicable, sex, age, breed and the name, address, and telephone number
of a contact person who can verify personal knowledge of the dog' s vac-
cination history. Annual progress reports and a final report of the
immunity-duration challenge study shall be submitted to the Depart-
ment. The reports shall include by date for each dog its rabies antibody
titers, other immunizations, medications, illnesses, unusual events and
death, if applicable, as well as any changes or developments in reference

Page 76.6

Title 17

State Department of Health Services

§2653

to animals, materials, methods, and procedures. The Department shall
supply firms with an outline to report the foregoing information. The out-
line will include the following items:

( 1 ) "Protocol for Proposed Rabies Vaccine Immunity Duration Chal-
lenge Study";

(2) "Procedures and Preliminary Data Attending Initiation of Canine
Rabies Vaccine Immunity Duration Challenge Study";

(3) "Progress Report: One Year Postvaccination";

(4) "Progress Report: Two Years Postvaccination";

(5) "Final Report";

(6) "Results of Challenge"; and

(7) "Progress Report for Three Years Postvaccination."

The Veterinary Public Health Unit, 714 P Street, Room 760, Sacra-
mento. California 95814 will provide this outline upon request.

(c) Dogs Used in Studies. No pound dogs or other dogs of undetermin-
able rabies vaccination history shall be used in the study. Dogs shall be
obtained from the original owner since birth or have verifiable histories.
Groups of vaccinates and control dogs shall be of approximately equal
composition, according to numbers, sex ratio (approximately 50:50),
age, and origin. As much as is possible, dogs of uniform size or confor-
mation shall be used. No dog shall be used which has had prior rabies im-
munization or which has detectable serum rabies neutralizing antibodies.
Dogs under 8 months of age used in studies shall not originate from
rabies-immunized mothers. No dog shall be over 1 1/2 years of age at
vaccination or when set aside as a control.

(d) Size of Challenge Groups. Challenge groups, both vaccinates and
nonimmunized controls, shall each consist of 30 or more dogs at chal-
lenge. Any additional (extra or back-up) dogs, intended to replace vacci-
nates or controls that die prior to challenge, shall be included in either the
vaccinate or the control group prior to the initiation of the study and sub-
sequently treated, sampled and reported on as either a vaccinate dog or
as a control dog. The use of additional sets of vaccinate and/or control
dogs to be challenged simultaneously, or at an earlier or later date, shall
not be recognized as representative of separate trials. Instead, the sero-
logical results subsequent to vaccination and the reactions to challenge
of all groups, sets, and individual dogs shall be included in the overall
analysis on a cumulative basis. Failed antibody response or failed reac-
tion to challenge at any time shall disqualify subsequent trial phases.

(e) Route and Site of Vaccination. MLV vaccines shall be inoculated
intramuscularly at one site in the thigh. Inactivated vaccines may be in-
oculated by any single route and single site which provides the required
protection against challenge at least 3 years post vaccination and is
shown to be safe. The exact site and route of inoculadon shall be de-
scribed.

(f) New Route and/or Site of Vaccination. If a firm changes its recom-
mended route and/or site of vaccination of a previously approved vac-
cine, the vaccine shall be tested as a new product, and the firm shall com-
plete another satisfactory immunity duration-challenge study of 3 years
or greater duration before the new route and/or site of vaccination shall
be approved.

(g) Additional Vaccinations. Excepting food and water, no vaccinate
or control dog shall be exposed to any vaccine, drug, or other substance
by any route within three weeks prior to any bleeding for antibody test
or within three weeks prior to or at any time after challenge with rabies
virus except at euthanasia.

(h) Serology. Standard serum virus-neutralization tests done in mice
(MSNT) or the rapid rabies fluorescent focus inhibition test (RFFIT)
shall be used in comparing the immunogenicity of different products. No
substitute test reagents or substitute tests shall be accepted.

( 1 ) Test results shall be reported for the vaccinate group and controls.
Serum virus-neutralization titrations shall be performed on sera of ( 1 ) all
dogs prior to vaccinadon; (2) vaccinates at the end of post vaccination
months 1 , 3, 6, 9, 1 2, 1 8, 24, 30 and 36 just prior to challenge; (3) controls
at the end of month 36 just prior to challenge; and (4) survivors just prior
to euthanasia.

(2) At years post vaccination, all vaccinate dogs shall have demon-
strable serum rabies antibody titers, the median titer being equal to, or
greater than. 1 : 15 by the MSNT or an equivalent test.

(3) At 3 years post vaccination, at least 90 per cent of vaccinates shall
have demonstrable titers by the MSNT, the median titer being equal to,
or greater than, 1 : 10 by the MSNT or an equivalent test.

(i) Incidental Deaths or Deletions. There shall be a complete account-
ing for all dogs used in the study, including any that die or are killed after
the start of the study or any withdrawn from participation for any reason.
Each such dog shall be accounted for by dates and details of illness, treat-
ment and death, the cause of death with supportive diagnostic test results,
and rabies serology records. Each such dog shall be tested for rabies in-
fection by Fluorescent Rabies Antibody (ERA) test followed by the
mouse inoculation test if the FRA test is negative.

(j) Challenge Virus and Dose. The challenge virus inoculum shall be
infective carnivore salivary gland suspension supemate of a North Amer-
ican carnivore "street" rabies virus. The dose of challenge virus given
shall be estimated by titration prior to challenge and confirmed by titra-
tion of residual challenge inoculum. The dose of challenge virus shall be
as low as possible while still achieving a mortality of 80-100 per cent
in controls. The dose given each dog shall not exceed 200,000 mouse in-
tracranial 50 percent lethal doses (MICLD50), or a demonstrably equiva-
lent dose as determined by an alternate method of titration.

(k) Challenge Route and Procedure. Only challenge virus inoculum
shall be inoculated into the masseter muscles of vaccinate dogs or control
dogs at any time. Challenge virus shall be inoculated intramuscularly into
the masseter muscles, the viral dose being divided into two equal parts
for bilateral inoculation. Should a challenge route or site other than the
intramasseter route be used, the firm employing the route or site shall
demonstrate in a trial previously approved by the Department, the effec-
tiveness and appropriateness of the post challenge holding period and
compensate for any related increase in incubation period and decrease in
susceptibility. All animals, vaccinates and controls, shall be challenged
at the same time, either on an alternate basis (i.e., a vaccinate, followed
by a control, followed by a vaccinate, etc.) or the vaccinates shall be chal-
lenged first and the controls challenged immediately afterwards. A sepa-
rate needle and a separate syringe shall be used for each dog.

(1) Individual Enclosure for Each Challenged Dog. Each dog shall be
kept in an individual enclosure, preventing its contact with any other ani-
mal.

(m) Post challenge Observation Period. Challenged dogs, retained in
isolation, shall be observed for a minimum of 90 days prior to final bleed-
mg, euthanasia, and rabies testing of their brains.

(n) Mortality in Challenged Animals. With rare exceptions, all vacci-
nates shall survive challenge. Eighty to one hundred percent of chal-
lenged controls shall die of rabies.

(o) Confirmatory Rabies Diagnostic Tests on Brains of Dogs that Die
and on Brains of Survivors. Brains of dogs that die and brains of dogs that
survive challenge shall be tested by fluorescent rabies antibody (FRA)
test, followed by mouse-inoculation test if the former is negadve; dead
mice shall be confirmed as rabies-infected by FRA test on their brains.
Dogs that die at any dme following administration of a live virus vaccine
shall be tested for possible rabies vaccine virus infection, using tests suit-
able to disclose, recover, and identify the strain of vaccine virus.
NOTE: Authority cited: Section 1920(b), Health and Safety Code. Reference: Sec-
tion 1920(b), Health and Safety Code.

History

1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

§ 2653. Origin and Integrity of Rabies Vaccine Virus.

The Department shall be provided with comprehensive information on
the origin, passage level, and sub-passage history of rabies viruses used
in the development and production of rabies vaccines being submitted for
approval. The integrity of the rabies virus used in the production of the
vaccine shall be maintained without further modification once the \ ae-
cine is approved for use in the Department's rabies control program.

Page 76.7

§2800

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTI:; Authority cited: Section 1920(b), Healtli and Safety Code. Reference: Sec-
tion 1920(b), Health and Safety Code.

History
1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).

Subchapter 2. Adult Health

History
Repealer of Subchapter 2 (Sections 2700, 2705, 2710 and 271 1 ) filed 9-27-85;
effective thirtieth day thereafter (Register 85, No. 39). For prior history, see
Register 58, No. 10.

Subchapter 2.5. Disorders Characterized
by Lapses of Consciousness

Article 1. Definitions

§ 2800. Activities of Daily Living.

"Activities of daily living" means bathing, dressing, feeding oneself,
brushing one's teeth, and performing more complex tasks such as gro-
cery shopping, cooking, management of personal finances, and operat-
ing a motor vehicle.

Note: Authority cited: Sections 100275 and 1039QO, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History

1. New subchapter 2.5 (articles 1-2, sections 2800-2812), article 1 (secdons
2800-2808) and section filed 5-17-2000; operative 10-2-2000 (Register 2000,
No. 20).

§ 2802. Alzheimer's Disease and Related Disorders.

"Alzheimer's disease and related disorders" means those illnesses that
damage the brain causing irreversible, progressive confusion, disorienta-
tion, loss of memory and judgment.

NOTE: Authority cited: Sections 100275 and 103900, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History
1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§ 2804. Diagnose.

"Diagnose" means to identify the existence of a medical condition in
a patient.

Note: Authority cited: Sections 100275 and 103900, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History
1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§ 2806. Disorders Characterized by Lapses of
Consciousness.

(a) "Disorders characterized by lapses of consciousness" means those
medical conditions that involve:

( 1 ) a loss of consciousness or a marked reduction of alertness or re-
sponsiveness to external stimuli; and

(2) the inability to perform one or more activities of daily living; and

(3) the impairment of the sensory motor functions used to operate a
motor vehicle.

(b) Examples of medical conditions that do not always, but may prog-
ress to the level of functional severity described in subsection (a) of this
section include Alzheimer's disease and related disorders, seizure disor-
ders, brain tumors, narcolepsy, sleep apnea, and abnormal metabolic
states, including hypo- and hyperglycemia associated with diabetes.
NOTE; Authority cited: Sections 100275 and 103900, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History
1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

§ 2808. Sensory Motor Functions.

"Sensory motor functions" means the ability to integrate seeing, hear-
ing, smelling, feeling, and reacting with physical movement, such as de-

pressing the brake pedal of the car to stop the car from entering an inter-
section with a green traffic light to avoid hitting a pedestrian crossing the
street.

NOTE: Authority cited: Sections 100275 and 103900, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History
1. New section filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

Article 2. Reporting

§ 2810. Reporting Requirements.

(a) Except as provided in Section 2812, a physician and surgeon shall
notify the local health officer within seven (7) calendar days of every pa-
tient 14 years of age or older, when a physician and surgeon has diag-
nosed a disorder characterized by lapses of consciousness (as defined in
Section 2806) in a patient.

(b) The report prepared pursuant to subsection (a) of this section shall
include:

(1) The name, address, date of birth, and diagnosis of the patient; and

(2) The name, address, and phone number of the physician and sur-
geon making the report.

NOTE: Authority cited: Sections 100275 and 103900, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History
1. New article 2 (sections 2810-2812) and section filed 5-17-2000; operative
10-2-2000 (Register 2000, No. 20).

§ 2812. Exceptions to Reporting.

A physician and surgeon shall not be required to notify the local health
officer of a patient with a disorder characterized by lapses of conscious-
ness if:

(a) The patient's sensory motor functions are impaired to the extent
that the patient is unable to ever operate a motor vehicle, or

(b) The patient states that he or she does not drive and states that he or
she never intends to drive, and the physician and surgeon believes these
statements made by the patient are true, or

(c) The physician and surgeon previously reported the diagnosis and,
since that report, the physician and surgeon believes the patient has not
operated a motor vehicle, or

(d) There is documentation in the patient's medical record that another
physician and surgeon reported the diagnosis and, since that report, the
physician and surgeon believes the patient has not operated a motor ve-
hicle.

NOTE; Authority cited: Secdons 100275 and 103900, Health and Safety Code.
Reference: Section 103900, Health and Safety Code.

History
1. New secfion filed 5-17-2000; operative 10-2-2000 (Register 2000, No. 20).

Subchapter 3. Services for Physically
Handicapped Children

Group 1 . Minimum Standards for the Care

of Physically Handicapped Children for

Local Communities in California

Article 1. General

§ 2890. Confidential Nature of Crippled Children's
Records.

NOTE: Authority cited: Secfions 208, 249, 268, and 271, Health and Safety Code.

History

1 . New section filed 6-22-50 as an emergency; effective upon filing (Register 20,
No. 6). For history of Group 1, see note to § 2900.

2. Change without regulatory effect pursuant to Section 100, Title 1, CaHfornia
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 1 3). (ED.

Page 76.8

Title 17

State Department of Health Services

§2922

NOTE: See Title 22. Division 2, Subdivision 7, Sections 41 6 10-42801 , not con-
secutive.)

§ 2900. Case Finding and Reporting.

NOTIi: Authority cited for § 2900 to 2904, inclusive: Sections 208 and 249, Health
and Safety Code.

History

1 . New Group 1 ( § 2900 to 2904. inclusive) filed 1 2-28-45; effective thirtieth day
thereafter (Register 3).

2. Sections renumbered 2900 to 2905, inclusive, and new Section 2901 filed
3-4^7; effective thirtieth day thereafter (Register 7).

3. Amended Group 1 (§ 2900 to 2905, inclusive) filed 2-8-52; effective thirtieth
day thereafter (Regi.ster 27, No. 3).

4. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealins section filed 3-9-90 (Register 90, No. 1 3). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Secfions 41610-42801 , not con-
secutive.)

§2901. Definition.

NOTE: Authority cited: Sections 208 and 429.35, Health and Safety Code. Refer-
ence: Section 429.35, Health and Safety Code.

History

1. Amendment filed 9-18-52; effective thirtieth day thereafter (Register 29, No.
6).

2. Repealer and new section filed 5-7-75; effecdve thirtieth day thereafter (Regis-
ter 75, No. 19).

3. Amendment of subsecfion (a)(20) and new subsection (a)(21) filed 5-10-79 as
an emergency; effective upon filing (Register 79. No. 19).

4. Certificate of Compliance transmitted to OAH 9-7-79 and filed 9-12-79 (Reg-
ister 79, No. 37).

5. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing secdon filed 3-9-90 (Register 90, No. 13). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Secfions 41610-42801, not con-
secutive.)

§ 2902. Records and Reports.

History

I. Change without regulatory effect pursuant to Secfion 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 4161 0-42801 , not con-
secutive.)

§ 2903. Diagnostic Services.

NOTE: Additional authority cited: Section 1509, Health and Safety Code.

History

1. Amendment filed 12-8-55; effective thirtieth day thereafter (Register 55, No.
18).

2. Amendment filed 2-9-67; effective thirtieth day thereafter (Register 67, No. 6).

3. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801, not con-
secutive.)

§ 2904. Treatment.

History

1. Amendment filed 12-8-55; effective thirtieth day thereafter (Register 55, No.
18).

2. Amendment filed 2-9-67; effective thirtieth day thereafter (Register 67, No. 6).

§ 2905. After-Care Services.

History

1. Amendment filed 4-29-53; effective thirtieth day thereafter (Register 53, No.
8).

2. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 4161 0-42801 , not con-
secutive.)

§ 2906. Authorization for Services.

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code, Reference:
Art. 2, Ch. 2, Pt. 1, Div. 1, Health and Safety Code.

History

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
17).

2. Change without regulatory effect pursuant to Section 100, Title 1. California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 1 3). (1:1).
NOTE: See Title 22, Division 2, Subdivision 7, Sections 4161 0-4280 1 , not con-
secutive.)

Article 2.

Immunization Adverse Reaction
Fund

§ 2907. Bone Marrow Transplantation for Cancer.

NOTE: Authority cited: Section 208(a), Health and Safety Code. Reference: Sec-
tion 273, Health and Safety Code.

History

1 . New section filed 1 2-26-86; effective thirtieth day thereafter (Register 86, No.
52).

2. Change without regulatory effect pursuant to Section 100, Title 1. California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801 , not con-
secutive.)

§ 2910. Program Administration.

NOTE: Authority cited: Sections 208 and 429.35, Health and Safety Code. Refer-
ence: Section 429.35, Health and Safety Code.

History

1 . New Article 2 (Sections 29 10-29 14, not consecutive) filed 5-1 0-79 as an emer-
gency; effective upon filing (Register 79, No. 19).

2. Certificate of Compliance transmitted to OAH 9-7-79 and filed 9-12-79 (Reg-
ister 79, No. 37).

3. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 1 3). (ED.
NOTE: See Titie 22, Division 2, Subdivision 7, Sections 4 1 61 0-4280 1 , not con-
secutive.)

§2912. Use of Fund.

NOTE: Authority cited: Sections 208 and 429.35, Health and Safety Code. Refer-
ence: Section 429.35, Health and Safety Code.

History

1. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 1 3). (ED.
NOTE: See Titie 22, Division 2, Subdivision 7, Sections 4161 0-4280 1 , not con-
secutive.)

§2914. Extensive l\/ledical Care.

NOTE: Authority cited: Sections 208 and 429.35, Health and Safety Code. Refer-
ence: Section 429.35, Health and Safety Code.

History
1. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 1 3). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 4161 0-4280 1 , not con-
secutive.)

Article 3.

Podiatrist and Family Practice
Physician Services

§ 2920. California Children Services (CCS).

NOTE: Authority cited: Section 208 (a). Health and Safety Code. Reference: Sec-
tion 255.5 and 255.6, Health and Safety Code.

History

1. New section filed 6-3-87; operative 7-3-87 (Register 87, No. 24).

2. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 1 3 ). ( ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 4161 0-4280 1 , not con-
secutive.)

§ 2921 . California Children Services (CCS) Panel.

NOTE: Authority cited: Section 208(a), Health and Safety Code. Reference: Sec-
tions 255.5 and 255.6, Health and Safety Code.

History

1. New section filed 6-3-87; operative 7-3-87 (Register 87, No. 24).

2. Change without regulatory effect pursuant to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 1 3 ). ( ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 4161 0^2801 , not con-
secutive.)

§ 2922. Expertise in the Care of Children.

NOTE: Authority cited: Section 208(a), Health and Safety Code. Reference: Sec-
tion 255.6, Health and Safety Code.

Page 76.9

§2923

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1. New section filed 6-3-87; operative 7-3-K7 (Register 87, No. 24).

2. Change without regulatory effect pursuani to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Resister 90, No. 1 3). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 4161 0-42801 , not con-
secutive.)

§ 2923. General Supervision.

NOTii: Authority cited: Section 208(a), Health and Safety Code. Reference: Sec-
tion 255.5, 262 and 268, Health and Safety Code.

History

1. New section filed 6-3-87; operative 7-3-87 (Register 87, No. 24).

2. Change without regulatory effect pursuani to Section 100, Title 1, California
Code of Regulations, repealing section filed 3-9-90 (Register 90, No. 13). (ED.
NOTE: See Title 22, Division 2, Subdivision 7, Sections 41610-42801 , not con-
secutive.)

Article 4. Genetically Handicapped Persons
Program

§ 2930. Genetically Handicapped Persons Program.

The Genetically Handicapped Persons Program (GHPP) is a health
care program within the California Children Services (CCS) Branch
which provides medical care and other related services for persons with
the genetically handicapping conditions specified in Section 2932 of this
chapter.

NOTE: Authority cited: Sections 208(a) and 341, Health and Safety Code. Refer-
ence: Section 341, Health and Safety Code.

History

1 . New section filed 1 2-28-87 as an emergency; operative 1 2-28-87 (Register 88,
No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-27-88.

2. Certificate of Compliance transmitted to OAL 4-4-88 and filed 5^1-88 (Regis-
ter 88, No. 19).

§ 2931 . California Children Services/Genetically

Handicapped Persons Program Special Care
Center.

(a) A California Children Services (CCS)/Genetically Handicapped
Persons Program (GHPP) Special Care Center is a medical center which
provides diagnostic and treatment services (inpatient, outpatient and
home) to CCS clients under 2 1 years of age who have GHPP eligible con-
ditions, and to GHPP clients over 21 years of age.

(b) California Children Services/Genetically Handicapped Persons
Program Special Care Centers include the following:

(1) Hemophilia Center

(2) Cystic Fibrosis Center

(3) Sickle Cell Disease Center

(4) Specified Inherited Neurologic Disease Center

(5) Amniocentesis Center

(6) Metabolic Disease Center

NOTE: Authority cited: Sections 208(a) and 341, Health and Safety Code. Refer-
ence: Sections 340, 341 and 342, Health and Safety Code.

History

1 . New section filed 1 2-28-87 as an emergency; operative 12-28-87 (Register 88,
No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-27-88.

2. Certificate of Compliance transmitted to OAL 4-4-88 and filed 5-4-88 (Regis-
ter 88, No. 19).

§ 2932. Medical Eligibility— Conditions.

(a) The following medical conditions are eligible for services through
the GHPP program:

( 1 ) Hemophilia, which includes any congenital hereditary hemoirhag-
ic state due to a defect in the hemostatic mechanism resulting from a defi-
ciency or abnormality in one of the plasma clotting factors or platelets
including:

(A) Factor I deficiency

(B) Factor II deficiency

(D) Factor VII deficiency

[The next page is 77.

Page 76.10

Title 17

State Department of Health Services

§2950

•

(E) Factor VIII deficiency

(F) Factor IX deficiency

(G) Factor X deficiency
(H) Factor XI deficiency

(1) Factor XIII deficiency

(J) von Willebrand's Disease

(K) Congenital liereditary platelet deficiency diseases or dysfunction
such as congenital thrombasthenia (Glanzman's thrombasthenia) and
thrombocytopathia

(2) Cystic fibrosis

(3) Hemoglobinopathies with anemia including:

(A) Sickle Cell Disease, but not sickle cell trait

(B) Thalassemia

(4) Chronic degenerative neurological diseases:

(A) Huntington's Disease

(B) Joseph's Disease

1 . Hereditary spastic paraplegia

2. Roussy-Levy Syndrome

3. Olivopontocerebellar degeneration

4. Refsum's disease

5. Charcot-Marie-Tooth Syndrome

(5) The following metabolic diseases:

(A) Disorder of amino-acid transport and metabolism

1. Phenylketonuria

2. Other disturbances of armoatic amino-acid metabolism
a. Tyrosinemia

3. Disturbances of branched chain amino-acid metabolism

a. Disturbances of metabolism of leucine, isoleucine, valine

b. Hypervalinemia

c. Intermittent branched-chain ketonuria

d. Leucine-induced hypoglycemia

e. Leucinosis

f. Maple syrup urine disease

g. Propionic and methylmalonic acidemias
h. Lactic and pyruvate metabolism disorders
i. Hereditary orotic (pyrimidine acidemia)

4. Disturbances of sulphur bearing amino-acid metabolism

a. Homocystinuiia

b. Hypermethioninemia

5. Urea cycle disorders

a. Argininosuccinic aciduria

b. Citrullinemia

c. Disorders of metabolism of ornithine, citrulline, argininossuccinic
acid, arginine, and ammonia

d. Hyperammonemia

e. Hyperomithinemia

(B) Disorders of carbohydrate transport and metabolism
1. Galactosemia

a. Galactose- 1 -phosphate uridyl transferase deficiency

b. Galactosuria

NoTE: Authority cited: Sections 208(a) and 341, Health and Safety Code. Refer-
ence: Sections 341 and 341.5, Health and Safety Code.

History

1 . New section filed 12-28-87 as an emergency; operative 1 2-28-87 (Register 88,
No. 2). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 4-27-88.

2. Certificate of Compliance transmitted to OAL 4-4-88 and filed 5-4-88 (Regis-
ter 88, No. 19).

Group 2. Registration as School
Audiometrists

Article 1. General

§ 2950. Qualifications.

The qualifications required for registration as school audiometrist
shall be as follows:

(a) Satisfactory completion of required training in audiology, audio-
metry and hearing assessment at an accredited university or college. Such
training must include a minimum of eight quarter hours, or equivalent,
academic and practical preparation in audiology, identification audiome-
try and hearing assessment in courses approved by the Hearing Conser-
vation Specialist of the State Department of Health Services. If the appli-
cant completed the required training more than five years prior to the date
of application for registration, the applicant must have had at least one
year of verified supervised experience in the interim in the administration
of hearing tests to school children in the public or parochial schools, or
in other tax maintained educational institutions in this State. Verification
will be documented in writing by the applicant's supervisor.

(b) Public health nurses and credentialed school nurses may either ful-
fill the requirements of subsection (a) or demonstrate satisfactory com-
pletion, at an accredited university or college, of a four quarter hours, or
equivalent, hearing assessment course approved by the Hearing Conser-
vation Specialist of the Department of Health Services.

(c) For purposes of subsections (a) and (b) accreditation of colleges or
universities shall be by one of the following accrediting associations:

(1) New England Association of School and Colleges.

(2) Middle States Association of Colleges and Secondary Schools.

(3) North Central Association of Colleges and Secondary Schools.

(4) Northern Association of Schools and Colleges.

(5) Southern Association of Colleges and Schools.

(6) Western Association of Schools and Colleges.

(d) Applicants for registration as school audiometrists shall complete
State Form Application for Registration as School Audiometrist PM 101
and submit the completed form to the State Department of Health Ser-
vices, 714 P Street, Sacramento, CA 95814.

(e) A registration fee of $10.00 shall accompany each application.

(f) An applicant for registration as school audiometrist shall receive
written notification informing the applicant that the application is com-
plete and approved, or that the application is deficient and what specific
information is required. Notification must occur within two weeks of re-
ceipt of the application by the State Department of Health Services. This
two week time period is a median based on a minimum of one week and
maximum of three weeks actual performance in 1985 and 1986.

(g) Within four weeks of receipt of an approved application, the State
Department of Health Services shall issue a certification of registration
to the applicant.

NOTE: Authority cited: Sections 208 and 1686, Health and Safety Code. Refer-
ence: Sections 1 685 and 1 686, Health and Safety Code; and Section 44879, Educa-
tion Code, and Section 15374 et seq.. Government Code.

History

1. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.
26). For prior history, see Register 69, No. 8.

2. Amendment of subsection (d) filed 6-25-86 as an emergency; cffecti\e upon
filing (Register 86, No. 26). A Certificate of Compliance must be transmitted
to OAL within 120 days or emergency language will be repealed on 10-23-86.

3. Ceruficate of Compliance transmitted to OAL 10-17-86 and filed 1 1-17-86
(Register 86, No. 47).

4. Amendment filed 7-7-87; operative 8-6-87 (Register 87, No. 29).

Page 77

§2951

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§2951. Testing Standards.

Schools conducting hearing testing shall comply with the following
criteria:

(a) Equipment.

( 1 ) Hearing threshold tests.

(A) Pure tone audiometers used for testing of hearing thresholds shall
be those manufactured to meet or exceed specifications for wide range
or limited range audiometers as defined b) American National Standards
Institute (ANSI) Specification Section 3.6-1969, Subsection 2.1.1 (pub-
lished in 1969) and shall be maintained to meet such specifications. Such
audiometers shall be designed to operate from alternating current supply
voltages and meet the stability standards defined in Subsection 4.6 of
American National Standards Institute (ANSI) Section 3.6-1969 Speci-
fications.

(2) Hearing screening test.

(A) Pure tone audiometers used for hearing screening tests shall be
those manufactured to meet or exceed specifications for wide range au-
diometers or limited range audiometers as defined by the American Na-
tional Standards Institute (ANSI) Section 3.6-1969, Subsections 2.1.1
and 2.1.2 and shall be maintained to meet such specifications.

(B ) Pure tone audiometers used for hearing screening tests shall not be
battery powered. Audiometers in use on the effective date of the amend-
ment to the regulations may be utilized until they no longer meet Ameri-
can National Standards Institute (ANSI) Section 3.6-1969 Specifica-
tions, Subsections 1 through 4.9.2.

(3) Care of equipment.

(A) Audiometric testing personnel shall be trained in the proper care
of the testing equipment.

(B) Biological checks.

Audiometric testing personnel shall maintain continuous surveillance
of the audiometer used, by performing biological checks as follows:

1 . Daily. A brief biological check of the audiometer shall be made each
day the audiometer is in use. The check shall consist of testing each ear-
phone on a person with stable audiometric thresholds that do not exceed
25 decibel hearing level at any frequency tested between 500 Hertz and
4000 Hertz and comparing the test results with the subject's baseline au-
diogram. The subject may be the audiometrist.

2. Monthly. A detailed biological check of the audiometer which in-
cludes a careful listening test of earphones to insure that the audiometer
displays no evidence of

a. Cross talk;

b. Signal distortion;

c. Transient clicks;

d. Abnormal noise; or,

e. Intermittent signal.

1. An electroacoustic calibration check of audiometers shall be made
at least every 12 months, or more frequently if indicated by the biological
checks, and meet or exceed the specifications outlined in Subsections 1
through 4.9.2., American National Standards for Audiometers, pub-
lished by the American National Standards Institute (ANSI), Inc. (pub-
lished in 1969).

2. A calibration chart, showing proof of performance, shall be kept
with the audiometer.

(b) Test environment.

(1) For audiometric threshold testing and screening testing, the envi-
ronmental noise level shall not exceed 41 .5 decibel sound pressure level
in the 500 Hertz band, 49.5 decibel sound pressure level in the 1 000 Hertz
band, and 54.5 decibel sound pressure level in the 2000 Hertz band, and
62 decibel sound pressure level in the 4000 Hertz band; or,

(2) The test environment shall be considered adequate if the noise lev-
els do not cause a threshold shift greater than 10 decibels at those fre-
quencies which must be included in a pure tone conduction threshold test.
This procedure may be performed on the audiometris.

(1) Each pupil shall be given a hearing screening test in kindergarten
or first grade and in second, fifth, eighth, tenth or eleventh grade and first
entry into the California public school system.

(A) A school district may request a waiver of the hearing screening test
for tenth and/or eleventh grade pupils once each school year. The request
for a waiver must be in writing and addressed to the State Department of
Health Services, Hearing Conservation Specialist. The waiver request
must include the dates of the school year for which the waiver is re-
quested and an alternative testing plan that will insure that each pupil at
risk of hearing loss will receive testing services. Pupils at risk of hearing
loss are: those exposed to loud noises, including loud music; pupils that
have been referred for testing by a parent or teacher; repeat tests for those
pupils for whom there was a previously documented problem, pupils who
have not had a hearing test for three years; and any pupil who has enrolled
for the first time in the school district. An approved waiver of the hearing
screening test does not exempt a school district from reporting require-
ments contained in Section 2951, (e).

(B) Each pupil enrolled in a special education program (as described
in Section 56001 of the Educafion Code), other than those pupils enrolled
for a hearing problem, shall be given a hearing test when enrolled in the
program and every third year thereafter. Hearing tests may be given more
frequently as needed, based on the individual education program team's
evaluation of each individual pupil.

(2) Pure tone audiometric screening tests shall be conducted at a level
not to exceed 25 decibels and shall include the frequencies 1000, 2000
and 4000 Hertz. A pupil's failure to respond to any of the required fre-
quencies constitutes a failure of the screening test. Individual tests may
be used for pupils of all ages. Group tests may only be used for pupils who
demonstrate reliable results.

(3) Pure tone air conduction threshold tests shall include the frequen-
cies 500, 1000, 2000 and 4000 Hertz and shall be given to:

(A) AH pupils who fail the screening tests;

(B) All pupils who are to be considered for further audiological or oto-
logical evaluation.

(d) Referral. The schools shall provide the parents or guardians of chil-
dren who fail the hearing tests with a written notification of the test results
and recommend that a medical and audiological evaluation be obtained
whenever the test demonstrates:

( 1 ) A hearing level of 30 decibels or greater for two or more frequen-
cies in an ear at 500, 1000, 2000 or 4000 Hertz, or a hearing level of 40
decibels or greater for one of the frequencies tested, 500 through 4(X)0
Hertz, on two threshold tests completed at an interval of at least two
weeks; or

(2) There is evidence of pathology, such as an infection of the outer
ear, chronic drainage, or a chronic earache.

(e) Reporting results.

( 1 ) Dates and results of all screening hearing testing shall be recorded
on each pupil's health record. Copies of all threshold tests shall be filed
with the pupil's health records.

(2) Each school shall prepare an annual report of the school hearing
testing program using Annual Report of Hearing Testing forms, PM 100,
provided by the State Department of Health Services with copies to the
district superintendent and the county superintendent of schools.
NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
1685 and 1686, Health and Safety Code; and Sections 44879 and 56001, Educa-
tion Code.

History

1 . New section filed 10-5-70; effective thirtieth day thereafter (Register 70, No.

41).

2. Amendment filed 6-28-73; effective thirtieth day thereafter (Register 73, No.
26).

3. Repealer and new section filed 7-7-87; operative 8-6-87 (Register 87, No. 29).

4. New subsection (c)(1)(A) and newly designated subsection (c)(1)(B) filed
3-7-95; operative 4-6-95 (Register 95, No. 10).

•

Page 78

Title 17

State Department of Health Services

§ 3030

Subchapter 4. The Infant Botulism
Treatment and Prevention Program

Article 1. Definitions

§ 3000.2. Botulism Immune Globulin.

"Botulism Immune Globulin" or "BIG" means the pharmaceutical
product which consists of human-derived or human-gene-derived im-
munoglobulin (antibody) molecules or active fragments thereof and ap-
propriate stabilizing agents that possesses the ability to neutralize botuli-
num or botulinum-like toxins.

NOTE: Authority cited: Section 123707(c), Health and Safety Code. Reference:
Sections 123700-123709, Health and Safety Code.

History

1. New subchapter4 (articles 1^), aiticle 1 (sections 3000.2-3000.4) and section
filed 6-3-98 as an emergency; operative 6-3-98 (Register 98, No. 23). A Cer-
tificate of Compliance must be transmitted to OAL by 10-1-98 or emergency
language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and
filed 1 1-4-98 (Register 98, No. 45).

§ 3000.4. Infant Botulism Treatment and Prevention
Program.

"Infant Botulism Treatment and Prevention Program" or "IBTPP"
means the unit of the California Department of Health Services mandated
by Health & Safety Code Section 123702.

NOTE: Authority cited: Section 123707(c), Health and Safety Code. Reference:
Sections 123700-123709, Health and Safety Code.

History

1 . New section filed 6-3-98 as an emergency; operative 6-3-98 (Register 98, No.
23). A Certificate of Compliance must be transmitted to OAL by 10-1-98 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and
filed 1 1-4-98 (Register 98, No. 45).

Article 2.

Distribution of Botulism Immune
Globulin

§ 3010. Distribution of Botulism Immune Globulin.

Only patients admitted to and treated in hospitals located in the United
States, its territories and possessions, and the federal Centers for Disease

Control and Prevention (CDC) shall be eligible recipients for the distri-
bution of BIG.

NOTE; Authority cited: Section 123707(c), Health and Safety Code. Reference:
Sections 123702, 123704(b), (c), (g) and 123705, Health and Safety Code.

History

1 . New article 2 (section 3010) and section filed 6-3-98 as an emergency; opera-
tive 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be trans-
mitted to OAL by 10-1-98 or emergency language will be repealed by opera-
tion of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and
filed 1 1-4-98 (Register 98, No. 45).

Article 3. Reporting Requirements for
Hospitals Receiving BIG

§ 3020. Reporting Requirements for Hospitals.

Within one week of discharge, the patient's hospital shall provide to
the IBTPP the following information on the patient treated with BIG:

(a) Admission and discharge summaries, and

(b) A listing of hospital charges, costs, and reimbursements for the pa-
tient's hospital stay.

Note: Authority cited: Section 123707(c), Health and Safety Code. Reference:
Sections 123704(b), (c), (e), (f) and 123705, Health and Safety Code.

History

1 . New article 3 (section 3020) and section filed 6-3-98 as an emergency; opera-
tive 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be trans-
mitted to OAL by 10-1-98 or emergency language will be repealed by opera-
tion of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and
filed 1 1-1-98 (Register 98, No. 45).

Article 4. Fees

§ 3030. Fee.

The per patient fee for Botulism Immune Globulin shall be $45,300.
Note: Authority cited: Section 123707(d), Health and Safety Code. Reference:
Sections 123702 and 123705, Health and Safety Code.

History

1 . New article 4 (section 3030) and secfion filed 6-3-98 as an emergency; opera-
tive 6-3-98 (Register 98, No. 23). A Certificate of Compliance must be trans-
mitted to OAL by 10-1-98 or emergency language will be repealed by opera-
tion of law on the following day.

2. Certificate of Compliance as to 6-3-98 order transmitted to OAL 9-23-98 and
filed 1 1-4-98 (Register 98, No. 45).

3. Amendment of section and Note filed 4-26-2005; operative 5-1-2004. Sub-
mitted to OAL for printing only pursuant to Health and Safety Code section
123702(d) (Register 2005, No. 17).

[The next page is 79.]

Page 78.1

Title 17

State Department of Health Services

§ 6000

Subchapter 5. Public Health Nursing

Group 1. Public Health Nursing

Article 1. Issuance of Public Health
Nursing Certificates

§ 4500. Public Health Nurse Certificate.

Note: Authority cited: Sections 208, 600, 602, 1 1 1 1 and 1 1 30, Health and Safety
Code. Reference: Sections 600, 602, 604, 605, 1 1 1 1 and 1 1 30, Health and Safety
Code.

History

1. Amendment filed 12-8-45 (Register 3).

2. Amendment filed 9-24-5 1 designated to be effective 1-1-54 (Register 25, No.
6).

3. Amendment filed 12-18-61 ; effective thirtieth day thereafter (Register 61, No.
26).

4. Repealer of subsection (c) filed 6-9-67; effective thirtieth day thereafter (Regis-
ter 67, No. 22).

5. Repealer of subsection (d) filed 4-14-72; effective thirtieth day thereafter (Reg-
ister 72, No. 16).

6. Amendment filed 3-9-87; effective thirtieth day thereafter (Register 87, No.
11).

7. Renumbering of former title 1 7, group 1 , article 1 (sections 4500-4504) to title
16. division 14, article 9 (sections 1490-1494), renumbering and amendment
offormer title 17, section 4500 to title 16, section 1490, and amendment of Note
filed 1-26-96; operative 2-28-96. Submitted to OAL for printing only (Regis-
ter 96, No. 5).

§ 4501. Qualifications and Requirements.

NoTf:; Authority cited: Sections 208, 600, 602, 11 1 1 and 1 1 30. Health and Safety
Code. Reference: Secfions 600, 602, 604, 605, 1 11 1 and 1 130, Health and Safety
Code.

History

1 . New section filed 4-14-72; effective thirtieth day thereafter (Register 72, No.
16).

2. Amendment filed 3-9-87; effective thirtieth day thereafter (Register 87, No.
11).

3. Editorial coiTCCtion of subsecdon (a)(2) (Register 90, No. 35).

4. Renumbering and amendment offormer title 17, section 4501 to new title 16,
section 1491 and amendment of Note filed 1-26-96; operative 2-28-96. Sub-
mitted to OAL for printing only (Register 96, No. 5).

§ 4502. Application for Public Health Nurse Certificate.

Note: Authority cited: Section 208, Health and Safety Code. Reference: Section
604, Health and Safety Code; and Section 2015.5, Code of Civil Procedure.

History

1. New section filed 3-9-87; effective thirtieth day thereafter (Register 87, No.
11).

2. Renumbering and amendment of former titie 17, section 4502 to new title 16,
section 1492 and amendment of Note filed 1-26-96; operative 2-28-96. Sub-
mitted to OAL for printing only (Register 96, No. 5).

§ 4503. Issuance of Application.

NOTE: Authority cited: Section 15376, Government Code. Reference: Section
15376, Government Code; and Section 1013(a), Code of Civil Procedure.

History

1. New section filed 3-9-87; effective thirtieth day thereafter (Register 87, No.
11).

2. Renumbering and amendment of former title 17, section 4503 to new title 16,
section 1493 and amendment of Note filed 1-26-96; operative 2-28-96. Sub-
mitted to OAL for printing only (Register 96, No. 5).

§ 4504. Appeal Process.

NOTE: Authority cited: Section 15378, Government Code. Reference: Section
15376 and 15378, Government Code.

History

1. New section filed 3-9-87; effective thirtieth day thereafter (Register 87, No.
11).

2. Renumbering and amendment of former title 17, section 4504 to new title 16,
section 1494 and amendment of Note filed 1-26-96; operative 2-28-96. Sub-
mitted to OAL for printing only (Register 96, No. 5).

Group 2. Trained Attendants

History

1. Originally pubHshed 7-15^5 (Title 17).

2. Repealer of §4600 to 4722, inclusive, filed 6-29-48 (Register 13, No. 1 ).

Subchapter 6. Tuberculosis Hospitals and
Sanatoria Receiving State Subsidy

(Originally Printed 8-13-45)
Note: Authority cited for Subchapter 6: Sections 102 and 208, Health and Safety
Code. Reference: Sections 3279, 3294, 3298 and 3299, Health and Safety Code.

History

1. Sections 5100 to 5176, inclusive, 4-12^8.

2. New Sections 5100 to 5199, inclusive, filed 4-22-48 (Register 12, No. 4).

3. Repealer of Subchapter 6 (Sections 5100-5199 and Appendix) and new Sub-
chapter 6 (Sections 5 1 00, 5 J 05, 5 1 06. 5 1 07, 5 108,511 5, 5 1 20, 5 1 25, 5 1 26 and
5127) filed 2-28-66; effective thirtieth day thereafter (Register 66, No. 6).

4. Repealer of Subchapter 6 (Sections 5 1 00-5 1 27, not consecutive) filed 9-23-85 ;
effective thirtieth day thereafter (Register 85, No. 39).

Subchapter 7. Venereal Diseases

Cross Reference: Sections 2636 (a) to (m). Title 17, Subchapter 1.7,
Reportable Diseases and Conditions.

§ 51 51 . Sexually Transmitted Diseases in Minors.

(a) A minor 12 years of age or older may give consent to the furnishing
of hospital, medical and surgical care related to the diagnosis and/or
treatment of any of the following non-reportable sexually transmissible
diseases:

(1) Candida genitalis.

(2) Chlamydia trachomatous.

(3) Condyloma acuminata.

(4) Hemophilus vaginahs (Gardnerella vaginale).

(5) Cytomegalovirus infection.

(6) Herpes genitalis.

(7) MoUuscum contagiosum.

(8) Non-gonococcal urethritis, vaginitis and cervicitis.

(9) Pediculosis (Phthirus pubis).

(10) Scabies (Sarcoptes scabiei).

(11) Trichomoniasis.

Note: Authority cited: Section 208 (a). Health and Safety Code; and Section 34.7,
Civil Code. Reference: Section 34.7, Civil Code.

History
1. New section filed 3-4-82; effective thirtieth day thereafter (Register 82, No.
10).

Subchapter 8. Immunization Against

Poliomyelitis, Diphtheria, Pertussis,

Tetanus, Measles (Rubeola), Rubella,

Haemophilus Influenzae Type B (Hib),

Mumps, and Hepatitis B

Article 1. Definitions

§ 6000. Admission.

"Admission" means a pupil's first entry in a given public or private
elementary or secondary school, child care center, day nursery, nursery
school, family day care home, or development center. "Admission" also
denotes a pupil's re-entry to one of these institutions after withdrawing
from a previous enrollment.

(a) "Unconditional admission" is admission based upon documenta-
tion of receipt of all required immunizations or upon documentation of
a permanent medical exemption or of a personal beliefs exemption to im-
munization in accordance with Section 605 1 .

Page 79

§6010

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) "Conditional admission" is admission based upon either documen-
tation of having received some but not all required immunizations and of
not being due for any vaccine dose at the time of entry or upon documen-
tation of a temporary medical exemption to immunization in accordance
with Section 6050. Continued attendance after conditional admission is
contingent upon receipt of the remaining required immunizations in ac-
cordance with Sections 6020 and 6035.

Note: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health
and Safety Code. Reference: Sections 3381 ( 120335), 120340, 120365, 120370
and 120375. Health and Safety Code.

History

1. Repealer and new Subchapter 8 (Sections 6000-6075) filed 3-22-78 as an
emergency; effective upon filing (Register 78, No. 12). For history of former
Subchapter 8, see Registers 61, No. 25; 62. No. 16; 63, No. 17; 66, No. 7: and
72, No. 11.

2. Repealer and new Subchapter 8 (Sections 6000-6075) filed 7-28-78; effective
thirtieth day thereafter (Register 78, No. 30).

3. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

4. Amendment of subchapter 8 heading, section and Note filed 3-29-96; opera-
tive 4-28-96 (Register 96, No. 13).

5. Editorial correction amending subchapter 8 heading (Register 97, No. 42).

§ 6010. Immunizing Agent.

NOTE: Authority cited: Sections 208 and 3390, Health and Safety Code. Refer-
ence: Section 3381, Health and Safety Code.

History

1 . Amendment filed 4-15-80 as an emergency; effective upon filing (Register 80,
No. 16). A Certificate of Compliance must be transmitted to OAH within 120
days or emergency language will be repealed on 8-14-80.

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80
(Register 80, No. 34).

3. Repealer filed 2-3-86; effecfive thirtieth day thereafter (Register 86, No. 6).

§6015. Pupil.

"Pupil" means a person under age 18 years admitted to or seeking ad-
mission to any private or public elementary or secondary school, child
care center, day nursery, nursery school, family day care home, or devel-
opment center.

NOTE: Authority cited: Sections 338 1(c) (120335(c)), 100275 and 120330, Health
and Safety Code. Reference: Sections 3381 (120335) and 120360, Health and
Safety Code.

History

1 . Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note-: filed 3-29-96; operafive 4-28-96 (Register
96. No. 13).

Article 2. Required Immunizations

§ 6020. Required Immunizations.

(a) The required immunizations for admission to and attendance at a
public or private elementary or secondary school, child care center, day
nursery, nursery school, family day care home, or developmental center
shall be those set forth, according to age, in Table 1 .

(b) In Table i of Section 6020 and in Table 2 of Section 6035, DTP (or
DPT) means diphtheria and tetanus toxoids and pertussis vaccine, in-
cluding DTaP vaccine. DT (or TD) and Td (or dT) means diphtheria and
tetanus toxoids.

(c) For pupils who have reached their seventh birthday, a history of any
preparations containing both diphtheria and tetanus toxoids (DTP, DT,
Td. etc.) shall be acceptable as meeting the requirement for tetanus and
diphtheria toxoids that is set forth in Table 1.

(d) Pupils who have reached their seventh birthday shall be exempt
from the pertussis and mumps immunization requirements.

(e) Combination vaccines that include measles, mumps, and rubella
components shall be acceptable as meeting the requirements for these
vaccines that are set forth in Table 1 .

(f) For pupils entering or advancing to the seventh grade, immuniza-
tion requirements are set forth in Table 1 .

(g) Pupils already admitted to California public and private schools at
the Kindergarten level or above before July 1 , 2001 are exempt from the
Varicella (chickenpox) requirement as set forth in Table 1 .

Page 80

Title 17

State Department of Health Services

§ 6020

Table 1 : Immunization Requirements

lii<itiiiiti(m

A^e

Vaccine

Total Doses Received

Child cai-e center, day
nursery, nursery school,
family day care home,
development center

Less than 2 months

None

Same as above

2 -3 months

1. Polio'

2. DTP

3. Hib

4. Hepatitis B

1. Polio'

2. DTP, or combination of DTP and diphtheria-tetanus
toxoids

3. Hib

4. Hepatitis B

1. Polio'

2. DTP, or combination of DTP and diphtheria-tetanus
toxoids

3. Hib

4. Hepatitis B

1 . Polio'

2. DTP, or combination of DTP and diphtheria-tetanus
toxoids '

3. Measles, rubella, and mumps

4. Hib

5. Hepatitis B

1. Polio'

2. DTP, or combination of DTP and diphtheria-tetanus
toxoids

3. Measles, rubella, and mumps

4. Hib3

5. Hepatitis B^

6. Varicella

1. Polio'

2. DTP, or combination of DTP and diphtheria-tetanus
toxoids

3. Measles, rubella, and mumps

1 dose
1 dose
1 dose
1 dose

Same as above

4-5 months

2 doses

2 doses
2 doses
2 doses

Same as above

6-14 months

2 doses

3 doses
2 doses
2 doses

Same as above

15-17 months

3 doses

1 dose of each separately
or combined on or after the
1st birthday

1 dose on or after the
1st birthday

2 doses

Same as above

1 8 months-5 years

3 doses

4 doses

I dose of each separately

or combined on or after the

1st birthday

1 dose on or after the

1st birthday

3 doses

1 dose

Elementary school at
kindergarten level and
above

4-6 years

4. Hepatitis B^

5. Varicella

1. Polio'

2. Diphtheria and tetanus toxoids, given as DTP,
DT, or Td (pertussis not required)

4 doses, except that a total of

3 doses is acceptable if at
least one dose was given on
or after the 4th birthday

5 doses, except that a total of

4 doses is acceptable if at
least one dose was given on
or after the 4th birthday.

1 dose of each, separately
or combined, on or after the
1st birthday. Pupils entering
a kindergarten (or first grade
if kindergarten skipped) are
required to have 2 doses of
measles-containing
vaccine, both given on or
after the first birthday
3 doses
1 do.se

Elementary school,
.secondary school

7-17 years

4 doses, except that a total of
3 doses is acceptable if at
least one dose was gi\en on
or after the 2nd birthday

At least 3 doses. One more
Td do.se is required if the
last do.se u as given hel'orc
the 2nd birthday. (See below
for additional
recommendations for 7tli
grade enrollment, effective
7/1/99.)

Page 81

§6025

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Institiilioii

Ai-e

Vaccine

Total Doses Received

3. Measles and rubella (mumps not required)

4. Varicella"'

1 dose of each, separately
or combined, on or after the
1st birthday. (See below for
additional requirements for
7th grade enrollment,
effective 7/1/99.)

1 dose aged 7 through 12
years for students not
admitted to California

schools before July 1, 2001.

2 doses for students aged 13
thi'ough 1 7 years not
admitted to California
schools before July 1. 2001.

Seventh Grade"*

Any

1. Hepatitis B

2. Measles . .

Recommended but not required: Tetanus-diphtheria,
given as DTP, DT, Td or Tetanus.

3 doses

2 doses of measles

-containing vaccine, both

given on or after the first

birthday.

One Td dose is
recommended if 5 years or
more have elapsed since the
last dose.

Any

1 8 years and older

None

' Oral polio vaccine (OPV) or inactivated polio vaccine (IPV) or any combination of these vaccines is acceptable.

- Applies only to children entering at kindergarten level (or at first grade level if kindergarten skipped) or below on or after August 1, 1997.

-' Required only for children who have not reached the age of 4 years 6 months.

^ Applies only to children (of any age) entering or advancing to the seventh grade on or after July 1, 1999.

"^ Children admitted to California schools at the Kindergarten level or above before July 1, 2001 are exempt from this requirement.

NOTE; Authority cited: Sections 100275, 120330 and 120335, Health and Safety
Code. Reference: Sections 120325, 120335, 12()370and 120375, Health and Safe-
ty Code.

History

1. Amendment filed 8-30-79; effective thirtieth day thereafter (Register 79, No.
35).

2. Amendment filed 4-15-80 as an emergency; effective upon filing (Register 80,
No. 16). A Certificate of Compliance must be transmitted to OAH within 120
days or emergency language will be repealed on 8-14-80.

3. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80
(Register 80, No. 34).

4. Amendment of subsections (c), (d),and(e) filed 10-3-80; effective thirtieth day
thereafter (Register 80, No. 40).

5. Repealer and new section filed 2-3-86; effective thirtieth day thereafter (Regis-
ter 86, No. 6).

6. Amendment of subsection (a), repealer of subsection (f) and subsection reletter-
ing, and amendment of Table 1 and Note filed 3-29-96; operative 4-28-96
(Register 96, No. 13).

7. Repealer of subsection (b), subsection relettering, amendment of newly desig-
nated subsection (b), and amendment of Table 1 and NOTE filed 5-22-97 as an
emergency; operative 5-22-97 (Register 97, No. 21). A Certificate of Com-
pliance must be transmitted to OAL by 9- 1 9- 97 or emergency language will be
repealed by operation of law on the following day.

8. Editorial correction of subsecdon (b) (Register 97, No. 37).

9. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and
filed 9-26-97 (Register 97, No. 39).

10. New subsection (f), amendment of Table 1 and amendment of Note filed
2-18-99 as an emergency; operative 2-18-99 (Register 99, No. 8). A Certifi-
cate of Compliance must be transmitted to OAL by 6-1 8-99 or emergency lan-
guage will be repealed by operation of law on the following day.

11. Editorial correction of table (Register 99, No. 27).

12. Certificate of Compliance as to 2-18-99 order transmitted to OAL 5-26-99
and filed 6-30-99 (Register 99, No. 27).

13. New subsection (g), amendment of Table 1 and amendment of Note filed
9-24-2002 as an emergency; operative 9-24-2002 (Register 2002, No. 39). A
Certificate of Compliance must be transmitted to OAL by 1-22-2003 or emer-
gency language will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 9-24-2002 order transmitted to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

Article 3. Admission to School, Child Care

Center, Day Nursery, Nursery School, Family

Day Care Home, or Development Center

§ 6025. Unconditional Admission.

Any pupil age 1 8 months or older who has received all the immuniza-
tions against poliomyelitis, diphtheria, tetanus, pertussis, measles (ru-
beola), rubella, Haemophilus influenzae type B, mumps, hepatitis B and
varicella (chickenpox) required for his or her age, as defined in Table 1 ,
Section 6020, or who has documented a permanent medical exemption
or a personal beliefs exemption to immunization in accordance with Sec-
tion 6051, shall be admitted unconditionally as a pupil to a given public
or private elementary or secondary school, child care center, day nursery,
nursery school, family day care home, or development center. However,
for some pupils admitted unconditionally to a child care center, day nurs-
ery, nursery school, family day care home, or development center, an ad-
ditional dose of DTP and/or polio vaccine will be required for admission
to school at kindergarten level and above, as indicated in Table 1 , Section
6020.

NOTE; Authority cited: Sections 100275, 120330 and 120335, Health and Safetv
Code. Reference: SecUons 120325, 120335, 120370 and 120375, Health and Safe-
ty Code.

History

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80
(Register 80, No. 34).

3. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

4. Amendment of article 3 heading, secfion and Note filed 3-29-96; operafive
4-28-96 (Register 96, No. 13).

Page 82

Title 17

State Department of Health Services

§ 6035

5. Amendment of section and NOTE filed 5-22-97 as an emergency; operative
5-22-97 (Register 97, No. 21 ). A Certificate of Compliance must be transmitted
to OAL by 9-1 9-97 oremergency language will be repealed by operation of law
on the following day.

6. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and
filed 9-26-97 (Register 97, No. 39).

7. Amendment of section and Noth filed 9-24-2002 as an emergency; operative
9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be trans-
mitted to OAL by 1-22-2003 oremergency language will be repealed by opera-
tion of law on the following day.

8. Certificate of Compliance as to 9-24-2002 order transmitted to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

§ 6030. Conditional Admission to Prekindergarten Level.

NOTE: Authority cited: Sections 208 and 3390, Health and Safety Code. Refer-
ence: Section 3381, Health and Safety Code.

History
1. Repealer filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

§ 6035. Conditional Admission.

(a) Any pupil seeking admission to a given public or private elementa-
ry or secondary school, child care center, day nursery, nursery school,
family day care home, or development center who lacks documentation
of having received all the required vaccine doses against poliomyelitis,
diphtheria, tetanus, pertussis, measles, rubella, Haemophilus influenzae
type B, mumps, hepatitis B and varicella (chickenpox) as specified in
Table 1 , Section 6020, and has not obtained a permanent medical exemp-
tion or a personal beliefs exemption to immunization in accordance with
Section 6051, may be admitted conditionally if:

(1) he or she has not received all the immunizations required for his
or her age group but has cominenced receiving doses of all the vaccines
in accordance with Table 2, is not currently due for any doses at tlie time
of admission (if he or she is due for any doses at this time they must be
obtained before admission), and the pupil's parent or guardian is notified
of the date by which the pupil must complete all the required immuniza-
tions in accordance with Table 2; or

(2) he or she is under age 1 8 months and has received all the immuniza-
tions required for his or her age group but will require additional vaccine
doses at an older age, and the pupil's parent or guardian is notified of the
date by which the pupil must complete all the remaining doses when Ihey
become due in accordance with Table 1 , Section 6020; or

(3) he or she has obtained a temporary medical exemption from immu-
nization in accordance with Section 6050, and the pupil's parent or
guardian is notified of the date by which the pupil must complete all the
required immunizations when the temporary exemption terminates; or

(4) he or she is a pupil entering a child care center governed by Educa-
tion Code Section 8263(c), where a different deadline for obtaining all
required immunizations may apply.

(b) The public or private elementary or secondary school, child care
center, day nursery, nursery school, family day care home, or develop-
ment center shall not allow the admission of any pupil seeking entry who
does not meet the requirements for admission under Section 6025 or
6035. The principal or administrator shall advise the pupil, or the parent
or guardian, to contact a physician or agency that provides immuniza-
tions.

Page 83

§6035

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Table 2: Conditional Admission Immunization Schedule

Vaccine

Dose

Time Intenxils

Polio'

1st dose .
2nd dose

3rd dose .

4th dose (Required only for
entry to kindergarten level
or above)

Before admission

As early as 6 weeks but no later than 10 weeks after the 1st

dose. Before adinission if 10 or more weeks have elapsed

since the 1st dose at the time of admission.

As early as 6 weeks but no later than 1 2 months after the

2nd dose. Before admission if 12 or more months have

elapsed since (he 2nd dose at the time of adinission.

Age 4-6 years: If the 3rd dose was given before the 4th
birthday one more dose is required before admission.
Age 7-17 years: If the 3rd dose was given before the
2nd birthday, one more dose is required before admission.

Diphtheria, Tetanus, and Pertussis
FOR PUPILS UNDER AGE 7 YEARS:

Diphtheria-tetanus-pertussis (DTP) or combination
of DTP and diphtheria-tetanus toxoids

FOR PUPILS AGE 7 YEARS AND OLDER:

Diphtheria-tetanus
(Pertussis not required)

1st dose .
2nd dose

3rd dose .

4th dose .

5th dose (Required only for
pupils ages 4-6 years
for entry to kindergarten
level and above)

1st dose

2nd dose

3rd dose

4th dose

Recommended but not required
for 7th grade entry^: Booster
dose of Td.

Before admission.

As early as 4 weeks but no later than 8 weeks after the
1st dose. Before admission if 8 or more weeks have
elapsed since the 1st dose at the time of admission.
As early as 4 weeks but no later than 8 weeks after the
2nd dose. Before admission if 8 or more weeks have
elapsed since the 2nd dose at the time of admission.
As early as 6 months but no later than 12 months after
the 3rd dose. Before admission if 12 or more months
have elapsed since the 3rd dose at the time of admission.

If the 4th dose was given before the 4th birthday, one
more dose is required before adinission.

Before admission.

As early as 4 weeks but no later than 8 weeks after the
1 St dose. Before admission if 8 or more weeks have
elapsed since the 1st dose at the time of admission.
As early as 6 months but no later than 1 2 months after the
2nd dose. Before admission if 12 or more months have
elapsed since the 2nd dose at the time of admission.
If the 3rd dose was given before the 2nd birthday, one
more dose is required before admission.

Before entry, 1 Td dose is recommended if 5 years or more
have elapsed since the last dose of DTP, DT, Td or Tetanus.

Measles

Note: For children entering kindergarten (or first grade
if kindergarten is skipped) on or after August 1, 1997,
two doses are required. For children entering 7th grade
on or after July 1, 1999, the series shall be in process
or completed.

One dose only

1 St dose

2nd dose ....

Before admission. If the pupil is under age 1 5 months, this
dose is required when age 15 months is reached.
Before admission.

As early as 1 month but no later than 3 months after
the 1st dose.

Rubella

One dose only
One dose only

Two doses . . .

One dose ....

1st dose

2nd dose ....

3rd dose

Before admission. If the pupil is under age 15 months, this
dose is required when age 15 months is reached.

Mumps (Not required for pupils age 7 years and older)

Before adinission. If the pupil is under age 15 months, this
dose is required when age 15 months is reached.

Hib

Children 2-14 months old

Children 15 months-4 1/2 years old

1st dose before admission. 2nd dose as early as 2 months
but no later than 3 months after the 1st dose.
Before admission.

Hepatitis B — For children entering at
kindergarten level (or first grade if kindergarten skipped)
or below on or after August 1, 1997. For children entering 7th
grade on or after July 1, 1999, the series shall be in process
or completed.

Before admission.

As early as 1 month but no later than 2 months after the first

dose.

Infants and children under age 18 months: As early as 2

months but no later than 12 months after the 2nd dose.

Also, no earlier than 4 months after the 1st dose.

Children age 1 8 months and older: As early as 2 months but

no later than 6 months after the 2nd dose. Also, no earlier

than 4 months after the 1st dose.

Varicella^ — For children aged 13 through 17 years
not admitted to California schools before July 1, 2001.

1st dose .
2nd dose

Before admission

As early as 4 weeks but no longer than 3 months after first

dose

^Oral polio vaccine (OPV) or inactivated polio vaccine (IPV) or any combination of these vaccines is acceptable.

-Applies only to children (of any age) entering or advancing to the 7th grade on or after July 1, 1999.

^Children admitted to California schools at the Kindergarten level or above before July 1, 2001 are exempt from this requirement.

Page 84

Title 17

State Department of Health Services

§6055

NOTF: Authority cited: Sections 100275, 120330 and 120335, Health and Safety
Code. Reference: Sections 120325, 120335, 120370and 120375, Health and Safe-
ty Code.

History

1. Amendment filed 8-30-79; effective thirtieth day thereafter (Register 79, No.
35).

2. Amendment of subsection (a) filed 4-15-80 as an emergency; effective upon
filing (Register 80, No. 16). A Certificate of Compliance must be transmitted
to OAH within 120 days or emergency language will be repealed on 8-14-80.

3. Certificate of Compliance transniitted to OAL 7-29-80 and filed 8-20-80
(Register 80, No. 34).

4. Repealer and new section filed 2-3-86; effective thirtieth day thereafter (Regis-
ter 86, No. 6).

5. Amendment of subsections (a), (b). Table 2 and Note filed 3-29-96; operative
4-28-96 (Register 96, No. 13).

6. Amendment of subsection (a). Table 2 and NOTE filed 5-22-97 as an emergen-
cy; operative 5-22-97 (Register 97, No. 21). A Certificate of Compliance must
be transmitted to OAL by 9-19-97 or emergency language will be repealed by
operation of law on the following day.

7. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and
filed 9-26-97 (Register 97, No. 39).

8. Amendment of Table 2 filed 2-18-99 as an emergency; operative 2-18-99
(Register 99, No. 8). A Certificate of Compliance must be transmitted to OAL
by 6-1 8-99 or emergency language will be repealed by operation of law on the
following day.

9. Certificate of Compliance as to 2-1 8-99 order transmitted to OAL 5-26-99 and
filed 6-30-99 (Register 99, No. 27).

10. Editorial correction of Table 2 (Register 99, No. 39).

1 1 . Amendment of subsection (a). Table 2 and Note filed 9-24-2002 as an emer-
gency; operative 9-24-2002 (Register 2002, No. 39). A Certificate of Com-
pliance must be transmitted to OAL by 1-22-2003 or emergency language will
be repealed by operation of law on the following day.

12. Certificate of Compliance as to 9-24-2002 order transmitted to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

§ 6040. Requirements for Continued Attendance.

An already admitted pupil who is subsequently discovered not to have
received all the immunizations which were required before admission or
who is subsequently discovered not to have complied with the require-
ments for conditional admission specified in Section 6035 shall continue
in attendance only if he or she receives all vaccine doses for which he or
she is currently due and provides documentation of having received such
doses no later than 1 0 school days after he or she or the parent or guardian
is notified. The school, child care center, day nursery, nursery school,
family day care home, or development center shall notify the pupil or the
parent or guardian of the time period (no longer than 10 school days)
within which the doses must be received.

NOTE: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health
and Safety Code. Reference: Sections 3381 (120335), 120340 and 120375 (a) and
(b), Health and Safety Code.

History

1 . Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 3-29-96; operative 4-28-96 (Register
96, No. 13).

§ 6045. Special Immunization Schedules.

(a) Immunization schedules not conforming to those specified in Sec-
tions 6020 and 6035 may be approved by the State Department of Health
Services when substantial medical or other conditions warrant, such as
during an outbreak or epidemic of a particular disease.
NOTE; Authority cited: Sections 208 and 3390, Health and Safety Code. Refer-
ence: Section 3381, Health and Safety Code.

History
1 . Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

§ 6050. Conditional Admission with Temporary Medical
Exemption.

A pupil who is temporarily exempt from immunization for medical
reasons shall be admitted on condition that required immunizations are
obtained at the termination of the exemption; the fact of the temporary
medical exemption shall be recorded on the California School Immuni-
zation Record, PM 286 (1/02) as provided in Section 6070. A pupil with
a temporary medical exemption may be subject to exclusion pursuant to
Section 6060.

NOTE: Authority cited: Sections 100275, 120330 and 120335, Health and Safety
Code. Reference: Sections 120325, 120335, 120365, 120370 and 102375, Health
and Safety Code.

History

1 . Amendtnent filed 4-15-80 as an emergency; effective upon filing (Register 80,
No. 16). A Certificate of Compliance must be transmitted to OAH within 120
days or emergency language will be repealed on 8-14-80.

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80
(Register 80, No. 34).

3. Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

4. Amendment of section and Note filed 9-24-2002 as an emergency; operative
9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be trans-
mitted to OAL by 1-22-2003 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 9-24-2002 order transmitted to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

§ 6051. Unconditional Admission with Permanent Medical
Exemption or Personal Beliefs Exemption.

A pupil with a permanent medical exemption or a personal beliefs ex-
emption to immunization shall be admitted unconditionally. A perma-
nent medical exemption shall be granted upon the filing with the govern-
ing authority of a written statement from a hcensed physician to the effect
that the physical condition of the pupil or medical circumstances relating
to the pupil are such that immunization is permanently not indicated. The
fact of the permanent medical exemption shall be recorded on the Cali-
fornia School Immunization Record, PM 286 (1/02) as provided in Sec-
tion 6070. A permanent medical exemption may be provided for one or
more vaccines. A physician may provide a written statement that the pu-
pil is medically exempt from the measles (rubeola) and/or varicella
(chickenpox) requirements as a result of having had measles (rubeola)
and/or varicella (chickenpox) disease, respectively. A physician may
provide a written statement that the pupil is medically exempt from the
rubella and/or mumps requirement as a result of having had laboratory
confirmed illness with the corresponding disease. A personal beliefs ex-
emption shall be granted upon the filing with the governing authority of
a letter or affidavit from the pupil's parent or guardian or adult who has
assumed responsibility for his or her care and custody in the case of a mi-
nor, or the person seeking admission if an emancipated minor, that such
immunization is contrary to his or her beliefs. The fact of the personal be-
liefs exemption shall be recorded on the California School Immunization
Record, PM 286 (1/02). A pupil with an exemption which is not based
on pre-existing immunity to disease may be subject to exclusion pur-
suant to Section 6060.

NOTE: Authority cited: Sections 100275, 120330 and 120335, Health and Safety
Code. Reference: Sections 120325, 120335, 120365, 120370 and 120375, Health
and Safety Code.

History

1 . Renumbering and amendment of a portion of former Section 6050 to Section
6051 filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 9-24-2002 as an emergency; operative
9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be trans-
mitted to OAL by 1-22-2003 or emergency language will be repealed by opera-
tion of law on the following day.

3. CerUficate of Compliance as to 9-24-2002 order transmitted to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

Article 4. Exclusion

§ 6055. Conditions for Admission Not Fulfilled.

The governing authority of the school, child care center, day nursery,
nursery school, family day care home, or development center shall ex-
clude from further attendance any pupil who fails to obtain the required
immunizations within no more than 10 school days following receipt of
the notice provided pursuant to Section 6040, unless the pupil is exempt
for medical reasons or personal beliefs, until the pupil provides written
evidence that he or she has received another dose of each required vac-
cine due at that time. Any pupil so excluded shall be reported to the atten-
dance supervisor or to the building adnunistrator.

NOTE: Authority cited: Sections 3381(c) (120335(c)), 100275 and 120330, Health
and Safety Code. Reference: Sections 3381 (120335), 120340, 120365, 120370
and 120375, Health and Safety Code.

Page 85

§6060

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1 . Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Note filed 3-2')-96i operative 4-28-96 (Register
96, No. 13).

§ 6060. Pupil Not Completely Immunized and Exposed to
Communicable Disease.

Whenever the governing authority has good cause to believe that a pu-
pil who is not completely immunized against a particular communicable
disease may have been exposed to that disease, that information shall be
reported by the governing authority immediately by telephone to the lo-
cal health officer. The local health officer shall determine whether the pu-
pil is at risk of developing the disease and, if so, may require the exclusion
of the pupil from that school, child care center, day nursery, nursery
school, family day care home, or development center until the comple-
tion of the incubation period and the period of communicability of the
disease.

NOTE: Authority cited: Sections 338 1 (c) ( 1 20335(c)), 1 00275 and 1 20330, Health
and Safety Code. Reference: Sections 3381 (120335) and 120375(c), Health and
Safety Code.

History

1 . Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section and Ncm; filed 3-29-96; operative 4-28-96 (Register
96, No. 13).

Article 5. Records As Evidence of
Immunization

§ 6065. Documentary Proof.

(a) There shall be a written record given to the person immunized or
to his or her parent or guardian, by the physician or agency performing
the immunization which shall contain the following information:

( 1 ) Name of the person.

(2) Birthdate.

(3) Type of vaccine administered.

(4) Month, day, and year of each immunization.

(5) Name of the physician or agency administering the vaccine.

(b) The written record shall be shown by the parent, guardian or person
immunized to the governing authority of the school, child care center,
day nursery, nursery school, family day care home, or development cen-
ter at the time of the pupil's admission and at subsequent times when re-
quired by the governing authority to determine the pupil's immunization
status. For the pupil to be admitted, the written record shall show at least
the month and year of each required vaccine dose. For doses of measles,
rubella and mumps vaccine given during the month of the first birthday
the record shall also show the specific date (i.e., month, day and year) of
immunization.

(c) When such written records are not available, the pupil shall not be
admitted and the parent or guardian shall be referred to a physician or
nurse for review of his or her immunization history and provision of im-
munizations as needed.

(d) Pupils who were admitted to a California school at kindergarten
level or above before March 5, 1986 on the basis of a parent or guardian's
having completed and signed a California School Immunization Record
PM 286 ( 1/02) as provided by Section 6070 that shows at least the month
and year each required vaccine dose was received (and also shows the
day of immunization if a measles, rubella, and/or mumps vaccine dose
was received during the month of the first birthday), rather than on the
basis of a parent or guardian's having provided a written record, as de-
scribed in Parts (a) and (b) of this Section, shall be allowed to continue
in attendance in California schools.

NOTE: Authority cited: Sections 100275, 120330 and 120335, Health and Safety
Code. Reference: Sections 120325, 120335, 12()370and 120375, Health and Safe-
ty Code.

History

1 . Amendment filed 2-3-86; effective thirtieth day thereafter (Register 86, No. 6).

2. Amendment of subsection (b) and Note filed 3-29-96; operative 4-28-96
(Register 96, No. 13).

3. Ainendment of section and Note filed 9-24-2002 as an emergency; operative
9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be trans-
mitted to OAL by 1-22-2003 or emergency language will be repealed by opera-
tion of law on the following day.

4. Certificate of Compliance as to 9-24-2002 order transmiued to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

§ 6070. School/Child Care Facility Immunization Record.

(a) The governing authority of each school, child care center, day nurs-
ery, nursery school, fatnily day care home, or development center shall
record each pupil's immunizations on the California School Immuniza-
tion Record, PM 286 (1/02) and is in its entirety, incorporated by refer-
ence which, at kindergarten level and above, shall be part of the mandato-
ry permanent pupil record as defined in Section 430 of Title 5, California
Code of Regulations.

(b) Each pupil's immunization record shall contain:

(1) Name of pupil.

(2) Birthdate (month, day and year).

(3) Date of unconditional or conditional admission (month, day, and
year).

(4) Type of vaccine and date (month, day, and year) each dose was ad-
ministered. Although month, day and year of vaccine administration
should be recorded, a California Immunization Record, PM 286, show-
ing only month and year of vaccine dose(s) shall be allowed, except that
for records showing measles, rubella, and/or mumps vaccine doses given
during the month of the first birthday, the date of immunization shall also
be recorded.

(5) Date and type of exemption, if any.

(d) For pupils at kindergarten level and above transferring between
school campuses within California or from a school in another state to a
school in California, if the mandatory permanent pupil record or other
immunization record has not been received at the time of entry to the new
school, the governing authority of the school may admit the pupil for a
period of up to 30 school days. If the mandatory permanent record or oth-
er immunization record has not arrived by the end of this period, the gov-
erning authority shall require the parent or guardian to present a written
immunization record, as described in Section 6065, documenting that all
currently due required immunizations have been received. If such a re-
cord is not presented, the pupil shall be excluded from further attendance
until he or she comes into compliance with the immunization require-
ments, as outlined in Sections 6020, 6035, and 6065.

(e) The governing authority shall see that the immunization record of
each pupil admitted conditionally is reviewed every 30 days until that pu-
pil has received all the required immunizations. Any immunizations re-
ceived subsequent to conditional admission shall be entered in the pupil's
immunization record.

Note; Authority cited: SecUons Sections 100275, 120330 and 120335. Health
and Safety Code. Reference: Sections 120325, 120335, 120370 and 120375,
Health and Safety Code.

History

1 . Amendment filed 2-3-86; effecdve thirtieth day thereafter (Register 86, No. 6).

2. Amendment of section heading, subsection (a) and Note filed 3-29-96; opera-
tive 4-28-96 (Register 96, No. 13).

3. Amendment of section and Note filed 9-24-2002 as an emergency; operative
9-24-2002 (Register 2002, No. 39). A Certificate of Compliance must be trans-
mitted to OAL by 1-22-2003 or emergency language will be repealed by opera-
tion of law on the following day.

4. Certificate of Compliance as to 9-24-2002 order transmitted to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

§ 6075. Reporting.

(a) The governing authority of each school, child care center, day nurs-
ery, nursery school, family day care home, or development center shall
file a report with the state and local health departments on the immuniza-
tion status of new entrants annually or when needed to determine immu-
nization status such as during an epidemic or potential epidemic. The
forms to be used for these reports are:

Page 86

Title 17

State Department of Health Services

§ 6500.19

(1) Schools with kindergartens: IMMUNIZATION ASSESSMENT
OF KINDERGARTEN STUDENTS— ANNUAL REPORT [PM 236
(3/01)] and this form in its entirety is incorporated by reference.

(2) Schools with seventh grades: IMMUNIZATION ASSESSMENT
OF SEVENTH GRADE STUDENTS [DHS 8259 (8/98)]. This form is
hereby incorporated by reference.

(3) Child care centers, day nurseries, nursery schools and development
centers: ANNUAL IMMUNIZATION REPORT ON CHILDREN EN-
ROLLED IN CHILD CARE CENTERS [DHS 8018 (3/01)] and this
form is in its entirety incorporated by reference or ANNUAL IMMUNI-
ZATION ASSESSMENT REPORT OF CHILDREN ENROLLED IN
CHILD CARE CENTERS— LINE LISTING [DHS 8387 (3/94)]. The
Department of Health Services or the local health department will pro-
vide the appropriate reporting form.

(4) Family day care homes: ANNUAL FAMILY DAY CARE HOME
IMMUNIZATION SURVEY [DHS 8529 (10/00)] and this form is in its
entirety incorporated by reference.

(b) The annual report shall contain at least the following information
on new entrants in kindergarten or lower level classes only:

( 1 ) Enrollment as of date of report.

(2) Number of new entrants admitted unconditionally specifying the
number who have received all immunizations, the number who are medi-
cally exempt and the number who are exempt for personal beliefs.

(3) Number of new entrants admitted conditionally specifying the
number of doses received of poliomyelitis, diphtheria, tetanus, pertussis,
measles, rubella, Haemophilus influenza type b (Hib), mumps, hepatitis
B, and varicella (chickenpox) vaccines.

(4) Other information requested by the State Department of Health
Services.

(c) Additional reports which include new entrants in all grades may be
requested during an epidemic or potential epidemic.

NOTE: Authority cited: Sections 100275, 120330 and 120335, Health and Safety
Code. Reference: Sections 120325, 120335, 120370 and 120375, Health and Safe-
ty Code.

History

1 . Amendment of subsection (b)(3) filed 4-1 5-80 as an emergency; effective upon
filing (Register 80, No. 16). A Certificate of Compliance must be transmitted
to OAH within 120 days or emergency language will be repealed on 8-14-80.

2. Certificate of Compliance transmitted to OAL 7-29-80 and filed 8-20-80
(Register 80, No. 34).

3. Amendment of subsection (a), new subsections (a)(l)-(3), and amendment of
subsection (b)(3) and Note filed 3-29-96; operative 4-28-96 (Register 96, No.
13).

4. Editorial correction of subsection (b)(3) (Register 97, No. 12).

5. Amendment of subsection (b)(3) and NOTE filed 5-22-97 as an emergency; op-
erative 5-22-97 (Register 97, No. 21). A Certificate of Compliance must be
transmitted to OAL by 9-19-97 or emergency language will be repealed by op-
eration of law on the following day.

6. Editorial correction of Note (Register 97, No. 37).

7. Certificate of Compliance as to 5-22-97 order transmitted to OAL 9-5-97 and
filed 9-26-97 (Register 97, No. 39).

8. Amendment of subsection (a)(1), new subsection (a)(2) and subsecfion renum-
bering filed 2-1 8-99 as an emergency; operative 2-18-99 (Register 99, No. 8).
A Certificate of Compliance must be transmitted to OAL by 6-18-99 or emer-
gency language will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 2-1 8-99 order transmitted to OAL 5-26-99 and
filed 6-30-99 (Register 99, No. 27).

10. Amendment of subsections (a)(1), (a)(3)-(4) and (b)(3) and amendment of
Note filed 9-24-2002 as an emergency; operadve 9-24-2002 (Register 2002,
No. 39). A Certificate of Compliance must be transmitted to OAL by
1-22-2003 or emergency language will be repealed by operation of law on the
following day.

1 1 . Certificate of Compliance as to 9-24-2002 order transmitted to OAL
1-17-2003 and filed 2-27-2003 (Register 2003, No. 9).

Subchapter 8.2. Immunization Against
Diphtheria, Tetanus, and Pertussis

History

1 . Repealer filed 3-22-78 as an emergency; effective upon filing (Register 78, No.
12). For prior history, see Register 72, No. 1 1.

Subchapter 9. Testing for Heritable
Disorders

Group 3. Newborn Screening Program

Subchapter 8.1. Immunization Against
Measles (Rubeola)

History

1 . Repealer filed 3-22-78 as an emergency; effective upon filing (Register 78, No.
12). For prior history, see Registers 67, No. 43; 67, No. 48; and 72, No. 11.

Article 1. Definitions

§ 6500. Birth Attendant.

"Birth attendant" means any person licensed or certified by the State
to provide maternity care and to deliver pregnant women or to practice
medicine.

Note. Authority cited: Secfions 124980 and 125000, Health and Safety Code.
Reference: Secfions 124980 and 125000, Health and Safety Code.

History

1. New subchapter 9 (secfion 6500) filed 12-1-65; designated effective 1-1-66
(Register 65, No. 23).

2. Amendment filed 10-5-66; effecfive thirtieth day thereafter (Register 66, No.
34)

3. Repealer filed 4-1 1-80; designated effecfive 9-1-80 (Register 80, No. 15).

4. Renumbering and amendment of former section 6500.5 to secfion 6500 filed
1 1-21-86; effecfive thirtieth day thereafter (Register 86, No. 47).

5. Amendment of subsecfion (r) and new subsecfions (s) and (t) filed by the Depart-
ment of Health Services with the Secretary of State on 1 2-22-89 as an emergen-
cy; operadve 12-22-89. Submitted to OAL forprinfing only pursuant to Health
and Safety Code secfion 309(g) (Register 90, No. 4).

6. Amendment of subsection (t) filed by the Department of Health Services with
the Secretary of State on 5-30-90 as an emergency; operafive 5-30-90. Sub-
mitted to OAL for prinfing only pursuant to Health and Safety Code section
309(g)(Register 90, No. 30).

7. Editorial correction of prinfing error in subsection (r) restoring HISTORY 5. and
renumbering previous HISTORY 5. to 6. (Register 91, No. 32).

8. Change without regulatory effect amending subchapter heading, adding group
3 heading, and amending article heading, secfion heading, secfion and Note
filed 10-12-2006 pursuant to secfion 100, fitle 1, California Code of Regula-
fions (Register 2006, No. 41).

§ 6500.1 . Days of Age.

"Days of age" means the measurement of the age of a newborn in
24-hour periods so that a newborn is one day of age 24 hours following
the hour of birth.

NOTE: Authority cited: Secfions 124980 and 125000, Health and Safety Code.
Reference: Secfions 124980 and 125000, Health and Safety Code.

History

1. Change without regulatory effect adopting secfion filed 10-12-2006 pursuant
to secfion 100, fitle I, California Code of Regulations (Register 2006, No. 41).
For prior history, see Register 87, No. 47.

§ 6500.5. Discharge.

"Discharge" means release of the newborn from care and custody of
the perinatal licensed health facility to the parents or into the community.
NOTE: Authority cited: Secfions 124980 and 125000, Health and Safety Code.
Reference: Secfions 124980 and 125000, Health and Safety Code.

History

1. Change without regulatory effect adopting secfion filed 10-12-2006 pursuant
to secfion 100, tide 1, California Code of Regulations (Register 2006, No. 41 ).
For prior history, see Register 87, No. 47.

§ 6500.1 9. Inadequate Specimen.

"Inadequate specimen" means a newborn's blood specimen which is
not suitable in quality or quantity to perform newborn screening for one
or more of the disorders covered by this Group.

NOTE: Authority cited: Secfions 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safely Code.

Page 87

§ 6500.25

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1 , California Code of Regulations (Register 2006, No. 41 ).

§ 6500.25. Initial Positive Test.

"Initial positive test" means a newborn's blood specimen which iden-
tified as positive for reporting purposes.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, titlel , California Code of Regulations (Register 2006, No. 41 ).

§ 6500.28. Initial Specimen.

"Initial specimen" means the first specimen collected subsequent to
birth, pursuant to this Group.

NOTE; Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title'l, California Code of Regulations (Register 2006, No. 41).

§6500.31. Initial Test.

"Initial test" means the first valid newborn screening test or combina-
tion of tests of a newborn for each disorder covered by this Group.
NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, title" 1, California Code of Regulations (Register 2006, No. 41).

§ 6500.35. Newborn.

"Newborn" means an infant 30 days of age and under.
Note: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History

1 . Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title" 1, California Code of Regulations (Register 2006, No. 41).

§ 6500.39. Newborn's Physician.

"Newborn's physician" means the physician responsible for the care
of the newborn after discharge from the hospital.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, tide 1, California Code of Regulations (Register 2006, No. 41).

§ 6500.45. Newborn Screening Area Service Center.

"Newborn Screening Area Service Center" means an institution, cor-
poration, hospital or university medical center:

(a) Having specialized expertise;

(b) Designated by the Department to serve a specific geographic area
of the State: and

(c) Contracted with the Department to provide follow-up, referral and
diagnosis of a preventable heritable or congenital disorder.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, tide 1, California Code of Regulations (Register 2006, No. 41).

§ 6500.46. Newborn Screening Laboratory.

"Newborn screening laboratory" means a laboratory operated by the
Department or a laboratory contracting with the Department to conduct
tests required by this Group.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, Utie 1, California Code of Regulations (Register 2006, No. 41).

§ 6500.57. Perinatal Licensed Health Facility.

"Perinatal licensed health facility" means any health facility licensed
by the State and approved to provide perinatal, delivery, newborn inten-
sive care, newborn nursery or pediatric services.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1 . Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, title 1 , California Code of Regulations (Register 2006, No. 41 ).

§ 6500.59. Preventable Heritable or Congenital Disorder.

"Preventable heritable or congenital disorder" means any disorder or
abnormality present at birth which is detectable by testing a newborn and
for which effective means of prevention or amelioration exists.
NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatoiy effect adopting section filed 10-12-2006 pursuant

to section 100, title 1 . California Code of Regulations (Register 2006, No. 41 ).

§ 6500.65. Recall Specimen.

"Recall specimen" means a specimen collected from a newborn be-
cause the initial test or combination of tests was positive for any of the
disorders covered by this Group.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatoiy effect adopting section filed 10-12-2006 pursuant

to section 100, title 1 , California Code of Regulations (Register 2006, No. 41).

§6500.67. Recall Test.

"Recall test" means a test ordered collected from a newborn because
the initial test or combination of tests was positive for any of the disorders
covered by this Group.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, tide 1 , California Code of Regulations (Register 2006, No. 41).

§ 6500.69. Repeat Specimen.

"Repeat specimen" means a specimen collected from a newborn fol-
lowing the newborn screening laboratory's report that a previously col-
lected specimen was either inadequate or that test results were inconclu-
sive.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Healdi and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, tide 1, California Code of Regulations (Register 2006, No. 41).

§ 6500.70. Repeat Test.

"Repeat test" means a test required by this Group to be repeated for a
newborn because the previous specimen or test results were inadequate
or test results were not complete.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, titie 1, California Code of Regulations (Register 2006, No. 41).

§ 6500.74. Sickle Cell Counselor.

"Sickle cell counselor" means a person who:

(a) Is a physician, or has a master's degree in genetic counseling and
is board eligible or board certified by the American Board of Medical Ge-
netics Provides, or is certified by the Department of Health Services as
having successfully completed an approved sickle cell counselor training
program; and

(b) Provides face-to-face information on the medical, social, and ge-
netic consequences of sickle cell disease and trait.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980, 125000 and 125025, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Page 88

Title 17

State Department of Health Services

§6503

§ 6500.77. Sickle Cell Education and Counseling Program.

"Sickle sell education and counseling program" means an educational
and counseling program in which the disease orientation is, in whole or
in major part, sickle cell disease.

Nt)TI-:: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference; Sections 124980, 125000 and 125025. Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1 , Cahfomia Code of Regulations (Regi.ster 2006, No. 41).

§ 6500.80. Transfer.

"Transfer" means release of the newborn from care and custody of one
perinatal licensed health focility to care and custody of another perinatal
licensed health facility, or admission to another perinatal licensed health
facility of a newborn from an out-of-state facility.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Article 2.

Testing and Follow-Up Program
Requirements

§ 6501 . Scope of Newborn Testing.

Each newborn bom in California shall be tested for galactosemia, he-
reditary hemoglobinopathies, phenylketonuria and primary congenital
hypothyroidism in accordance with procedures in this Group.
NOTE; Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980, 125000, 125001 and 125025, Health and Safety
Code.

History

1. New section filed 4-1 1-80; designated effective 9-1-80 (Register 80, No. 15).

2. Amendment filed 1 1-21-86; effective thirtieth day thereafter (Register 86, No.

47).

3. Amendment of subsections (a) and (c) filed by the Department of Health Ser-
vices with the Secretary of State on 12-22-89 as an emergency; operative
12-22-89. Submitted to OAL for printing only pursuant to Health and Safety
Code Section 309(g) (Register 90, No. 4).

4. Change without regulatory effect adding article 2 heading and amending section
and Note filed 10-12-2006 pursuant to secdon 100, Utle 1, California Code of
Regulations (Register 2006, No. 41).

§6501.2. Religious Objection.

(a) The provisions of Section 6501 shall not apply if a parent or legally
appointed guardian objects to a test on the ground that it conflicts with
his or her religious beliefs or practices. If the parent or legal guardian re-
fuses to allow the collection of a blood specimen, such refusal shall be:
( 1 ) made in writing, (2) signed by a parent or legally appointed guardian,
and (3) included in the newborn's medical or hospital record.

(b) Birth attendants or physicians shall provide to parent(s) or legally
appointed guardian(s) who object to the test on the basis it is in conflict
with their religious beliefs or practices, a refusal form approved by the
Department and shall obtain the appropriate signature(s) upon the form.
If the parent(s) or legally appointed guardian(s) is unable to read such
material, it shall be translated or read to such person(s) in a language un-
derstood by such persons.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting secfion filed 10-12-2006 pursuant
to section 100, Utle 1, Cahfomia Code of Reguladons (Register 2006, No. 41).

§ 6502. Fatal Condition.

The provisions of Section 6501 shall not apply if the newborn has a
condition almost certain to be fatal in the first 30 days of life. The progno-
sis shall be documented in the medical record.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Section 125000, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to secfion 100, title 1, California Code of Regulations (Register 2006, No. 41 ).
For prior history, see Register 87, No. 47.

§6502.1. Confidentiality.

(a) All information, records of interview, written reports, statements,
notes, memoranda, or other data procured by an individual, group or re-
search team in the course of any testing under this Group shall be confi-
dential and shall be used solely for the purposes of medical intervention,
counseling, or specific research project approved by the Department.

(b) Except as provided by law, such information shall not be exhibited
nor disclosed in any way, in whole or in part, by any individual, group,
or research team except with the written consent of the person or his/her
legally authorized representadve unless such data can be made available
in a manner which preserves anonymity of the persons tested.

NOTE; Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Secdons 124980 and 125000, Health and Safety Code.

History

1 . New section filed by the Department of Health Services with the Secretary of
State on 5-30-90 as an emergency; operative 5-30-90. Submitted to OAL for
printing only pursuant to Health and Safety Code section 309(g) (Register 90,
No. 30).

2. Change without regulatory effect amending subsection (a) and Note filed
10-12-2006 pursuant to section 100, Utle 1, Cahfomia Code of Reguladons
(Register2006, No. 41).

§ 6503. Newborn Screening Laboratory Requirements.

(a) The Department shall designate laboratories and tests to be used for
Department required newborn tests. Such laboratories shall be either lab-
oratories operated by the Department for quality control confirmatory
and emergency testing or contractor laboratories licensed as clinical lab-
oratories under the Business and Professions Code.

(b) Perinatal licensed health facilides and birth attendants shall submit
required specimens to the newborn screening laboratory designated by
the Department.

(c) Contract newborn screening laboratories shall be limited to labora-
tories that shall have submitted a bid acceptable to the Department on a
competitive contract to provide laboratory services in sufficient volume
to cover all of the newborns born in a geographical area, as defined by
the Department, plus an appropriate emergency capacity. The Depart-
ment will define not more than six areas and may combine areas if neces-
sary to reduce costs or assure statewide coverage.

(d) Notwithstanding (c) above a comprehensive prepaid group prac-
tice direct health care service plan with 20,000 or more births in the last
completed calendar year for which complete statistics are available may
have a laboratory serving a comprehensive prepaid group practice health
care service plan designated a newborn screening laboratory under terms
of a written agreement as defined in Section 6508(b) or may provide ser-
vices in conformity with the terms of a mutually acceptable contract for
services.

(e) Newborn screening laboratories shall participate in a proficiency
testing program conducted by the Department's laboratory and shall
maintain levels of performance acceptable to the Department.

(f) Newborn screening laboratories contracting with the Department
shall be subject to on-site inspections and review of laboratory perform-
ance of tests and laboratory records.

NOTE: Authority cited: Secdons 124980 and 125000 , Health and Safety Code.
Reference: Secdons 124980, 125000 and 125001, Health and Safety Code.

History

1. New secdon filed 4-1 1-80; designated effecdve 9-1-80 (Register 80, No. 15).

2. Amendment filed 8-29-80 as an emergency; effective upon filing ( Register 80.
No. 35). A certificate of compliance must be filed within 1 20 days or emergenc)
language will be repealed 12-28-80.

3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-^12-81
(Register 81, No. 3).

4. Amendment filed 1 1-21-86; effecdve thirtieth day thereafter (Register 86, No.
47).

5. Amendment of subsections (d) and (e) filed by the Department of Health Ser-
vices with the Secretary of State on 12-22-89 as an emergency; operative
12-22-89. Submitted to OAL for printing only pursuant to Health and Safety
Code Secdon 309(g) (Register 90, No. 4).

Page 89

§6504

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

6. Change without regulatory effect amending section heading and Note filed
10-12-2006 pursuant to section 100, title 1, California Code of Regulations
(Register2006. No. 41).

§ 6504. Parent Education: Birth Attendants.

All birth attendants engaged in providing perinatal care shall provide
pregnant women, prior to the estimated date of delivery, with a copy of
the informational material, entitled "Important Information for Parents,"
provided by the Department.

NOTE: Authority cited; Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

History

1 . New section filed 4-1 1-80; designated effective 9-1-80 (Register 80, No. 15).

2. Amendment of subsection (f) filed 8-29-80 as an emergency (Register 80, No.
35). A certificate ofcompliance must be filed within 120 days or emergency lan-
guage will be repealed on 12-28-80.

3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81
(Register 81, No. 3).

4. Repealer and new section filed 11-21-86; effective thirtieth day thereafter
(Register 86, No. 47).

5. Change without regulatory effect amending section heading, section and Note
filed 10-12-2006 pursuant to section 100, title 1, California Code of Regula-
tions (Register 2006, No. 41).

§ 6504.2, Parent Education: Perinatal Licensed Health
Facilities.

Perinatal licensed health facilities shall provide each pregnant woman
admitted for delivery with a copy of the informational material provided
by the Department, entitled "Important Information for Parents" prior to
collection of the blood speciinen if such information has not been pro-
vided pursuant to Section 6504. If a woman is unable to read such materi-
al, it shall be translated or read to her in a language she understands.
NOTE: Authority cited: Secfions 124980 and 125000, Health and Safety Code.
Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to secfion 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6504.4. Specimen Collection Forms.

(a) Department approved specimen collection forms shall not be co-
pied, printed, reproduced, acquired, purchased or distributed other than
as provided for in this Group.

(b) Such Department approved specimen collection forms shall be ful-
ly and accurately completed by birth attendants, perinatal licensed health
facilities and laboratories; and a copy shall be filed in each newborn's
inedical record.

Note; Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to secfion 100, title 1, CaUfomia Code of Regulations (Register 2006, No. 41).

§ 6504.6. Record Maintenance.

Perinatal licensed health facilities shall maintain such records as are
necessary to assure compliance with this Group and provide the Depart-
ment with such data as may be periodically required including, but not
limited to, information on all newborns discharged or transferred from
the facility without collection of a blood specimen. All such information
and records shall be confidential, but shall be open to examination by the
Department personnel or its designated agents for any purpose directly
connected with the administration of the newborn screening program.
Note: Authority cited: Secfions 124980 and 125000, Health and Safety Code.
Reference: Sections 124980, 125000 and 125001, Health and Safety Code.

History
1. Change without regulatory effect adopting secfion filed 10-12-2006 pursuant

to section 100, fitle 1 , California Code of Regulations (Register 2006, No. 41).

§ 6505. Collection of Specimens.

(a) Birth attendants, laboratories and hospitals shall collect specimens
using the technique for blood collection distributed by the Department.

(b) Physicians or birth attendants who are caring for newborns bom in
perinatal licensed health facilities shall have blood specimens collected

using Department-approved specimen collection forms in accordance
with criteria distributed by the Department including the following:

(1) A specimen must be collected from any untested infant prior to
blood transfusion.

(2) For newborns discharged before six days of age, a blood specimen
shall be obtained as close to the time of discharge from the perinatal li-
censed health facility as is practical regardless of age or feeding history,
unless the newborn is transferred for continuing care to another perinatal
licensed health facility on or before the sixth day of age. Perinatal li-
censed health facilities which discharge infants before 24 hours of age
may request a waiver from this requirement documenting how such new-
boms will be tested on or before 6 days of age. Such alternative testing
schedules must be approved in writing by the Department.

(3) For newborns remaining in perinatal licensed health facilities be-
yond five days of age, a blood specimen shall be obtained from the new-
bom on the sixth day of age regardless of feeding history.

(4) For newborns received by transfer on or before six days of age, the
receiving hospital shall obtain a blood specimen as close to discharge as
possible, and if not discharged by the sixth day, a blood specimen shall
be obtained on the sixth day of life.

(c) For newborns not born in a perinatal licensed health facility but ad-
mitted to a perinatal licensed health facility within the first six days of
age, a specimen shall be obtained as close to discharge as possible, and
if not discharged by the sixth day of life, a blood specimen shall be ob-
tained on the sixth day of life unless the newborn's physician has evi-
dence that the specimen was previously obtained and records the results
of the test in the newborn's medical record.

(d) For newborns not born in a perinatal licensed health facility but ad-
mitted to a perinatal licensed health facility after six days of age but with-
in the first 30 days of age, a blood specimen shall be obtained within 48
hours after admission unless the newborn's physician has evidence that
the specimen was previously obtained and records the results of the test
in the newborn's medical record.

(e) Physicians attending sick newborns who exhibit symptoms
suggestive of galactosemia, hypothyroidism or phenylketonuria (PKU),
in addition to immediate diagnostic tests from local laboratory sources,
shall have a blood specimen collected from the newborn and submitted
to a newborn screening laboratory using forms purchased from the De-
partment.

(f) Physicians attending critically ill newborns who require special
care may postpone collection of a blood specimen until the newborn's
emergency life threatening condition is stabilized.

(g) Birth attendants or physicians attending newborns not bom in a
perinatal licensed health facility and not subsequently admitted to a li-
censed health facility during the first six days of age, shall have a blood
specimen collected from the newborn between the second and sixth days
of age and submitted to a newborn screening laboratory using forms ob-
tained from the Department.

(h) If a newborn is bom outside of a perinatal licensed health facility
and the birth is not attended by a birth attendant and the newbom is not
subsequently admitted to a perinatal licensed health facility within the
first ten days of age, the person required to register the birth shall arrange
for a blood specimen to be collected and submitted to a newbom screen-
ing laboratory between the second and tenth day of age.

(i) Initial specimens shall be collected using a Department-approved
form and shall be placed in the United States mail or other approved chan-
nel of transmittal to the assigned Department-approved laboratory as
soon as possible, but not later than 12 hours after they are obtained.

(j) The blood specimen and information obtained during the testing
process becomes the property of the State and may be used for program
evaluation or research by the Department or Department-approved
scientific researchers without identifying the person or persons from
whom these results were obtained, unless the person or his/her legally au-
thorized representative specifically prohibits such use in writing.

•

Page 90

Title 17

State Department of Health Services

§ 6507.1

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Rel'cicnce: Sections 124980 and 125000, Health and Safety Code.

History

1 . New section filed 4-1 1-80; designated effective 9-1-80 (Register 80, No. 15).
For history of former section, see Registers 78, No. 34 and 74, No. 18.

2. Amendinent of subsection (i) filed 8-29-80 as an emergency; effective upon
filing (Register 80, No. 35). A certificate of compliance must be filed within 1 20
days or emergency language will be repealed on 12-28-80.

3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81
(Register 81, No. 3).

4. Repealer and new section filed 11-21-86; effective thirtieth day thereafter
(Register 86, No. 47).

5. Amendment of subsections (b), (c), (0 and (i), and new subsection (j) filed by
the Department of Health Services with the Secretary of State on 12-22-89 as
an emergency; operative 12-22-89. Submitted to OAL for printing only pur-
suant to Health and Safety Code Section 309(g) (Register 90, No. 4).

6. Change without regulatory effect amending NoTi; filed 10-12-2006 pursuant
to seclion 100, fitle 1, California Code of Regulations (Register 2006, No. 41).

§ 6506. Medical Record Review.

(a) Perinatal licensed health facilities shall review each newborn's
medical record within 14 days from the date of discharge to determine
that the results of required tests are filed in the newborn's medical record,
or that a parent's or legal guardian's signed refusal has been filed in the
newborn's medical record.

(b) Whenever a perinatal licensed health facility determines that a
specimen has been obtained, but there are no results available in the new-
born's medical record the facility shall send written notification within
five days to the Department.

NOTE: Authority cited: Secdons 124980 and 125000, Health and Safety Code.
Reference: Secdons 124980 and 125000, Health and Safety Code.

History

1 . New Section filed 4-1 1-80; designated effecdve 9-1-80 (Register 80, No. 15).

2. Repealer and new section filed 11-21-86; effective thirtieth day thereafter
(Register 86, No. 47).

3. Change without regulatory effect amending section heading, section and Note
filed 10-12-2006 pursuant to section 100, title 1, California Code of Regula-
dons (Register 2006, No. 41).

§ 6506.2. Newborns Discharged from a Perinatal Licensed
Health Facility Without Testing.

(a) Whenever a perinatal licensed health facility determines that a dis-
charged newborn has not received the mandated tests, the facility shall
contact the newborn's physician by telephone to inform him/her that a
specimen must be obtained and immediately send written notification to
the newborn's physician and the Department. If the newborn's physician
cannot be contacted or will not obtain a specimen, the perinatal licensed
health facility shall notify the Department-approved Newborn Screen-
ing Area Service Center by telephone and shall send written notification
within five days to the Newborn Screening Area Service Center and the
Department.

(b) When the newborn's physician is notified by telephone by the per-
inatal licensed health facility that a newborn was discharged from the
perinatal licensed health facihty before a specimen was taken, the new-
bom's physician shall make every reasonable effort to have a specimen
obtained within five days of notification. If the newborn's physician can-
not obtain the specimen, the Newborn Screening Area Service Center
shall be notified by the newborn's physician by telephone. Such tele-
phone notification shall be noted in the newborn's physician's records,
specifying the date of notification, the person notified and the informa-
tion provided.

NOTE: Authority cited: Secdons 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 1 00, dde 1 , Cahfomia Code of Regulations ( Register 2006, No. 4 1 ) .

§ 6506.6. Follow-Up to Reports of Inadequate Specimen.

When the newborn's physician is notified by the laboratory by tele-
phone that a specimen is inadequate, the physician so notified shall make
every reasonable effort to have an adequate specimen obtained within
five days of notification. If the newborn's physician so notified, cannot

obtain the repeat specimen, the physician shall notify the Newborn
Screening Area Service Center as soon as possible by telephone. Such
telephone nofification shall be noted in the newborn's physician's re-
cords specifying the date of notification, the person nofified and the in-
formation provided.

NOTE: Authority cited: Sections 124980 and 125000. Health and Safety Code.
Reference: Secdons 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting secdon filed 10-12-2006 pursuant
to secdon 100, title 1, California Code of Regulations (Register 2006, No. 41 ).

§ 6506.8, Follow-Up to Reports of Initial Positive Result.

When the newboiTi's physician is notified by telephone by the Depart-
ment-approved Newborn Screening Area Service Center of an initial
positive test result, the newborn's physician shall obtain an adequate re-
call blood specimen from the newborn and submit it to the designated
laboratory within 48 hours. If the recall blood specimen cannot be ob-
tained within 48 hours, the newborn's physician shall notify the Newborn
Screening Area Service Center by telephone. Such telephone notification
shall be noted in the newborn's physician's records, specifying the date
of notification, the person notified and the information provided.
NOTE: Authority cited: Secdons 124980 and 125000, Health and Safety Code.
Reference: Secdons 124980 and 125000, Health and Safety Code.

History

1. Change without regulatoi^ effect adopting secdon filed 10-12-2006 pursuant
to secdon 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6506.10. Repeat and Recall Specimen Collection and
Transmittal.

Repeat and recall specimens required by this Group shall be collected
on Department approved forms, placed in appropriate containers, and
shall be placed in the United States mail or other approved channel of
transmittal to the assigned Department-approved laboratory as soon as
possible, but not later than 1 2 hours after they have been obtained.
NOTE; Authority cited: Secdons 124980 and 125000, Health and Safety Code.
Reference: Secdons 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopting secdon filed 10-12-2006 pursuant

to secdon 100, dtle 1, California Code of Reguladons (Register 2006, No. 41).

§ 6506.12. Diagnosis Reporting.

All physicians making an initial diagnosis of a preventable heritable
disorder for which testing is required under this Group shall report such
diagnosis and provide the informadon necessary for follow-up and in-
vestigation to the Department.

NOTE: Authority cited: Secdons 124980 and 125000, Health and Safety Code.
Reference: Secdons 124980 and 125000, Health and Safety Code.

History
1. Change without regulatory effect adopdng secdon filed 10-12-2006 pursuant

to secdon 100, dtle 1, California Code of Reguladons (Register 2006, No. 41).

§6507. Failure to Comply.

Willful or repeated failure to comply with this Group shall be referred
by any person having knowledge of non-compliance to the appropriate
hcensing authority. Failure to report may constitute grounds for disci-
plinary action including revocation of license.

NOTE: Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Secdons 124980, 124985 and 125000, Health and Safety Code.

History

1. Change without regulatory effect adopting secdon filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41).
For prior history, see Register 90, No. 4.

§ 6507.1 . Local Agency Responsibilities.

(a) The county registrar of births shall provide a copy of the informa-
tional material prepared and provided by the Department to each person
registering the birth of a newborn that occurred outside of a perinatal li-
censed health facility when the said newborn was not admitted to a perin-
atal licensed health facility within the first 30 days of age. The local
health officer and the Department shall be notified of each such registra-
tion by the county registrar.

(b) Each local health department in the county where a newborn re-
sides shall be responsible for making every reasonable effort to obtain

Page 91

§ 6507.2

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

specimens when requested by the Department-approved Newborn
Screening Area Service Center or the Department. If after every reason-
able effort a specimen cannot be obtained, the local health department
may, after 30 days, with approval from the Department, terminate efforts.
Note; Authority cited: Sections 124980 and 125000, Health and Safety Code.
Reference: Sections 124980 and 125000. Health and Safety Code.

History

1 . Renumbering of former Section 6507 to Section 6507. 1 filed by the Department
of Health Services with the Secretary of State on 12-22-89 as an emergency;
operative 1 2-22-89. Submitted to OAL for printing only pursuant to Health and
Safety Code Section 309(2) (Register 90, No. 4). For prior history, see Register
86, No. 47.

2. Change without regulatory effect amending section heading, section and Note-:
filed 10-12-2006 pursuant to section 100, title 1, California Code of Regula-
tions (Register 2006. No. 41).

3. Editorial coiTection of section heading (Register 2006, No. 44).

Article 3. Sickle Cell Programs

§ 6507.2. Sickle Cell Education and Counseling Program
Requirements.

(a) Each sickle cell education and counseling program shall apply for
and obtain written approval from the Department of Health Services.
Such approval shall be contingent upon compliance with all sections of
this Group.

(b) Each sickle cell education and counseling program shall:

( 1 ) Provide counseling services to the clients.

(2) Employ State-approved sickle cell counselors to perform all of the
counseling following, or relating to, any abnormal hemoglobinopathy
finding.

(3) Demonstrate, upon request by the Department of Health Services,
that each of its counselors successfully participates in State-approved
educational programs which serve to update the knowledge and enhance
the proficiency of such counselors.

(4) Have a physician with special training and experience in pediatric
hematology to serve as medical director or consultant to order and inter-
pret laboratory tests used in counseling.

(5) Have written protocols to protect the confidentiality and security
of all records containing personal information.

(6) Use only State-approved educational materials.

(7) Use any laboratory that meets the Department's standards for
sickle cell hemoglobin testing.

Note: Authority cited: Sections 124980, 125000 and 125025, Health and Safety
Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safe-
ty Code.

History

1 . New section filed by the Department of Health Services with the Secretary of
State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL
for printing only pursuant to Health and Safety Code Section 309(g) (Register
90, No. 4).

2. Change without regulatory effect adding article 3 heading and amending section
heading, subsection (a) and Note filed 10-12-2006 pursuant to section 100,
title 1, California Code of Regulations (Register 2006, No. 41).

§ 6507.3. Certification of a Sickle Cell Counselor.

(a) A sickle cell counselor shall obtain a certificate of approval from
the Department of Health Services upon presentation of written evidence
that he or she has:

(1) Completed a course at a sickle cell counselor training center ap-
proved by the Department with such center's endorsement of his or her
ability to function as a sickle cell counselor, and/or

(2) Successfully completed an examination or examinations which
demonstrate his or her knowledge or expertise in the field, and one or
more personal interviews to demonstrate an understanding of, and ability
to communicate with persons who have sickle cell disease or sickle cell
trait.

(b) All sickle cell counselors must provide documentation of comple-
tion of State-approved training to update skills and knowledge on an an-
nual basis.

(c) This section shall not apply to physicians.
NOTE: Authority cited: Sections 124980, 125000 and 125025, Health and Safety
Code. Reference: Sections 125000, 125025 and 125030, Health and Safety Code.

History

1 . New section filed by the Department of Health Services with the Secretai^ of
State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL
for printing only pursuant to Health and Safety Code section 309(g) (Reeister
90, No. 4).

2. Repealer of .section 6507.3 and renumbering of section 6507.4 to section 6507.3
filed 4-20-92 as an emergency; operative" 4-20-92 (Register 92, No. 18). A
Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency
language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and
filed 9-28-92 (Register 92, No. 40).

4. Change without regulatory effect amending section heading and Notf-: filed
10-12-2006 pursuant to section 100, title 1, California Code of Regulations
(Register 2006, No. 41).

§ 6507.4. Voluntary Participation.

Participation by any person in a sickle cell education and counseling
program in which medical information is obtained through interview,
test or other ascertainment procedure shall be wholly voluntary and shall
not be a prerequisite to eligibility for, or receipt of, any other services or
assistance from, or to participation in any other program.
NOTE: Authority cited: Sections 124980, 125000 and 125025, Health and Safety
Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safe-
ty Code.

History

1. New section filed by the Department of Health Services with the Secretary of
State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL
for printing only pursuant to Health and Safety Code section 309(a) (Register
90, No. 4).

2. Renumbering of section 6507.4 to section 6507.3 and renumbering of section

6507.5 to section 6507.4 filed 4-20-92 as an emergency; operative 4-20-92
(Register 92, No. 1 8). A Certificate of Compliance must be transmitted to OAL
8-18-92 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and
filed 9-28-92 (Register 92, No. 40).

4. Change without regulatory effect amending Note filed 10-12-2006 pursuant
to section 100, title'l, California Code of Regulafions (Register 2006, No. 41).

§ 6507.5. Informed Consent.

(a) A sickle cell education and counseling program shall obtain in-
formed consent from each adult upon whom testing or any other screen-
ing procedure is to be performed. If the person is a minor other than a
newborn, informed consent shall be obtained from such child's parent or
guardian. An informed consent shall be obtained from an emancipated
minor without the need for parent or guardian consent.

(b) The informed consent shall be in writing in format approved by the
Department and shall be signed by the person, by his or her guardian or,
except in the case of an emancipated minor, by his or her parent.
NOTE: Authority cited: Section 124980, 125000 and 125025, Health and Safety
Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safe-
ty Code.

History

2. Renumbering of section 6507.5 to section 6507.4 and renumbering of section

6507.6 to section 6507.5 filed 4-20-92 as an emergency; operative 4-20-92
(Register 92, No. 1 8). A Certificate of Compliance must be transmitted to OAL
8-18-92 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-1 7-92 and
filed 9-28-92 (Register 92, No. 40).

4. Editorial correction of History 2 (Register 95, No. 18).

5. Change without regulatory effect amending Note filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6507.6. Approval of Hemoglobin Testing Laboratories.

(a) All laboratories that accept specimens from an approved sickle cell
counseling program shall be in compliance with the Business and Profes-
sions Code governing licensed clinical laboratory operations and person-
nel (commencing with Section 1200 of the Business and Professions
Code) or be an approved public health laboratory operated in accordance
with the California Health and Safety Code, Section 101 150 et seq.

Page 92

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(b) All laboraiories involved in sickle cell screening as specified in this
Article shall use a test or combination of tests with demonstrated ability
to distinguish hemoglobins including F, A, S, C, D, and E, as well as the
thalassemias.

(c) The State Department of Health Services shall have the responsi-
bility of monitoring sickle cell screening laboratories coming under the
scope of this Article. Such monitoring may be accomplished by on-site
inspections and proficiency testing, or any other effective method. The
Department may deny, revoke, or suspend the approval of any laboratory
which does not comply or continue to comply with the above qualifica-
tions.

NOTE: Authority cited: Sections 124980. 125000 and 125025. Health and Safety
Code. Reference: Sections 124980, 125000. 125025 and 125030, Health and Safe-
ty Code.

History

1 . New section filed by the Department of Health Services with the Secretary of
State on 12-22-89 as an emergency; operative 12-22-89. Siibinitted to OAL
for printing only pursuant to Health and Safety Code section 309(g) (Register
90, No. 4).

2. Renumbering of section 6507.6 to section 6507.5 and renumbering of section
6507.7 to section 6507.6 filed 4-20-92 as an emergency; operative 4-20-92
(Register 92, No. 1 8). A Certificate of Compliance must be transmitted to OAL
8- 1 8-92 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and
fded 9-28-92 (Register 92, No. 40).

4. Change without regulatory effect amending section heading, section and Note
filed 10-12-2006 pursuant to section 100, title 1, California Code of Regula-
tions (Register 2006, No. 41).

§ 6507.7. Sickle Cell Trait Carrier Follow-Up Vendor.

(a) A sickle cell trait follow-up vendor shall mean any sickle cell edu-
cation and counseling program that:

( 1 ) Is approved under this Group, and

(2) Signs a vendor agreement to provide services in accordance with
Department policies, including a fee schedule provided by the Depart-
ment. The Department may obtain and provide reimbursements for any
or all follow-up services authorized as a result of newborn sickle cell
screening from such approved vendors.

NOTE: Authority cited: Sections 124980, 125000 and 125025, Health and Safety
Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safe-
ty Code.

History

1 . Renumbering of section 6507.7 to section 6507.6 and new section filed 4-20-92
as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of
Compliance must be transmitted to OAL 8-1 8-92 or emergency language will
be repealed by operation of law on the following day.

2. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and
filed 9-28-92 (Register 92, No. 40).

3. Change without regulatory effect amending section heading, section and Note
filed 10-12-2006 pursuant to section 100, title 1, Cahfornia Code of Regula-
tions (Register 2006, No. 41).

Article 4.

Newborn Screening Participation
Fee

§ 6508. Newborn Screening Fee Collection.

(a) Perinatal licensed health facilities and birth attendants shall obtain
from the Department a sufficient supply of specimen collection forms to
permit collection of a blood specimen from each newborn required to be
tested under this Group.

(b) The Department shall collect a fee for each specimen record form
provided and a program participation fee for all services provided. The
fee for a specimen form shall be $1 and for program services shall be
$101.75 except for a comprehensive prepaid group practice direct health
care service plan with 20,000 or more births in the last completed calen-
dar year for which complete statistics are available, which elects to pro-
vide testing, follow-up and/or counseling services to its members. The
fee for such plans shall be equal to the Department's cost of administra-
tion of the newborn screening program, to be determined by reducing the
$101 .75 program service fee by the annual statewide average per infant
contracted cost of laboratory testing, follow-up and/or counseling ser-

vices rendered during the previous fiscal year. In order to qualify for this
special fee a medical group serving a comprehensive prepaid group prac-
tice direct care service plan with 20,000 or more births shall sign a written
agreement which contains the same standards and conditions, except as
to payment or where specifically waived, as are applicable to the new-
bom screening laboratories and Newborn Screening Area Service Cen-
ters, adhere to the regulations governing the program, and to submit to
monitoring and evaluation of compliance. Failure to comply with these
conditions after being given written notification and 30 days to correct
deviations shall result in loss of the option. In the event the option is lost
the State shall designate appropriate contractors to provide services.

The provisions of this section shall apply even if the newborn is part
of a State-approved demonstration project.

(c) Birth attendants and physicians attending newborns who are under
six days of age and who were not bom in perinatal licensed health facili-
ties and not subsequently admitted to perinatal licensed health facilities
shall obtain a sufficient supply of specimen record forms to permit col-
lection or shall arrange for a collection of a blood specimen from each
such newborn attended.

(d) Birth attendants and physicians attending newborns and perinatal
licensed health facilities shall not charge parents or third parties responsi-
ble for medical care coverage fees for participation in the newborn
screening program in addition to those specified in this section, except
for reasonable fees for costs of blood specimen collection and handling
which shall not exceed $6.

(e) The perinatal licensed health facility shall make available to the re-
sponsible physician, at no additional charge, specimen collection ser-
vices or a specimen record form for obtaining either a repeat specimen
for an inadequate specimen or a specimen on a newborn discharged with-
out the test having been obtained.

(f) Birth attendants and physicians submitting a blood specimen for
newborn screening on a form other than those approved by the Depart-
ment shall be charged a handling fee of $5 in addition to the usual fee for
program services and specimen record form specified in (b) above for
each such specimen.

NOTE: Authority cited: Sections 124977, 124996, 125000, 131050, 131051 and
131200, Health and Safety Code. Reference: Sections 124977, 124996, 125000
and 125001, Health and Safety Code.

History

1. New section filed 1 1-2 1-86; effective thirtieth day thereafter (Register 86, No.
47).

2. Amendment filed 12-6-90 as an emergency print only; operative 12-6-90
(Register 91, No. 14). A Certificate of Compliance must be transmitted to OAL
by April 5, 1991 , or emergency language will be repealed by operation of law
on the following day.

3. Certificate of Compliance as to 1 2-6-90 order transmitted to OAL 3-19-9 1 and
filed 4-8-91 (Register 91, No. 19).

4. Amendment filed 8-7-91 by the Department of Health Services with the Secre-
tary of State, operative 8-7-91 . Submitted to OAL as an emergency for printing
only pursuant to Health and Safety Code section 309 (Register 91, No. 50).

5. Amendment of subsection (b) filed 6-30-92 with Secretary of State by the De-
partment of Health Services; operative 7-1-92. Submitted to OAL as an emer-
gency for printing only pursuant to Health and Safety Code sections 289.7(b)
and 309(h) (Register 92, No. 27).

6. Certificate of Compliance as to 6-30-92 order transmitted lo OAL 10-20-92
and filed 1 1-20-92 (Register 92, No. 47).

7. Editorial correction of History 5. (Register 92, No. 47).

8. Amendment of subsecfions (b) and (t) and amendment of Noth filed 6-6-97 as
an emergency; opeiafive 6-6-97 (Register 97, No. 24). This regulatory action
is deemed an emergency exempt from OAL review and was filed directly with
the Secretary of State pursuant to Health and Safety Code section 1250()0(h).
These amendments shall remain in effect until revised or repealed by DHS pur-
suant to Health and Safety Code section 125000(j).

9. Amendment of subsection (b) and Note filed 12-28-200 1 as an emer<jcncv; op-
erative 12-28-2001 (Register 2001, No. 52). A Certificate of Compliance must
be transmitted to OAL by 4-29-2002 or emergency language will be repealed
by operation of law on the following day.

10. Certificate of Compliance as to 12-28-2001 order transmitted to OAL
4-9-2002 and filed 5-16-2002 (Register 2002, No. 20).

11. Amendment of subsection (b) and amendment of Noti; filed 6-28-2002 as an
emergency; operative 6-28-2002 (Register 2002, No. 26). A Certificate of
Compliance must be transmitted to OAL by 10-28-2002 or emergency lan-
guage will be repealed by operation of law on the following day.

Page 93

§6510

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

12. Certificate of Compliance as to 6-28-2002 order transmitted to OAL
10-25-2002 and filed 12-2-2002 (Register 2002, No. 49).

1 3. Amendment of subsection (b) and NoTt-; filed by the Department of Health Ser-
vices with the Secretary of State 12-31-2004 as an emergency: operative
12-31-2004 (Register 2005, No. 1). Compliance with Health and Safety Code
section 124977 must be completed by 5-2-2005. Pursuant to Health and Safety
Code section 124977, this amendment is exempt from OAL review and was
submitted for printing only.

14. Compliance with Health and Safety Code section 124977(d)(1) as to
12-31-2004 order filed 4-29-2005. Exempt from OAL review pursuant to
Health and Safety Code section 1 24977(d)(2). Submitted to OAL for filing pur-
suant to Government Code section 1 1343.8 (Register 2005, No. 20).

15. Change without regulatory effect adding article 4 heading and amending sec-
tion heading and section filed 10-12-2006 pursuant to section 100, title 1,
California (Zode of Regulations (Register 2006, No. 41 ).

16. Amendment of subsection (b) and amendment of NoTt- filed as an emergency
by the Department 9-7-2007; operative 9-7-2007. Submitted to OAL for print-
ins only pursuant to Health and Safety Code section 1 24977 (Register 2007, No.
42^

17. Statement of Compliance pursuant to Health and Safety Code section
124977(d)( 1 ) as to 9-7-2007 order filed 4-2-2008. Exempt from OAL review
pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL
for filing pursuant to Govemmenl Code section 1 1343.8 (Register 2008, No.
14).

18. Editorial cortection of Histories 13 and 14 (Register 2008, No. 15).

§ 6510. Rhesus (Rh) Hemolytic Disease of the Newborn.

NOTE: Authority cited: Sections 151, 208 and 306(b), Health and Safety Code.
Reference: Sections 304, 305 and 306, Health and Safety Code.

History

1. New section filed 3-16-70; effective thirtieth day thereafter (Register 70, No.
12).

2. Amendment of subsection (a)( 1 ) filed 2-2-7 1 ; effective thirtieth day thereafter
(Register 71, No. 6).

3. Editorial correction filed 1 1-5-84 (Register 84, No. 45).

4. Change without regulatory effect renumbering former section 6510 to section
6529 filed 10-12-2006 pursuant to secdon 100, title 1 , California Code of Reg-
ulations (Register 2006, No. 41).

Group 5.

Prenatal (Multiple Marker) Testing
Program

Article 1. Definitions

§6521. Alpha-Fetoprotein.

"Alpha-fetoprotein" means the protein substance in maternal semm
and amniotic fluid, the concentration of which is tested to determine the
probability that the fetus has a neural tube defect. For the purpose of this
Group, alpha-fetoprotein may be abbreviated and referred to as "AFP,"
maternal serum alpha-fetoprotein may be abbreviated and referred to as
"MS-AFP," and amniotic fluid alpha-fetoprotein may be abbreviated
and referred to as "AF-AFP."

NOTE; Authority cited: Secfions 124980, 125000 and 125070, Health and Safety
Code. Reference: Secfions 124975, 124980, 124990, 125000, 125001, 125050
and 125070, Health and Safety Code.

History

1. New article 2 (sections 6521-6529, not consecutive) filed by the Department
of Health Services with the Secretary of State on 4-7-86 as an emergency; ef-
fective upon filing. Submitted to OAL for printing only pursuant to Government
Code section 11343.8 (Register 86, No. 16).

2. Amendment of subsecfion (h) filed by the Department of Health Services with
the Secretary of State on 6-16-88 as an emergency; effective 7-1-88. Sub-
mitted to OAL for printing only pursuant to ( lovemment Code section 1 1343.8
(Register 88, No. 27).

3. Certificate of Compliance as to 6-16-88 order transmitted to OAL 10-19-88
and filed 1 1-18-88 (Register 88, No. 48).

4. New subsections (n)-(n)(3) and amendment of Note filed 4-20-92 as an emer-
gency; operafive 4-2(>-92 (Register 92, No. 18). A Certificate of Compliance
must be transmitted to OAL 8-18-92 or emergency language will be repealed
by operafion of law on the following day.

5. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-1 7-92 and
filed 9-28-92 (Register 92, No. 40).

6. Amendment of subsection (n)(l), new subsections (n)(2) and (n)(4), subsecfion
renumbering and amendment of Note filed 10-1-92 as an emergency; opera-

tive 10-1-92 (Register 92, No. 40). Submitted to OAL for printing only pur-
suant to Government Code section 1 1343.8.

7. Certificate of Compliance as to 10-1-92 order filed 3-3-92 (Register 93, No.
10).

8. Amendment of section and Note filed 6-14-96 as an einergency; operative
6-14-96. Submitted to OAL for printing only pursuant to Government Code
secfion 1 1343.8 (Register 96. No. 24).

9. Editorial correction of History 8 (Register 97, No. 12).

10. Amendment of sub.section (p)(l) filed 3-14-97 by the Department of Health
Services with the Secretary of Stale; operative 3-14-97. Submitted to OAL as
an emereency for printing only pursuant to Health and Safety Code section
125000 (Register 97, No. 12),

11. Amendment of subsection (e) filed 9-25-97; operative 9-25-97. Submitted
to OAL for printine only pursuant to Health and Safety Code section 125000
(Register 97, No. 39).

12. Change without regulatoi^ effect adding group 5 heading, renumbering former
article 2 to new article 1, and amending section heading, section and Note filed
10-12-2006 pursuant to section 100. dtle 1, California Code of Regulations
(Register 2006, No. 41).

§6521.3. Analyte.

"Analyte" means any constituent or substance the concentration of
which is related to the presence of a birth defect and is analyzed and re-
ported by prenatal screening laboratories as part of a Departmentally pro-
vided or administered prenatal screening program including alpha-feto-
protein, human chorionic gonadotrophin and estriol.
NOTE: Authority cited: Sections 124980. 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050
and 125070, Health and Safety Code.

History
1 . Change without regulatory effect adopting section filed 10-12-2006 pursuant
to secfion 100, title 1, California Code of Regulafions (Register 2006, No. 41).

§6521.5. Birth Defect.

"Birth defect" means any functional or structural defect caused by fail-
ure or error in the development of a fetus that is capable of being prenatal-
ly detected and for which the Department has provided a surveillance or
screening program including neural tube defects, ventral wall defects,
and chromosomal defects.

Note: Authority cited: Secfions 124980, 125000 and 125070, Health and Safety
Code. Reference: Secfions 124975, 124980, 124990, 125000, 125001, 125050
and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopfing section filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§6521.7. Clinician.

"Clinician" means physician, physician assistant, nurse midwife,
nurse practitioner or any other person licensed or certified by the State
to provide prenatal care to pregnant women or to practice medicine.
NOTE: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050
and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6521 .9. Differential Diagnostic Screening Tests and
Procedures.

"Differential diagnostic screening tests and procedures" means those
additional screening tests, methods, examinations or activities which are
performed consequent to a positive blood screening test and which are
used to distinguish between the presence of a birth defect of the fetus and
other causes of positive blood screening tests.

Note: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050,
125065 and 125070, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1 , California Code of Regulations (Register 2006, No. 41).

§ 6521 .1 1 . Expanded AFP Follow-Up Vendor.

"Expanded AFP follow-up vendor" means any facility, clinic, institu-
tion, health maintenance organization, or physician that:

(a) Submits documentation verifying that it meets the standards pub-
lished by the Department for approval as a comprehensive prenatal diag-

Page 94

Title 17

State Department of Health Services

§ 6521.31

nosis center entitled: Prenatal Diagnosis Center Standards and Defini-
tions 1997. This document in its entirety is hereby incorporated by
reference in this section;

(b) Has had the documentation verified by a state visit; or

(c) Has had experience in the provision of follow-up of women with
abnormal MS-AFP results as defined by California's MS-AFP Program
prior to April 1 , 1992; and

(d) Receives notification of approval as a Prenatal Diagnosis Center;
and

(e) Signs a vendor agreement to provide such services in accordance
with Department policies including a fee schedule published by the De-
partment entitled: Vendor Agreement March 1, 1996, and incorporated
by reference herein. The Department may obtain and provide reimburse-
ment for any or all follow-up services authorized as the result of MS-
AFP screening from any or all such approved vendors.

NOTI-;: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050,
125065 and 125070. Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41 ).

§ 6521.13. Expanded AFP Prenatal Birth Defects Screening
Laboratory.

"Expanded AFP prenatal birth defects screening laboratory" means a
laboratory approved by the Department to conduct prenatal screening
laboratory tests to determine the concentration of analytes and perform
other analysis related to birth defects specified as part of state adminis-
tered testing.

NOTE: Authority cited: Sections 124980. 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050,
125065 and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6521 .1 5. Expanded AFP Prenatal Screening for Birth
Defects.

"Expanded AFP prenatal screening for birth defects" means the se-
quence of screening tests of initial and repeat blood tests and, where med-
ically indicated, differential diagnostic screening tests and procedures
authorized by the Department and provided by Department-approved
vendors.

NOTE: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050,
125065 and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6521 .1 7. Gestational Age.

"Gestational age" means the number of days elapsed since the first day
of the last normal menstrual period. Gestational age may be calculated
as the number of days from known or suspected conception plus 14 days
or estimated by ultrasound examinaUon and measurements.
NOTE: Authority cited: Sections 124980, 125000 and 125070, Heahh and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050
and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6521 ,1 9. Inadequate Specimen.

"Inadequate specimen" means a blood specimen collected from a
pregnant woman which is not suitable in quality or quantity, was col-
lected before the 1 05th or after the 140th day of gestation, or was not doc-
umented with the clinical information necessary for test result interpreta-
tion to perform valid prenatal screening for birth defects of the fetus.

NOTE: Authority cited: Sections 124980, 125000 and 125070. Health and Safety
Code. Reference: Sections 124975. 124980. 124990, 125000, 125001. 1250.50,
125065 and 125070, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41 ).

§ 6521 .21 . Initial Screening Positive Test.

"Initial screening positive test" means an initial screening test of a
specimen which gives a positive result for reporting purposes pursuant
to this Group.

NOTE: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001. 125050,
125065 and 125070, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1 , California Code of Regulations (Register 2006, No. 41 ).

§ 6521 .23. Initial Specimen.

"Initial specimen" means the first adequate specimen collected from
a pregnant woman pursuant to this Group.

Note: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050.
125065 and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant

to section 1 00, title 1 , California Code of Regulations (Register 2006, No. 41 ).

§6521.25. Method.

"Method" means the instruments, devices, reagents, steps and proce-
dures used in a laboratory to measure the concentration of analytes in
samples of maternal serum or amniotic fluid.

Note: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050,
125065 and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title I, California Code of Regulations (Register 2006, No. 41).

§ 6521 .27. Neural Tube Defect.

"Neural tube defect" means any malformation caused by failure of the
developing spine and skull to properly close. Examples are spina bifida
and anencephaly.

Note: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050,
125065 and 125070, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

§ 6521 .29. Prenatal Diagnosis Center.

"Prenatal diagnosis center" means any facility in California which is
approved by the Department to provide differential diagnostic tests and
procedures for the prenatal evaluation or detection of genetic diseases,
disorders, and birth defects of the fetus.

NOTE: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050,
125065 and 125070, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, title 1 , California Code of Regulations (Register 2006, No. 41 ).

§ 6521 .31 . Repeat Specimen.

"Repeat specimen" means a blood specimen collected from a pregnant
woman following the screening laboratory report that a previously col-
lected blood specimen was either an inadequate specimen or that the
screening test results were positive or inconclusive.
Note: Authority cited: Sections 124980, 125000 and 125070, Health and Safety
Code. Reference: Sections 124975, 124980, 124990. 125000, 125001, 125050,
125065 and 125070, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to section 100, titie 1, California Code of Regulations (Register 2006, No. 41 ).

Page 94.1

§6523

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 3. Testing and Follow Up Program
Requirements

§ 6523. Expanded AFP Prenatal Birth Defects Screening
Laboratories and Analytical Methods.

(a) The Department shall approve Expanded AFP prenatal birth de-
fects screening laboratories. Such laboratories shall be licensed as clini-
cal laboratories under Division 2. Chapter 3 (commencing with Section
1200) of the Business and Professions Code.

(b) Approved Expanded AFP prenatal birth defects screening labora-
tories shall be limited to the following:

( 1 ) A laboratory that shall have obtained a contract from the Depart-
ment under applicable laws and regulations to provide laboratory ser-
vices in sufficient volume to provide the prenatal birth defects screening
test to all pregnant women in a designated geographic area defined by the
Department, plus an emergency testing capacity that will be specified by
contract. The Department will define not more than 6 geographic areas
and may combine geographic areas if necessary to reduce costs or assure
statewide coverage.

(2) A laboratory exclusively serving a comprehensive prepaid group
practice or health care service plan with 20,000 or more births in the last
completed calendar year for which complete statistics are available may
be approved for testing consistent with the terms of a mutually acceptable
contract for services.

(c) Expanded AFP prenatal birth defects screening laboratories ap-
proved by the Department shall comply with all laboratory standards for
quality assurance issued by the Department and shall participate in a pro-
ficiency testing program approved and/or conducted by the Department
and shall maintain levels of performance acceptable to the Department.

(d) Analytical methods to be used in the measurement of each analyte
concentration in maternal serum shall be designated and/or approved by
the Department.

(e) Analytical methods to be used in the measurement of the analyte
concentration in amniotic fluid, and other adjunctive tests performed on
amniotic fluid shall be designated and/or approved by the Department.
Note: Authority cited: Sections 125000(e) and 125070, Health and Safety Code.
Reference: Sections 124980, 125000(e) and 125070, Health and Safety Code.

History

1 . New section filed by the Department of Health Services with the Secretary of
State on 4-7-86 as an emergency; effective upon filing. Submitted to OAL for
printing only pursuant to Government Code Section 1 1343.8 (Register 86, No.
16).

2. Amendment of section heading, section and NOTE filed 6-14-96 as an emergen-
cy; operative 6-1 4-96. Submitted to OAL for printing only pursuant to Govern-
ment Code section 1 1343.8 (Register 96, No. 24).

3. Editorial correction of History 2 (Register 97, No. 12).

4. Repeal of subsections (b)(3) and (f) filed 3-14-97 by the Department of Health
Services with the Secretary of State; operative 3-14-97. Submitted to OAL as
an emergency for printing only pursuant to Health and Safety Code section
125000 (Register 97, No. 12).

5. Amendment of subsection (b)(2) filed 9-25-97; operative 9-25-97. Submitted
to OAL for printing only pursuant to Health and Safety Code section 125000
(Register 97, No. 39).

6. Change without regulatory effect adding article 3 heading filed 10-12-2006
pursuant to section 100, title 1, California Code of Regulafions (Register 2006,
No. 41).

§ 6525. Prenatal Diagnosis Centers and Laboratories.

The Department shall approve prenatal diagnosis centers and prenatal
diagnosis methods and Expanded AFP Birth Defect Screening Laborato-
ries and laboratory methods and shall institute such quality control and
proficiency testing as is necessary to assure the accuracy of testing. No
laboratory shall offer or provide prenatal birth defect screening diagnos-
tic tests on California residents without having obtained prior approval
from the Department.

NOTE: Authority cited: Sections 125050, 125055 and 125070, Health and Safety
Code. Reference: Sections 124980, 125000 and 125070, Health and Safety Code.

History

2. Amendment of section heading, section and Noti-; filed 6-14-96 as an emergen-
cy; operative 6-14-96. Submitted to OAL for printing only pursuant to Govern-
ment Code section 1 1343.8 (Register 96, No. 24).

3. Editorial coirection of History 2 (Register 97, No. 12).

§ 6527. Clinician Requirements.

(a) Clinicians shall provide or cause to be provided to all pregnant
women in their care before the 1 40th day of gestation, or before the 1 26th
day from conception, as estimated by medical history or clinical testing,
information regarding the use and availability of prenatal screening for
birth defects of the fetus. This information shall be in a format to be pro-
vided or approved by the Department and shall be given at the first prena-
tal visit and discussed with each pregnant woman.

(b) The provisions of subsection (a) shall not apply if the pregnant
woman has completed more than 140 days of gestation or 1 26 days post
conception, as estimated by medical history or clinical testing, and this
fact is entered in the medical record.

(c) Clinicians shall cause to be provided to all pregnant women who,
after being provided with the information pursuant to subsection (a), vol-
untarily request prenatal screening for birth defects of the fetus, the op-
portunity, the circumstances of which are to be documented in the medi-
cal record, to read and sign an informed consent document in a format
provided or approved by the Department.

(d) If the pregnant woman consents to testing, the clinician shall ar-
range for prenatal screening directly or by referral to another clinician by:

(1) Fully and accurately completing all required specimen collection
forms provided by the Department for this purpose;

(2) Collecting or arranging for the collection of an initial specimen fol-
lowing state directions for collection provided;

(3) As soon as possible, but within 24 hours of collection, place or
cause to be placed all initial and repeat specimens in the channel of trans-
mittal to the designated Expanded AFP prenatal birth defects screening
laboratory.

(e) Blood collection forms and blood collection and mailing kits
supplied by the Department shall not be copied, printed, reproduced, ac-
quired, purchased, substituted or distributed other than as specified for
use in the Expanded AFP Prenatal Birth Defects Screening Program ad-
ministered by the Department.

(f) When notified that a blood specimen is inadequate for testing, the
clinician shall make a reasonable effort to have an adequate specimen ob-
tained as soon as possible but not more than five (5) days after such iiotifi-
cation.

(g) For each woman in their care who was prenatally screened for birth
defects of the fetus and who has an initial screening positive test, the cli-
nician shall:

(1) Inform the woman that authorized follow-up services are available
at Expanded AFP Follow-up Vendors, and that the program participa-
tion fees or laboratory test fee covers the authorized services.

(2) Report on the form provided by the Department for this purpose,
within 30 calendar days of the end of the pregnancy, the outcome of preg-
nancy and status of each fetus, or infant resulting therefrom.

(h) The test results shall be confidential so that such information shall
only be released with the knowledge and specific written consent of the
woman tested. Persons authorized by the Department to conduct and
monitor screening and/or to provide and monitor differential diagnostic
follow-up services shall be provided information without necessity of
specific written consent.

(i) Recognizing the strict gestational and time limits wherein prenatal
detection of birth defects of the fetus is feasible, clinicians shall make ev-
ery reasonable effort to schedule screening and differential diagnostic
tests and procedures appropriately with respect to the gestational dates
of the pregnant woman.

Page 94.2

Title 17

State Department of Health Services

§ 6540.1

(j) Willful or repeated failure to comply with these regulations shall be
referred by any person having knowledge of noncompliance to the appro-
priate licensing authority.

Note: Authority cited: Sections 125000 and 125070, Health and Safety Code.
Reference: Sections 124980 (b), (c), (d), (h), (j) and 125070, Health Safety Code.

History

2. New subsection (_j) filed by the Department of Health Services with the Secre-
tary of State on 6-1 6-88 as an emergency; effective 7-1-88. Submitted to OAL
for printing only pursuant to Government Code Section 1 1343.8 (Register 88,
No. 27).

3. Certificate of Compliance as to 6-16-88 order transmitted to OAL 10-19-88
and filed 1 1-18-88 (Register 88, No. 48).

5. AmendiTient of section and Notk filed 6-14-96 as an emergency; operative
6-14-96. Submitted to OAL for printing only pursuant to Government Code
section 1 1343.8 (Register 96, No. 24).

6. Editorial correction of History 5 (Register 97, No. 12).

7. Amendment of subsections (a), (c), (d)(1) and (d)(2), repealer of subsection (e),
subsection relettering, and amendment of newly designated subsection (g)( 1 )
filed 3-14-97 by the Department of Health Services with the Secretary of Stale;
operative 3-14-97. Submitted to OAL as an emergency for printing only pur-
suant to Health and Safety Code secfion 125000 (Register 97, No. 12).

8. Editorial correcdon of subsection (g) and Note (Register 97, No. 41).

9. Change without regulatory effect amending section heading filed 10-12-2006
pursuant to secfion 1 00, title 1 , California Code of Regulations (Register 2006,
No. 41).

§ 6529. Rhesus (Rh) Hemolytic Disease.

(a) Medical staffs of hospitals and physicians thereof shall in provid-
ing for the care of pregnant women determine that a blood specimen has
been obtained for the determination of rhesus (Rh) blood type or shall ob-
tain or cause to be obtained a blood specimen within 24 hours of termina-
tion of pregnancy whether by delivery or by spontaneous or therapeutic
abortion for this purpose.

(b) All cases, or suspected cases of rhesus (Rh) hemolytic disease of
the newborn, shall be reported to the Department of Health Services. Ev-
ery patient diagnosed in any licensed hospital as having such condition
shall be reported by the hospital on the form provided by the Department
for this purpose. The hospital shall notify the physician making the diag-
nosis that such a report has been filed.

NOTE: Authority cited: Sections 124980 and 125000. Health and Safety Code.
Reference: Sections 124980, 125075 and 125085, Health and Safety Code.

History

1 . New section filed by the Department of Health Services on 4-7-86 as an emer-
gency; effective upon filing. Submitted to OAL for printing only pursuant to
Government Code section 11343.8 (Register 86, No. 16).

2. Amendment of subsection (a) filed by the Department of Health Services with
the Secretary of State on 6-16-88 as an emergency; effective 7-1-88. Sub-
mitted to OAL for printing only pursuant to Government Code secfion 1 1343.8
(Register 88, No. 27).

3. Certificate of Compliance as to 6-16-88 order transmitted to OAL 10-19-88
and filed 1 1-18-88 (Register 88, No. 48).

4. Amendment filed 8-7-91 by the Department of Health Services with the Secre-
tary of State; operafive 8-7-91 . Submitted to OAL as an emergency for printing
only pursuant to HeaUh and Safety Code section 309 (Register 91, No. 50).

5. Amendment of subsecfion (a) filed 6-30-92 with Secretary of State by the De-
partment of Health Services; operative 7-1-92. Submitted to OAL as an emer-
gency for printing only pursuant to Health and Safety Code secfions 289.7(b)
and 309(h) (Register 92, No. 27).

6. Certificate of Compliance as to 6-30-92 order transmitted to OAL 10-20-92
and filed 1 1-20-92 (Register 92, No. 47).

7. Editorial correcfion of History 5. (Register 92, No. 47).

8. Amendment of subsecfions (a) and (b) and amendment of Note filed 6-6-97
as an emergency; operafive 6-6-97 (Register 97, No. 24). This regulatory acdon
is deemed an emergency exempt from OAL review and was filed directly with
the Secretary of State pursuant to Health and Safety Code sections 125000(h)
and 125070(b). These amendments shall remain in effect unfil revised or re-
pealed by DHS pursuant to Health and Safety Code sections 125000(j) and
125070(c).

9. Amendment of subsecfion (a) and amendment of Note filed 2-26-98 as an
emergency; operative 2-26-98 (Register 98, No. 10). Submitted to OAL for
printing only pursuant to Health and Safety Code secfion 125000.

10. Change without regulatory effect repeaUng former section 6529 and renum-
bering former secfion 6510 to new secfion 6529, including amendment of sec-

tion heading, section and Note filed 10-12-2006 pursuant to section 100. title
1, California Code of Regulations (Register 2006, No. 41).

§ 6531 . Reporting of Neural Tube Defects.

(a) All cases of neural tube defect in a fetus or an infant under one year
of age shall be reported to the Department.

(b) This report shall be made:

(1) By the health facility in which the case is initially diagnosed;

(2) By the physician making the initial diagnosis if the case is not diag-
nosed in a health facility;

(3) Within 30 calendar days of the initial diagnosis;

(4) On the form to be provided by the Department for this purpose.
Note: Authority cited: Section 125070, Health and Safety Code. Reference: Sec-
tion 125070, Heahh and Safety Code.

History

1 . New section filed by the Department of Health Services with the Secretary of
State on 10-9-85 as an emergency; effective upon filing. Submitted to OAL for
printing only pursuant to Government Code Section 1 1 343.8 (Reeister 85, No.
45).

2, Change without regulatory effect amending subsection (a) and Note: filed
10-12-2006 pursuant to secfion 100, title 1. California Code of Regulations
(Register 2006, No. 41).

§ 6532, Reporting of Chromosomal Disorders.

(a) All cases of Down's syndrome or other chromosoinal defects in a
fetus or an infant under one year of age shall be reported to the Depart-
ment. Chromosomal defects shall mean any abnormality in structure or
number of chromosomes.

(b) This report shall be made:

(1) by the cytogenic laboratory performing the chromosomal analysis
or by the physician making the diagnosis;

(2) within 30 calendar days of the initial diagnosis;

(3) on a form to be provided by the Department for this purpose.
NOTE: Authority cited: Section 125000, Health and Safety Code. Reference: Sec-
fion 125000, Health and Safety Code.

History

1 . New section filed by the Department of Health Services with the Secretary of
State on 2-24-89 as an emergency; operative on 3-1-89. Submitted to OAL for
printing only pursuant to Government Code Secfion 1 1343.8 (Register 89, No.
10).

2. Change without regulatory effect amending Note filed 10-12-2006 pursuant
to section 100, title 1 , California Code of Regulafions (Register 2006, No. 41 ).

Article 4.

Prenatal Screening Fee
Collection

§ 6540. Program Participation Fee.

The all-inclusive program participation fee for maternal serum alpha
fetoprotein, used as a single marker to screen neural tube defects only,
shall be $57. The all-inclusive program participation fee for maternal se-
mm alpha fetoprotein and one or more addifional markers used for
screening for NTD and Down Syndrome, shall be $155. The fee shall be
paid to the Department by the woman being tested or by any third party
which is legally responsible for her care including any health care service
plan, managed health care plan, managed care plan, prepaid health plan
or prepaid group practice health care service plan as defined in or li-
censed in accordance with Health and Safety Code Section 1 340 et seq.
NOTE; Authority cited: Sections 124977, 124996, 125055, 125070 and
125000(h), Health and Safety Code. Reference: Sections 124996, 125000(b) and
(f), 125001, 125050, 125060 and 125065, Health and Safety Code.

History

1 . Change without regulatory effect adopting article 4 (secfions 6540-6540. 1 ) and
secfion filed 10-12-2006 pursuant to section 100, title 1, California Code of
Regulafions (Register 2006, No. 41).

2. Change without regulatory effect amending secfion and Note filed 2-16-2007
pursuant to secfion 100, fitle 1, California Code of Regulations (Register 2007,
No. 7).

§ 6540.1. Prepaid Group Practice Plan.

Health care providers which contract with a prepaid group practice
health care service plan that annually has at least 20,000 births among its
membership may provide, without contracting with the Department, any

Page 94.3

§6600

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

or all of the testing and counseling services required to be provided under
tiiis Group, if the services meet quality standards established by the De-
partment and the plan pays that portion of a fee established under Section
6540 which is directly attributable to the Department's cost of adminis-
tering the testing or counseling service and any required testing or coun-
seling services provided by the state for plan members during the pre-
vious fiscal year. This option must be executed under terms of a written
agreement. Payment by the plan shall be deemed to fulfill any obligation
the provider or the provider's patient ma> have to the Department to pay
a fee in connection with the testing or counseling service.
NOTK: Authority cited: Sections 124996, 125070 and 125000(h) and (j). Health
and Safety Code. Reference: Sections 124996, 125000(b) and (f), 125001,
125050. 125055, 125060 and 125065, Health and Safety Code.

History
1. Change without regulatory effect adopting section filed 10-12-2006 pursuant
to secdon 100, title 1, California Code of Regulations (Register 2006, No. 41 ).

Subchapter 10. Tuberculosis Screening of

Employees and Volunteers in Private,

Parochial and Nursery Schools

Article 1. Definitions

§ 6600. Employee.

An employee of the school is a person on the school's payroll, part

time or full time.

NOTE: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:

Sections 3450-3455, Health and Safety Code.

History

1. New Subchapter 10 (Sections 6600 through 6608) filed 4-3-68; effective thir-
tieth day thereafter (Register 68, No. 14).

§6601. Volunteer.

A volunteer is a person not on the school's payroll who meets the fol-
lowing criteria: (a) contributes time and services in support of the
school's operation, (b) whose work is regularly scheduled by the school
on a continuing basis at least once montWy, and (c) who works on the
school premises during school hours.

§ 6602. Private and Parochial Schools.

Private and parochial schools are schools offering elementary and sec-
ondary daily education in any of the grades, kindergarten through
twelfth.

§ 6603. Nursery School.

Nursery school is any school receiving and caring for one or more chil-
dren of preschool age on a partial or full time basis.

§ 6604. Elementary School.

Elementary school is any school offering instruction in any of the
grades kindergarten through eighth.

§ 6605. Secondary School.

Secondary school is any school offeiing instruction in any of the
grades, ninth through twelfth.

§ 6606. Minimum Examination.

Minimum examination required is a chest X-ray or the approved skin
test. If the tuberculin test is positive (10 mm. or over), it must be followed
by a chest X-ray. Private physicians, local health departments or local
Tuberculosis and Health Associations may provide these tests and X-
rays.

§ 6607. Approved Skin Test.

Approved skin test is the intradermal Mantoux 5 TU (.0001 mgm)
PPD.

Article 2. Records as Evidence of
Compliance

§ 6608. Records as Evidence of Compliance.

A school will have satisfactorily complied with the requirements of the
law if by two weeks after the opening of the school year the school admin-
istrator provides the local health officer with a statement certifying (a) the
number of persons employed, (b) the number of volunteers, and (c) that
the required certificate for each, signed by a physician licensed to prac-
tice medicine in California, or a notice from a public health agency or unit
of the Tuberculosis and Health Association indicating freedom from ac-
tive tuberculosis is on file and available for verification. Thereafter, the
legal requirements will be met by obtaining the certificate prior to or
within two weeks of date of employment, or acceptance of a volunteer,
and repeating every two years.

Subchapter 1 1 . First Aid and

Cardiopulmonary Resuscitation Training

Standards for Public Safety Personnel

Article 1. General

§ 6701 . Application and Scope.

NOTE; Authority cited: Sections 208 and 217, Health and Safety Code. Reference:
Section 217, Health and Safety Code.

History

1 . New Subchapter 1 1 (Sections 6701-6722, not consecutive) filed 5-2-75; effec-
tive thirtieth day thereafter (Register 75, No. 18).

2. Amendment filed 1-16-80; effective thirtieth day thereafter (Register 80, No.

3).

3. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing section filed 6-21-90; operafive 6-21-90 (Reg-
ister 90, No. 34).

§ 6702. Time Limitation for Training.

NOTE: Authority cited: Sections 208 and 217, Health and Safety Code. Reference:
Section 217, Health and Safety Code.

History

1. Amendment filed 1-16-80; effective thirtieth day thereafter (Register 80, No.
3).

2. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing section filed 6-21-90; operative 6-21-90 (Reg-
ister 90, No. 34).

Article 2. Definitions

§ 6705. Definitions.

NOTE: Authority cited: Sections 208 and 217, Health and Safety Code. Reference:
Section 217, Health and Safety Code.

History

1. Amendment filed 1-16-80; effective thirtieth day thereafter (Register 80, No.
3).

2. Change without regulatory effect pursuant to section 100, Title 1, Cahfornia
Code of Regulations repealing section filed 6-21-90; operative 6-21-90 (Reg-
ister 90, No. 34).

[The next page is 95.]

Page 94.4

Article 3. Training Standards

§ 671 0. Scope of Course.

NOTE: Authority cited: Sections 208 and 217, Health and Safety Code. Reference:
Section 217, Health and Safety Code.

History
1. Amendment filed 1-16-80; effective thirtieth day thereafter (Register 80, No.

3).

•

Title 17

State Department of Health Services

§6801

•

2. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing section filed 6-2 1-90; operative 6-21-90 (Res-
ister 90, No. 34).

§ 671 1 . Required Topics.

NOTIi: Authority cited: Sections 208 and 217, Health and Safety Code. Reference:
Section 217, Health and Safely Code.

History

1. Amendment filed 1-16-80; effective thirtieth day thereafter (Register 80, No.
3).

2. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing section filed 6-21-90; operative 06-21-90
(Register90, No. 34).

§6712. Special Requirements.

NOTE: Authority cited: Sections 208 and 2 1 7, Health and Safety Code. Reference:
Section 217, Health and Safety Code.

History

1. Amendment filed 1-16-80; effective thirtieth day thereafter (Register 80, No.
3).

2. Change without regulatory effect pursuant to section 100, Title 1. California
Code of Regulations repealing section filed 6-21-90; operative 6-21-90 (Reg-
ister 90, No. 34).

§6714. Testing.

NOTE: Authority cited: Sections 208 and 217, Health and Safety Code. Reference:

Section 217, Health and Safety Code.

History

1. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing section filed 6-21-90; operative 6-2 1-90 (Reg-
ister 90, No. 34).

§ 6715. Validation of Course Completion.

NOTE: Authority cited: Sections 208 and 217, Health and Safety Code. Reference:
Section 217, Health and Safety Code.

History

1. Amendment filed 1-16-80; effective thirtieth day thereafter (Register 80, No.
3).

2. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing section filed 6-21-90; operative 6-21-90 (Reg-
ister 90, No. 34).

§ 6716. Retraining Requirements.

NOTE: Authority cited: Secdons 208 and 217, Health and Safety Code. Reference:
Section 217, Health and Safety Code.

History

1. Amendment filed 1-16-80; effecdve thirtieth day thereafter (Register 80, No.
3).

2. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing secdon filed 6-21-90; operative 6-21-90 (Reg-
ister 90, No. 34).

History
1. Change without regulatory effect pursuant to section 100, Title 1, California
Code of Regulations repealing section filed 6-21-90; operative 6-21-90 (Reg-
ister 90, No. 34).

Article 4. Designated Agencies

§ 6720. Course Approval.

NOTE: Authority cited: Sections 208(a) and 217, Health and Safety Code. Refer-
ence: Section 217, Health and Safety Code.

History

1 . Amendment filed 5-22-80; effective thirtieth day thereafter (Register 80, No.
21).

2. Change without regulatory effect pursuant to secdon 100, Tide 1, California
Code of Regulations repealing secdon filed 6-21-90; operative 6-21-90 (Reg-
ister 90, No. 34).

§ 6721. Additional Requests for Designation.

NOTE; Authority cited: Secdons 208 and 2 1 7, Health and Safety Code. Reference:

Section 217, Health and Safety Code.

History

1. Change without regulatory effect pursuant to secdon 100, Tide 1, California
Code of Regulations repealing secdon filed 6-21-90; operative 6-2 1 -90 (Reg-
ister 90, No. 34).

§ 6722. Program Review.

Note: Authority cited: Secdons 208 and 2 1 7, Health and Safety Code. Reference:
Secdon 217, Health and Safety Code.

Subchapter 12. Ambulance Personnel*

NOTE; Authority cited: Secdons 208 and 1 760, Health and Safety Code. Addition-
al authority cited: Secdon 1760.5, Health and Safety Code. Reference: Sections
1760 and 1760.5, Health and Safety Code.

History

1. New subsection (c) filed 8-19-76 as an emergency; effective upon filing (Reg-
ister 76, No. 34). For prior history, see Register 74, No. 52.

2. Certificate of Compliance filed 12-15-76 (Register 76, No. 51).

3. Repealer of Article 1 (Secdons 6750-6752) and new Article 1 (Sections
6750-6752) filed 2-17-78; effective thirtieth day thereafter (Register 78, No.
7).

4. Repealer of Subchapter 12 (Sections 6750-6760, not consecutive) filed
9-27-85; effecdve thirtieth day thereafter (Register 85, No. 39). For prior histo-
ry, see Registers 78, No. 7, and 74, No. 52.

* Renumbered from Subchapter 1 1 (Register 74, No. 52).

Subchapter 13. Child Health and Disability
Prevention Program

Article 1. Definitions

§ 6800. Health Assessment.

(a) "Health assessment" means the following:

( 1 ) A comprehensive health and developmental history, and a physical
examination.

(2) Appropriate health screening procedures and immunizations.

(3) Evaluation of results in terms of needed diagnosis and treatment.

(4) Providing the person screened with a copy of the results and an ex-
planation of their meaning.

(5) Health education appropriate to the person's age and health status,
including anti-tobacco use education.

NOTE: Authority cited: Secdons 208 and 321, Health and Safety Code; and Sec-
don 12, Assembly Bill 75 (Chapter 1331. Statutes of 1989). Reference: Sections
321.2, 324 and 24165.3, Health and Safety Code.

History

1. Repealer of Subchapter 13 (Sections 6800-6984, not consecutive) and new Sub-
chapter 13 (Secdons 6800-6874, not consecutive) filed 3-29-79; designated
effecdve 5-1-79 (Register 79, No. 15). For history of prior subchapter, see Reg-
isters 75, No. 9; 75, No. 14; 75, No. 15; 75, No. 31; 76, No. 1 1; 76, No. 14; 76,
No. 21; 76, No. 29; 76, No. 44; 76, No. 46; 76, No. 49.

2. Repealer and new secdon filed 1 1-28-79 as an emergency; effecdve upon filing
(Register 79, No. 48). A Certificate of CompUance must be filed within 1 20 days
or emergency language will be repealed on 3-28-80.

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

4. Amendment of subsection (a)(2) filed 2-27-90 as an emergency pursuant to
Secdon 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90,
No. 9). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 6-27-90.

5. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-1 9-90 and
filed 7-18-90 (Register 90, No. 38).

§6801. Community.

"Community" means an individual county, or a city and county, or
counties acting jointly, or a city which operates an independent health
agency. In the instance of a city providing the services described in this
subchapter, the powers granted a governing body of a county to operate
a child health and disability prevention program shall be vested in the
governing body of that city.

NOTE: Authority cited: Secdons 208 and 32 1 , Health and Safety Code. Reference:
Secdons 320, et seq., Health and Safety Code.

History
I. New secdon filed 1 1-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

Page 95

§6802

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Certificate of Compliance filed 3-27-80 (iiegister 80, No. 13).

§ 6802. Community Child Health and Disability Prevention
Program.

(a) "Community child health and disability prevention (CHDP) pro-
gram" means a community based and operated program of activities, ap-
proved and funded by the Department, necessary to comply with federal
and state legislation and regulations that require:

(1) CHDP services to be made available to Medi-Cal beneficiaries
from birth to 21 years of age, and to be I'eimbursed by the State.

(2) Health assessment and referral to diagnosis and irealment services
to be made available to ( 1 ) children who are not Medi-Cal beneficiaries
from birth until 90 days after entrance into the first grade, and (2) all per-
sons under 1 9 years of age whose family income is not more than 200%
of the federal poverty level. State reimbursement of the costs of health
assessment and referral to diagnostic and treatment services for these
children is limited by the amount of funds appropriated by the Legisla-
ture, and is made available only for those children who meet the age and
family income criteria defined by the State Department of Health Ser-
vices' Child Health and Disability Prevention Program.

(3) Children entering first grade to present a certificate within 90 days
after entrance that they have received health assessment within the prior
1 8 months. A waiver signed by the child's parent or guardian indicating
that they do not want or are unable to obtain such health assessment and
evaluation services for their children shall be accepted in lieu of the cer-
tificate.

NOTE: Authority cited: Sections 208 and 321. Health and Safety Code; and Sec-
tion 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections
320 and 24165.3, Heahh and Safety Code.

History

1. Amendment filed 1 1-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (a)(2) filed 2-27-90 as an emergency pursuant to
Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90,
No. 9). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and
filed 7-18-90 (Register 90, No. 38).

§ 6804. Contract Counties.

"Contract counties" means those counties which contract with the De-
partment for health services and which have not elected to provide the
services themselves. The Department is responsible for the child health
and disability prevention programs in those counties.
NOTE: Authority cited: Secdons 208 and 32 1 . Health and Safety Code. Reference:
Sections 320, et seq.. Health and Safety Code.

§ 6806. Department.

"Department" means the State Department of Health Services.
NOTE: Authority cited: Sections 208, 320.2 and 321 , Health and Safety Code. Ref-
erence: Sections 320, et seq.. Health and Safety Code.

§ 6808. Diagnosis.

NOTE: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Sections 320, et seq., Health and Safety Code.

History

1 . Repealer filed 1 1-28-79 as an emergency; effective upon filing (Register 79,
No. 48). A Certificate of Compliance must be filed within 120 days or emergen-
cy language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§6810. Director.

"Director" means the Director of the State Department of Health Ser-
vices, unless otherwise specified.

NOTE: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Sections 320, et seq.. Health and Safety Code.

§ 6812. Governing Body.

"Governing Body" means, except where indicated otherwise in this
subchapter, the county board of supervisors, or boards of supervisors in
the case of counties acting jointly or the city council in the case of a city.
NOTE: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Sections 320 et seq.. Health and Safety Code.

§ 6813. Initiation of Treatment.

"Initiation of treatinent" means the first encounter for treatment of the
medical and the dental problems disclosed during the health assessment.
NOTE: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Section 323.7, Health and Safety Code.

History

1 . New section filed 1 1-28-79 as an emergency; effecfive upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 1 20 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Comphance filed 3-27-80 (Register 80, No. 13).

§ 6814. Medi-Cal Beneficiary.

(a) "Medi-Cal beneficiary" means an individual under 21 years of age
who is eligible for and certified to receive services under provisions of
the California Medical Assistance Program (Chapter 7 of Part 3 of Divi-
sion 9 of the Welfare and Institutions Code, beginning with Section
14000). Medi-Cal beneficiaries include:

(1) Persons who are certified eligible to receive cash grants under one
of the public assistance programs.

(2) Persons who are certified eligible to receive medically needy or
medically indigent Medi-Cal benefits.

(3) Other persons who are certified eligible to receive noncash grant
Medi-Cal benefits. Other persons include the following:

(A) Children not in school and not in training.

(B) Persons receiving in-home supportive services.

(C) Persons who have lost AFDC eligibility, but are continuing to re-
ceive Medi-Cal benefits for four months from the date of lost eligibility.

(D) Persons who were discontinued from cash grants solely due to a
20 percent Social Security increase in 1977.

NOTE: Authority cited: Secdons 208 and 321, Health and Safety Code. Reference:
Sections 320, et seq.. Health and Safety Code.

History

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3 . Amendment of subsection (a)(3)(C) filed 5-22-80; effective thirtieth day there-
after (Register 80, No. 21).

•

Page 96

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§6822

§6816. Person.

"Person" means anyone from birth to 21 years of age eligible to re-
ceive services specified in this subchapter. Persons include newborns, in-
fants, children, youth, emancipated minors, young adults and adults. In
those instances where the person is not an adult or an emancipated minor,
"person" means the person, or his/her parent(s) or guardian(s).
NOTH; Authority ciled: Sections 208 and 32 1 , Health and Safety Code. Reference:
Sections 320, et seq.. Health and Safety Code.

§6817, Clinical Laboratory.

"Clinical Laboratory" means a facility for examining and testing spec-
imens for the purpose of obtaining scientific data which may be used to
ascertain the presence, progress, and source of disease in human beings.
NOTH: Authority cited: Sections 208 and 321, Health and Safety Code; Section
14105, Welfare and Institutions Code. Reference: Section 320, Health and Safety
Code; Section 14132, Welfare and Institutions Code; and Section 635.6, Business
and Professions Code.

History
1. New section filed 2-23-93; operative 3-25-93 (Register 93, No. 9).

§6818. Screening.

NOTK: Authority cited: Sections 208 and 321, Health and Safety Code. Reference:
Sections 320, et seq.. Health and Safety Code.

History

1. Repealer filed 1 1-28-79 as an emergency; effective upon filing (Register 79,
No. 48). A Certificate of Compliance must be filed within 120 days or emergen-
cy language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§ 6819. Child Health and Disability Prevention Services in
Contract Counties.

The organizational unit within the Department which is responsible
for health services in contract counties shall develop annual plans and
budgets, and shall conduct a program which is acceptable to the Child
Health and Disability Prevention Program, and which is in accordance
with the provisions of this subchapter.

NOTE: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Section 321.2, Health and Safety Code.

History

1 . New section filed 1 1-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 1 20 days or emer-
gency language vv'ill be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

Article 2. Program Administration

§ 6820. Advisory Boards.

(a) Membership. Membership in an advisory board shall be as follows:

( 1 ) Members appointed to the local advisory board by the local gov-
erning body shall include, but not be limited to, individuals who, at the
time of their appointment, are representatives of health professions con-
cerned with child health, school health personnel and parents of children
eligible to receive services under provisions of this subchapter, whether
or not the services are eligible for state reimbursement.

(2) The governing body may recognize individuals as alternates who
have professional or parent qualifications equivalent to that of the mem-
ber.

(3) The governing body shall not appoint any employee of the local
health department to the advisory board, except that the director and
deputy director of the community child health and disability prevention
program shall be ex officio, nonvoting members of the board.

(4) Individuals appointed to the advisory board as parents of children
eligible to receive services shall neither be employed by an individual or
an agency providing health services to the public for fee, nor be a provid-
er of health services to the public for fee.

(b) Responsibilities. The local advisory board shall be responsible for
the reviewing, advising and reporting functions related to the community
child health and disability prevention program as specified in Section

321.7, Health and Safety Code. The advisory board may also advise the
local governing body and appropriate governmental agencies on health
matters additional to the community child health and disability preven-
tion program, such as maternal and child health in general.

(c) Tenure. Members of the advisory board shall serve at the pleasure
of the appointing authority for a term of three years, except that one-third
of the members first appointed in each jurisdiction shall serve for three
years, one-third of the members for two years and one-third of the mem-
bers for one year.

(d) Meetings. The advisory board shall meet at least twice each year,
once before March 1, and once after March 1 but before September 1 . In
addition, the board shall meet on the call of the chairperson of the board
or on the call of one-third of its members. Public notice shall be given
of the date, time and location of each meeting in advance of the meeting.
Meetings shall be open to the public.

(e) Reimbursement. Advisory board members and alternates shall
serve without compensation, except that members, and alternates when
acting in lieu of members, shall be reimbursed under the approved com-
munity plan for actual and necessary expenses incurred in connection
with the performance of their duties. Parent members may additionally
be reimbursed for their actual and necessary costs of child care and lost
wages.

NOTE: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Section 321.7, Health and Safety Code.

§ 6822. Director and Deputy Director.

(a) Designation. Each governing body, except those in contract coun-
ties whose programs are administered by the Department, shall appoint
a physician, licensed to practice medicine in California, as Director,
Child Health and Disability Prevention Program. The director shall have
administrative responsibility for the organizational unit concerned with
child health in the local health department as defined in Section 1 102,
Health and Safety Code. If the director is an existing health official, the
director or local appointing authority shall also appoint a Deputy Direc-
tor, Child Health and Disability Prevention Program, with experience in
the dehvery of health services to children and youth who is assigned to
the organizational unit for which the Director, Child Health and Disabil-
ity Prevention Program, has direct administrative responsibility.

(b) Responsibilities. The responsibilities of the director shall include,
but not be Hmited to:

( 1 ) Developing and implementing the community child health and dis-
ability prevention program plan and assuring its compliance with federal
and state regulations. To the extent possible, this plan should relate to all
community health services for children and youth, and to the integration
and coordination of these services with the community's child health and
disability prevention program.

(2) Managing funds granted under the state-approved community
plan.

(3) Completing all reports and maintaining all records required by the
Department.

(4) Providing support staff and services to the community child health
and disability prevention advisory board.

(5) Preparing an annual report to the governing body.

(c) Reimbursement. The salary and necessary expenses of the commu-
nity child health and disability prevention program director or deputy di-
rector may be reimbursed by the State under the approved community
plan to the extent that the services are directly related to the community
child health and disability prevention program. However, if the director
is a health officer as defined in Sections 45 1 , 502 or 940 of the Health and
Safety Code, no funds from this program shall be used directly or indi-
rectly for reimbursement of the healtli officer's services rendered to the
program. If the director is an existing health official other than the health
officer, the official's salary may be reimbursed to the extent the official
renders services to the program as indicated in the program's approved
annual plan and budget.

Page 97

§6824

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Title 17

NoTi;: Authority cited: Sections 208 and 321, Health and Safety Code. Reference:
Sections 321(a) and 322, Health and Safety Code.

History

1 . Amendment of subsections (a) and (c) filed 1 1-28-79 as an emergency; effec-
tive upon filing (Register 79, No. 48). A Certificate of Compliance must be filed
within 120 days or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80. No. 13).

§ 6824. State and Local Responsibilities.

(a) Annual plan and budget. On or before March 15 of each year, each
governing body shall submit to the Department's Child Health and Dis-
ability Prevention Program the following:

(1) A summary of the previous fiscal year's activity ending the pre-
vious June 30.

(2) A summary of the current fiscal year's activity from the previous
July 1 to the date of the revised budget submittal. A projection of activi-
ties from the date of the revised budget submittal through June 30 of the
current fiscal year is desirable, but optional.

(3) A description of the community program to be offered the next fis-
cal year, including expected program performance goals and activities.
Descriptive material submitted as part of a previously state-approved
plan need not be repeated. If the community child health and disability
prevention program plan is part of the community's more comprehensive
child health plan, the more comprehensive plan may be submitted in lieu
of a separate community child health and disability prevention program
plan.

(4) A budget for the next fiscal year beginning July 1 .

(A) The community child health and disability prevention program
budget for the budget year shall be limited to those items, including
equipment and remodeling, required to implement the plan approved by
the Department's Child Health and Disability Prevention Program.

(B) If the amount appropriated in the State Budget Act and enacted into
law for the budget year differs from the amount in the budget submitted
by the Governor, each local governing body shall submit to the Depart-
ment's Child Health and Disability Prevention Program an additional re-
vised plan and budget that reflects the share of the reduction determined
by the Director to be applicable to that community child health and dis-
ability prevention plan.

(5) A preliminary budget estimate for the following fiscal year begin-
ning the following July 1.

(6) A current agreement between the community child health and dis-
ability prevention program and the county welfare department relating
to the provision and documentation of child health and disability preven-
tion services to Medi-Cal beneficiaries and setting forth the responsibili-
ties of the community program and the county welfare department to as-
sure adequate informing, outreach, referral and follow-up.

(7) Other information which may be required by the Department's
Child Health and Disability Prevention Program.

(b) Informing Medi-Cal beneficiaries. Medi-Cal beneficiaries shall
be informed as follows:

( 1 ) No later than 60 days following the date of a family ' s initial Medi-
Cal eligibility determination or of determination after a period of ineligi-
bility, the family must be informed of the availabiUty of CHDP services
including dental services. This must be done in writing and using face-
to-face contact by a person who can explain these services and benefits.
A family who loses and regains eligibility more than twice within a
twelve-month period need not be informed more than twice in that
twelve-month period. Informing includes the offer of services, assis-
tance with scheduling appointments and transportation, and document-
ing responses.

(2) If no member of an eligible family participates in the program, the
family must be informed in writing at least once each year beginning Oc-
tober 1, 1980. Informing includes offering CHDP services, offering as-
sistance with transportation and scheduling appointments, and docu-
menting responses.

(3) Each of the following must be used to inform an eligible family:

(A) Clear, nontechnical materials for those families who are to be in-
formed in writing.

(B) Procedures suitable for informing persons who are illiterate, blind,
deaf, or cannot understand the English language.

(4) A family being informed about the program must be given the fol-
lowing information:

(A) The benefits of preventive health and dental services.

(B) How medical and dental services can be obtained.

(D) The health assessment and dental services that are offered.

(E) A summary of the State's periodicity schedule.

(F) That recipients can receive both initial and periodic health asses-
stnents and dental services according to the State's periodicity schedule.

(G) That treatment services shall be provided for problems disclosed
during screening.

(H) That assistance in referral shall be provided.

(I) That assistance with transportation shall be provided if the person
requests it.

(J) That assistance in scheduling appointments shall be provided if the
person requests this assistance.

(K) That as long as the person remains eligible for Medi-Cal, he or she
may request these services at any time in the future if the decision is post-
poned at the time of initial informing.

(L) That the person may choose to receive CHDP services from a pro-
vider of the person's choice, and that if the provider does not offer the full
range of CHDP services specified in this subchapter, the person can re-
ceive the services not offered if the person makes a request to the commu-
nity CHDP program or welfare department. If such request is made, as-
sistance in scheduling appointments and transportation shall be offered,
and the responses documented.

(M) That these CHDP services are available from approved providers
at no cost to the family.

(c) Information and training for county welfare employees. Informa-
tion and training for county welfare department personnel shall be as fol-
lows:

( 1 ) The State Departments of Health Services and Social Services shall
provide information, training and materials necessary to ensure that
county social services and welfare eligibility personnel, and other appro-
priate welfare department employees, are fully informed as to the pur-
pose, nature, scope and benefits of CHDP services.

(2) Such employees shall be trained in methods of information dis-
seminafion that will encourage and modvate eligible individuals to make
use of such preventive medical programs.

(3) The provision of such training shall be verified in appropriate sec-
tions of the annual plans submitted to the Department' s Child Health and
Disability Prevention Program by community child health and disability
prevention programs.

(d) Information and training for local health department personnel. In-
formation and training for local health department personnel shall be as
follows:

( 1 ) The Department shall provide such information, training and mate-
rials necessary to ensure that appropriate local health department person-
nel and other appropriate county and municipal employees are informed
as to the purpose, nature, scope and benefits of CHDP services.

(2) Such employees shall be trained in methods of information dis-
semination that will encourage and moUvate eligible individuals to make
use of such preventive medical programs.

(3) The provision of such training shall be verified in appropriate sec-
Uons of the annual plans submitted to the Department's Child Health and
Disability Prevention Program by community child health and disability
prevention programs.

(e) Required services. Each community child health and disability pre-
vention program shall provide, in accordance with this subchapter, at
least the following services:

Page 98

Title 17

State Department of Health Services

§6830

( 1 ) Outreach and health education, including anti-tobacco use educa-
tion.

(2) Referral to dentist.

(3) Referral to a health assessment.

(4) Health assessment.

(5) Certification for school entry.

(6) Referral to diagnosis and treatment.

(7) Diagnosis and treatment.

(f) Records and information. Each community child health and dis-
ability prevention program shall keep records and provide information
on the results of health assessments and follow-up to diagnosis and treat-
ment, and other data about the persons served as may be required by the
Department's Child Health and Disability Prevention Program.

(g) Other responsibilities. The Department shall provide the follow-
ing:

(1) Regulations and minimum standards for quality preventive health
services for children and youth, including anti-tobacco use education
guidelines.

(2) Consultation services on all aspects of community program devel-
opment.

(3) Appropriate data collection and reporting forms.

(4) Documentation and data, made available at the state or local level,
on all aspects of the program including:

(A) The results of informing services.

(B) The results of screening services.

(D) The results of anti-tobacco education services.

(5) Management reports for state and local program use.

(6) Reports required by the federal Early Periodic Screening Diagno-
sis and Treatment Program.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code; and Sec-
tion 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections
320, 321.2, 322.5, 324 and 24165.3, Health and Safety Code.

History

1 . Repealer and new section fded 1 1-28-79 as an emergency; effective upon filing
(Register 79, No. 48). A Certificate of Compliance must be filed within 120 days
or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsecUon (b)(1) filed 5-22-80; effective thirtieth day thereaf-
ter (Register 80, No. 21).

4. Amendment of subsections (e)(1) and (g) filed 2-27-90 as an emergency pur-
suant to Secfion 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Regis-
ter 90, No. 9). A Certificate of Compliance must be transmitted to OAL within
120 days or emergency language will be repealed by operation of law on
6-27-90.

5. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-1 9-90 and
filed 7-18-90 (Register 90, No. 38).

§ 6826. State and Local Information and Training
Responsibilities.

NOTE: Authority cited: Sections 208 and 32 1 , Health and Safety Code. Reference:
Sections 320, et seq.. Health and Safety Code.

History

1. Repealer filed 11-28-79 as an emergency; effecdve upon filing (Register 79,
No. 48). A Certificate of Compliance must be filed within 1 20 days or emergen-
cy language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§ 6828. Sanctions for Noncompliance.

(a) If the Chief of the State Child Health and Disability Prevention Pro-
gram determines that a reasonable period of technical consultation and
assistance has been provided or arranged for by the State Child Health
and Disability Prevention Program, and further determines that a com-
munity child health and disability prevention program director fails to
comply with any state or federal law or regulation governing child health
and disability prevention services, or with the approved community plan,
the Chief of the State Child Health and Disability Prevention Program
shall notify the local governing body in writing of the specific areas of
noncompliance. A copy of the notice shall be sent to the community pro-

gram director, the county welfare department director, and to the local
child health and disability prevention program advisory board.

(b) If the local governing body fails to provide substantial evidence to
the Chief of the State Child Health and Disability Prevention Program
within 30 days that the community program director is complying and
shall continue to comply with the laws, regulations and the approved
community plan, the Director shall convene a hearing for the community
program to show cause why the Director should not take action to secure
compliance. The Director shall invite the community child health and
disability prevention program's advisory board and other persons or or-
ganizations interested in the community's child health and disability pre-
vention program to present comments at such hearing. The Department
shall give the community program, concerned individuals and organiza-
tions, and the general public at least 15 days notice of such hearing.

(c) The Director shall consider the case on the record established at the
hearing and render findings and decision on the issues within 30 days fol-
lowing the hearing. The findings and decision shall be submitted in writ-
ing by the Director to the local governing body. A copy of the notice shall
be sent to the community program director, the county welfare depart-
ment director, and to the local child health and disability prevention pro-
gram advisory board.

(d) If the Director determines that there is a failure on the part of the
community child health and disability prevention program to comply
with any state or federal law or regulation governing child health and dis-
ability prevention services, or the approved community plan, the Depart-
ment may invoke any of the following sanctions:

(1) Consistent with federal and state law, withhold part or all of state
and federal funds from such community until the local governing body
provides written documentation of compliance to the Director.

(2) Bring an action in mandamus or such other action in court as may
be appropriate to compel compliance.

(e) Nothing in this section shall be construed as relieving the local gov-
erning body of the responsibility to provide funds necessary to continue
the child health and disability prevention services required by Sections
320, et seq.. Health and Safety Code.

NOTE: Authority cited: Secfions 208 and 321 , Health and Safety Code. Reference:
Secdons 320, et seq., Health and Safety Code.

Article 3. Eligibility for Services and
Reimbursement

§ 6830. Eligibility for Services.

(a) Medi-Cal beneficiaries shall be eligible for periodic health asses-
sments, and for diagnosis and treatment, if necessary, in accordance with
the provisions of this subchapter.

(b) Any child

(1) between birth and 90 days after entrance into the first grade who
is not a Medi-Cal beneficiary and

(2) all persons under 19 years of age whose family income is not more
than 200 percent of the federal poverty level shall be eligible for health
assessments in accordance with the provisions of this subchapter. Avail-
ability of services and reimbursement for these services shall depend on
the amount of funds appropriated by the Legislature for the services as
specified in section 6832(b).

NOTE: Authority cited: Secfions 208 and 321, Health and Safety Code; and Sec-
tion 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections
322.5. 323.7 and 24165.3, Health and Safety Code.

History

1. Amendment filed 1 1-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 1 20 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsecfion (b) filed 2-27-90 as an emergency pursuant to Sec-
tion 12, Chapter 1331, Statutes of 1989; operafive 2-27-90 (Register 90. No.
9). A Certificate of Compliance must be transmiued to OAL within 120 days or
emergency language will be repealed by operation of law on 6-27 90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19 90 and
filed 7-18-90 (Register 90, No. 38).

Page 99

§6832

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 6832. Eligibility for Reimbursement.

(a) The costs of periodic health assessments provided to Medi-Cal
beneficiaries shall be reimbursed by the Slate in accordance with the
schedule of maximum allowances specified in section 6868.

(b) If the amount of funds appropriated in the State Budget Act are suf-
ficient, the costs of health assessments provided to ( i ) children between
birth and 90 days after entrance into the first grade, who are not Medi-Cal
beneficiaries, and (2) all persons under 19 years of age whose family in-
come is not more than 200 percent of federal poverty level shall be reim-
bursed by the State. To the extent that funds are not sufficient, these costs
shall be reimbursed only for those children who meet the age and family
income criteria defined by the Department's Child Health and Disability
Prevention Program.

(c) The costs of diagnosis and treatment services provided to Medi-
Cal beneficiaries as a result of health assessments shall be reimbursed by
the State in accordance with the Medi-Cal fee schedules, subject to any
applicable Medi-Cal program limitations.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code; and Sec-
tion 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections
322.5, 323.2 and 24165.3, Health and Safety Code.

History

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (b) filed 2-27-90 as an emergency pursuant to Sec-
non 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No.
9). A Certificate of Compliance must be transmitted to OAL within 120 days or
emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-19-90 and
filed 7-18-90 (Register 90, No. 38).

Article 4. Required Services

§ 6840. Required Services.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code. Reference:
Secfions 321.2 (a)-(e). Health and Safety Code.

History

1 . Repealer filed 12-1-79 as an emergency; effecfive upon filing (Register 79, No.
48). A Certificate of Compliance must be filed within 120 days or emergency
language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§ 6842. Outreach and Health Education.

(a) Plan. Each community child health and disability prevention pro-
gram shall develop, plan and implement community outreach and health
education activities which are related to the community's needs and re-
sources. Activities may include, but are not limited to, community orga-
nization, staff training, consultation with children and families, staff ser-
vices to community child health and disability prevention program
advisory boards, and the development and dissemination of information-
al and educational material for the public, potential users and providers
of the program's services, advisory board members, local agencies and
community groups.

(b) Outreach. An outreach program shall be as follows:

(1) Community child health and disability prevention programs shall
develop outreach programs to involve persons in the use of preventive
health services. Outreach and health education services shall be designed
to ensure that the only reason eligible persons do not participate in the
health assessment and referral for diagnosis and treatment portions of the
program is because they intelligently and knowingly decline such partici-
pation for reasons unrelated to availability and accessibility of the health
assessment, diagnosis and treatment services.

(2) In cooperation with the community child health and disability pre-
vention program, the governing body of every school district or private
school which has children enrolled in kindergarten shall, at the time the
parent or guardian registers a child in kindergarten, inform the parents or
guardians as follows:

(A) It is statutorily required that children provide, within 90 days after
entrance into the first grade, either a certificate to the school documenting
that within the prior 18 months the child has received the appropriate
health assessment required by law, or a waiver signed by the parent or
guardian indicating that they do not want or are unable to obtain such
health assessments for their children.

(B) The health assessment that is required is available from the child's
usual source of health care, the local health department, some schools
and other places in the community.

(C) Rather than wait until the child actually enters first grade, it is ad-
visable to get the health assessment as early as possible, preferably within
six months prior to kindergarten entrance, at which time it is also required
that the child's immunizations (a part of the total health assessment) be
brought up to date.

(3) The parents or guardians of children entering the first grade who
do not have documentation that the appropriate health assessment has
been done or waived shall be informed by the school at that time as fol-
lows:

(B) The health assessment that is required is available from the child's
usual source of health care, the local health department, some schools
and other places in the community.

(c) Informing. Persons eligible to receive CHDP services shall be in-
formed, using effective methods to involve them and in a language un-
derstandable to them, about the following:

(1) The value of preventive health services.

(2) Health assessments.

(3) The need for prompt diagnosis and appropriate treatment of sus-
pected disabilities.

(4) The nature, scope and benefits of the Child Health and Disability
Prevention Program.

(d) Health Education. Health education, including anti-tobacco use
education, shall be an integral part of the health assessment.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code; and Sec-
tion 12, Assembly Bill 75 (Chapter 1 331, Statutes of 1989). Reference: Sections
321.2, 323.5, 324.2 and 24165.3, Health and Safety Code.

History

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsection (d) filed 2-27-90 as an emergency pursuant to Sec-
tion 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90, No.
9). A Certificate of Compliance must be transmitted to OAL within 120 days or
emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Compliance as to 2-27-90 order transmitted to OAL 6-1 9-90 and
filed 7-18-90 (Register 90, No. 38).

§ 6843. Referral to Dentist.

(a) Availability.

(1) A direct referral to a dentist shall be made for eligible Medi-Cal
beneficiaries three years of age and older unless dental services have
been declined. The dental referral is for the purpose of diagnosis and
treatment. Dental treatment consists of dental care needed for relief of
pain and infections, restoration of teeth and maintenance of dental health.

(2) An inspection of the teeth, gums and mouth is part of the health
assessment, and referral to a dentist shall be made if appropriate.

(b) Informing and training responsibilities. The provisions of Section
6824 also apply to the information and training responsibilities of the
state and community child health and disability prevention programs re-
garding informing Medi-Cal beneficiaries of the availability of dental
services, how the services may be obtained, and of the assistance avail-
able with transportation and scheduling appointments.

Page 100

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(c) Frequency. An annual referral to a dentist for dental services shall
be offered each eligible Medi-Cal recipient three years of age and older.
Dental providers, approved for participation in the Medi-Cal program,
shall be reimbursed for diagnosis resulting from this annual referral, and
for dental care needed for relief of pain and infections, restoration of teeth
and maintenance of dental health.

(d) Offer of assistance with transportation and scheduling appoint-
ments. Medi-Cal beneficiaries shall be offered assistance with transpor-
tation and scheduling appointments for initial and periodic dental exami-
nations. The response to tliis offer shall be recorded, and this assistance
shall be provided if requested by the beneficiary.

(e) Completion of referral. All reasonable steps shall be taken to ensure
that Medi-Cal beneficiaries eligible to receive an initial or a periodic
dental examination, and who request a referral, complete the referral. An
initial dental examination shall normally be completed within 120 days
from either the date the beneficiary requests the referral, or the date the
beneficiary was certified eligible to receive Medi-Cal benefits, whichev-
er occurs later. A periodic dental examination shall normally be com-
pleted within 1 20 days from either the date the beneficiary requests the
referral, or the last day of the month in which the annual dental examina-
tion was due, whichever occurs earlier.

(0 Referral sources. The first source of referral for dental services shall
be the person's usual source of licensed dental care. If no usual source
of licensed dental care can be identified, the person shall be given, with-
out prejudice for or against any one source, the names and locations of
at least three sources of dental care, when available, which have been ap-
proved as providers of dental services by the California Medical Assis-
tance Program. Although the family or recipient may choose to receive
dental diagnostic and treatment services from a provider of its choice, to
be eligible for state reimbursement, these services shall be provided by
Medi-Cal approved providers and in accordance with the provisions of
the California Administrative Code, Title 22, Division 3 and subject to
any applicable Mcdi-Cal program limitations.

(g) Documentation. If initial or periodic dental services were not pro-
vided to a Medi-Cal beneficiary who had requested such services and
who also had requested assistance with transportation or scheduling ap-
pointments for services, documentation must exist showing that the fam-
ily or person lost eligibihty, could not be located despite a good faith ef-
fort to do so, or the person's failure to receive the services was due to an
action or decision by the family or person, rather than a failure by the
community child health and disability prevention program to meet re-
quirements of this subchapter, including the requirement to offer and pro-
vide assistance with transportation and scheduling appointments for ser-
vices.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code. Reference:
Sections 321.2, 322.7 and 323.7, Health and Safety Code.

History

1. New section filed 1 1-28-79 as an emergency; effective upon filing (Register

79, No. 48). A Certificate of Compliance must be filed within 1 20 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13). 3. Amendment
of subsection (a)(]) filed 5-22-80; effective thirtieth day thereafter (Register

80, No. 21).

3. Amendment of subsection (a) ( 1) filed 5-22-80; effective thirtieth day thereaf-
ter (Register 80, No. 21).

§ 6844. Referral to Health Assessment.

(a) The following shall apply to all persons eligible to receive health
assessments under the provisions of this subchapter:

( 1 ) All reasonable steps, including assistance in scheduling and com-
pleting appointments if requested, and in following up initial efforts,
shall be taken to ensure that persons eligible to receive health asses-
sments, and who request a health assessment, receive it.

(2) Appointments for requested health assessments shall be completed
in a reasonable period of time, normally not to exceed 60 days.

(3) The first source of referral for a health assessment shall be the per-
son's usual source of health care. Preference should be given to the com-
prehensive care provider. If no usual source of health care can be identi-

fied, the person shall be given, without prejudice for or against any one
provider, the names and locations of at least three providers, when avail-
able, who have been approved as providers of health assessments by the
community child health and disability prevention program director. The
availability of health assessments directly from the clinic operated by the
community program may also be made known to the person.

(4) Although a person may choose to receive a health assessment from
a provider of the person's choice, to be eligible for state reimbursement,
the health assessment shall be provided by providers who have been ap-
proved to bill the Department for these services.

(b) Additional to (a), above, the following shall apply to Medi-Cal
beneficiaries who request health assessments:

( 1 ) Medi-Cal beneficiaries shall be offered assistance with transporta-
tion and scheduling health assessment appointments. The response to
this offer shall be recorded, and this assistance shall be provided if re-
quested by the beneficiary.

(2) If a person chooses to receive a health assessment from a provider
that does not furnish the full range of services as specified in this sub-
chapter, the community child health and disability prevention program
shall, if requested, provide or arrange for provision of all such services
that are not offered by that provider. At the time of the request, the person
must be offered assistance with transportation and scheduling appoint-
ments. The response to this offer shall be recorded, and this assistance
shall be provided if requested.

(3) If an initial or a periodic health assessment is not provided to a
Medi-Cal beneficiary who requests such services and who also requests
assistance with transportation or scheduling appointments for services,
documentation must exist showing that the family or person lost eligibil-
ity, could not be located despite a good faith effort to do so, or the per-
son's failure to receive the services was due to an action or decision by
the family or person, rather than a failure by the community child health
and disability prevention program to meet requirements of this subchapt-
er, including the requirement to offer and provide assistance with trans-
portation and scheduling appointments for services.

NOTE: Authority cited: Sections 208 and 32 1 , Health and Safety Code. Reference:
Sections 321.2 (d) and 323.7, Health and Safety Code.

History

1 . Repealer and new section filed 1 1-28-79 as an emergency: effective upon filing
(Register 79, No. 48). A Certificate of Compliance must be filed within 1 20 days
or emergency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§ 6846. Health Assessment.

(a) Conditions. The following conditions apply to health assessments
provided to eligible persons:

(1) A health assessment shall not be provided without the voluntary
consent of the patient.

(2) A health assessment shall not be provided to minors without the
prior and written consent of the minor's parent or guardian unless one or
more of the following circumstances exist:

(A) The minor is emancipated.

(B) The minor is married.

(D) Provision of the service is exempted from parental consent by fed-
eral or state statute or regulation.

(b) Required screening procedures. Unless medically contraindicated
or deemed inappropriate by the health assessment provider, or refused by
the person, health assessments shall include the following procedures:

( 1 ) Health and developmental history.

(2) Unclothed physical examination including assessment of physical
growth.

(3) Assessment of nutritional status.

(4) Inspection of ears, nose, mouth, throat, teeth and gums.

(5) Vision screening.

(6) Hearing screening.

(7) Tuberculin testing and laboratory tests appropriate to age and sex,
including tests for anemia, diabetes and urinary tract infections.

Page 101

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

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(8) Testing for sickle cell trait and lead poisoning where appropriate.

(9) Immunizations appropriate to age and health history necessary to
make status current. (Patient shall also receive, subsequent to the health
assessment, any immunizations which could not be given during the
assessment, and any immunizations necessary to complete a series which
could not be completed during the assessment.)

(10) Health education and anticipatory guidance appropriate to age
and health status.

(c) Additional screening procedures. A community child health and
disability prevention program may include screening procedures in its
program, additional to the ones included in this section, if these proce-
dures are approved by the Department and the Stale Child Health Board.

(d) Rechecks. In those instances where a person is eligible for state re-
imbursement of health assessment costs, reimbursement may be made
for one recheck of those screening procedures (excluding the Health His-
tory and Physical Examination) and laboratory tests where such a re-
check is medically indicated because questionable or marginal results
were obtained during the prior screening.

(e) Results of health assessment. The results of the health assessment
shall be handled as follows:

( 1 ) Health assessment providers shall provide the person with a copy
of the results of the screening tests, with an appropriate explanation of the
results. Such notification and discussion of screening test results, unless
provided by a licensed or certified practitioner of the healing arts, shall
be free of diagnostic statements or suggestions that the person needs any
particular treatment. Specifically, no medical care or special education
plan shall be instituted solely on the basis of the health screening results.

(2) The results of the health assessment shall be recorded on forms pro-
vided by the Department.

(f) Concurrent diagnosis and treatment. Nothing in these regulations
shall be interpreted to mean that a licensed or certified practitioner of the
healing arts may not provide diagnosis and treatment, in conjunction with
the health assessment, if medically indicated.

(g) Nonspecified procedures. Health screening procedures that are ap-
proved for reimbursement by the Department are specified, together with
their maximum allowable reimbursements, in Section 6868. Reimburse-
ment for procedures not specified in Section 6868 shall not be made with-
out written approval of the Department.

NOTE: Authority cited: Sections 208, 321 and 323.7, Health and Safety Code. Ref-
erence: Sections 321.2 and 324, Health and Safety Code.

History

1. New NOTE filed 4-16-79. conecting inadvertent omission from 3-29-79 fil-
ing of Subchapter 3 (Register 79, No. 15).

2. Repealer and new section filed 1 1-28-79 as an emergency; effective upon filing
(Register 79, No. 48). A Certificate of Compliance must be filed within 1 20 days
or emergency language will be repealed on 3-28-80.

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§ 6847. Periodicity of Health Assessments.

(a) Eligibility. Medi-Cal beneficiaries who have received an initial
health assessment are also eligible for subsequent, periodic health asses-
sments.

(b) Notifying and Offering Assistance. Persons eligible for periodic
assessments shall be notified before each assessment is due of their en-
titlement to the assessment, and of the availability of assistance with
transportation and scheduling appointments. The informing may be in
writing. Tlie response to this offer shall be recorded, and this assistance
shall be provided if requested by the beneficiary.

(c) Frequency. Persons eligible for periodic health assessments shall
receive one assessment during each age period listed below. The first age
at which the next health assessment is due is the age of the person at the
previous assessment plus the interval indicated in the parenthesis after
that age period in the table shown in this subsection. However, a periodic
assessment may be done at any time from the beginning to the end of each
age period. Persons will be considered overdue for an assessment on the
first day he or she enters a new age period without assessment having
been performed in the previous age period.

For example, a child receiving an assessment at two and one-half
years of age is first due for the next assessment at three and one-half years
of age (the age at the time of previous assessment, two and one-half plus
the time interval between assessinents for that age group, one year). The
assessment is overdue when the child is four years old. There is no time
interval in the 1 7-20 age period because no additional assessments will
be given after that assessment. Initial and periodic assessments, and the
initiation of any needed treatment, shall normally be completed within
120 days from either the last day the person is eligible for assessment in
any age period or the day the person is notified that the next assessment
is due, whichever occurs first.

The following table is a guide for the minimum frequency at which
health assessments shall be provided to persons eligible for periodic
assessments:
Under 1 month old (1 month)

1 through 2 months old (2 months)

3 through 4 months old (2 months)

5 through 6 months old (2 months)

7 through 9 months old (3 months)

10 through 12 months old (3 months)

13 through 17 months old (5 months)

18 through 23 months old (6 months)

2 years old (1 year)

3 years old (1 year)

4 through 5 years old ■ (2 years)

6 through 8 years old (3 years)

9 through 12 years old (4 years)

13 thi-ough 16 years old (4 years)

1 7 through 20 years old

(d) Additional Health Assessments. The frequency indicated in this
section is considered a minimum for preventive health care. More fre-
quent health assessments will be reimbursed when the additional asses-
sment is deemed appropriate by the health assessment provider. Circum-
stances which may indicate the need for more frequent assessments
include the following:

(1) The parents have or the person has a particular need for education
and guidance.

(2) There is the presence or possibility of perinatal disorders (such as
low birth weight, low Apgar scores at birth, prolonged labor).

(3) The person is or will be exposed to a potentially stressful environ-
ment— for example, camp or contact sports — before the next periodic
health assessment indicated by the periodicity schedule is due.

(e) Limitations. Reimbursement at more frequent intervals will not be
made for a health assessment of an individual for the purpose of monitor-
ing or treating a specific disease or disorder previously diagnosed, or for
a person whose overall health status requires ongoing treatment care.
Such individuals are still eligible for regular assessments if they are
otherwise eligible for CHDP services.

NOTE: Authority cited: Sections 208, 321 and 323.7, Health and Safety Code. Ref-
erence: Sections 320 and 323.7, Health and Safety Code.

History

1. New section filed 1 1-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Ceilificate of Compliance must be filed within 1 20 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. Amendment of subsections (c) and (d)(2) filed 5-22-80; effective thirtieth day
thereafter (Register 80, No. 21).

§ 6848. Certification for School Entry.

(a) If a child receives a health assessment under provisions of this sub-
chapter, and must present documentafion to the school in which the child
is to enroll that the appropriate health screening procedures specified in
Section 6846 have been performed, the physician, certified pediatric
nurse practitioner or certified family nurse practitioner providing or su-
pervising such screening shall give the child or parent or guardian a cer-
tificate documenting that the child has received the appropriate health
screening procedures. The certificate shall be provided whether the cost
of the health assessment is reimbursed by the State or paid on behalf of
the child.

(b) A child may be certified for school entry by the child's personal
physician, certified pediatric nurse practitioner or certified family nurse

Page 102

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§6852

praclitioncr without receiving a further health assessment if the child has
receixed a physical examination and ongoing comprehensive medical
care from that physician, certified pediatric nurse practitioner or certified
family nurse practitioner during the 18 months preceding entry into the
first grade, or within 90 days thereafter, and that care has included all the
applicable health screening procedures outlined in Section 6846.

(c) The health certification for school entry shall be on the form pro-
vided by the Department, Report of Health Examination For School
Entry, PM 171 A(6/84).

NOTH: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Section 323..'i. Health and Safety Code; Section 14132.41, Welfare and Institu-
tions Code; and Sections 2834, 2835, 2835.5 and 2836, Business and Professions
Code.

History

1. New .section filed 4-16-79, correcting inadvertent omission of section 6848
from 3-29-79 filing of .subchapter 3; effective 5-16-79 (Register 79, No. 15).

2. Amendment filed 1 1-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

4. Amendment of subsections (a), (b), and Noth filed 10-27-93 as an emergency;
operative 10-27-93 (Register 93, No. 44). A Certificate of Compliance must be
transmitted to OAL by 2-25-94 or emergency language will be repealed by op-
eration of law on the following day.

5. Certificate of Compliance as to 10-27-93 order with amendment of subsection
(c) transmitted to OAL 2-23-94 and filed 4-6-94 (Register 94, No. 14).

§ 6850. Referral to Diagnosis and Treatment.

(a) The following shall apply to all persons for whom diagnosis and
treatment is indicated as a result of initial or periodic health assessments
received under the provisions of this subchapter:

(1) All reasonable steps, including assistance in scheduling and com-
pleting appointments shall be taken to ensure that persons receive needed
diagnosis and treatment services. This referral assistance shall include
giving the family or person the names, address and telephone numbers
of providers who have expressed a willingness to furnish, at little or no
expense to the family, those treatment services which are not reimburs-
able by the Department.

(2) Appointments for diagnostic and treatment services shall be com-
pleted in a reasonable period of time, normally not to exceed 60 days
from the time of the health assessment.

(3) The health assessment provider shall be responsible for assisting
the person in completing diagnosis and treatment. Such assistance may
be rendered directly by the provider or through the provider' s agreements
with the community child health and disability prevention program, ap-
propriate agency or individual.

(4) The first source of referral for diagnosis and treatment shall be the
person's usual source of licensed or certified health care. If a referral is
required and no regular source of licensed or certified health care can be
identified, the provider shall provide a list of at least three appropriate
sources of care, when available, without prejudice for or against any spe-
cific source or licensed profession. One of the referral sources may be the
health assessment provider. State reimbursement for diagnostic and
treatment services provided to Medi-Cal beneficiaries can be made only
to providers who have been approved for participation in the Medi-Cal
program.

(5) The community child health and disability prevention program
shall:

(A) Identify those persons eligible for CHOP services who can obtain
needed medical or remedial services through a grantee under Title V of
the Social Security Act (Maternal and Child Health and Crippled Chil-
dren's Services).

(B) Ensure that persons eligible for Title V services are informed of
available services, and referred, if they desire, to Title V grantees that of-
fer services appropriate to the persons' needs.

(6) The source of health care selected by the person shall be indicated
on the CHDP assessment form. If that source is other than the assessment
provider, a copy of the CHDP referral form or equivalent shall be pro-

vided, with the person's written permission, to the identified source of
healthcare.

(b) Additional to (a), above, the following shall apply to Medi-Cal
beneficiaries for whom diagnosis and treatment is indicated as a result of
initial or periodic health assessments:

( 1 ) Medi-Cal beneficiaries, who requested assistance with transporta-
tion or scheduling the appointment for the health assessment, shall be of-
fered assistance with transportation and scheduling appointments for
diagnosis and treatment. The response to this offer shall be recorded, and
this assistance shall be provided if requested by the beneficiary.

(2) Medi-Cal beneficiaries, who did not request assistance with trans-
portation or scheduling the appointment for the health assessment, may
request assistance with transportation and scheduling appointments for
diagnosis and treatment. If the beneficiary requests such assistance, the
request shall be documented and the assistance shall be provided.

(3) Treatment needed as a result of an initial health assessment shall
normally be initiated within 1 20 days from either the date the beneficiary
requested the health assessment, or the date the beneficiary was certified
eligible to receive Medi-Cal benefits, whichever occurs later. Treatment
needed as a result of aperiodic health assessment shall normally be initi-
ated within 120 days from either the date the beneficiary requested the
health assessment, or the last day of the month in which the beneficiary's
age exceeds the oldest allowable age for the health assessment according
to the periodicity schedule specified in Section 6847, whichever occurs
earlier.

(4) If diagnostic and treatment services are not provided to a Medi-Cal
beneficiary who requests such services and who also requests assistance
with transportation or scheduling appointments for such services, docu-
mentation must exist showing that the family or recipient declined the
services, lost eligibility, could not be located despite a good faith effort
to do so, or the recipient's failure to receive the services was due to an
action or decision by the family or recipient, rather than a failure by the
community child health and disability prevention program to meet re-
quirements of this subchapter, including the requirement to offer and pro-
vide assistance with transportadon and scheduling appointments for ser-
vices.

(c) Each community child health and disability prevention program
shall be responsible for developing and maintaining a referral and
follow-up system for diagnosis and treatment, and for ensuring that re-
ferral is carried out. The referral and follow-up system shall be specified
in the community's child health and disability prevention program plan.
Agreements between the community program and providers, and be-
tween the community program and other appropriate individuals and
agencies participating in the community program, may be part of the re-
ferral and follow-up system.

NOTE: Authority cited : Sections 208 and 32 1 , Health and Safety Code. Reference:
Sections 321 .2, 323.7 and 324, Health and Safety Code.

History

1. New section filed 4-16-79, correcting inadvertent omission of Section 6850
from 3-29-79 filing of Subchapter 3; effective 5-16-79 (Register 79, No. 15).

2. Repealer and new secUon filed 1 1-28-79 as an emergency; effective upon filing
(Register 79, No. 48). A Certificate of Compliance must be filed within 120 days
or emergency language will be repealed on 3-28-80.

3. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

4. Amendment of subsections (a)(4) and (6) filed 5-22-80; effective thirtieth day
thereafter (Register 80, No. 21).

§ 6852. Diagnosis and Treatment.

(a) To be eligible for state reimbursement, diagnostic and treatment
services, which may be required by Medi-Cal beneficiaries as a result ol'
a health assessment received, shall be provided by providers approved
for participation in the California Medical Assistance Program. The diag-
nostic and treatment services shall be in accordance with the provisions
of the California Administrative Code, Title 22, Division 3 and subject
to any applicable Medi-Cal program limitations.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code. Reference:
Section 323, Health and Safety Code.

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Title 17

History

2. Certificate of Compliance filed 3-27-80 (Register 80. No. 13).

3. Amendment filed 5-22-80; effective thirtieth day thereafter (Register 80, No.
21).

Article 5. Providers of Health Screening
and Evaluation Services

§ 6860. Conditions of Participation.

(a) Dental diagnostic and treatment services shall be provided by or
under the supervision of a dentist licensed to practice dentistry in Califor-
nia. To be eligible for state reimbursement, billing for dental services
shall be in accordance with the regulations governing the California
Medical Assistance Program.

(b) Health assessments shall be performed in accordance with the pro-
visions of this subchapter as follows:

( 1 ) By, or under the supervision and/or responsibility of, a physician
licensed to practice medicine in California.

(2) By a certified family nurse practitioner or certified pediatric nurse
practitioner, as defined in Title 22, Section 51 170.3(b) and (c), respec-
tively.

(c) Each individual, partnership, clinic, group, association, institution,
or public or private agency desiring to participate in a community child
health and disability prevention program as a provider of health asses-
sments only, or as a provider of comprehensive health care, shall notify
the director of that program of such intent. Notification shall be made to
the director of each community child health and disability prevention
program in which it is desired to provide service. Notification shall be in
the manner established by the community program director.

(d) Physicians, medical clinics, medical groups, certified pediatric
nurse practifioners or certified family nurse practitioners may be ap-
proved for participation as providers in the community program by the
community program director on receipt by the director of written notifi-
cation stating the following:

( 1 ) The physician, certified pediatric nurse practitioner, certified fami-
ly nurse practitioner, medical clinic, or medical group understands the re-
quirements of the Child Health and Disability Prevention Program, and
desires to participate in it as either a comprehensive care provider or as
a provider of health assessments only.

(2) If parts of the required health assessment are not available through
the physician, certified pediatric nurse practitioner or certified family
nurse practitioner, the physician or certified family nurse practitioner or
certified pediatric nurse practitioner shall refer the person to other pro-
viders approved by the community program for completion of those
parts.

(e) Agencies and organizaUons (other than physicians and physician
groups) desiring to participate in the community program, where physi-
cians or other persons under physician stipervision will be employed to
do parts of the health assessment, shall state in writing the qualifications
of the screening personnel when noUfying the community program direc-
tor of their intent to participate as providers. Participation of such agen-
cies and organizations shall require the written approval of the communi-
ty program director, and compliance with the provisions of this
subchapter and with any standards that may be established by the com-
munity program director.

(0 If the community child health and disability prevention program di-
rector determines that a provider, previously approved for participation
in the community program, is not providing services in accordance with
provisions of this subchapter or the standards established by the commu-
nity program, the community program director may withdraw the ap-
proval.

(g) Prepaid health plans, their subcontractors or sub-subcontractors,
under contract to the Department to provide medical care to Medi-Cal
enrollees are exempted from the provisions of this section only for CHDP
services that are provided to their Medi-Cal enrollees. If such a prepaid
health plan wishes to provide CHDP services to persons other than their
Medi-Cal enrollees. full compliance with this section is required.

(h) Health assessments may be conducted in public and private school
facilities provided that, with respect to private school facilities, no ser-
vices provided thereon pursuant to this subchapter and financed by pub-
lic funds shall result in any material benefit to, or be conducted in a man-
ner which furthers any educational or other mission of, such a school or
any person or entity maintaining the school.

(i) Health assessments shall be made available to eligible persons as
defined in this subchapter without regard to race, religion, sex, national
origin, citizenship, marital status, parenthood or source of payment.

(j) Clinical laboratories, may be approved for participation as provid-
ers in the community program by the community program director on re-
ceipt by the director of written notification stating that the clinical labora-
tory understands the requirements of the Child Health and Disability
Prevention Program, and desires to participate in it as a provider of labo-
ratory services.

NOTE: Authority cited: Sections 208 and 321 , Health and Safety Code. Reference:
Section 321(c), Health and Safety Code; Sections 655.6. 2834, 2835, 2835.5 and
2836, Business and Professions Code; Section 141 32.41 , Welfare and Institutions
Code; and 42 U.S.C. Section 1396d(a).

History

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. New subsecfion (a) filed and existing subsections (a) through (h) relettered to
(b) through (i) fUed 5-22-80; effective thirtieth day thereafter (Register 80. No.

21).

4. New subsection (j) and amendment of Note filed 2-23-93; operative 3-25-93
(Register 93, No. 9).

5. New subsections (b)(l)-(3), amendment of subsection (b) and (d)-(d)(2) and
Note filed 10-27-93 as an emergency; operative 10-27-93 (Register 93, No.
44). A Certificate of Compliance must be transmitted to OAL by 2-25-94 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 1 0-27-93 order with amendment of subsections
(b)-(b)(2) transmitted to OAL 2-23-94 and filed 4-6-94 (Register 94, No. 14).

§ 6862. Types of Providers.

(a) A health assessment provider shall be a physician, physician group,
certified family nurse practitioner, certified pediatric nurse practitioner,
or public or private agency or organization that provides the services spe-
cified in this subchapter to persons eligible to receive those services.

(b) A provider may agree to provide health assessments only, or may
agree to be a comprehensive care provider, that is. to provide health
assessments and diagnosis and follow-up services.

(c) A health assessment-only provider shall meet the following condi-
tions unless failure to meet any of them is due to circumstances other than
the provider's inaction:

(1) Assure completion of the full range of health assessment services
appropriate to the individual as defined in section 6846, including anti-
tobacco use education and the completion of immunizations and immu-
nization series which could not be given during the health assessment,
but which are necessary to make the immunization status current.

(2) Provide referral for diagnosis and treatment, as specified in secUon
6850, for all persons identified as needing such services as a result of
health assessments.

(d) A comprehensive care provider shall be certified by the Depart-
ment for parficipation in the California Medical Assistance program and
shall meet the following conditions unless failure to meet any of them is
due to circumstances other than the provider's inaction:

(1) Assure completion of the full range of health assessment services
appropriate to the person as defined in section 6846, including anti-to-
bacco use education and the completion of immunizations and immuni-

Page 104

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§6868

/ation series which could not be given during the health assessment, but
which are necessary to make the immunization status current.

(2) Initiate diagnosis and treatment, or referral for diagnosis and treat-
ment, for all persons identified as needing such services as a result of the
health assessment.

(3) Assume overall case management of the person in the event of sub-
sequent referrals which may be part of the needed diagnosis and treat-
ment program.

(4) Assure the provision of subsequent, periodic health assessment at
the frequency indicated in section 6847.

(5) Be available as a source of primary care on a continuing basis to
the person in the event subsequent medical services are requested.

(6) Maintain a health record for each person.

(e) A clinical laboratory provider shall be a clinical laboratory that
meets the definition of the Medi-Cal program in Title 22, California
Code of Regulations (CCR), Section 51211.2.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code; and Sec-
tion 12, Assembly Bill 75 (Chapter 1331, Statutes of 1989). Reference: Sections
321, 323 and 24165.3, Health and Safety Code; Sections 655.6. 2834, 2835,
2835.5 and 2836, Business and Professions Code; Section 14132.41, Welfare and
Institutions Code; and 42 U.S.C. Section 1396d{a).

History

1. Amendment filed 1 1-28-79 as an emergency; effective upon filing (Register
79, No. 48 ). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80. No. 13).

3. Amendment of subsections (c) and (d) filed 2-27-90 as an emergency pursuant
to Section 12, Chapter 1331, Statutes of 1989; operative 2-27-90 (Register 90,
No. 9). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 6-27-90.

4. Certificate of Comipliance as to 2-27-90 order transmitted to OAL 6-19-90 and
filed 7-18-90 (Register 90, No. 38).

5. New subsection (e) and amendment of Note filed 2-23-93; operafive 3-25-93
(Register 93, No. 9).

6. Amendment of subsection (a) and Note filed 10-27-93 as an emergency; op-
erative 10-27-93 (Register 93, No. 44). A Certificate of Compliance must be
transmitted to OAL by 2-25-94 or emergency language will be repealed by op-
eration of law on the following day.

7. Certificate of Compliance as to 10-27-93 order transmitted to OAL 2-23-94
and filed 4-6-94 (Register 94, No. 14).

Article 6. Claiming for Services

§ 6866. Procedures.

(a) The health assessment provider shall inquire of all persons receiv-
ing health assessments under provisions of this subchapter as to the per-
son's entitlement to third-party reimbursement for such services. Where
such entitlement exists, it shall be billed as follows:

(1) Insurance carriers shall be billed where such entitlement exists.

(2) The Department' s Child Health and Disability Prevention Program
shall be billed, in the manner specified by the program, for health asses-
sments provided to the following persons:

(A) Medi-Cal beneficiaries if those services are not reimbursable un-
der ( 1 ), above.

(B) Persons who are not Medi-Cal beneficiaries and for whom ser-
vices are not reimbursable under (1), above, but who meet the age and
family income criteria specified by the Department's Child Health and
Disability Prevention Program.

(3) Persons enrolled in prepaid health plans that contract with the De-
partment shall receive CHDP services from the prepaid health plan in
which they are enrolled in accordance with the contract existing between
the prepaid health plan and tht Department.

(4) Persons may be billed directly for health assessments which are not
reimbursable under (1 ) or (2), above, or the services may be provided at
no cost to the person if the provider chooses.

(b) Eligibility for state-subvened health assessments shall be deter-
mined by the screening provider prior to the provision of such services.

(c) Each provider who bills the Department's Child Health and Dis-
ability Prevention Program for health assessments rendered pursuant to
the provisions of this subchapter shall accept as total reimbursement for

those services the amount reimbursed by the Department, and shall make
no additional charges to any individual or to the Department's Child
Health and Disability Prevention Program for such services.

(d) Providers' reimbursement claims for health assessments rendered
under the provisions of this subchapter shall be subject to audit by the
State anytime within three years beginning with the year in which the
claim was filed.

(e) A clinical laboratory may bill the Department's Child Health and
Disability Prevention Program for cytologic examinations of gynecolog-
ic slides taken during the course of a CHDP health assessment, or other
laboratory services resulting from a CHDP health assessment as follows:

( 1 ) The clinical laboratory shall accept as total reimbursement for the
services rendered the amount reimbursed by the Department, and shall
make no additional charge to any individual, provider, or to the Depart-
ment's Child Health and Disability Prevention Program.

(2) Each claim for reimbursement must be accompanied by a legible
copy of the CHDP health assessment provider's claim form, the Confi-
dential Screening/Billing Report (PM 1 60) (revision 10/9 1 ), which indi-
cates the name, address, and CHDP provider number of the clinical labo-
ratory that will bill the CHDP program for the examination of
gynecologic slides or other laboratory services.

(3) Clinical laboratories claims for reimbursement will not be pro-
cessed for payment without the cross-reference information required in
(2) above.

NOTE: Authority cited: Sections 208 and 32 1 , Health and Safety Code. Reference:
Section 323.2 (a). Health and Safety Code; and Section 655.6, Business and Pro-
fessions Code.

History

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

3. New subsections (e)-(e)(3) and amendment of Note filed 2-23-93; operative
3-25-93 (Register 93, No. 9).

§ 6868. Schedule of Maximum Allowances.

(a) Health screening procedures. Reimbursement for the procedures
listed in this subsection, when billed in accordance with this subchapter,
shall be the amount billed by the provider for the procedures performed,
up to the maximum allowances specified in this subsection. For purposes
of this subsection: new patient means a person who has not previously
received a health assessment from the examiner, and there is no health
assessment record for the person established with the provider; extended
visit means a visit in which the patient requires as much or more time to
be given a health assessment as does a new patient; routine visit means
a visit in which the patient requires less rime than ordinarily needed with
a new patient or an extended visit.

MAXIMUM
HEALTH SCREENING PROCEDURE ALLOWANCE

History and Physical Examination by Comprehensive Care Provider
New Patient or Extended Visit

Adolescent (age 1 2 through 20 years) $49.51

Late childhood (age 5 through 1 1 years) 43.32

Early childhood (age 1 through 4 years) 40.84

Infant (birth through 1 1 months) 38.37

Routine Visit

Adolescent (age 12 through 20 years) 39.60

Late childhood (age 5 through 1 1 years) 33.43

Early childhood (age 1 through 4 years) 30.95

Infant (birth through 1 1 months) 2846

By Health Assessment — Only Provider
New Patient or Extended Visit

Adolescent (age 12 through 20 years) 43.32

Late childhood (age 5 through 1 1 years) 37.13

Early childhood (age 1 through 4 years) 34.65

Infant (birth through 1 1 months) 32.18

Routine Visit

Adolescent (age 12 through 20 years) 37.13

Late childhood (age 5 through 1 1 years) 30.95

Early childhood (age 1 through 4 years) 28.46

Infant (birth through 11 months) 25.99

Pelvic Exam 10.00

Vision Screening

Page 105

§6870

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

MAXIMUM
HEALTH SCREENING PROCEDURE ALLOWANCE

Snellen eye test or equivalent visual acuity test

Age 7 years and older $ 2.02

Age 3 thi'ough 6 years 4.00

Hearing Screening

Pure Tone Audiometry 9.21

Tuberculin Testing

Multiple Puncture 4.54

Mantoux (intracutaneous) 7.53

(b) Laboratory Tests. For laboratory tests listed in this subsection that
the provider performs, reimbursement shall be either the provider's usual
charge to the general public for the test or the maximum allowance speci-
fied in this subsection, whichever is less. If a laboratory test is performed
by other than the screening provider, for instance by an outside laborato-
ry, the screening provider may bill the Department's Child Health and
Disability Prevention Program for the charge made to the provider by the
laboratory (except for cytologic examination of a gynecologic slide as
described below), plus a charge not to exceed $4.63 for the provider's
collection and handling of the specimen. The total shall not exceed the
maximum allowance specified in this subsection for the laboratory test.

If a clinical laboratory performs a cytologic examination of a gyneco-
logic slide taken during the course of a CHOP health assessment, or other
laboratory services resulting from a CHDP health assessrnent, the clini-
cal laboratory may bill the Department's Child Health and Disability Pre-
vention Program the clinical laboratory's usual charge to the general
public not to exceed the maximum allowance specified in this subsection.
The health assessment provider may bill the program a charge not to ex-
ceed $4.63 for the provider's collection and handling of the specimen.
The total charge from the clinical laboratory and the health assessment
provider shall not exceed the maximum allowance specified in this sub-
section for cytologic tests. Clinical laboratory tests shall be performed in
the manner and by persons and laboratories that meet the relevant stan-
dards established in the Health and Safety Code, the Business and Profes-
sions Code and Title 17 of the California Code of Regulations.

MAXIMUM
LABORA TORY TEST ALLOWANCE

Blood Tests

Hematocrit $3.01

Hemoglobin 3.01

Sickle Cell Status (Electrophoresis) 30.11

Blood Lead Screening

Blood Lead Level Determination 22.45

Phenylalanine (PKU) Blood 4.54

Urine Tests

Urinalysis, routine, complete 4.54

Urine "Dipstick" 2.87

Tests for Microorganisms

Culture for Neisseria Gonorrhea 6.02

Cytologic Tests

Papanicolaou (Pap) Smear 1 1 .22

Ova and Parasites, direct smears, concentration and identification 12.39

VDRL, RPR or ART 4.56

Chlamydia Test 19.25

(c) Immunizations. Reimbursement for the immunizations listed in
this subsection, when billed in accordance with this subchapter, shall be
the amount billed by the provider for the immunizations given, up to the
maximum allowances specified in this subsection. However, if the pro-
vider uses vaccine supplied at no cost to the provider by the Department' s
Immunizafion Assistance Program, the maximum reimbursement for ad-
ministration of the vaccine shall be the amount determined by the Depart-
ment rather than the amount specified in this subsection. The maximum
reimbursement rate for the professional component of administering an
immunization under this subsection shall be $4.52. The maximum allow-
able reimbursement for the ingredient component of an immunization
shall be based on prevailing market acquisition costs as determined by
the Department's fiscal intermediary.

IMMUNIZATION

DPT (diphtheria and tetanus toxoids with pertussis vaccine) First,

second, third of series; booster.
Td (combined tetanus and diphtheria toxoids, adult type)

Dd (combined tetanus and diphtheria toxoids, pediatric type)

Hib (Haemophillus Influenza Type b) vaccine

Hib (Haemophillus Influenza Type b) conjugate vaccine

HibTITER

Polio: IPV (inactivated trivalent poliovirus vaccine)
First, second, third of series, or booster

TOPV (trivalent oral polio virus vaccine) First, second, third of series;
booster.

Measles vaccine

Rubella vaccine

Mumps vaccine

MR (measles, rubella) vaccine

MMR (measles, mumps, rubella) vaccine

MuR (mumps, rubella) vaccine

HBVAC (hepatitis B vaccine) (Pre-exposure)

HBIG (hepatitis B immune globulin) (Post exposure)
NOTE: Authority cited: Sections 208 and 321, Health and Safety Code, and Sec-
tions 14105 and 14124.5, Welfare and Institutions Code. Reference: Sections 323
and 323.2 (a). Health and Safety Code; and Section 14105, Welfare and Institu-
tions Code; Items 4260-1 1 1-001, Chapter 258, Statutes of 1984, and Statutes of
1985, Chapter 111, Items 4260-1 1 1-001 and 890; and Section 655.6, Business
and Professions Code.

History

1 . Amendment filed 8-1-84 as an emergency; effective upon filing (Register 84,
No. 31). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 1 1-29-84. For prior history,
see Register 81, No. 52.

2. Certificate of Compliance transmitted to OAL 11-27-84 and filed 12-27-84
(Register 84, No. 52).

3. Amendment filed 8-1-85 as an emergency; effective on filing (Register 85, No.
32). A Certificate of Compliance must be transmitted to OAL within 120 days
or emergency language will be repealed on 1 1-29-85.

4. Certificate of Compliance transmitted to OAL 11-20-85 and filed 12-27-85
(Register 85, No. 52).

5. Amendment of section and Note filed 2-23-93; operative 3-25-93 (Register
93, No. 9).

Article 7. Records, Reporting and
Confidentiality

§ 6870. Records.

Records shall be maintained by the community child health and dis-
ability prevention program, and those participating in it, for the purposes
and in the manner specified by the Department's Child Health and Dis-
ability Prevention Program.

NOTE: Authority cited: Sections 208 and 32 1 , Health and Safety Code. Reference:
Sections 321.2 (c) and 321.2 (h). Health and Safety Code.

§ 6872. Reporting.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code. Reference:
Sections 320, et seq., Health and Safety Code.

History

1. Repealer filed 1 1-28-79 as an emergency; effective upon filing (Register 79,
No. 48). A Certificate of Compliance must be filed within 120 days or emergen-
cy language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

§ 6874. Confidentiality.

(a) All information and results of the health assessments of each per-
son shall be confidential and shall not be released without the informed
consent of the person or parent or guardian.

(b) The results of the health assessment shall not be released to any
public or private agency, even with the consent of the person or parent
or guardian, unless accompanied by a professional interpretation of what
the results mean.

NOTE: Authority cited: Sections 208 and 321, Health and Safety Code. Reference:
Secfion 324.5, Health and Safety Code.

History

1. Amendment filed 11-28-79 as an emergency; effective upon filing (Register
79, No. 48). A Certificate of Compliance must be filed within 120 days or emer-
gency language will be repealed on 3-28-80.

2. Certificate of Compliance filed 3-27-80 (Register 80, No. 13).

Page 106

Title 17

State Department of Health Services

§6903

•

Subchapter 14. Stop Tobacco Access to
Kids Enforcement (STAKE) Act Program

§6901. Definitions.

(a) "Decoy" means a 15 or 16 year old individual participating in an
inspection carried out by the Department to determine compliance with
California law prohibiting the sale of a tobacco product to a minor.

(b) "Department" means the Department of Health Services or a local
law enforcement agency that has entered into an enforcement delegation
contract with the Department of Health Services.

(c) "Inspection" means a law enforcement activity conducted by the
Department in which a decoy, under the direct supervision of a regularly
employed peace officer, attempts to purchase a tobacco product at a retail
site.

(d) "Minor" means any individual under 1 8 years of age.

(e) "Person" means any individual, partnership, company, estate, pub-
lic or private institution, association, organization, group, city, county,
city and county, political subdivision of this state, other governmental
agency within the state, and any representative agent, or agency of any
of the foregoing.

(f) "Retail site" means any outlet that provides tobacco products for
sale to consumers including, but not limited to, an establishment, vending
machine, vehicle, mobile unit, stationary mobile unit, booth, stand, or
concession.

(g) "Sale" means the transfer or exchange for consideration or other-
wise furnishing of a tobacco product to a consumer for the purpose of
consumption or use, and not for re-sale.

(h) "Seller" means the owner of any retail business or any employee
of the retail business authorized to make sales of tobacco products to con-
sumers.

(i) "Tobacco product" means any substance containing tobacco leaf,
including, but not limited to, cigarettes, cigars, pipe tobacco, snuff,
chewing tobacco, or dipping tobacco.

(j) "Valid identification" means a document issued by a federal, state,
county, or municipal government, or subdivision or agency thereof, in-
cluding, but not limited to, a motor vehicle operator's license or an identi-
fication card issued to a member of the Armed Forces, which contains the
name, date of birth, description, and photograph of the individual.

(k) "Vending machine" means any mechanical device, the operation
of which depends upon the insertion of money, trade checks, tokens or
other things representative of value and which dispenses or vends tobac-
co products.

NOTE: Authority cited: Sections 22952(b) and 22952(d), Business and Profes-
sions Code; and Section 208, Health and Safety Code. Reference: Sections 22951,
22952(b), 22952(c), 22952(d)(l)-(7), 22954, 22956, 22957 and 22958 Business
and Professions Code.

History

1 . New section filed 1 2-20-89 as an emergency; operative 1 2-20-89 (Register 89,
No. 52). A Certificate of Compliance must be transmitted to OAL within 1 20
days or emergency language will be repealed by operation of law on 4-19-90.

2. Repealed by operation of Government Code 1 1346.1(g) filed 1-22-91 (Regis-
ter 91, No. 19).

3. Amendment of subchapter 14 heading, deletion of article 1 heading and new
section filed 12-22-95 as an emergency; operative 12-22-95 (Register 95, No.
51). A Certificate of Compliance must be transmitted to OAL by 4-20-96 or
emergency language will be repealed by operation of law on the following day.

4. Amendment of subchapter 14 heading, deled on of article 1 heading and new
section refiled 4-17-96 as an emergency, including amendment of Note; op-
erative 4-17-96 (Register 96, No. 16). A Certificate of Compliance must be
transmitted to OAL by 8-1 9-96 or emergency language will be repealed by op-
eration of law on the following day.

5. Amendment of subchapter 14 heading, deletion of article 1 heading and new
section refiled 8-12-96 as an emergency; operative 8-12-96 (Register 96, No.
33). A Certificate of Compliance must be transmitted to OAL by 12-10-96 or
emergency language will be repealed by operation of law on the following day.

6. Hditoridl correction of Note and of HISTORY 4 and HISTORY 5 (Register 96, No.
50).

7. Amendment of subchapter 14 heading, deletion of article 1 heading and new
section refiled 1 2-1 0-96 as an emergency, including amendment of Note; op-

erative 12-10-96 (Register 96, No. 50). A Certificate of Compliance must be
transmitted to OAL by 4-9-97 or emergency language will be repealed by oper-
ation of law on the following day.
8. Certificate of Compliance as to 12-10-96 order, including amendment of sub-
chapter heading and subsection (b), transmitted to OAL 1-8-97 and filed
2-3-97 (Register 97. No. 6).

§ 6902. Warning Sign; Identification.

(a) At each retail site that sells or furnishes tobacco products a sign
shall be conspicuously posted so that it is likely to be read by a consumer
during a sale at each cash register, vending machine or any other point
at which sales occur. The sign shall meet the following specifications:

(1) Contain the following words with initial letters capitalized in the
following manner: The Sale of Tobacco Products to Persons Under 1 8
Years of Age Is Prohibited by Law and Subject to Penalties. Valid Identi-
fication May Be Required. To Report an Unlawful Tobacco Sale Call
1-800-5ASK-4-ID. Business and Professions Code Section 22952.

(2) Be square in shape and no smaller than 5.5 inches high by 5.5 in-
ches wide (30.25 square inches) or be rectangular in shape and no smaller
than 3.66 inches high by 8.5 inches wide (31.11 square inches). A sign
may be larger; however, the sign shall be proportionate to one set of the
dimensions set forth in this subdivision.

(3) Be printed in ink that is of high contrast from the color of the back-
ground material. (Examples are black ink on white paper or dark blue ink
on yellow paper.)

(4) Located at least one-third inch from the top and sides, the follow-
ing required words shall be no smaller than 20 point medium or bold Hel-
vetica or Futura type face: "The Sale of Tobacco Products to Persons Un-
der 1 8 Years of Age Is Prohibited by Law and Subject to Penalties. Valid
Identificafion May Be Required." Located at least one-third inch from
the sides, the following required words shall be no smaller than 30 point
medium or bold Helvetica or Futura type face and in all cases 6 point size
larger than all other text: "To Report an Unlawful Tobacco Sale Call
1-800-5ASK-4-ID." Located at least one-quarter inch from the sides
and bottom, the required legal citation "Business and Professions Code
Section 22952" shall be no smaller than 1 2 point medium or bold Helveti-
ca or Futura type face.

(b) The seller shall request valid identification from any individual
who attempts to purchase a tobacco product if that individual reasonably
appears to the seller to be under 1 8 years of age.

Note: Authority cited: Section 22952(b), Business and Professions Code. Refer-
ence: Sections 22952(b) and 22956, Business and Professions Code.

History

1 . New section filed 1 2-22-95 as an emergency; operative 1 2-22-95 (Register 95,
No. 51). A Certificate of Compliance must be transmitted to OAL by 4-20-96
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 4-17-96 as an emergency; operative 4-20-96 (Register 96,
No. 16). A Certificate of Compliance must be transmiUed to OAL by 8-19-96
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 8-12-96 as an emergency; operative 8-1 2-96 (Register 96,
No. 33). A Certificate of Compliance must be transmitted to OAL by 1 2-1 0-96
or emergency language will be repealed by operation of law on the following
day.

4. Editorial cortection of subsection (a)(1) (Register 96, No. 50).

5. New section refiled 12-10-96 as an emergency; operative 12-10-96 (Register
96, No. 50). A Certificate of Compliance must be transmitted to OAL by 4-9-97
or emergency language will be repealed by operation of law on the following
day.

6. Certificate of Compliance as to 1 2-10-96 order transmitted to OAL 1 -8-97 and
filed 2-3-97 (Register 97, No. 6).

§ 6903. Inspections; Decoys.

(a) The Department shall conduct inspections using decoys who shall
present the appearance of an individual under 18 years of age. For pur-
poses of verifying that a decoy appears to be under 1 8 years of age at the
time of the inspecfion, a photograph or video recording of the decoy shall
be taken prior to and on the same day as the inspecfion and shall be re-
tained by the Department.

(b) A decoy, if requested, shall present valid idenfification.

Page 107

§6904

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(d) Within 2 working days of a sale ol" tobacco to a decoy during an
inspection, the peace officer who originally accompanied and supervised
the decoy during the inspection, shall return to the retail site, advise the
seller of the inspection and violation, and identify the decoy to the seller
by means of a photograph taken the same day as the inspection.

(e) The Department may use video recording equipment, including
video, audio, photographic and other audio/visual recording equipment,
to record and document an inspection.

(f) Inspections of retail sites may be conducted: (1 ) on the basis of ran-
dom selection in a given geographic area; or (2) in response to reports of
violations of Penal Code section 308 subsection (a) or of Business and
Professions Code section 22958; or (3) in response to reports of unlawful
sales over the toll-free telephone number authorized by subdivision (b)
of section 22952 of the Business and Professions Code.

NOTH: Authority cited: Section 22952(d), Business and Professions Code. Refer-
ence: Sections 22952(b), 22952(c), 22952(d)( 1 )-(7) and 22958, Business and Pro-
fessions Code; and Section 308, Penal Code.

History

1 . New section filed 1 2-22-95 as an emergency ; operative 1 2-22-95 (Register 95,
No. 51). A Certificate of Compliance must be transmitted to OAL by 4-20-96
or emergency language will be repealed by operation of law on the following
day.

2. Editorial correction of subsection (f) (Register 96, No. 16).

3. New section refiled 4-17-96 as an emergency; operative 4-20-96 (Register 96,
No. 16). A Certificate of Compliance must be transmitted to OAL by 8-19-96
or emergency language will be repealed by operation of law on the following
day.

4. New section refiled 8-12-96 as an emergency; operative 8-12-96 (Register 96,
No. 33). A Certificate of Compliance must be transmitted to OAL by 12-10-96
or emergency language will be repealed by operation of law on the following
day.

5. Editorial correction of subsection (e) (Register 96, No. 50).

6. New section refiled 12-10-96 as an emergency; operative 12-10-96 (Register
96, No. 50). A Certificate of Compliance must be transmitted to OAL by 4-9-97
or emergency language will be repealed by operation of law on the following
day.

7. Certificate of Compliance as to 12-10-96 order, including amendment of sub-
section (d), transmitted to OAL 1-8-97 and filed 2-3-97'(Register 97, No. 6).

8. Change without regulatory effect amending subsection (b) filed 2-25-2003 pur-
suant to section 100, title 1 , California Code of Regulations (Register 2003, No.
9).

§ 6904. Defenses.

Failure to comply with the procedures set forth in Subdivision (d) of
Section 22952 of the Business and Professions Code and Title 17, Cah-
fomia Code of Regulations, Section 6903 shall be a defense to any action
brought pursuant to the STAKE Act (Division 8.5 of the Business and
Professions Code).

NOTE: Authority cited: Section 22952(d), Business and Professions Code. Refer-
ence: Sections 22952(d)(l)-(8), Business and Professions Code.

History

1 . New section filed 1 2-22-95 as an emergency : operative 1 2-22-95 (Register 95,
No. 51). A Certificate of Compliance must be transmitted to OAL by 4-20-96
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 4-17-96 as an emergency; operative 4-20-96 (Register 96,
No. 16). A Certificate of CompUance must be transmitted to OAL by 8-19-96
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 8-12-96 as an emergency; operative 8-12-96 (Register 96,
No. 33). A Certificate of Compliance must be transmitted to OAL by 12-10-96
or emergency language will be repealed by operation of law on the following
day.

4. New section refiled 12-10-96 as an emergency; operative 12-10-96 (Register
96, No. 50). A Certificate of Compliance must be transmitted to OAL by 4-9-97
or emergency language will be repealed by operation of law on the following
day.

5. Certificate of Compliance as to 12-10-96 order, including amendment of sec-
tion, transmitted to OAL 1-8-97 and filed 2-3-97 (Register 97, No. 6).

§ 6905. Annual Report of Tobacco Retail Sites.

(a) Each cigarette or tobacco products distributor or wholesaler and
each cigarette vending machine operator as required in Business and Pro-

fessions Code section 22954 shall, within 45 days after the end of the cal-
endar year, annually file a report listing the retail sites, including dealers
as defined in Revenue and Taxation Code section 30012, to which it pro-
vided tobacco products during the calendar year just ended. This report
of retail sites shall be filed with the Department of Health Services, To-
bacco Control Section, 601 North 7th Street, M.S. 555, P.O. Box 942732,
Sacramento, CA 94234-7320. The first report shall be submitted for the
calendar year beginning January 1. 1995. The annual report shall contain
the following:

( 1 ) The name of the cigarette or tobacco products distributor or whole-
saler or cigarette vending machine operator company.

(2) The address and telephone number of the company's principal ex-
ecutive office.

(3) The name, title, and address of the representative of the company
to whom correspondence regarding this report should be addressed.

(4) The name, title and signature of the official authorized to sign the
report on behalf of the company.

(5) A certification made pursuant to Code of Civil Procedure Section
2015.5 by the authorized person whose signature appears on the report
as follows:

"I certify under penalty of perjury under the laws of the State of Cali-
fornia that the information contained in the report is true and correct:

(Date) (Signature)

(6) A list of each retail site's name and the physical location of the re-
tail site to which the company supplied tobacco products or vending ma-
chines for the preceding calendar year. The list shall include, on separate
lines, the full name, street address, city and zip code of each retail site.
For those companies with computer capability, the list of the retail sites
is also required to be submitted on a computer diskette as a flat ASCII file,
or other format to be specified by the Department of Health Services, on
one or more 3 1/2 inch or 5 1/4 inch floppy diskette(s). For those com-
panies without computer capability, submission of the list on a computer
diskette is not required. For the second and subsequent year that the com-
pany files this report, the company is required to either submit the infor-
mation required by this subsection or report only changes to the first re-
port. Where a company opts in the second or subsequent year to report
only changes to the first or previous report, such second or subsequent
report shall include and clearly identify name or address changes of the
retail sites, additional retail sites to which it supplies tobacco products or
vending machines and retail sites to which it no longer supplies tobacco
products or a vending machine.

NOTE: Authority cited: Secdon 100275, Health and Safety Code. Reference: Sec-
tion 22954, Business and Professions Code; Section 30012, Revenue and Taxation
Code; and Section 2015.5, Code of Civil Procedure.

History

1 . New section filed 1 2-22-95 as an emergency; operative 12-22-95 (Register 95,
No. 51). A Certificate of Compliance must be transmitted to OAL by 4-20-96
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 4-17-96 as an emergency, including amendment of Note;
operafive 4-17-96 (Register 96, No. 16). A Certificate of Compliance must be
transmitted to OAL by 8-1 9-96 or emergency language will be repealed by op-
eration of law on the following day.

3. New section refiled 8-1 2-96 as an emergency; operafive 8-12-96 (Register 96,
No. 33). A Certificate of Compliance must be transmitted to OAL by 12-10-96
or emergency language will be repealed by operation of law on the following
day.

4. Editorial cortection of History 2 and History 3 (Register 96, No. 50).

6. Certificate of Compliance as to 12-10-96 order transmitted to OAL 1-8-97 and
filed 2-3-97 (Register 97, No. 6).

•

Page 108

Title 17

State Department of Health Services

§7110

Chapter 5. Sanitation (Environmental)

(Originally Printed 8-15-45)

Subchapter 1. Engineering (Sanitary)

Group 1 . Domestic Water Supplies Quality
and Monitoring

NOTH: Authority cited: Section 4026, Health and Safety Code. Reference: Sec-
tions 4010-4037, Health and Safety Code.

History
1. Repealer of Group I (Articles 1-5, Sections 7001-7025, not consecutive) filed
1 1-4-77; effective thirtieth day thereafter (Register 77, No. 45).

Group 1 .1 . Waterworks Standards

NOTE: Authority cited: Sections 208 and 4010. 1 (h). Health and Safety Code. Ref-
erence: Sections 4010.1(h). 4012, 4013, and 4019, Health and Safety Code.

History

1. New Group I.l (Sections 7050-7081, not consecutive) filed 2-1-74; effective
thirtieth day thereafter (Register 74, No. 5).

2. Repealer of Group 1.1 (Sections 7050-7081, not consecutive) filed 12-6-79;
effective thirtieth day thereafter (Register 79, No. 49).

Group 2.

Certification of Water Treatment
Facility Operators

Article 1 . General

§7100. Purpose.

NOTE: Authority cited: Sections 208 and 4074, Health and Safety Code. Refer-
ence: Section 4082, Health and Safety Code.

History

1. New Group 2 (Sections 7100-7134) filed 4-5-73; effective thirtieth day there-
after (Register 73, No. 14).

2. Repealer filed 9-22-86; effective thirtieth day thereafter (Register 86, No. 39).

3. Repealer of group 2 (articles 1-8, sections 7100-7134) filed 12-26-2000 as an
emergency; operative 1-1-2001 (Register 2000, No. 52). A Certificate of Com-
pliance must be transmitted to OAL by 5-1-2001 or emergency language will
be repealed by operation of law on the following day.

4. Repealer of group 2 (articles 1-8, sections 7100-7134) refiled 4-25-2001 as an
emergency; operative 5-2-2001 (Register 2001, No. 17). A Certificate of Com-
pliance must be transmitted to OAL by 8-30-2001 or emergency language will
be repealed by operation of law on the following day.

5. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7101. Definition.

Note: Authority cited: Sections 208 and 4074, Health and Safety Code. Refer-
ence: Secuon 4082, Health and Safety Code.

History
1. Repealer filed 9-22-86; effective thirtieth day thereafter (Register 86, No. 39).

Article 2. Responsibility of Water Supplier

§ 71 03. Employment of Certified Operator.

NOTE: Authority cited: Sections 208 and 4074, Health and Safety Code. Refer-
ence: Section 4082, Health and Safety Code.

History
1 . Repealer filed 9-22-86; effective thirtieth day thereafter (Register 86, No. 39).

§7104. Operator-in-Tralning.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tions 106875, 106885 and 106910, Health and Safety Code.

History
1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency; operafive
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-

mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

2. Repealer of section and new Note refiled 4-25-2001 as an emereencv; opera-
tive 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be
transmitted to OAL by 8-30-2001 or emergency language will be repealed by
operation of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7105. Remote Area.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106885, Health and Safety Code.

History

1. New Note filed 12-3-84 (Register 84, No. 49).

2. Repealer of section and amendment of Nori-: filed 12-26-2000 as an emergen-
cy: operative 1-1-2001 (Register 2000, No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

3. Repealer of secfion and amendment of Note refiled 4-25-2001 as an emergen-
cy; operative 5-2-2001 (Register 2001. No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operation of law on the following day.

4. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

Article 3. Responsibility of Operators

§7106. Certification Requirements.

NOTE: Authority cited: Secdons 208 and 4074, Health and Safety Code. Refer-
ence: Section 4082, Health and Safety Code.

History
1 . Repealer filed 9-22-86; effecdve thirtieth day thereafter (Register 86, No. 39).

§ 71 07. Grade of Operator.

NOTE: Authority cited: Secfion 100275, Health and Safety Code. Reference: Sec-
tions 106875-106885. Health and Safety Code.

History

1. Repealer of section and new Note filed 12-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

2. Repealer of section and new Note refiled 4—25-2001 as an emergency; opera-
five 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be
transmitted to OAL by 8-30-2001 or emergency language will be repealed by
operation of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Regi.stcr 2001, No. 33).

Article 4. Issuance of Certificates

§ 71 09. Requirements for Certification.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tions 106875-106885, Health and Safety Code.

History

1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

2. Repealer of section and new Note refiled 4-25-2001 as an emergency; opera-
tive 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be
transmitted to OAL by 8-30-2001 or emergency language will be repealed by
operation of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7110. Application.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106885, Health and Safety Code.

History

1. New Note filed 12-3-84 (Register 84, No. 49).

2. Repealer of section and amendment of Note filed 12-26-2000 as an emergen-
cy; operative 1-1-2001 (Register 2000, No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

3. Repealer of section and amendment of Note refiled 4-25-2001 as an emergen-
cy; operafive 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language v, ill be re-
pealed by operation of law on the following day.

Page 108.1

§ 7110.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 1 0.1 . Processing an Application for Certification.

NOTE: Authority cited: Section 15376, Government Code; and Section 100275,
Health and Safety Code. Reference: Section 15376, Government Code: and Sec-
tion 106885, Health and Safety Code.

History

1. New section filed 1 1-20-87; operative 12-20-87 (Register 87, No. 48).

2. Repealer of section and amendment of NoTii filed 12-26-2000 as an emergen-
cy; operative 1-1-2001 (Register 2000. No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

3. Repealer of section and amendment of NoTi : refiled 4-25-2001 as an emergen-
cy; operative 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operation of law on the following day.

4. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 1 0.2. Processing Time.

NOTE: Authority cited: Section 15376, Government Code; and Section 100275,
Health and Safety Code. Reference: Section 15376, Government Code; and Sec-
tion 106885, Health and Safety Code.

History

1. New section filed 1 1-20-87; operaUve 12-20-87 (Register 87, No. 48).

2. Repealer of section and amendment of NoTi; filed 12-26-2000 as an emergen-
cy; operative 1-1-2001 (Register 2000, No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

3. Repealer of section and amendment of Noti. refiled 4-25-2001 as an emergen-
cy; operative 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operation of law on the following day.

4. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 1 1 . Application Review.

NOTE: Authority cited: SecUons 208 and 4074, Health and Safety Code. Refer-
ence; Section 4082, Health and Safety Code.

History
1. Repealer filed 9-22-86; effecfive thirtieth day thereafter (Register 86, No. 39).

§ 71 1 2. Notification to Applicants.

Note: Authority cited: Secfion 100275, Health and Safety Code. Reference: Sec-
tions 106875-106885, Health and Safety Code.

History

1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency; operative
1-1-2001 (Register 2000. No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

2. Repealer of section and new Note refiled 4--25-2001 as an emergency; opera-
tive 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be
transmitted to OAL by 8-30-200 1 or emergency language will be repealed by
operation of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 1 3. Certification Without Examination for Certain
Persons Employed Prior to April 30, 1973.

Note: Authority cited: Sections 208 and 4074, Health and Safety Code. Refer-
ence: Sections 4082, Health and Safety Code.

History

1. Amendment filed 7-1-75; effective thirtieth day thereafter (Register 75, No.
27).

2. Repealer filed 9-22-86; effecfive thirtieth day thereafter (Register 86, No. 39).

§ 71 1 4. Minimum Qualifications for Examination.

Note: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106910, Health and Safety Code.

History

1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

2. Repealer of secfion and new Note refiled 4-25-2001 as an emergency; opera-
five 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be
transmitted to OAL by 8-30-2001 or emergency language will be repealed by
operafion of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

Article 5. Types of Certification

§ 71 1 6. Regular Certification.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tions 106875-106885. Heahh and Safety Code.

History

1 . Repealer of section and new Noti; filed 1 2-26-2000 as an einergency ; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 1 7. Temporary Certification.

NOTE; Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
fions 106875-106885, Health and Safety Code.

History

1 . Repealer of secfion and new Note filed 1 2-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 1 8. Limited Certification.

NOTE; Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tions 106875-106885, Health and Safety Code.

History

1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of CompHance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
fion of law on the following day.

2. Repealer of section and new Note refiled 4-25-2001 as an emergency; opera-
five 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be
transmitted to OAL by 8-30-2001 or emergency language will be repealed by
operafion of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

Article 6. Certification Issuance, Renewal,
Suspension and Revocation

§ 7120. Issuance and Renewal.

NOTE: Authority cited: Secfion 100275, Health and Safety Code. Reference: Sec-
tions 106875-106885, Health and Safety Code.

History

1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 21 . Suspension for Failure to Renew Certificate.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tions 106875 and 106890, Health and Safety Code.

History

1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency ; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

2. Repealer of section and new Note refiled 4-25-2001 as an emergency; opera-
five 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be

Page 108.2

Title 17

State Department of Health Services

§7134

transmitted to OAL by 8-30-2001 or emergency language will be repealed by
operation of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7122. Revocation of Certificate.

Note. Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tions 106875-106885, Health and Safety Code.

History

1 . Repealer of section and new Note filed 1 2-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§ 71 23. Posting of Certificate.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106885, Health and Safety Code.

History

1. New NoTi-: filed 12-3-84 (Register 84, No. 49).

3. Repealer of section and amendment of Note refiled 4-25-2001 as an emergen-
cy; operative 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operation of law on the following day.

4. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

Article 7. Examination

§ 7125. Frequency of Examinations.

NOTE: Authority cited: Sections 208 and 4074, Health and Safety Code. Refer-
ence: Section 4082, Health and Safety Code.

History
1 . Repealer filed 9-22-86; effective thirtieth day thereafter (Register 86, No. 39).

§ 7126. Examination Content.

NOTE: Authority cited: Sections 208 and 4074, Health and Safety Code. Refer-
ence: Section 4082, Health and Safety Code.

History

1. Repealer filed 9-22-86; effective thirtieth day thereafter (Register 86, No. 39).

§7127. Examination Procedure.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106880, Health and Safety Code.

History

1 . Repealer of section and new Note filed 12-26-2000 as an emergency; operative
1-1-2001 (Register 2000, No. 52). A Certificate of Compliance must be trans-
mitted to OAL by 5-1-2001 or emergency language will be repealed by opera-
tion of law on the following day.

2. Repealer of section and new Note refiled 4—25-2001 as an emergency; opera-
tive 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance must be
transmitted to OAL by 8-30-2001 or emergency language will be repealed by
operation of law on the following day.

3. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

Article 8. Fees

§7130. Application Fee.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106890. Health and Safety Code.

History
1. New Note filed 12-3-84 (Register 84, No. 49).

2. Amendment filed 1-13-87; effective thirtieth day thereafter (Register 87, No.
3).

3. Repealer of section and amendment of Note filed 1 2-26-2000 as an emergen-
cy; operative 1-1-2001 (Register 2000, No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

4. Repealer of section and amendment of Note refiled 4-25-2001 as an emergen-
cy; operative 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7131. Renewal Fee.

NOTE: Authority cited: Section 100275. Health and Safety Code. Reference: Sec-
tion 106890, Health and Safety Code.

History

1. New Note filed 12-3-84 (Register 84. No. 49).

2. Amendment filed 1-13-87; effective thirtieth day thereafter (Resister 87, No.
3).

3. Repealer of section and amendment of Note filed 12-26-2000 as an emergen-
cy; operative 1-1-2001 (Register 2000, No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

4. Repealer of section and amendment of Note refiled 4-25-200 1 as an emergen-
cy; operative 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operafion of law on the following day.

5. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7132. Reexamination Fee.

NoTE; Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106890, Health and Safety Code.

History

1. New Note filed 12-3-84 (Register 84, No. 49).

2. Amendment filed 1-13-87; effective thirtieth day thereafter (Register 87, No.
3).

3. Repealer of section and amendment of Note filed 12-26-2000 as an emergen-
cy; operadve 1-1-2001 (Register 2000, No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

4. Repealer of section and amendment of Note refiled 4-25-2001 as an emergen-
cy; operadve 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7133. Penalty Fee.

NOTE: Authority cited: Section 100275, Health and Safety Code. Reference: Sec-
tion 106890, Health and Safety Code.

History

1. New Note filed 12-3-84 (Register 84, No. 49).

2. Amendment filed 1-13-87; effective thirtieth day thereafter (Register 87, No.
3).

3. Repealer of section and amendment of Note filed 12-26-2000 as an emergen-
cy; operative 1-1-2001 (Register 2000, No. 52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

§7134. Duplicate Certificate Fee.

NOTE: Authority cited: Secdon 100275, Health and Safety Code. Reference: Sec-
don 106890, Health and Safety Code.

History

1. New Note filed 12-3-84 (Register 84, No. 49).

2. Amendment filed 1-13-87; effecdve thirtieth day thereafter (Register 87. No.
3).

3. Editorial correction of Authority cite (Register 95, No. 33).

Page 108.3

§7557

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Repealer of section and amendment of Ncm filed 12-26-2000 as an emergen-
cy; operative 1-1-2001 (Register 2000, No .52). A Certificate of Compliance
must be transmitted to OAL by 5-1-2001 or emergency language will be re-
pealed by operation of law on the following day.

5. Repealer of section and amendment of Note refiled 4-25-2001 as an emergen-
cy; operative 5-2-2001 (Register 2001, No. 17). A Certificate of Compliance
must be transmitted to OAL by 8-30-2001 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 4-25-2001 order transmitted to OAL
7-12-2001 and filed 8-13-2001 (Register 2001, No. 33).

Group 3. Drain Wells

Article 1. Drain Wells

§ 7557. Drain Wells.

NOTE: Authority cited: Section 208. Health and Safety Code. Reference: Section
208. Health and Safety Code.

[The next page is 109.]

Page 108.4

Title 17

State Department of Health Services

§ T17-7588

History
1 . Repealer of Group 3 (Article 1 , Section 7557) filed 2-21-85; effective upon fil-
ing pursuant to Government Code Section 1 1346.2(d) (Register 85, No. 8).

Group 4. Drinking Water Supplies

Article 1. General

§ 7583. Definitions.

In addition to the definitions in Section 4010. 1 of the Health and Safety
Code, the following terms are defined for the purpose of this Chapter:

(a) "Approved Water Supply" is a water supply whose potability is
regulated by a State of local health agency.

(b) "Auxiliary Water Supply" is any water supply other than that re-
ceived from a public water system.

(d) "AWWA Standard" is an official standard developed and ap-
proved by the American Water Works Association (AWWA).

(e) "Cross-Connection" is an unprotected actual or potential connec-
tion between a potable water system used to supply water for drinking
purposes and any source or system containing unapproved water or a
substance that is not or cannot be approved as safe, wholesome, and pota-
ble. By-pass arrangements, jumper connections, removable sections,
swivel or changeover devices, or other devices through which backflow
could occur, shall be considered to be cross-connections.

(f) "Double Check Valve Assembly (DC)" is an assembly of at least
two independently acting check valves including tightly closing shut-off
valves on each side of the check valve assembly and test cocks available
for testing the watertightness of each check valve.

(g) "Health Agency" means the California Department of Health Ser-
vices, or the local health officer with respect to a small water system.

(h) "Local Health Agency" means the county or city health authority.

(i) "Reclaimed Water" is a wastewater which as a result of treatment
is suitable for uses other than potable use.

(j) "Reduced Pressure Principle Backflow Prevention Device (RP)" is
a backflow preventer incorporating not less than two check valves, an au-
tomatically operated differential relief valve located between the two
check valves, a tightly closing shut-off valve on each side of the check
valve assembly, and equipped with necessary test cocks for testing.

(k) "User Connection" is the point of connection of a user's piping to
the water supplier's facilities.

(1) "Water Supplier" is the person who owns or operates the public wa-
ter system.

(m) "Water User" is any person obtaining water from a public water
supply.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History

1 . Repealer of Articles 1 through 10 and New Articles 1 through 4 (Sections 7583,
7588 through 7594, 7603 through 7605, and 7615 through 7622) filed 5-8-53;
effective thirtieth day thereafter (Register 53, no. 8).

2. New section filed 5-26-87; operative 6-25-87 (register 87, No. 23).

§117-7583. Purpose.

Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ 7584. Responsibility and Scope of Program.

The water supplier shall protect the public water supply from contami-
nation by implementation of a cross-connection control program. The
program, or any portion thereof, may be implemented directly by the wa-
ter supplier or by means of a contract with the local health agency, or with
another agency approved by the health agency. The water supplier's

cross-connection control program shall for the purpose of addressing the
requirements of Sections 7585 through 7605 include, but not be limited
to, the following elements:

(a) The adoption of operating rules or ordinances to implement the
cross-connection program.

(b) The conducting of surveys to identify water user premises where
cross-connections are likely to occur,

(c) The provisions of backflow protection by the water user at the
user's connection or within the user's premises or both,

(d) The provision of at least one person trained in cross-connection
control to carry out the cross-connection program,

(e) The establishment of a procedure or system for testing backflow
preventers, and

(f) The maintenance of records of locations, tests, and repairs of back-
flow preventers.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. New section filed 5-26-87; operative 6-25-87 (Register 87. No. 23).

§ 7585. Evaluation of Hazard.

The water supplier shall evaluate the degree of potential health hazard
to the public water supply which may be created as a result of conditions
existing on a user's premises. The water supplier, however, shall not be
responsible for abatement of cross-connections which may exist within
a user's premises. As a minimum, the evaluation should consider: the ex-
istence of cross-connections, the nature of materials handled on the prop-
erty, the probability of a backflow occurring, the degree of piping system
complexity and the potential for piping system modification. Special
consideration shall be given to the premises of the following types of wa-
ter users:

(a) Premises where substances harmful to health are handled under
pressure in a manner which could permit their entry into the public water
system. This includes chemical or biological process waters and water
from public water supplies which have deteriorated in sanitary quality.

(b) Premises having an auxiliary water supply, unless the auxiliary
supply is accepted as an additional source by the water supplier and is ap-
proved by the health agency.

(c) Premises that have internal cross-cormections that are not abated
to the satisfaction of the water supplier or the health agency

(d) Premises where cross-connections are likely to occur and entry is
restricted so that cross-connection inspections cannot be made with suf-
ficient frequency or at sufficiently short notice to assure that cross-con-
nections do not exist.

(e) Premises having a repeated history of cross-connections being es-
tablished or re-established.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Secfion 4026, Health and Safety Code.

History

1. New section filed 5-26-87; operadve 6-25-87 (Register 87, No. 23).

§ 7586. User Supervisor.

The health agency and water supplier may. at their discretion, require
an industrial water user to designate a user supervisor when the water
user's premises has a multipiping system that convey various types of
fluids, some of which may be hazardous and where changes in the piping
system are frequently made. The user supervisor shall be responsible for
the avoidance of cross-connections during the installation, operation and
maintenance of the water user's pipelines and equipment.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History

1. New section filed 5-26-87; operafive 6-25-87 (Register 87, No. 23).

§117-7588. Cross-Connection.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Page 109

§ T17-7589

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§117-7589. Approved Water Supply.

NOTE: Authority cited: Sections 208 and 4026, Healtli and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-7590. Auxiliary Supply.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-7591 . Approved Check Valve.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-7592. Approved Double Check Valve Assembly.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-7593. Air-Gap Separation.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-7594. Approved Reduced Pressure Principle
Backflow Prevention Device.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Secdon 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Article 2. Protection of Water System

§ 7601 . Approval of Backflow Preventers.

Backflow preventers required by this Chapter shall have passed labo-
ratory and field evaluation tests performed by a recognized testing orga-
nization which has demonstrated their competency to perform such tests
to the Department.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1 . New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ 7602. Construction of Backflow Preventers.

(a) Air-gap Separation. An Air-gap separation (AG) shall be at least
double the diameter of the supply pipe, measured vertically from the
flood rim of the receiving vessel to the supply pipe; however, in no case
shall this separation be less than one inch.

(b) Double Check Valve Assembly. A required double check valve as-
sembly (DC) shall, as a minimum, conform to the AWWA Standard
C506-78 (R83) adopted on January 28, 1978 for Double Check Valve
Type Backflow Preventive Devices which is herein incorporated by ref-
erence.

(c) Reduced Pressure Principle Backflow Prevention Device. A re-
quired reduced pressure principle backflow prevention device (RP) shall,
as a minimum, conform to the AWWA Standard C506-78 (R83) adopted
on January 28, 1 978 for Reduced Pressure Principle Type Backflow Pre-
vention Devices which is herein incorporated by reference.

Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Page 110

Title 17

State Department of Health Services

§ 7605

§ 7603. Location of Backflow Preventers.

(a) Air-gap Separation. An air-gap separation shall be located as close
as practical to the user's connection and all piping between the user's
connection and the receiving tank shall be entirely visible unless other-
wise approved in writing by the water supplier and the health agency.

(b) Double Check Valve Assembly. A double check valve assembly
shall be located as close as practical to the user's connection and shall be
installed above grade, if possible, and in a manner where it is readily ac-
cessible for testing and maintenance.

(c) Reduced Pressure Principle Backflow Prevention Device. A re-
duced pressure principle backflow prevention device shall be located as
close as practical to the user's connection and shall be installed a mini-
mum of twelve inches (12") above grade and not more than thirty-six
inches (36") above grade measured from the bottom of the device and
with a minimum of twelve inches (12") side clearance.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ 7604. Type of Protection Required.

The type of protection that shall be provided to prevent backflow into
the public water supply shall be commensurate with the degree of hazard
that exists on the consumer's premises. The type of protective device that
may be required (listed in an increasing level of protection) includes:
Double Check Valve Assembly-(DC), Reduced Pressure Principle
Backflow Prevention Device-(RP), and an Air-gap Separation-(AG).
The water user may choose a higher level of protection than required by
the water supplier. The minimum types of backflow protection required
to protect the public water supply, at the water user's connection to prem-
ises with various degrees of hazard are given in Table 1 . Situations which
are not covered in Table 1 shall be evaluated on a case-by-case basis and
the appropriate backflow protection shall be determined by the water
supplier or health agency.

TABLE 1
TYPE OF BACKFLOW PROTECTION REQUIRED

Minimum Type

of Backflow

Degree of Hazard Prevention

(a) Sewage and Haziirdous Substances

(1) Premises where there are waste water pumping and/or AG
treatment plants and there is no interconnection

with the potable water system. This does not include a
single-family residence that has a sewage lift pump. A RP may
be provided in lieu of an AG if approved by the health
agency and water supplier.

(2) Premises where hazardous substances are handled in any manner AG
in which the substances may enter the potable water system.

This does not include a single-family residence that has a sewage
lift pump. A RP may be provided in lieu of an AG if approved by the
health agency and water supplier.

(3) Premises where there are irrigation systems into which fertilizers, RP
herbicides, or pesticides are, or can be, injected.

(b) Auxiliary Water Supphes

( 1 ) Premises where there is an unapproved auxiliary water supply AG
which is interconnected with the public water system. A RP or DC

may be provided in lieu of an AG if approved by the health agency and
water supplier.

(2) Premises where there is an unapproved auxiliary water supply and RP
there are no interconnections with the public water system. A DC may

be provided in lieu of a RP if approved by the health agency and
water supplier.

( 1 ) Premises where the public water system is used to AG
supplement the recycled water supply.

(2) Premises where recycled water is used, other than as allowed in RP
paragraph (3), and there is no interconnection with the potable water

system.

Degree of Hazard

Minimum Type
of Backflow
Prevention

(3) Residences using recycled water for landscape irrigation as
part of an approved dual plumbed use area established pursuant to
sections 60313 through 60316 unless the recycled water supplier
obtains approval of the local public water supplier, or the Department
if the water supplier is also the supplier of the recycled water, to utilize
an alternative backflow protection plan that includes an annual
inspection and annual shutdown test of the recycled water and potable
water systems pursuant to subsection 60316(a).

(d) Fire Protection Systems

(1) Premises where the fire system is directly supplied from the DC
public water system and there is an unapproved auxiliary water supply

on or to the premises (not interconnected).

(2) Premises where the fire system is supplied from the public water AG
system and interconnected with an unapproved auxiliary water supply.

A RP may be provided in lieu of an AG if approved by the health agency
and water supplier.

(3) Premises where the tire system is supplied from the public water DC
system and where either elevated storage tanks or fire pumps which take
suction from private reservoirs or tanks are used.

(4) Buildings where the fire system is supplied from the public water DC
system and where recycled water is used in a separate piping system

within the same building.

(e) Dockside Watering Points and Marine Facilities

(1) Pier hydrants for supplying water to vessels for any purpose. RP

(2) Premises where there are marine facilities. RP
(0 Premises where entry is restricted so that inspections for RP
cross-connections cannot be made with sufficient frequency or at
sufficiently short nofice to assure that they do not exist.

(g) Premises where there is a repeated history of cross-connections RP

being established or re-established.

NOTE; Authority cited: Section 1 16375, Health and Safety Code; and Section
1 352 1 . Water Code. Reference: Section 1 1 6375. Health and Safety Code; and Sec-
tions 13520, 13521 and 13554(a)(3), Water Code.

History

1. New section filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

2. Editorial correction of first paragraph and Table 1, subsection (d)(1) (Register
95, No. 49).

3. Amendment of section and Note filed 1 1-2-2000; operaUve 12-2-2000 (Reg-
ister 2000, No. 44).

§ 7605. Testing and IVIaintenance of Backflow Preventers.

(a) The water supplier shall assure that adequate maintenance and peri-
odic testing are provided by the water user to ensure their proper opera-
tion.

(b) Backflow preventers shall be tested by persons who have demon-
strated their competency in testing of these devices to the water supplier
or health agency.

(c) Backflow preventers shall be tested at least annually or more fre-
quently if determined to be necessary by the health agency or water
supplier. When devices are found to be defective, they shall be repaired
or replaced in accordance with the provisions of this Chapter.

(d) Backflow preventers shall be tested immediately after they are in-
stalled, relocated or repaired and not placed in service unless they are
functioning as required.

(e) The water supplier shall notify the water user when testing of back-
flow preventers is needed. The notice shall contain the date when the test
must be completed.

(f) Reports of testing and maintenance shall be maintained by the wa-
ter supplier for a minimum of three years.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer and new section filed 5-26-87; operative 6-25-87 (Register 87, No.
23).

Page 111

§ T17-7603

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 3. Protection of Public Water
System at Service Connection

§ T1 7-7603. Where Protection Is Required.

NOTL: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Heahh and Safety Code.

History

1 . Amendment filed 3-5-71 ; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-7604. Type of Protection.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History

1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

Article 4. Protection of Potable Water
System Within Premises

§ T1 7-761 5. Separate Drinking Water Systems.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-761 6. Fire System.

NOTE; Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 208, Health and Safety Code.

History

1 . Amendment filed 3-5-7 1 ; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).
§ T1 7-761 7. Process Waters.

NOTE: Authority cited: Secfions 208 and 4026, Health and Safety Code. Refer-
ence: Section 208, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ 11 7-761 8. Sewage Treatment Plants and Pumping
Stations.

Note: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Section 208, Health and Safety Code.

History
1. Repealer filed 5-26-87; operadve 6-25-87 (Register 87, No. 23).

§ T1 7-761 9. Plumbing Connections.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Secfion 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operative 6-25-87 (Register 87, No. 23).

§ T1 7-7620. Pier and Dock Hydrants.

NOTE: Authority cited: Sections 208 and 4026, Health and Safety Code. Refer-
ence: Secfion 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operadve 6-25-87 (Register 87, No. 23).

§ T1 7-7621 . Marking Safe and Unsafe Water Lines.

NOTE: Authority cited: Secfions 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operafive 6-25-87 (Register 87, No. 23).

§ T1 7-7622. Water Supervisor.

NOTE: Authority cited: Secfions 208 and 4026, Health and Safety Code. Refer-
ence: Section 4026, Health and Safety Code.

History
1. Repealer filed 5-26-87; operafive 6-25-87 (Register 87, No. 23).

Article 5. Domestic Water Supply
Reservoirs

§ 7623. Intent of Regulations.

Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Refer-
ence: Sections 4012-4015, 4051, 4463 and 4470.1. Health and Safety Code.

History

1 . New Article 5 (7623 through 7630) filed 1 2-1 4-56; effective thirtieth day there-
after (Register 56, No. 22).

2. Repealer filed 9-10-87; operafive 10-10-87 (Register 87, No. 37).

§ 7624. Application of Regulations.

Note: Authority cited: Secfions 208 and 4051, Health and Safety Code. Refer-
ence: Secfions 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code.

History

1. Repealer filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§ 7625. Definitions.

(a) "Domestic water supply reservoir" as used herein means a reser-
voir used to impound or store water intended solely or primarily for do-
mestic purposes.

(b) "Distribution reservoir" as used herein means a reservoir, directly
connected with the distribution system of the domestic water supply proj-
ect, used primarily to care for fluctuations in demand which occur over
short periods of from several hours to several days, or as local storage in
case of emergency such as a break in a main supply Une or failure of
pumping plant.

Note: Authority cited: Sections 208 and 4051, Health and Safety Code. Refer-
ence : Secfions 40 1 2-40 1 5, 4050, 405 1 , 4463 and 4470. 1 , Health and Safety Code.

History
1. Amendment filed 9-10-87; operafive 10-10-87 (Register 87, No. 37).

§ 7626. Application for Permit.

(a) Recreational use on and around a domestic water supply reservoir
is prohibited unless specifically authorized in a water supply permit.

(b) Within 30 calendar days of receipt of an application for a permit
or petition for permit modification pursuant to Section 4011 or 4019,
Health and Safety Code, the Department shall inform the applicant in
writing that it is either complete and accepted for filing or that it is defi-
cient and what specific information or documentation is required to com-
plete the application. An application is considered complete if it is in
compliance with the requirements of Section 4012, Health and Safety
Code. For proposed water system improvements, new water systems or
a "project" as defined in Section 15378, Title 14, California Administra-
tive Code where environmental documentation is required, a copy of
such documentation shall be included in the application.

(c) Within 90 calendar days from the date of filing of a completed
application, the Department shall inform the applicant in writing of its
decision regarding an application.

(d) The Department's time periods for processing an application from
the receipt of the initial application to the final decision regarding is-
suance or denial of a water permit based on the Department's actual per-
formance during the two years preceding the proposal of this section,
were as follows:

(1) The median time was — 7.5 months

(2) The minimum time was — 1.5 months

(3) The maximum time was — 85.5 months

Note; Authority cited: Sections 208, 4011, 4012, 4019 and 4051, Health and
Safety Code; and Section 15376, Government Code. Rs-,ference: Secfions 4012,
4019, 4050, 4051, 4463 and 4470. 1 , Health and Safety Code; Secfion 15376, Gov-
ernment Code; and Sections 21000-21176, Public Resources Code.

History
1. Amendment filed 9-10-87; operafive 10-10-87 (Register 87, No. 37).

§ 7627. Data to Accompany Application.

(a) The application for a permit to allow recreational use shall be ac-
companied by detailed information, including but not limited to, the fol-
lowing:

Page 112

Title 17

State Department of Health Services

§7712

(1) Maps showing the reservoir area, including location of water
works facilities, area to be open for recreational use and location of sani-
tary facilities to be provided for the public.

(2) Data on the size of the reservoir, length of time of water storage in
the reservoir, topography of the reservoir site, prevalence of wind-in-
duced currents and other factors that may affect the quality of the stored
water and movement of possible contaminants to the water intake.

(3) Data on the size of the protective zone to be provided between the
area of recreational use and point of water withdrawal for the water sup-
ply.

(4) A statement describing the type of recreational use proposed and
the maximum number of persons, cars, vehicles and boats allowed in the
area.

(5) A description of the water supplier's program, personnel and fi-
nancing to control the recreational use, including maintenance and oper-
ations of recreational and sanitary facilities, and supervision of the peo-
ple permitted in the area.

NOTE: Authority cited: Sections 208 and 4051, Health and Safety Code. Refer-
ence: Sections 401 2, 401 9, 4050, 405 1 , 4463 and 4470. 1 , Health and Safety Code.

History

1. Amendment filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§ 7628. Guides to Evaluating Application.

NOTE: Authority cited: Sections 208 and 4051, Health and Safety Code. Refer-
ence: Sections 4012-4015, 4051, 4463 and 4470.1, Health and Safety Code.

History
I. Repealer filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

§ 7629. Reservoirs for Which Permits May Be Granted.

When the department finds that the intended recreational use will not
render the water supply as delivered to the consumers impure, unwhole-
some or unpotable, permit for such use will be issued. Subject to the de-
partment findings the following types of domestic water supply reser-
voirs may be used for recreational purposes:

( 1 ) Reservoirs from which water is continuously and reliably treated
by filtration and chlorination; provided that for smaller water systems,
under special circumstances satisfactory to the State Department of F*ub-
lic Health, approved dual chlorination may be acceptable;

(2) Reservoirs from which water is withdrawn by open channels or
other conduits and subsequently stored again in reservoirs falling in the
category of Section 7629(1) before reaching a distribution reservoir, or
before entering the distribution system or a consumer's premises.

§ 7630. Kinds of Recreational Use Allowed or Prohibited.

NOTE: Authority cited: Sections 208 and 4051, Health and Safety Code. Refer-
ence: Sections 4012-4015, 4051, 4463 and 4470.1, Heahh and Safety Code.

History

1. Repealer filed 9-10-87; operative 10-10-87 (Register 87, No. 37).

Article 12. Production and Distribution of
Bottled Water

History

1. Repealer of Article 12 (Sections 7695-7701) filed 1-31-74; effective thirtieth
dav thereafter (Register 74, No. 5). For history of prior Article, see Register 53,
N6. 10

Article 1 1 . Delegation of Authority

Pursuant to Section 4025 of the Health and

Safety Code (Permits for Small Water

Systems)

NOTE: Authority cited: Sections 208 and 4025, Health and Safety Code. Refer-
ence: Sections 4010-4035, Health and Safety Code.

History

1. New Article 1 1 (Sections 7690 7691 and 7692) filed 4-1 9-50 (Register 20, No.
1).

2. Repealer of Article 1 1 (Sections 7690-7692) filed 8-19-85; effective thirtieth
day thereafter (Register 85, No. 34).

Group 5. Sanitary Control of Shellfish

Introduction
All regulations in this group with section numbers preceded by T17-
contain building standards which appear in the California Administrative
Code, Title 24, Part 6, Division T 1 7 and, to the extent that they are build-
ing standards, are included here for convenience and continuity.

Article 1 . Shellfish Certificates

§ 7706. Shellfish Bed Certificate Issuable by the State
Board of Public Health.

Any person, firm, or corporation engaged in the cultivating or harvest-
ing of oysters, clams, or mussels for sale to the public for human con-
sumption shall possess a vaUd certificate issued by the State Board of
Public Health.
NOTE: Authority cited: Secfion 208, Health and Safety Code.

History
1. Repealer of Group 5 (Sections 7706 through 7749) and new Group 5 (Sections
7706 through 7714, 7719, 7720 7725, 7730 through 7733, 7738 through 7762)
filed 12-19-55; effective thirtieth day thereafter (Register 55, No. 18).

§ 7707. Shellfish Plant Certificate Issuable by the State
Board of Public Health.

Any person, firm, or corporation operating a plant engaged in culling,
shucking, packing or repacking fresh oysters, clams or mussels for sale
to the public for human consumption shall hold a valid certificate issued
by the State Board of Public Health.

§ 7708. Authority of State Board of Public Health to
Revoke or Suspend Certificate.

Each certificate so issued shall be revocable or subject to suspension
by the State Board of Public Health if for any reason the safety of the
shellfish as an article of food is not assured or if the standards set forth
herewith are not maintained at all times.

§ 7709. Expiration and Renewal of Certificates.

A certificate issued under these regulations shall be valid for a period
not to exceed one year and shall expire on February 1 5th of each year. An
application for renewal of a certificate shall be made by January 1 st of
each year if an applicant desires to continue to hold a certificate. No cer-
tificate can be transferred.

§7710. Definition.

For purpose of these regulations, the term "shellfish" is hereby de-
clared to mean and include all varieties of oysters, clams, and mussels.

§ 771 1 . Types of Certificates.

Shellfish certificates issued hereunder shall be of the following classi-
fications:

A. Shellfish beds and shellfish stock derived therefrom for human con-
sumption.

B. Shellfish culling, shuclcing, packing, and repacking plants and
shucked shellfish produced therefrom for human consumption.

C. A "limited" certificate may be granted as provided under Section
7744.

§ 771 2. Application for Certificate.

The applicant for a certificate to operate in either of the classifications
described above shall file with the State Department of Public Health a

Page 113

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written request accompanied by a detailed description of the shellfish
beds or shellfish handling plants and a map showing the location of the
beds or facilities. With the application shall be filed a description of the
proposed source or sources of shell or shucked slock. He shall also file
with the State Department of Public Health an agreement to comply with
each and all of these regulations.

§ 7713. No Shellfish Grown in the State of California to Be
Sold or Distributed Unless Certified.

No shellfish grown in the State of California shall be sold or distributed
except from growing areas that have been approved and have been
granted a valid cerfificate by the State Board of Public Health under these
regulations. Shellfish shall not be sold or distributed from growing areas
in other states unless each lot of shellfish obtained therefrom bears a cer-
tificate number designating a certificate of cleanliness and safety issued
by the State Department of Health of the state in which the shipment orig-
inates acceptable to the California State Department of Public Health.

§ 7714. No Shucked Shellfish to Be Sold or Distributed
Unless Certified.

No shucked shellfish shall be sold or distributed except where such
shellfish have been handled in plants for which a certificate has been is-
sued by the State Board of Public Health under these regulations.
Shucked shellfish from other states shall not be sold or distributed unless
each lot of shucked shellfish obtained therefrom bears a certificate num-
ber designating a certificate of cleanliness and safety issued by the State
Department of Health of the state in which the shipment originates ac-
ceptable to the California State Department of Public Health.

Article 2. Safety of Shellfish and Health of
Employees

§ 7719. Safety of Shellfish for Human Consumption.

No shellfish shall be sold or distributed for human consumption unless
it is safe as an article of food and is free from filth.

§ 7720. Persons Infected With Communicable Diseases.

Persons who are infected with or are carriers of organisms of typhoid
fever, dysentery, sepdc sore throat, or certain other communicable dis-
eases which might be transmitted through shellfish or who have infected
wounds or open lesions on exposed portions of the body shall not be
employed in the growing beds or shucking, packing, or repacking plant.
If the owner or manager has reason to suspect that any employee has con-
tracted such a communicable disease, he shall immediately exclude said
employee from the growing beds or plant.

Article 3. Records

§ 7725. Record of Operations.

A daily record of shellfish received and shipped shall be kept showing
kinds of shellfish, designation of the beds from which derived, name of
grower, name of shipper, and name of consignee. These records shall be
available for inspection by the State Department of Public Health or its
agents during all reasonable hours. Upon request these records shall be
submitted to the State Department of Public Health.

Article 4. Shellfish Beds

§ 7730. Cleanliness of Shellfish Growing Areas.

Shellfish beds shall be located in growing areas not adversely affected
by sewage, other wastes, or human and recreational activity. All opera-
tion of the beds shall be such as not to adversely affect the cleanliness of
the growing area.

§ 7731 . Boat Sanitation.

All boats, scows, and appurtenances thereto used in the taking of
shellfish or used in the transportation of shellfish from the beds to plants
or used in the water over the shellfish beds shall be kept in such a state
of cleanliness and repair that shellfish growing on the bed and handled
and stored thereon shall not be subject to contamination. Decks, holds,
or bins used for storage and/or transporting of shellfish on boats shall not
be washed with polluted water. Persons in boats over the shellfish beds
shall not discharge human wastes to the waters. Adequate facihties shall
be provided for disposal of human wastes from persons working on the
shellfish beds.

§ 7732. Shellfish from Uncertified Areas Brought into
Certified Beds.

Shellfish growing in uncertified areas may not be brought into a bed
for which a certificate has been issued unless special approval is first
granted by the State Department of Public Health. Such approval shall be
in writing and granted only on condition that the method of transplanting
and fiming of arrival of the shellfish will insure that the transplanted
shellfish remain in the approved growing area at least 30 days before har-
vesting for sale for human consumption. This translating area must be in
separate portions of the bed and one in which no other shellfish are held.

§ 7733. Water Quality.

Shell stock shall not be cleaned, stored, floated, or condifioned in wa-
ter, the standard of which is not as rigid as that required at certified shel-
lfish beds.

Article 5. Plants and Operations

§717-7738. Culling Plants.

Culling plants shall be located in areas free from insanitary condidons
and faulty sewage disposal. They shall be provided with an ample supply
of water under adequate pressure from a source approved by the State De-
partment of Public Health for the purpose of hosing down floor and
benches and cleaning the shellfish. Floors and premises shall be kept in
a clean and sanitary condition.

§ 7739. Storage.

Shellstock in storage shall be adequately protected from contamina-
tion at all times. Dry shellstock shall not be stored on floors. Storage areas
must be kept clean at all times. Containers shall be clean and in good con-
dition.

§ 7740. Cleanliness of Shellstock.

Only shellstock that is reasonably clean and reasonably free of mud
shall be shipped or marketed. Oysters, clams, or mussels which are dead
or do not have tight shells shall not be shipped or marketed.

§7741. Shipping.

Shellstock shall be handled and shipped under such temperature as
will keep them alive. Each lot of shellstock shall be shipped in clean con-
tainers such as bags, boxes, or barrels so as to prevent spoilage or contam-
ination during shipping. Each lot shall be plainly marked with the name
and address of the shipper, the certificate number of the bed from which
the oysters, clams, or mussels were obtained, and the date of harvest.

§ 7742. Shucking and Packing Plants and Equipment.

Shellfish shall be shucked and packed in such a manner that they are
not subject to contamination. Shellstock shall be free of mud when they
are shucked. Only live shellfish shall be shucked. Shucked shellfish shall
not remain on the shucking table for more than one hour unless refriger-
ated at .50 degrees Fahrenheit or less.

§ 7743. Washing.

All shucked shellfish shall be properly washed and shall be free of
sand, mud and other foreign material. Methods and equipment used for
washing the shucked shellfish shall be adequate to accomplish this pur-

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§7759

pose and shall be approved by the State Health Department. All water
used for washing the shellfish shall meet the requirements of Section
T17-7753 of these regulations.

History

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Register 71, No. 10).

§ T1 7-7744. Plant Arrangement.

Unless shellfish are shucked directly into packing containers with no
further processing, the shucking and packing processes shall be done in
separate rooms. There shall be installed in the partition between the two
rooms a delivery window through which the shucked stock is passed to
the packing room. Provision shall be made for storing the employees'
outer garments, aprons, gloves, etc., in a separate room.

* In special instances where shucking is done on a small scale for local
retail sales, shucking and packing may be permitted in a single room if
approved by the State Department of Public Health. This single room and
all operations shall conform to all requirements of these regulaUons ex-
cept that of separate shucking and packing rooms. "Limited" certificates
shall be issued in these instances and all containers of shucked shellfish
shall be clearly labeled or marked with the words "limited certificate"
and the appropriate certificate number.

* Not a building standard.

§ 7745. Floors.

The floors of all rooms in which shellfish are stored, shucked, washed,
packed, or otherwise processed shall be constructed of concrete or other
equally impervious material, graded to drain quickly, free from cracks or
uneven surfaces that might interfere with proper cleaning or drainage,
and maintained in a clean and satisfactory condition.

§ T1 7-7746. Walls and Ceilings.

Walls and ceilings shall be maintained in a smooth, clean, washable,
light-colored condition. They shall be impervious to moisture and shall
be kept in good repair. Walls contiguous to benches shall, to a height of
two feet above the bench top, be of smooth concrete, metal or equally
nonabsorbent material.

§717-7747. Screening.

The plant shall have all openings effectively screened with not less
than 16-mesh screening, unless other effective means are provided to
prevent the entrance of flies and other insects.

§717-7748. Light.

Ample light to work by shall be provided in all working rooms. A light
intensity of not less than 10 foot-candles shall be maintained on all work-
ing surfaces when workers are at their working positions.

§ 71 7-7749. Ventilation.

Adequate ventilation shall be provided to prevent condensation on
ceilings or other surfaces.

§ 71 7-7750. 7oilet Facilities.

Every shellfish culling, shucking, packing, or repacking plant shall be
provided with clean and adequate toilet facilities conveniently located.*
No toilet room shall be used for the storage of garments, food products,
containers, or equipment. Construction and maintenance of toilets shall
comply with all local and state regulations.

* Not a building .standard.

§ 71 7-7751 . Handwashing Facilities.

An adequate number of lavatories shall be provided at locations con-
veniently to toilet rooms and shellfish handling operations, including
running hot and cold water, soap, and individual disposal towels. The use
of a common towel is prohibited.

All employees shall wash their hands thoroughly with running water
and soap on beginning work and after each visit to the toilet. Signs to this

effect shall be posted in conspicuous places in the plant and in the toilet
rooms.

§ 71 7-7752. Sewers and Drains.

Sewage and other liquid wastes shall be discharged into public sewers
wherever possible. Where private sewage or waste disposal systems
must be utilized they shall be constructed in accordance with state and
local regulations pertaining thereto. Plant waste systems shall be proper-
ly trapped and vented. Waste liquids shall be disposed of in a manner that
will not adversely affect the quality of the water in which shellfish are
grown or stored. Waste lines from washing machines shall have suitable
protection against the possibility of sewage or wastes entering these ma-
chines.

§ 7753. Water Supply.

Shucking, packing, or repacking plants shall be provided with an amp-
le supply of water under adequate pressure from a source approved by the
State Department of Public Health. The supply shall be accessible to all
parts of the plant, adequate in quantity, and of a safe sanitary quality. No
cross-connections with unapproved supplies or other possible sources of
contamination shall be permitted.

§ 7754. Benches and Stands.

All benches and stands shall be of smooth concrete, metal, or other
nonabsorbent material, free from cracks or crevices, and so constructed
that drainage is complete and rapid. Shucking blocks shall be removable
unless an integral part of the bench and shall be of solid one-piece con-
strucfion.

§ 7755. Construction of Utensils and Equipment.

All shucking pails, opening knives, blowers, skimmers, tanks, tubs,
trays, measures, colanders, paddles, or other equipment or utensils which
may come in contact with shucked shellfish shall be made of not readily
corrodible, smooth, impervious material and shall be constructed in such
a manner as to eliminate grooves, seams, and cracks where foreign par-
ticles, dirt, and slime might collect. Perforations in the skimmers, colan-
ders, and blower trays shall be smooth to facilitate cleaning. Skimmers,
ladles, and colanders of wire-mesh construction are not permitted. The
top rim of every tank, tub, and tray shall be at least 30 inches above the
floor.

§ 7756. Aprons and Finger Cots.

All persons who handle shucked shellfish shall wear clean aprons and
coats of washable and waterproof material. If finger cots or similar
shields for protecting the palm of the hand are worn, they shall be of
clean, washable and waterproof material.

§ 7757. Refrigeration.

Unless shellfish are delivered to the consumer immediately upon com-
pletion of shucking, refrigeradon facilities shall be provided capable of
cooling the shucked shellfish to a temperature below 50 degrees Fahren-
heit within two hours after the shellfish are shucked, and keeping them
at this temperature until delivered to the consumer. If shucked shellfish
are frozen, they shall be kept in a frozen condition until delivered to the
consumer. The refrigerator or icebox shall have an impervious lining.
The floor shall be graded to drain quickly. An accurate thermometer shall
be kept in the refrigerator or icebox. Refrigerators shall be kept clean and
sanitary at all times.

§7758. Ice.

Ice used for the processing of shucked shellfish shall be obtained from
an approved source and shall be stored and handled in a sanitary manner.
No ice shall be allowed to come in contact with shucked shellfish.

§ 7759. Cleaning.

The floors, walls, and, if necessary, ceilings in the plant shall be
cleaned at the end of each day's operations and flushed with water. All
equipment, utensils, benches, etc., which come in contact with shucked
shellfish shall be thoroughly scoured at the end of each day's operations.

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The premises shall be kept clean and free of litter and rubbish. Equipment
and articles not required in the processing of the shellfish shall be ex-
cluded from the plant.

§ 7760. Sterilization of Equipment.

All utensils, equipment, or working surfaces coming in contact with
shucked shellfish after being thoroughly cleansed shall be sterilized by
methods approved by the State Department of Public Health. Sterilized
equipment shall be protected from recontamination between usages.

§7761. Paci<ing and Shipping.

Shucked shellfish shall be packed and shipped either in single-service
containers made of clean impervious materials or in properly designed,
returnable containers* which have received adequate cleansing and bac-
tericidal treatment. All containers shall be stored in a manner that will
protect them from contamination. Containers holding one gallon or more
must be positively sealed or so sealed that tampering with the container
can easily be detected. Each can, container, or package shall bear the
name of the shipper, certificate number of the shucking, packing, or re-
packing plant, and date packed. The date may be in code if the code is
registered with the State Department of Public Health.

NOTE: Authority cited: Sections 202, 205(d) and 208, Health and Safety Code.
Reference: Sections 26542; 28312-28315 and 28440, Health and Safety Code.

History
1. Amendment filed 5-3-67; effective thirtieth day thereafter (Register 67, No.
18).

* Returnable containers will be accepted only for interplant shipment of
shucked shellfish.

§ 7762. Repacking Sliucked Stock.

Repacking of shucked shellfish shall only be done if contamination of
the shellfish will not occur. Repacking of shucked stock shall be in con-
formance with all sections of these regulations dealing with shucking and
packing of shellfish.

Group 6. Public Swimming Pools

NOTE: Authority cited for Group 6: Sections 1 02 and 208, Health and Safety Code.
Reference: Sections 24100 through 24109, Health and Safety Code.

History

1. Originally printed 8-15-45 (Title 17).

2. Repealer of Group 6 (Sections 7774 throuah 7872) and new Group 6 (Sections
7774, 7775, 7780 through 7810, 7820 through 7833) filed 9-30-60; effective
thirtieth day thereafter (Register 60, No. 21 ).

3. Group 6 repealer and adoption refiled 1 1-15-60; effective thirtieth day thereaf-
ter (Register 60, No. 23).

4. Amendment filed 6-7-74; effective thirtieth day thereafter (Register 74, No.
23).

5. Repealer of Group 6 (Articles 1, 2-2.1 and 3, Sections 7774-T17-7833) filed
10-16-80; designated effective 10-1-81 (Register 80, No. 42).

6. Editorial correction of effecfive date of History Note No. 5 (Register 80, No. 52).

7. Editorial change filed 9^1-81 redesignating effective date of 10-16-80 order
from 10-1-81 to 12-30-81 (Register 81, No. 36).

8. Deletion of Group 6 text (Sections 7774-Tl 7-7833) which was repealed effec-
tive 12-30-81 (Register 89, No. 37).

Group 7.

Article 1.

Bottled Water and Water Vending
Machines

Water Bottler and Water Vendor
Responsibilities

(3) Maintain adequate water quality monitoring;

(4) Take whatever investigative or corrective action is necessary to as-
sure that a pure, wholesome and potable water is supplied to consumers.

(b) Each water vending machine operator shall:

( 1 ) Operate and maintain all water vending machines under his control
in a sanitary manner;

(2) Maintain adequate water quality monitoring;

(3) Take whatever investigative or corrective action is necessary to as-
sure that a pure, wholesome and potable water is supplied to consumers.
NOTE: Authority cited: Sections 1 02, 208 and 4041 , Health and Safety Code. Ref-
erence: Sections 4040-4043. inclusive. Health and Safety Code.

History

1 . New Group 7 (Sections 7861-7883) filed 1-31-74; effecfive thirtieth day there-
after (Register 74, No. 5). For history of former Group 7, see Register 68, No.

49.

2. Amendment filed 6-14-78; effective thirtieth day thereafter (Register 78, No.

24).

Article 2. Definitions

§ 7862. Definitions.

(a) "Department" means the California Department of Health.

(b) "Approved" means approved in writing by the Department.

(c) "Bottler" means a person, firm, partnership, or corporation, or oth-
er business organization owning and/or operating a water bottling plant.

(d) "Vended Water" means water dispensed by way of a water vending
machine.

(e) "Water-vending machine" means any self-service device which
upon insertion of a coin, coins, or token, or upon receipt of payment by
other means, dispenses unit servings of water in bulk into a customer's
container, without the necessity of refilling the machine between each
operation.

(f) "Mineral Water" means bottled drinking water containing more
than 500 milligrams per liter of total dissolved solids and/or one or more
chemical constituents in excess of the concentrations listed in the Federal
Bottled Water Quality Standards, 21 CFR, Section 103.35 (d).

NOTE: Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Ref-
erence: Sections 4040-4043, Health and Safety Code.

History

1. Amendment filed 6-14-78; effective thirtieth day thereafter (Register 78, No.
24).

2. Editorial correction of Note (Register 97, No. 37).

Article 3. Water Quality

§ 7863. Bottled and Vending Machine Water Quality.

(a) Quality standards for bottled water withdrawn from sealed bottles,
and water from vending machines at point of discharge to customer' s
container, shall conform to Federal Water Quality Standards for Bottled
Water, 21 CFR, Section 103.35 except:

(1) Mineral water shall be exempt from chemical quality standards of
21 CFR, Section 103.35 (d);

(2) Bottled fluoridated water shall contain 1 .0 ± 0. 1 milligrams per li-
ter fluoride ion.

Note: Authority cited: Sections 208 and 4041, Health and Safety Code. Refer-
ence: Section 4041, Health and Safety Code.

History

1 . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24).

2. Editorial correction of NOTE filed 7-12-84 (Register 84, No. 28).

Article 4. Good Manufacturing Practices

§7861. General.

(a) Each water bottler shall:

(1) Exercise due care and diligence to protect water sources under his

control; § 7864. Water Bottling Plants.

(2) Provide and effectively operate and maintain water treatment, (a) Bottlers shall comply with the following Good Manufacturing

bottling, capping, bottle washing and product storage facilities;

Practices:

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§ 7870

( 1 ) Federal standards relating to Processing and Bottling of Bottled
Drinking Water, 21 CFR. Section 129.

(2) Federal Standards Relating to Human Foods; Current Good Man-
ufacturing Practice in manufacture, processing, packing or holding, 21
CFR, Section 110.

(3) Regulations for Sanitation in Food Plants, 17 CAC 12235-12285.

(b) Prior to bottling, bottled water shall be subject to effective treat-
ment by ozonation, ultraviolet or other treatment approved by the Depart-
ment.

NOTI-;: Authority cited: Sections 102. 208 and 4041 , Health and Safety Code. Ref-
erence: Sections 4040-4043 Health and Safety Code.

History
I . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24).

§ 7865. Water Vending Machines.

(a) Products from each water vending machine shall be sampled by the
vending machine operator once every six months or coliform organisms.

(b) Prior to discharge to the customer' s container, water vended by ma-
chine shall be subject to effective treatment by ultraviolet or other treat-
ment approved by the Department.

Note: Authority cited: Sections 1 02, 208 and 4041 , Health and Safety Code. Ref-
erence: Sections 4040-4043, Health and Safety Code.

History
1 . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24).

§ 7866. Cleaning and Sanitizing of Containers.

(a) Bottler shall utilize at least one of the following cleaning/sanitizing
processes for multi-use bottles or containers:

( 1 ) Any of the federal sanitizing procedures listed in 2 1 CFR, Section
129.80 (d).

(2) Exposing all interior surfaces to not less than two and one-half per-
cent caustic solution at a minimum temperature of 120F for not less than
one minute where high velocity jets are used or for not less than three
minutes where soaker type bottle washers are used.

A final rinsing of the bottle inside, using operations or product water
shall be used to remove traces of any caustic sanitizing agent.

(3) Any other method approved in writing by the Department.
Note; Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Ref-
erence: Sections 4040-4043, Health and Safety Code.

History
1 . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24).

§ 7867. Water Dispensers.

(a) Dispensers for bottled water, fumished by the water bottler or dis-
tributor, shall be delivered to the consumer's premise in a clean, sanitary
condition, protected from dust, dirt or other contamination.

(b) Ollas or other water-holding dispensers, both refrigerated and non-
refrigerated, shall be checked for cleanliness each time the dispenser is
serviced by the bottler or distributor's representative and when necessary
returned to the bottler or distributor for cleaning and sanitizing before re-
use.

NOTE; Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Ref-
erence: Sections 4040^043, Health and Safety Code.

History
1 . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24),

§ 7868. Labels and Advertising.

(a) Mineral water shall be plainly labeled "Mineral Water," and the la-
bel shall show amounts of any mineral substance which exceed bottled
water standards, 21 CFR. Section 103.35. and the source of the water.
NoTE; Authority cited: Sections 102, 208 and 4041, Health and Safety Code. Ref-
erence: Sections 4040-4043, Health and Safety Code.

History
1 . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24).

Article 5.

Out-of-state Bottler or
Distributor

§ 7869. Applications.

Application for a license by an out-of-state bottler or by a distributor
of water bottled out of state shall be submitted with sufficient information
to demonstrate that the water is pure, wholesome and potable. This infor-
mation shall be included in a report prepared by the agency having au-
thority over bottled water in the state where the water is bottled. If no
agency has specific authority over bottled water, the report shall be pre-
pared by a registered civil engineer with recognized experience and com-
petence in the field of water sanitation and/or food production. The appli-
cant may contract with the Department for out-of-state inspections and
preparation of the report necessary to support issuance of the license. The
report shall include, but not be limited to, the following:

(a) Where applicable, a copy of the out-of-state laws and regulations
on bottled water and the license issued.

(b) A report on compliance or noncompliance with all water quality
and sampling and water bottling requirements specified in this chapter.

(c) A statement from the out-of-state regulatory agency and the appli-
cant that they will inform the Department of contamination or illness as-
sociated with the bottled water shipped into the State.

(d) Information on type and quantity of bottled water shipped into the
State and how the bottled water is packaged, transported and stored upon
arrival before distribution in the State.

NOTE; Authority cited: Sections 1 02, 208 and 4041 , Health and Safety Code. Ref-
erence: Sections 4040-4043, Health and Safety Code.

History
1 . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24).

Article 6. Licenses and Fees

§ 7870. Licenses.

a) Water Bottling Plants.

The owners or operators of each water bottling plant shall make appli-
cation for license on forms provided by the Department. The application
and license fee shall be submitted for a calendar year. License fees pay-
able are due on or before January 1 and shall be in accordance with Table
1 . For new bottling operations, the fee shall be $500.00 for the first calen-
dar year's operation. For water bottled out of state, license fees shall be
in accordance with Table 1 . Average weekly production shall be deter-
mined by dividing the number of gallons shipped into California during
the previous year by 52.

TABLE 1
WATER BOTTLING PLANT LICENSE ETiE SCHEDULE

Last Year's Average Current

Weekly Production Animal

Bottled Water (in Gallons) License Fee

2,500 or less $100

2,501 to 10,000 $200

10,001 to 25,000 S^OO

25,001 to 50,000 S40()

Over 50,000 ' SOO

(b) Water Vending Machines.

Each water vending machine owner or operator shall make application
and obtain a license for each machine operated under his control. The an-
nual license fee for each approved machine shall be $5 per calendar year.
A decal or seal provided by the Department indicating a license fee has
been paid shall be affixed in a prominent place to each vending machine
in service.

Page 117

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Each model of a water vending machine shall be approved by the De-
partment. For newly designed machines or existing machines with modi-
fications, adequate data shall be submitted regarding ability of the ma-
chine to comply with the standards of design and to continuously and
reliably deliver water complying with waicr quality standards prescribed
in Section 7863. The evaluation fee for each model of a new machine and
existing machines with modifications affecting the quality of the water
produced shall be in accordance with Table 2. The Department may ac-
cept, without payment of a fee, the evaluation of anew or modified model
by a recognized independent laboratory.

TABLE 2
WATER VENDING MACHINE EVALUATION FEE SCHEDULE

New machine $500

Existing machine with major modifications $200

Existing machine with minor modifications $50

NOTl:: Authority cited: Sections 102, 208 and 404L Health and Safety Code. Ref-
erence: Sections 4040-4043, Health and Safety Code.

History
1 . Repealer and new section filed 6-14-78; effective thirtieth day thereafter (Reg-
ister 78, No. 24).

§ 7871 . Doors and Windows.

History
1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7872. Toilet — Handwashing Facilities.

History

1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7873. Plant Maintenance.

History
1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7874. Personnel — Cleanliness.

History

1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7875. Cleaning and Sanitizing of Containers.

History
1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7876. Filling and Closures.

History

1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7877. Dry Storage.

History
1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7878. Water Dispensers.

History
1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7879. Water Vending Machines.

History
1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7880. Records.

History
1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7881 . Labels and Signs.

History
1 . Repealer filed 6-14-78; effective thutieth day thereafter (Register 78, No. 24).

§ 7882. Applications.

History

1 . Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

§ 7883. Licenses.

History
L Repealer filed 6-14-78; effective thirtieth day thereafter (Register 78, No. 24).

Group 8. Sanitary Inspections

Article 1. Sale of Rat Exterminators

§ 7925. Sale of Rat Exterminators.

The sale or exposure for sale of alleged rodent exterminators, the man-
ufacture of which is based upon the use of cultures of bacteria which may
contaminate human food supplies, is hereby prohibited.

Article 2. Capture, Holding, Shipment and
Sale of Wild Rodents

§ 7933. Definitions.

(a) Vector Management Unit.

"Vector management unit" means the organizational entity within the
Department of Health with primary responsibility for the surveillance,
prevention and control of insects and other animals of public health sig-
nificance.

(b) Wild Rodent.

"Wild rodent" means wild ground squirrels, chipmunks, rats, mice or
any other members of the order Rodentia occurring in nature in Califor-
nia except muskrats and beavers.

History

1 . New section filed 1-20-78; effective thirtieth day thereafter (Register 78, No.
3).

§ 7934. Registration.

(a) Each person holding a valid scientific collecting permit issued by
the Department of Fish and Game pursuant to Fish and Game Code Sec-
tion 2576, who captures or holds in quarantine wild rodents with the in-
tent to sell them shall register annuaiiy with the health officer of each ju-
risdiction in which the wild rodents are captured or quarantined.

(b) The local health officer shall notify the vector management unit,
within seven days, of each person registered.

NOTE: Authority cited for Article 2: Sections 102 and 208, Health and Safety

Code. Reference: SecUons 205. 3053 and 3114, Health and Safety Code.

History

1 . Amendment of Article 2 ( 7934 added, 7935-7937 amended) filed 7-1-66 as
an emergency; effective upon filing (Register 66, No. 20). 2. Certificate of Com-
pliance— Secdon 11422.1, Government Code, filed 10-25-66 (Register 66,
No. 37).

3. Amendment filed 1-20-78; effective thirtieth day thereafter (Register 78, No.
3).

§ 7935. Disinfestation, Quarantine and Shipment of Wild
Rodents.

(a) No person shall sell any wild rodent which has not been disinfected
of ectoparasites and quarantined pursuant to the provisions of this Sec-
tion.

(b) Disinfestation of rodents shall be as follows:

(1) Any person capturing wild rodents with the intent to sell shall, in
the locality of capture, disinfest each rodent of ectoparasites using the
1977 "Specifications for disinfestation of wild rodents captured and held
for sale" issued by the vector management unit.

(2) Upon release from quarantine and prior to shipment, each rodent
shall again be disinfected using the 1977 "Specifications for disinfesta-
tion of wild rodents captured and held for sale" issued by the vector man-
agement unit.

(1) The rodents shall be segregated and confined in cages by species,
and date and locality of capture, with the date and specific locality of cap-
ture clearly designated on the cages.

(2) The rodents shall be held in quarantine for a period of two weeks
prior to the date of shipment.

(3) If a rodent dies, the quarantine of all remaining rodents in that cage
shall be extended two weeks from the date of that death or any later death.

Page 118

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§ 7941.6

(4) Each rodent death shall be reported to the local health officer within
two working days of the rodent's death.

(5) Rodent carcasses shall be promptly frozen pending collection by
the local health officer.

(d) Shipment of rodents shall be as follows:

( 1 ) A statement shall accompany the shipment and shall bear the
names and addresses of the shipper and receiver, the date of shipment,
the location and dates of capture, and certification that the rodents have
been quarantined and disinfested of ectoparasites.

(2) Such statement shall be retained by the receiver for a period of one
year.

(3) On the date of shipment, the shipper shall submit two copies of the
shipment statement to the local health officer, who shall forward, within
seven days, one copy to the vector management unit.

History
1. Amendment filed 1-20-78; effective thirtieth day thereafter (Register 78, No.
3).

§ 7936. Reports.

The local health officer shall report all deaths of wild rodents held in
quarantine to the vector management unit and ship the carcasses of such
rodents to the State laboratory for examination as directed by the vector
management unit.

History
1. Amendment filed 1-20-78; effective thirtieth day thereafter (Register 78, No.

3).

§ 7937. Disposition of Trapped Wild Rodents.

All wild rodents trapped in the same general area within which a rodent
or other animal has been found to be infected with plague or other disease
communicable to man shall be subjected to such quarantine, isolation,
disinfestation or other procedure which the vector management unit finds
necessary for the protection of the public health.

History
1 . Amendment file 1-20-78; effective thirtieth day thereafter (Register 78, No. 3).

Group 9. Registered Sanitarians GTP

Article 1 . Internship Program

§ 7941 .1 . Internship Program.

An internship program shall include field training equivalent to 600
hours of supervised field experience or completion of six months of su-
pervised field experience in a local environmental health jurisdiction
during the formal undergraduate or graduate course studies for the degree
in environmental health and shall include experience in at least six envi-
ronmental program areas. Three of the areas of field experience shall be
selected from the following six basic environmental program areas: food
protection, waste management (liquid, solid, and hazardous), water sani-
tation, housing and institutions, recreational swimming areas and waters,
and vector control. Experience in the three remaining environmental pro-
gram areas shall be selected from the following: air sanitation, safety and
accident prevention, land development and use, disaster sanitation, elec-
tromagnetic radiation, milk and dairy products sanitation, noise control,
occupational health, rabies and animal disease control, and any of those
from the six basic program areas above not previously selected.
Note: Authority cited: Section 520, Health and Safety Code. Reference: Section
520, Health and Safety Code.

History

1. Repealer of former Article 1 (Sections 7941 and 794 1.5) and new Article 1 (Sec-
tion 7941.1) filed 5-3-85; effective thirtieth day thereafter (Register 85, No.
18). For prior history, see Register 73, No. 26.

2. Change without regulatory effect repealing Group 9 (Articles 1-5, Sections
7941.1—7941.6 and 7942-7946) pursuant to Section 100, Title 1, California
Code of Regulations filed 10-20-89 (Register 89, No. 49).

Article 2. Approval of Educational
Institutions

§ 7941.2. Approved Educational Institution.

In order to be approved by the Department, an institution shall be on
the list of accredited colleges or universities maintained by the U.S. Of-
fice of Education and shall meet the curriculum requirements specified
in Section 7941 .5(b) if providing course work leading to a degree in envi-
ronmental health.

NOTE: Authority cited: Section 520. Health and Safety Code. Reference: Section
520. Health and Safety Code.

History

1 . Repealer of former Article 2 (Section 7942) and new Article 2 (Sections 7941 .2
and 7941.3) filed 5-3-85; effective thirtieth day thereafter (Register 85. No.
18). For prior history, see Register 68, No. 29.

2. Change without regulatory effect repealing Group 9 (Articles 1-5, Sections
7941.1—7941.6 and 7942-7946) pursuant lo Section 100. Title 1, C^alifornia
Code of Regulations filed 10-20-89 {Register 89, No. 49).

§ 7941 .3. Review of Curriculum.

Institutions requesting approval of their environmental health degree
program shall first submit their curriculum to the Sanitarian Registration
Certification Committee for review and if it meets the prescribed curricu-
la as specified in Section 7941.5(b) it shall be submitted to the Depart-
ment for approval.

NOTE: Authority cited: Section 520, Health and Safety Code. Reference: Section
520, Health and Safety Code.

History

1. Change without regulatory effect repeahng Group 9 (Articles 1-5, Sections
7941.1—7941.6 and 7942-7946) pursuant to Section 100, Title 1, California
Code of Regulations filed 10-20-89 (Register 89, No. 49).

Article 3. Registration Procedures

§ 7941.4. Certification of Registration.

NOTE: Authority cited: Section 520, Health and Safety Code. Reference: Section
522, Health and Safety Code.

History

1. New Article 3 (Section 7941.4) filed 5-3-85; effective thirtieth day thereafter
(Register 85, No. 1 8). For prior history, see Register 58, Nos. 5 and 1 1 and No.
4.

2. Change without regulatory effect repealing Group 9 (Articles 1-5, Sections
7941.1-7941.6 and 7942-7946) pursuant to Section 100, Title 1, California
Code of Regulations filed 10-20-89 (Register 89, No. 49).

Article 4. Minimum Educational and
Experience Qualifications for Admission to
the Examination for Registered Sanitarians

§ 7941.5. Educational and Experience Requirements.

NOTE: Authority cited: Section 520, Health and Safety Code. Reference: Section
520, Health and Safety Code.

History

1 . Renumbering of former Section 7941 .5 to Section 7942 and new Article 4 ( Sec-
tions 7941.5, 7941.6 and 7942) filed 5-3-85; effective thirtieth day thereafter
(Register 85, No. 18). For prior history, see Register 73, No. 26.

2. Change without regulatory effect repealing Group 9 (Articles 1-5. Sections
7941.1—7941.6 and 7942-7946) pursuant to Section 100, Title I. California
Code of Regulations filed 10-20-89 (Register 89. No. 49).

§ 7941 .6. Cross-Certification with Department of Food and
Agriculture.

NOTE: Authority cited: Section 520, Health and Safety Code. Reference: Section

517, Health and Safety Code.

History

1. Change without regulatory effect repealing Group 9 (Articles 1-5. Sections
7941.1—7941.6 and 7942-7946) pursuant to Section 100, Title 1. California
Code of Regulations filed 10-20-89 (Register 89. No. 49).

Page 119

§7942

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 7942. Exceptions.

NOTH: Authority cited: Section 542(b). Health and Safety Code.

History

1 . Repealer of former Section 7492 and renumbering of former Section 7941 .5 to
Section 7942 filed 5-3-85; effective thirtieth day thereafter (Register 85, No.
18).

Article 5. Application Procedures for
Sanitarian Registration

§ 7943. Application Submission, Completion and
Notification.

NOTI-:: Authority cited: Section 208. Health and Safety Code; and Section 15376,
Government Code. Reference: Section 520. Health and Safety Code; and Sections
15376 and 15378, Government Code.

History

1 . New Article 5 (Sections 7943-7946) filed 5-3-85; effective thirtieth day there-
after (Register 85, No. 1 8). For history of fonner Section 7944, see Register 58,

No. 5.

2. Change without regulatory effect repeating Group 9 (Articles 1-5, Sections
7941.1—7941.6 and 7942-7946) pursuant to Section 100, Title 1, California
Code of Regulations filed 10-20-89 (Register 89, No. 49).

§ 7944. Application Review Period.

NOTE; Authority cited: Section 208, Health and Safety Code; and Section 15376,
Government Code. Reference: Section 520, Health and Safety Code; and Secfions
15376 and 15378, Government Code.

History
1. Change without regulatory effect repealing Group 9 (Articles 1-5, Sections
7941.1—7941.6 and 7942-7946) pursuant to Section 100, Title 1, California
Code of Regulations filed 10-20-89 (Register 89, No. 49).

§ 7945. Application Decision Period.

NOTE: Authority cited: Section 208, Health and Safety Code; and Section 15376,
Government Code. Reference: Secfion 520, Health and Safety Code; and Sections
15376 and 15378, Government Code.

History

1. Change without regulatory effect repealing Group 9 (Articles 1-5, Sections
7941.1—7941.6 and 7942-7946) pursuant to Section 100, Title 1, California
Code of Regulations filed 10-20-89 (Register 89, No. 49).

§ 7946. Median, Minimum, and Maximum Application
Processing Times.

NOTE: Authority cited: Section 208, Health and Safety Code; and Section 15376,
Government Code. Reference: Section 520, Health and Safety Code; and Sections
15376 and 15378, Government Code.

Group 10. Sanitation, Healthfulness and

Safety of Ocean Water-Contact Sports

Areas

Article 1. Intent of Regulations

NOTE: Authority cited: Sections 208 and 24156. Health and Safety Code. Refer-
ence: Sections 24156 and 24157, Health and Safety Code.

History

1. New Group 10 (§ 7950 through 7961) filed 2-18-58; effective thirtieth day
thereafter (Register 58, No. 3).

2. Repealer of Article 1 (Sections 7950 and 795 1 ) filed 7-1 5-85; effective thirtieth
day thereafter (Register 85, No. 29).

Article 2. Definitions

§ 7952. Public Water-Contact Sports Area Defined.

Public water-contact sports area means any area so designated ( 1 ) by
a regional water pollution control board, or (2) by any other authorized
and responsible public agency.

NOTE: Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Section 24156, Health and Safety Code.

History
1. New NOTE filed 3-20-84 (Register 84, No. 12).

§ 7953. Public Beach Defined.

NOTE; Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Section 24156, Health and Safety Code.

History

1. Repealer filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§ 7954. Safety Program Defined.

NOTE: Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Section 24156, Health and Safety Code.

History
1 . Repealer filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§ 7955. Refuse Defined.

NOTE: Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Section 24156, Health and Safety Code.

History

1 . Repealer filed 7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§ 7956. storm Drain.

"Storm drain" means a conveyance through which water flows onto
or adjacent to a public beach and includes rivers, creeks, and streams,
whether in natural or in man-made channels.

NOTE; Authority cited: Sections 100275, 1 15880 and 1 16075, Health and Safety
Code. Reference: Sections 1 15880, 1 16075 and 1 ^6080, Health and Safety Code.

History

1 . New section filed 7-26-99 as an emergency; operative 7-26-99 (Register 99,
No. 31). A Certificate of Comphance must be transmitted to OAL by 1 1-23-99
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15-99
and filed 1 1-30-99 (Register 99, No. 49).

Article 3. Sanitation

NOTE; Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Section 24156, Health and Safety Code.

History
1 . Repealer of Article 3 (Section 7956) filed 7-15-85; effective thirtieth day there-
after (Register 85, No. 29).

Article 4. Healthfulness

§ 7957. Physical Standard.

No sewage, sludge, grease, or other physical evidence of sewage dis-
charge shall be visible at any time on any public beaches or water-contact
sports areas.

NOTE; Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Section 24156, Health and Safety Code.

History
1. New NOTE filed 3-20-84 (Register 84, No. 12).

§ 7958. Bacteriological Standards.

(a) The minimum protective bacteriological standards for waters adja-
cent to public beaches and public water-contact sports areas shall be as
follows:

( 1 ) Based on a single sample, the density of bacteria in water from each
sampling station at a public beach or public water contact sports area
shall not exceed:

(A) 1 ,000 total coliform bacteria per 100 milliUters, if the ratio of fecal/
total coliform bacteria exceeds 0. 1 ; or

Page 120

Title 17

State Department of Health Services

§7971

(B) 10,000 total coliform bacteria per 100 milliliters; or

(D) 104 enterococcus bacteria per 100 milliliters.

(2) Based on the mean of the logarithms of the results of at least five
weekly samples during any 30-day sampling period, the density of
bacteria in water from any sampling station at a public beach or public
water contact sports area, shall not exceed:

(A) 1.000 total coliform bacteria per 100 milliliters; or

(B) 200 fecal coliform bacteria per 100 milliliters; or

(b) Water samples shall be submitted for bacteriological analyses to
a laboratory certified by the Environmental Laboratory Accreditation
Program, California Department of Health Services in microbiology for
methods for the analysis of the sample type.

NOTE; Authority cited: Sections 100275, 1 15880 and 1 16075, Health and Safety
Code. Reference: Sections 11 5880, 11 6075 and 1 16080, Health and Safety Code.

History

1. Amendment filed 7-15-85; effective thirtieth day thereafter (Register 85, No.
29).

2. Repealer and new section and amendment of Noth filed 7-26-99 as an emer-
gency; operative 7-26-99 (Register 99, No. 31 ). A Certificate of Compliance
must be transmitted to OAL by 1 1-23-99 or emergency language will be re-
pealed by operation of law on the following day.

3. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15-99
and filed 1 1-30-99 (Register 99, No. 49).

§ 7959. Bacteriological Sampling.

(a) In order to determine that the bacteriological standards specified
in 7958 above are being met in a water-contact sports area designated by
a Regional Water Quality Control Board in waters affected by a waste
discharge, water samples shall be collected at such sampling stations and
at such frequencies as may be specified by said board in its waste dis-
charge requirements.

(b) In waters of a public beach or water-contact sports area that "^as not
been so designated by a Regional Water Quality Control Board, water
samples shall be collected at such sampling stations and at such frequen-
cies as may be determined by the local health officer or the Department.
Local health officers shall be responsible for the proper collection and
analysis of water samples in such areas.

Note: Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Secfions 24156 and 24157, Health and Safety Code.

History
1. Amendment filed 7-15-85; effective thirtieth day thereafter (Register 85, No.
29).

§ 7960. Corrective Action.

When a public beach or public water-contact sports area fails to meet
the standards as set forth in 7957 or 7958 above, the local health officer
or the Department, after taking into consideration the causes therefor,
may at his or its discretion close, post with warning signs, or otherwise
restrict use of said public beach or public water-contact sports area until
such time as conrective action has been taken and the standards as set
forth in 7957 and 7958 above are met.

Note: Authority c:ited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Secfions 24156 and 24157, Health and Safety Code.

History
1. Amendment filed 7-15-85; effective thirtieth day thereafter (Register 85, No.
29).

§ 7961 . Public Beaches Visited by More Than 50,000

People Annually and Adjacent to Storm Drains.

(a) Waters adjacent to a public beach shall be tested for bacteria identi-
fied in Section 7958 on at least a weekly basis from April 1 to October
3 1 , inclusive, if the beach is

( 1 ) Visited by more than 50,000 people annually, and

(2) Located adjacent to a storm drain that flows in the summer.

(b) Water samples shall be taken from locations that include areas af-
fected by storm drains. Samples shall be taken in ankle- to knee-deep
water, approximately 4 to 24 inches below the water surface.

(c) When testing reveals that the waters adjacent to a public beach fail
to meet any of the standards set forth in Section 7958(a)(1) the local
health officer shall post the beach pursuant to Health and Safety Code
Section 1 15915, and shall use the standards of Section 7958(a)( 1 ) and (2)
in determining the necessity to restrict the use of or close the public beach
or portion thereof

(d) In the event of a known release of untreated sewage into waters ad-
jacent to a public beach, the local health officer shall:

( 1 ) Immediately post and close the beach or a portion thereof or other-
wise restrict its use unfil the source of the sewage release is eliminated;

(2) Sample the affected waters; and

(3) Confinue closure or restriction of the beach or a portion thereof and
posting the beach until testing results establish that the standards of Sec-
tion 7958(a)(1) are safisfied.

Note: Authority cited: Sections 100275, 1 15880 and 1 16075. Health and Safety
Code. Reference: Sections 1 15880. 1 16075 and 1 16080, Health and Safety Code.

History

1. New secfion filed 7-26-99 as an emergency; operative 7-26-99 (Register 99.
No. 31). A Certificate of Compliance must be transmitted to OAL by 11 -23 99
or emergency language will be repealed by operation of law on the follow ing
day.

2. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15-99
and filed 1 1-30-99 (Register 99, No. 49).

§ 7962. Duties imposed on a Local Public Officer or
Agency.

Pursuant to Health and Safety Code Secfions 1 15880(h), 1 15885(g),
and 1 15915(c), any duty imposed upon a local public officer or agency
by Secfion 7961 shall be mandatory only during a fiscal year in which the
Legislature has appropriated sufficient funds, as determined by the State
Director of Health Services, in the annual Budget Act or otherwise for
local agencies to cover the costs to those agencies associated with perfor-
mance of these duties.

NOTE: Authority cited: Secfion 100275, Health and Safety Code. Reference: Sec-
dons 1 15880, 1 15885 and 1 15915, Health and Safety Code.

History

1. New secfion filed 7-26-99 as an emergency; operative 7-26-99 (Register 99,
No. 3 1 ). A Certificate of CompUance must be transmitted to OAL by ri-23-99
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 7-26-99 order transmitted to OAL 10-15 99
and filed 1 1-30-99 (Register 99, No. 49).

Article 5. Safety

NOTE: Authority cited: Sections 208 and 24156, Health and Safety Code. Refer-
ence: Section 24156, Health and Safety Code.

History
1 . Repealer of Article 5 (Section 7961 ) filed 7-15-85; effective thirtieth day there-
after (Register 85, No. 29).

Group 10.1. Sanitation of Public Beaches

Article 1 . Intent of Regulations

NOTE: Authority cited: Secfions 208 and 427.3, Health and Safety Code. Refer-
ence: Secfions 427.3. 427.5, 427.6 and 427.9, Health and Safety Code.

History

1 . New Group 1 0. 1 (Secfions 7970 through 7994) filed 8-30-72; effective thirtieth
day thereafter (Register 72, No. 36). Sections 7982, 7990 and 7993 approved
by Buildings Standards Commission 7-28-72.

2. Repealer of Article 1 (Section 7970) filed 3-4-85; effective thirtieth day there-
after (Register 85, No. 10).

Article 2. Definitions and Exemptions

§ 7971 . Beach.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Sections 427.3, 427.5, 427.6 and 427.9, Health and Safety Code.

History
1. Repealer filed 3-4—85; effecfive thirtieth day thereafter (Register 85. No. 10).

Page 121

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 7972. Saltwater Body.

Saltwater Body means the ocean, a marine bay, estuary or lagoon.

NOTC: Authority cited: Sections 208 and 427 3, Health and Safety Code. Refer-
ence: Section 427, Health and Safety Code.

History

I. Hditorial correction filed 8-9-84 (Register 84, No. 32).

§ 7973. Freshwater Body.

Freshwater Body means a natural or artificial lake, river, reservoir,
stream or canal.

NOTli: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7974. Refuse.

Refuse means domestic or industrial garbage, rubbish, or other debris
adversely affecting public health and safety as specified by the Health
Officer.

NOTIi: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7975. Sanitation.

Sanitation means the maintenance of a safe and healthful environment
by means of removal of refuse; provision of sanitary toilet and handwash-
ing facilities; disposal of sewage and liquid wastes; protection of bathing
water quality; provision of pure, wholesome and potable drinking water;
and control of harmful insects, rodents and animals.
NOTH: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7976. Recreational Purposes.

Recreational purposes include but are not limited to, swimming,
camping, scenic enjoyment, fishing, shellfish gathering, surfing, scuba
or snorkel diving, boating, equestrianship, use of recreational vehicles,
jogging, walking, and beachcombing.

Note: Authority cited: Secfions 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427, Health and Safety Code.

History

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7977. Public Health and Safety.

Public health and safety means the maintenance of an environment
that contributes to human well being, and in which there is an absence of
human disease, ill health or injury.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7978. Health Officer.

Health Officer means the legally appointed Health Officer of the
county or city having jurisdiction of the area in which a public beach is
located.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.5, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7979, Exemption.

Sections 7981 through 7991 of Title 17 shall not apply when the
Health Officer determines that the beach is maintained primarily as an
open space. The criteria, among others, that may be evidence of open
space is lack of developed access, lack of jiarking facilities, lack of life-
guard services, or where casual use normally does not exceed 50 people
per mile of shoreline.

Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. Amendment filed 3-4-85; effective thirtieth day thereafter (Register 85, No.
10).

§ 7980. Review by Health Officer.

No persons shall begin con.struction, reconstrucfion or alteration of
any public beach sanitation facility without first submitting plans, speci-
fications and other such information, as may be required, to the Health
Officer for his review and written approval. If no action is taken within
fifteen (15) days of submission of plans, the project shall be deemed ap-
proved. If the Health Officer disapproves, the reason shall be so stated
in writing.

NOTE; Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1 . New NOTE filed 8-9-84 (Register 84. No. 32).

Article 3. Day Use Beaches

§7981. Application.

The provisions of this article shall be applicable to public beaches
where overnight camping is not permitted.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History

1 . New NOTE filed 8-9-84 (Register 84, No. 32).

§7982. Toilets.

Toilets shall conform to the State Plumbing Code, Part 5, Title 24, Cal-
ifornia Administrative Code. Portable toilets may be substituted for
plumbed toilets.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Sections 427.3, Health and Safety Code.

History

1. Amendment filed 3-4-85; effective thirtieth day thereafter (Register 85, No.
10).

§ 7983. Water Supply.

Water when provided for drinking, showers, or handwashing shall be
from a source approved by the Health Officer.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7984. Maintenance.

Toilets shall be available to the public at all times the beach is officially
open for use. All facilities must be maintained in a clean and sanitary con-
dition at all times.

NOTE; Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7985. Refuse Handling.

(a) Refuse containers approved by the Health Officer shall be provided
at all public beaches.

(b) All refuse shall be stored in the container in a manner which will
not create a nuisance.

(c) Containers shall be emptied at frequencies sufficient to prevent
overflow and to be maintained in a sanitary condifion.

(d) Every public beach shall be maintained in a clean condition free of

refuse.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History

1. New NOTE filed 8-9-84 (Register 84, No. 32).

§7985.1. Animals.

No person shall bring onto or allow any animal, except guide dogs
used by the blind, to remain on any beach which has been designated a

•

Page 122

Title 17

State Department of Health Services

§ 7990

public swimming beach by the state, or any city, county, or city and
county and where lifeguards are provided, except that horses may be rid-
den on designated equestrian trails and areas.

This regulation is not intended to prohibit or supersede any local ordi-
nance now in effect or which may be enacted.

NOTH: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

Hlstory

1. New section filed 8-3-73; effective thirtieth day thereafter (Register 73, No.
31).

2. Kditorial coirection of NOTE filed 8-9-84 (Register 84, No. 32).

§ 7986. Implementation.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. Repealer filed 3-4-85; effective thirtieth day thereafter (Register 85, No. 10).

Article 4. Beaches Allowing Overnight
Camping

§ 7987. Application.

The provisions of this article shall be applicable to public beaches used
for overnight camping.

NOTE: Authority cited: Secfions 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7988. Refuse Handling.

(a) Refuse containers approved by the Health Officer shall be provided
in every camping area.

(b) All refuse shall be stored and removed in a manner that will not
create a nuisance.

maintained in a clean and safe condition.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1 . New NOTE filed 8-9-84 (Register 84, No. 32).

§7988.1. Animals.

No person shall bring onto or allow any animal, except guide dogs
used by the blind, to remain on any beach which has been designated a
public swimming beach by the state, or any city, county, or city and
county and where lifeguards are provided, except that horses may be rid-
den on designated equestrian trails and areas.

This regulation is not intended to prohibit or supersede any local ordi-
nance now in effect or which may be enacted.

NotH: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History

1. New section filed 8-3-73; effective thirtieth day thereafter (Register 73, No.
31).

2. Editorial correction of NOTE filed 8-9-84 (Register 84, No. 32).

§ 7989. Campsites.

(a) No travel trailer, camp car, recreational vehicle or tent shall be lo-
cated closer than six feet from any building or other travel trailer, camp
car, recreational vehicle or tent on an adjacent lot or campsite.

(b) Each vehicular lot or campsite in a camping area shall have direct

access.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History

1. Editorial correcfion of NOTE filed 8-9-84 (Register 84, No. 32).

§ 7990. Sanitary Facilities.

(a) Toilets shall conform to the State Plumbing Code, Part 5, Title 24,
California Administrative Code.

(b) Shower baths or other bathing facilities are not required; however,
when provided, they shall conform to the State Plumbing Code, Part 5,
Title 24, California Administrative Code.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. Amendment filed 3^t-85; effective thirtieth day thereafter (Register 85, No.
10).

[The next page is 123.]

Page 122.1

Title 17

State Department of Health Services

§ 8006

§7991. Maintenance.

All sanitary facilities shall be maintained in a clean and safe condition.
NOTH: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History

1. New NOTK filed 8-9-84 (Register 84. No. 32).

§ 7992. Disposal of Sewage Wastes.

(a) Wastewater or material from plumbing fixtures shall not be per-
mitted to be deposited upon the ground.

(b) Campsites not provided with a drain inlet shall not be occupied by
a travel trailer, cannp car, or recreational vehicle equipped with plumbing
unless the drain outlet of the vehicle is capped or as otherwise provided
by part (c) of this section. Each campsite for use by vehicles equipped
with toilets, unless self-contained shall be provided with a three-inch
drain inlet.

(d) Trailer sanitation stations approved by the Health Officer and de-
signed to receive the discharge of sewage holding tanks of self-contained
vehicles shall be installed or available in an accessible location to every
public beach campground area in which there are campsites not provided
with drain inlets designed to receive the discharge of sewage wastes.
Trailer sanitation stations shall be provided on the basis of one station for
each 100 such campsites or portion thereof.

(e) Trailer sanitation stations shall be designed and constructed as re-
quired by Sections 5570 through 5580, Title 25, California Administra-
tive Code.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History

1 . New NOTE filed 8-9-84 (Register 84, No. 32).

§ 7993. Laundry Facilities.

Laundry facilities are not required; however, when provided they shall
conform to the State Plumbing Code, Part 5, Title 24, California Admin-
istrative Code.

Note: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. Amendment filed 3-4-85; effective thirtieth day thereafter (Register 85, No.
10).

§ 7994. Water Supply.

When provided, potable water shall be from a source approved by the
Health Officer and obtainable from faucets installed not more than 400
feet from each campsite. Potable water shall be adequate for all the re-
quirements of the camping area.

NOTE: Authority cited: Sections 208 and 427.3, Health and Safety Code. Refer-
ence: Section 427.3, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

Group 11. Food Crop Growing and
Harvesting Sanitation

Article 2. Definitions

§117-8001. Food Crop.

NOTE: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.21, Health and Safety Code.

History

1 . Amendment filed 6-12-70; effective thirtieth day thereafter (Resister 70. No.

24).

2. Repealer filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

§117-8002. Privacy.

NOTE; Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.25, Heakh and Safety Code.

History
1. Repealer filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

§ 8003. Toilet Facilities.

Toilet facilities include water flush toilets, chemical toilets, or sanitary
privies where lawful, in portable or fixed form.

NOTE: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.23, Health and Safety Code.

History

1. New NOTE filed 8-9-84 (Register 84, No. 32).

2. Editorial renumbering of former Section T17-8003 to Section 8003 (Register
85, No. 32).

Article 3. Toilet Facilities

§ 8004. General Standards.

Toilet facilities shall meet the following standards:

(a) Toilet facilities shall provide a minimum area of eight (8) square
feet, with a minimum width of two and one-half (2 1/2) feet for each toilet
seaL A minimum area often (10) square feet, with a minimum width of
two and one-half (2 1/2) feet, shall be required when a urinal is included.
Sufficient addifional space shall be included if handwashing facilities are
within the facility.

(b) Units housing toilet and handwashing facilities shall be rigidly
constructed and their inside surfaces shall be of nonabsorbent material,
smooth, readily cleanable, and finished in a light color.

(c) Units housing toilet and handwashing facilities shall be ventilated
and provided with self-closing doors, lockable from the inside.
NOTE: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.25, Health and Safety Code.

History
1. Renumbering and amendment of former Section T17-8004 to Section 8(X)4
filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

§ 8005. Chemical Toilet Standards.

The wastewater tank on chemical toilets shall be constructed of dura-
ble, easily cleanable material and have a minimum tank capacity of forty
gallons. Construction shall be such as to prevent splashing on the occu-
pant, field, or road.

NOTE: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Sections 5474.23 and 547.29, Health and Safety Code.

History
1. Renumbering and amendment of former Section T17-8005 to Section 8005
filed 8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

Article 1. intent of Regulations

Article 4. Servicing of Units

§ T1 7-8000. Intent of Regulations.

NOTE: Authority cited: Secdons 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.20, Health and Safety Code.

History

1. New Group 1 1 (Sections 8000 through 8013) filed 4-13-66; effective thirtieth
day thereafter (Register 66, No. 9).

2. Repealer of Article 1 (Section T17-8000) filed 8-6-85; effective thirtieth day
thereafter (Register 85, No. 32).

§ 8006. Suitable Chemicals.

Odor control and solid liquefying chemicals that are effective at all

times shall be used in chemical toilet waste holding tanks.

Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.29, Health and Safety Code.

History
1. Amendment filed 8-6-85; effective thirtieth day thereafter (Register 85, No.
32.)

Page 123

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§8007

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 8007. Disposal of Contents of Chemical Tanks.

Contents of chemical tanks shall be disposed of by draining or pump-
ing into a sanitary sewer, an approved septic tank of sufficient capacity
to handle the wastes, a suitably sized and constructed holding tank, ap-
proved by the local health department, or by any other method approved
by the local health department.

NOTI-: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.25, Health and Safety Coile.

History

1. New NOTE filed 8-9-84 (Register 84, No 32).

§ 8008. Standards.

Handwashing facilities shall meet the following standards:

(a) Pure, wholesome, and potable water shall be available for hand-
washing.

(b) Signs shall be posted, indicating that the water is only for hand-
washing purposes.

(d) Handwashing facilities shall be provided at the unit or in the imme-
diate vicinity.

Note: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.26, Health and Safety Code.

History
1 . Repealer of former Section 8008, and renumbering and amendment of former

Section 8012 to Section 8008 filed 8-6-85; effective thirtieth day thereafter

(Register 85, No. 32).

§ 8009. Privies.

Privies shall be moved to a new site or taken out of service when the
pit is filled to within two feet of the adjacent ground surface. The pit con-
tents shall be covered with at least two feet of well-compacted dirt when
the privy is moved.

NOTE: Authority cited: Sections 208 and 5474.29. Health and Safety Code. Refer-
ence: Section 5474.25, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

§8010. Toilets.

It shall be the responsibility of the employer to insure that toilets are
serviced and maintained in a clean, sanitary condition and kept in good
repair at all times.

NOTE; Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.25, Health and Safety Code.

History
1. New NOTE filed 8-9-84 (Register 84, No. 32).

Article 5. Supplies

§ 8011 . Toilet Paperholder.

Toilet paper shall be provided in a suitable holder in each toilet unit.
NOTE: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Secfion 5474.25, Health and Safety Code.

History
1. Amendment filed 8-6-85; effective thirtieth day thereafter (Register 85, No.

32).

Article 6. Handwashing Facilities

§8012. Standards.

NOTE: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.26, Health and Safety Code.

History
1. Renumbering and amendment of Section T17-8012 to Section 8008 filed
8-6-85; effective thirtieth day thereafter (Register 85, No. 32).

Article 7. Waste Wash Water Disposal

§ 8013. Water Flush Toilets and Handwashing Facilities. .

Water flush toilets and handwashing facilities shall conform to the
(Compiled) State Building Standards Code, Part 5, Title 24, California
Administrative Code.

NOTE: Authority cited: Sections 208 and 5474.29, Health and Safety Code. Refer-
ence: Section 5474.25. Health and Safety Code.

History

1 . Repealer and new section filed 8-6-85; effective thirtieth day thereafter (Regis-
ter 85, No. 32).

Group 12. Reclaimed Waste Water

§ 8025. Intent.

NOTE: Authority cited for Group 12: Section 102, Health and Safety Code. Refer-
ence: Section 13521, Water Code.

History

1. New Group 12 (Sections 8025 through 8050) filed 5-20-68; effective thirtieth
day thereafter (Register 68, No. 20).

2. Repealer of Group 12 (Sections 8025-8050) filed 4-2-75; effective thirtieth
day thereafter (Register 75, No. 14).

Subchapter 1.5. Regulations for

Implementation of the California

Environmental Quality Act of 1970

(Originally Printed 7-21-73)

NOTE: Authority cited: Section 208, Health and Safety Code, and Secfion 21082,
Public Resources Code. Reference: Section 2 1 000 et seq.. Public Resources Code.

History

1. New Subchapter 1 .5 (Sections 8100-8113.5) filed 7-2^ -73; effective thirtieth
day thereafter (Register 73, No. 29).

2. Amendment filed 1 1-21-79; effective thirtieth day thereafter (Register 79, No.
47).

3. Repealer of Subchapter 1 .5 (Sections 8100-81 13.5) filed 10-12-83; effecfive
thirtieth day thereafter (Register 83, No. 42).

Subchapter 2. Foods and Drugs

Group 1. Rules and Regulations

§ 1 01 01 . Order Promulgating Regulations.

Under the authority of Sections 200 through 208, 26321, 26542,
28013, 28153, 28182, 28243, 28339, 28440, 28508, 28663.5 and 28709
of the Health and Safety Code, and Section 1147 of the Agricultural
Code, the following regulations for the enforcement of Division 21 of the
Health and Safety Code are hereby promulgated.

These regulations shall take effect on September 1, 1954.

The regulations now in force are hereby repealed as of the date the new
regulations herein promulgated shall become effective.

NOTE: Authority cited for subchapter 2 filed 7-29-54: Secfions 200 through 208,
26321, 26542, 28013, 28153, 28182, 28243, 28339, 28440, 28508. 28663.5,
28709, Health and Safety Code, and Secfion 1147, Agricultural Code.

History

1. Originally printed August 15, 1945 (Title 17).

2. For repealers, added sections, amendments and revisions of former subchapter
2, refer to Registers 8, No. 3; 10, No. 6; 13, No. 2; 16, No. 5; 17, No. 2; 18, No.
4; 19, No. 2; 20, No. 1; and 26, No. 3.

3. Repealer and new subchapter 2 filed 7-29-54; designated effective 9-1-54
(Register 54, No. 16).

§ 10102. General Regulations.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

Page 124

(4-1-90)

Title 17

State Department of Health Services

§ 10375

•

§10103. Constitutionality.

If any section, subsection, clause, sentence, or phrase of these regula-
tions or standards is for any reason held to be invalid or unconstitutional,
such decision shall not affect the remaining portions of these regulations
or standards. The State Board of Public Health hereby declares that it
would have adopted the remaining portions of these regulations or stan-
dards irrespective of the fact, that any such section, subsection, clause,
sentence, or phrase of these regulations or standards be declared invalid
or unconstitutional.

§10150. Cosmetic Regulations.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 33).

by 5-1-97 or emergency language will be repealed by operation of law on the
following day.

2. New article 1 (section 10200) and section refiled 4-29-97 as an emergency; op-
erative 5-2-97 (Register 97, No. 18). A Certificate of Compliance must be
transmitted to OAL by 9-2-97 or emergency language will be repealed by oper-
ation of law on the following day.

3. Certificate of Compliance as to 4-29-97 order transmitted to OAL 8-28-97 and
filed 10-9-97 (Register 97, No. 41 ).

Article 1. Definitions

§10200. Dietary Supplement.

(a) "Dietary supplement"

( 1 ) Means an article (other than tobacco) intended to supplement the
diet that bears or contains one or more of the following dietary ingredi-
ents:

(A) A vitamin,

(B) A mineral,

(D) An amino acid,

(E) A dietary substance for use by humans to supplement the diet by
increasing the total dietary intake, or

(F) A concentrate, metabolite, constituent, extract, or combination of
any ingredient described in clause (A), (B), (C), (D), or (E);

(2) Means a product that

(A) Is labeled as a dietary supplement and

(B) Is intended for ingestion in tablet, capsule, powder, softgel, gelcap,
or liquid form, or if not intended for ingestion in such a form

(3) Does

(A) Include an article that is approved as a new drug in compliance
with Health and Safety Code section 1 1 1 550, subdivision (a) or (b), certi-
fied as an antibiotic under the Federal Food, Drug, and Cosmetic Act, 2 1
U.S.C. section 357, and/or licensed as a biologic under the Public Health
and Safety Act, 42 U.S.C. section 262 and was, prior to such approval,
certification, or license, marketed as a dietary supplement or as a food,
unless the article, when used as or in a dietary supplement under the con-
ditions of use set forth in the labeling for such dietary supplement is adul-
terated under California Health and Safety Code section 1 10545, and

(B) Not include

1. An article that is approved as a new drug in compliance with Health
and Safety Code section 1 1 1 550, subdivision (a) or (b), certified as an an-
tibiotic under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. sec-
tion 357, and/or licensed as a biologic under the Public Health and Safety
Act, 42 U.S.C, section 262, or

2. An article authorized for investigation as a new drug, antibiotic, or
biologic for which substantial clinical investigations have been instituted
and for which the existence of such investigations has been made public,
and which was not, before its approval, certification, licensing, or autho-
rization, marketed as a dietary supplement.

(b) A dietary supplement may be a food or a drug, or both a food and
a drug, as these terms are defined in Health and Safety code sections
109935 and 109925.

Note: Authority cited: Sections 100275, 1 10065 and 1 10100, Health and Safety
Code. Reference: Secfions 110175, 110290, 110545, 110620, 110625, 110630,
1 10660. 1 10705, 1 10760, 1 10765 and 1 10770, Health and Safety Code.

History
1. New article 1 (section 10200) and section filed 10-15-96; operative 1-1-97
(Register 96, No. 42). A Certificate of Compliance must be transmitted to OAL

Article 2. Drugs and Devices Regulations

DRUGS AND DEVICES

§ 10350. Labeling Defined (26207).

History
1. Repealer filed 9-1-78; effecUve thirtieth day thereafter ( Register 78, No. 35).

§ 1 0355. Truth of Labeling (26208).

HlSTOI^Y
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).

§10360. New Drugs— Definition.

Newness of a drug may arise by reason (among other reasons) of:

(a) The newness for drug use of any substance which composes such
drug, in whole or in part, whether it be an active substance or a men-
struum, excipient, carrier, coating, or other component;

(b) The newness for drug use of a combination of two or more sub-
stances, none of which is a new drug;

(c) The newness for drug use of the proportion of a substance in a com-
bination, even though such combination containing such substance in
other proportion is not a new drug;

(d) The newness of use of such drug in diagnosing, curing, mitigating,
treating, or preventing a disease, or to affect a structure or function of the
body, even though such drug is not a new drug when used in another dis-
ease or to affect another structure or function of the body; or

(e) The newness of a dosage, or method or duration of administration
or application, or other condition of use prescribed, recommended, or
suggested in the labeling of such drug, even though such drug when used
in other dosage, or other method or duration of administration or applica-
tion, or different condition, is not a new drug.

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Section 26021, Health and Safety Code.

History

1. Amendment filed 6-27-60; effecfive thirtieth day thereafter (Register 60, No.
15).

2. Amendment of section heading and repealer of subsecfion (f) filed 12-17-85;
effective thirtieth day thereafter (Register 85, No. 51).

§ 1 0365. Drugs— Name (26230).

History

1 . Repealer filed 1 2-1 7-85; effective thirtieth day thereafter ( Regi.ster 85, No. 5 1 ).

§ 10370. Poisonous Insecticides and Rodenticides, Use of
(26234(2)).

History
1. Repealer filed 9-1-78; effecfive thirtieth day thereafter (Register 78, No. 35).

§ 10371. Drugs: Current Good Manufacturing Practice in
Manufacture, Processing, Packaging, Labeling
or Holding (26234(3)).

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Section 26234(3), Health and Safety Code.

History

1 . New section filed 1-3-66; effective thirtieth day thereafter (Register 66. No. 1 ).

2. Repealer filed 9-1-78; effecUve thirtieth day thereafter (Register 78. No. 35).

§ 1 0375. Blending of Certified Coal Tar Colors (26235 (2)).

History

1. Amendment filed 8-17-56; effecfive thirtieth dav thereafter (Register 56. No.
16).

2. Repealer filed 12-1 7-85; effecfive thirtieth day thereafter (Register 85. No. 5 1 ).

Page 125

§ 10376

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 10376. Drug and Device Manufacturing Licenses.

(a) The fee for a manufacturer's license as required by Sections 26685
and 26688 of the Health and Safety Code is $200.00 and will cover a peri-
od of 12 months. The license is not transferable and will not be prorated.

(h) Manufactur-ers of human prescription daigs shall pay an additional
license fee of $100.00 per year, plus the fingerprint processing fee
charged by the California Department of Justice.

(c) Application for Drug Manufacturing License shall be made on
State Department of Health form #EH-52 (Rev. 4/93). Applications for
a Device Manufacturing License shall be made on State Department of
Health form #EH-72.

(d) Applications for a Drug Manufacturing License shall include the
following information on or attached to the application form:

( 1 ) The name of the license applicant, and the full business address and
telephone number of the manufacturing facility;

(2) All trade or business names used by the license applicant;

(3) Name{s) of the person(s) in charge of manufacturing;

(4) Name, address and telephone number of the person responsible for
correspondence;

(5) The type of ownership or operation (for example, partnership, as-
sociation, corporation, or individual/sole proprietorship);

(6) The name(s) of the owner and/or operator of the license applicant,
including:

(A) If an individual, the name of the indi\ idual; if a sole proprietorship,
the name of the sole proprietor and the name of the business entity;

(B) If a partnership or other unincorporated association, the name of
each partner or member, and name of the partnership or association;

(C) If a corporation, the corporate name, and the state of incorporation,
the name and title of each corporate officer and director; and

(D) The name of each person holding more than 5 percent equity, or
debt liability of the applicant.

(7) Types of products to be manufactured;

(8) Type of processing to be utilized;

(9) Signature of license applicant under penalty of perjury affirming
that the information in the application is true and accurate;

(10) Printed name and title of the individual signing the application;

(11) Date appUcation was signed; and

(12) For human prescription drug manufacturers only:

(A) properly completed Disclosure Statement (form #EH-53 (rev.
4/93)), two properly completed fingerprint cards, and fingerprint pro-
cessing fee for each person in charge of manufacturing and each person
whose name is required to be included in the license application under
Paragraphs (d)(6)(A) through (d)(6)(C). However, where the license
applicant is a corporation, partnership, or other business association and
the total number of partners, members, or corporate officers, directors,
and shareholders (as the case may be) exceeds five, the application shall
so state, and the documents and fee described in this Paragraph shall only
be submitted for each person in charge of manufacturing, and

1. For corporadons: of the corporate officers who reside in California,
or who reside outside California, but are involved in the roufine opera-
tions of the manufacturing facility, the documents and fee shall be sub-
mitted for each of the five highest ranking officers in this group, and

2. For partnerships, joint ventures, and similar business associafion: of
the partners or members who reside in California, or who reside outside
California, but are involved in the roudne operations of the manufactur-
ing facility, the documents and fee shall be submitted for each of the five
persons in this group who own the largest interests in the applicant entity.

(B) Fingerprint cards and fingerprint prcessing fee shall only be sub-
mitted once for each person. If there is a change of any person in charge
of manufacturing or any person occupying a position listed in Paragraphs
(d)(6)(A) through (d)(6)(C), fingerprint cards and processing fee shall be
submitted for each new or additional person.

(C) Other persons listed in Paragraph (d)(6) may be required by the
Department to submit the documents described in this Paragraph as nec-
essary to determine the qualificafions of the applicant.

(e) Within 30 calendar days of receipt of a drug manufacturing license
applicafion, the Department shall inform the applicant in writing that it
is either complete and accepted for filing or that the application is defi-
cient and what specific information or documentation is required to com-
plete the applicafion. An application is considered complete when all in-
formation, documents, and fees required in this Section have been
received by the Department.

(f) Within 240 calendar days from the date of filing of a completed
drug manufacturing license application, the Department shall inform the
applicant in wrifing of its decision regarding a drug manufacturing li-
cense application. The median time for the Department to process a drug
manufacturing license application from acceptance of the initial applica-
fion to the final license decision has been 29 calendar days; the minimum
dme was one calendar day; the maximum fime was 919 calendar days.
NOTK: Authority cited: Section 1.S376, Government Code and Sections 102, 208,
26202, 26209 and 26688, Health and Safety Code. Reference: Sections 26685,
26687, 26688 and 26689, Health and Safety Code.

History

1 . New section filed 3-16-69 as an emergency; designated effective 7-1-69 (Reg-
ister 69, No. 20).

2. Certificate of Compliance— section 1 1422.1, Gov. Code, filed 7-29-69 (Regis-
ter 69, No. 31).

3. Amendment filed 7-21-76; effective thirtieth day thereafter (Register 76, No.
30).

4. Amendment of section heading, new subsection (b) and renumbering and
amendment of following paragraph and repealer of subsections (c)-(d) and new
subsections (d)-(f) and amendment of Note filed 9-25-92 as an emergency;
operative 9-25-92 (Register 92, No. 39). A Certificate of Compliance niust be
transmitted to OAL 1-25-93 or emergency language will be repealed by opera-
tion of law on the following day.

5. Amendment refiled I -20-93 as an emergency; operative 1-26-93 (Register 93,
No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or
emergency language will be repealed by operation of law on the following day.

6. Editorial correction of History 5. (Register 93, No. 20).

7. Certificate of Compliance as to 1-20-93 order including amendment of subsec-
tions (c) and (d)(12)(A), and repealer and new subsections (d)(12)(A)l.-2.
transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, Kr,. 28).

§10377. Definitions.

(a) The definifions set forth in this Secfion apply to Sections 10376
through 10377.8 only.

(b) Blood means whole blood collected from a single donor and pro-
cessed either for transfusion or further manufacturing.

(d) Controlled Substance means, unless otherwise specified, a drug,
substance, or immediate precursor which is listed in any schedule in
Health and Safety Code Sections 1 1054, 1 1055, 1 1056, 1 1057, or 1 1058,
or which is regulated as a controlled substance under the Controlled Sub-
stances Act (21 U.S.C. § 801 et seq.) or the Controlled Substances Im-
port and Export Act (21 U.S.C. § 951 et seq.).

(e) Drug sample means a unit of a human prescripfion drug that is not
intended to be sold and is intended to promote the sale of the drug.

(f) Human prescripfion drug means any drug intended for human use
required by State law to be dispensed only by a prescripfion, including
finished dosage forms and acfive ingredients subject to Section 26660 of
the Health and Safety Code.

(g) Acfive ingredient means any component that is intended to furnish
pharmacological acfivity or other direct effect in the diagnosis, cure, mit-
igafion, treatment, or prevenfion of disease, or to affect the structure of
any funcfion of the body of man, including those components that may
undergo chemical change in the manufacture of the drug product and be
present in the drug product in a modified form intended to furnish the spe-
cified activity or effect.

(h) Component means any ingredient intended for use in the manufac-
ture of a drug product, including those that may not appear in the drug
product.

(i) Manufacturer means any person who prepares, compounds, propa-
gates, processes, or fabricates any drug. The term manufacturer includes

Page 126

Title 17

State Department of Health Services

§ 10377.4

anyone who repackages or otherwise changes the container, wrapper, or
laheHng of any drug in furtherance of the distribution of the dmg. The
term manufacturer does not include:

( 1 ) A retailer who repackages from a bulk container at the time of sale
to its ultimate consumer; or

( 2) Anyone who sells, purchases, or trades blood or blood components
intended for transfusion, provided that the blood or blood components
are prepared using physical or mechanical means, not chemical pro-
cesses.

(j ) Transfusion means a use of blood or blood components in which the
blood or blood components are administered into a vein of a human being
for treatment of disease, including physical injury.
NOTIi: Authority cited: Sections 102, 208 and 26202, Health and Safety Code.
Reference: Section.s 26209, 26685, 26686 and 26688, Health and Safety Code.

History

1 . New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92,
No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-20-93 as an emergency; operative 1 -26-93 (Register 93,
No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or
emergency language will be repealed by operation of law on the following day.

3. Hditorial correction of History 2. (Register 93, No. 20).

4. Editorial correction of printing error in subsection (e) (Register 93, No. 28).

5. Certificate of Compliance as to 1-20-93 order includins amendment of subsec-
tion (d) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§ 1 0377.1 . Qualifications.

(a) A license to manufacture human prescription drugs may be denied
on the ground that the license applicant is not qualified by reason of the
applicant's experience to manufacture and distribute human prescription
drugs in a safe manner and in compliance with federal, state, and local
drug laws. In the case of a partnership, association, or corporation, an
applicant's experience includes the experience of each person whose
name is required to be included in the license application. An applicant's
experience includes, but is not limited to, the following factors:

(1) Any conviction of the applicant under any federal, state, or local
laws relating to drugs, including drug samples, wholesale or retail drug
distribution, or distribution of controlled substances;

(2) Any felony conviction of the applicant under federal, state, or local
laws which is substantially or rationally related to the qualifications,
functions, and duties of a licensed human prescription drug manufactur-
er; a crime shall be considered substantially or rationally related to quah-
fications. functions, or duties of human prescription drug manufacturer
if, reasonably or to a substantial degree, it evidences present or potential
unfitness of a licensee to perform the functions authorized by the license
in a manner consistent with the public health, safety, or welfare.

(3) The applicant's past experience in the manufacture or distribution
of drugs, including controlled substances;

(4) The furnishing by the applicant of false or fraudulent material in
any application made in connection with drug manufacturing or distribu-
tion;

(5) Suspension or revocation by federal, state, or local government of
any license or permit currently or previously held by the applicant for the
manufacture or distribution of any drugs, including controlled sub-
stances;

(6) Compliance with licensing requirements under drug or device li-
censes previously granted by the Department, if any;

(7) Compliance with requirements to maintain and/or make available
to the Department those records required under the Sherman Food, Drug,
and Cosmetic Law (Health and Saf. Code § 26000 et seq.) and the regula-
tions adopted pursuant to that law;

(8) Compliance with requirements to make available to federal, state,
or local law enforcement officials those records described in 21 Code of
Federal Regulations section 205.50 (55 Fed. Reg. 38025-38026 (Sept.
14. 1990)); and

(9) History of addiction or habitual use of any controlled substance,
narcotic, prescription drug, or alcoholic beverage.

(b) As used in subsection (a), "conviction" includes a plea, verdict, or
finding of guilt regardless of whether sentence has been imposed, but
does not include:

(1 ) any conviction for an offense specified in subdivision (a) or (b) of
Health and Safety Code Section 1 1361.5 which became final more than
two years prior to the date of the license application, or

(2) any conviction under Health and Safety Code Section 1 1557 or its
successor Section 1 1366 when that conviction was stipulated or desig-
nated to be a lesser included offense of the offense of possession of mari-
juana;

(c) The Department may deny a license to a license applicant if it deter-
mines that the granting of such a license would not be in the public inter-
est, based on factors which are substantially or rationally related to pro-
tecting the public from adulterated or misbranded human prescription
drugs.

NOTli: Authority cited: Sections 102, 208, 26202 and 26209, Health and Safct\
Code. Reference: Sections 26611, 26612. 26689 and 26691, Health and Safety
Code.

History

1. New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92.
No. 39). A Certificate of Compliance must be transmitted to OAL 1-25 93 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-20-93 as an emergency; operative 1 -26-93 ( Register 93.
No. 4). A Certificate of Compliance must be transmitted to OAL 5-26 93 or
emergency language will be repealed by operation of law on the following day.

3. Editorial correction of History 2. (Register 93, No. 20).

4. Editorial correction of printing error in subsection (a)(6) (Register 93, No. 28).

5. Certificate of Compliance as to 1-20-93 order including new subsections
(b)-(b)(2) and subsection relettering, transmitted to OAL 5-26-93 and filed
7-8-93 (Register 93, No. 28).

§ 10377.2. Revocation and Suspension.

(a) Any conviction of any violation of federal, state, or local drug laws
shall be grounds for suspending or revoking a license to manufacture hu-
man prescription drugs.

(b) Any action or conduct which would have warranted denial of a li-
cense to manufacture human prescription drugs shall be grounds for sus-
pending or revoking a license to manufacture human prescription drugs.
NOTE: Authority cited: Sections 102, 208 and 26202, Health and Safety Code.
Reference: Sections 26688, 26689, 26691 and 26801, Health and Safety Code.

History

1. New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92,
No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Register93,
No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or
emergency language will be repealed by operation of law on the following day.

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and
filed 7-8-93 (Register 93, No. 28).

§10377.3. Compliance.

Human prescription drug manufacturers and their officers, agents,
representafives, and employees shall comply with the requirements of
Sections 10377.4, 10377.5, 10377.6, 10377.7, and 10377.8 relating to
human prescription drugs.

NOTE: Authority cited; Sections 102, 208, 26202 and 26209. Health and Safety
Code. Reference: Secfions 2661 1, 26612 and 26689, Health and Safety Code.

History

1. New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92.
No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or
emergency language will be repealed by operation of law on the following day.

3. Editorial correction of History 2. (Register 93. No. 20).

4. Certificate of Compliance as to 1-20-93 order transmitted to OAL 5 26 93 and
filed 7-8-93 (Register 93, No. 28).

§ 10377.4. Requirements for the Storage and Handling of
Human Prescription Drugs.

(a) All facilities at which human prescription manufacturers manufac-
ture, store, warehouse, handle, offer, market, display, or othcrw ise hold

Page 126.1

§ 10377.5

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

human prescription drugs shall be secure from unauthorized entry and
shall have adequate security conditions, as follows:

( 1 ) Access from outside the premises shall be kept to a minimum and
be well-controlled;

(2) The outside perimeter of the premises shall be well-lighted; and

(3) Entry into areas where human prescription drugs are held shall be
limited to authorized personnel.

(b) All such facilities shall be equipped with an alarm system to detect
entry after hours.

(c) All such facilities shall be equipped with an alarm system that will
provide suitable protection against theft and diversion. When appropri-
ate, the security system shall provide protection against theft or diversion
that is facilitated or hidden by tampering with computers or electronic re-
cords.

(d) Each outgoing shipment of human prescription drugs shall be care-
fully inspected for identity of the human prescription drugs and to ensure
that there is no delivery of human prescription drugs that have been dam-
aged in storage or held under improper conditions. Records of noncon-
forming drugs and their disposition shall be established and maintained,
and shall include the name and label potency of the drug product, dosage
form, lot number, quantity, reason for nonconformance, name of the in-
spector, date of inspection, and disposition.

(e) Human prescription drugs manufactured by the licensee, which are
outdated, damaged, deteriorated, misbranded, or adulterated, shall be
quarantined and physically separated from other prescription drugs until
they are destroyed or brought into compliance with all applicable laws
by reprocessing or relabeling. Records of drugs quarantined shall be es-
tablished and maintained, and shall include the name and label potency
of the quarantined drug product, dosage form, lot number, reason for the
quarantine, name of the person responsible for the quarantine, location
of quarantined drug product, date of disposition, and ultimate disposition
of the quarantined drug product.

NOTH: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety
Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

History

1. New section filed 9-23-92 as an emergency; operative 9-25-92 (Register 92,
No. 39). A Certificate of Comphance must be transmitted to OAL 1-25-93 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93,
No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or
emergency language will be repealed by operation of law on the following day.

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order including amendment of subsec-
fion (a) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).

§ 1 0377.5. Requirements for the Establishment and
Maintenance of Human Prescription Drug
Records.

(a) Human prescription drug manufacturers shall establish and main-
tain inventories and records of all transactions regarding the disposal of
human prescription drugs. These records shall include the following in-
formation:

( 1 ) The identity and quantity of the human prescription drugs disposed
of; and

(2) The dates of disposal of the human prescription drugs.

(b) Inventories and records of receipt, distribution, disposal, and other
disposition of human prescription drugs, including records described in
Section 10377.4(d) and (e), shall be made available for inspection and
photocopying by the Department or any authorized federal, state, or local
law enforcement agency officials for a period of at least three years fol-
lowing distribution, disposal, or other disposition.

(c) Inventories and records of receipt, distribution, disposal, and other
disposition of human prescription drugs, including records described in
Section 10377.4(d) and (e), that are kept at the inspection site or that can
be immediately retrieved by computer or other electronic means shall be
readily available for authorized inspection during the retention period.
Records kept at a central location apart from the inspection site and not

electronically retrievable shall be made available for inspection as soon
as possible, but no later than two working days after a request by an au-
thorized official of a federal, state, or local law enforcement agency.

(d) Human prescription drug manufacturers shall establish and main-
tain lists of officers, directors, managers, and other persons in charge of
human prescription drug manufacturing, distribution, storage, and han-
dling, including a description of their duties and a summary of their quali-
fications.

NOTE; Authority cited; Sections 102. 208, 26202 and 26209. Health and Safety
Code. Reference: Sections 2661 1. 26612 and 26689. Health and Safely Code.

History

1 . New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92.
No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93.
No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or
emergency language will be repealed by operation of law on the following day.

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order including amendment of subsec-
tion (b) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93. No. 28).

§ 1 0377.6. Written Policies and Procedures for the
Handling of Human Prescription Drugs.

(a) Human prescription drug manufacturers shall establish, maintain,
and adhere to written policies and procedures, which shall be followed
for the security and disposition of human prescription drugs including
policies and procedures for identifying, recording, and reporting losses
or thefts, and for correcting all errors and inaccuracies in inventories.

(b) Human prescription drug manufacturers shall include in their writ-
ten policies and procedures the following:

(1) A procedure to be followed for handling recalls and withdrawals
of human prescription drugs. This procedure shall be adequate to deal
with recalls and withdrawals due to:

(A) Any action initiated at the request of the Department, the federal
Food and Drug Administration or other federal, state, or local '?w en-
forcement or other government agency;

(B) Any voluntary action by the manufacturer to remove defective or
potentially defective human prescription drugs from the market; or

(C) Any action undertaken to promote public health and safety by re-
placing existing merchandise with an improved product or new package
design;

(2) A procedure to ensure that the manufacturer is prepared for, pro-
tected against, and is ready to handle any crisis that affects security or op-
eration of any facility in the event of fire, flood, or other natural disaster,
or strike or other situations of local, state or national emergency; and

(3) A procedure to ensure that any outdated human prescription drugs
shall be segregated from other drugs and destroyed. This procedure shall
provide for written documentation of the disposition of outdated human
prescription drugs. This documentation shall be maintained for at least
three years after disposition of the outdated human prescription drugs.
NOTE: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety
Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

History

1. New section filed 9-25-92 as an emergency; operafive 9-25-92 (Register 92,
No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93,
No. 4). A Certificate of Compliance must be transmitted to OAL 5-26-93 or
emergency language will be repealed by operation of law on the following day.

3. Editorial correcfion of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1 -20-93 order transmitted to OAL 5-26-93 and
filed 7-8-93 (Register 93, No. 28).

§ 10377.7. Inspection by Federal, State, and Local Law
Enforcement Officials.

Human prescription drug manufacturers shall permit authorized fed-
eral, state, and local law enforcement officials to enter and inspect their
premises and deUvery vehicles, and to audit their records and written op-
erating procedures, during business hours or any other reasonable times
and in a reasonable manner, to the extent authorized by law.

Page 126.2

Title 17 State Department of Health Services § 10377.7

NoTIi: Authority cited: Sections 102. 208 and 26202, Health and Safety Code. 2. New section refiled 1-20-93 as an emergency; operative 1-26-93 (Registcr4.3,

Reference: Section 26689, Health and Safety Code. No. 4). A Certificate of Compliance must be transmitted to OAL 5-26 93 or

History emergency language will be repealed by operation of law on the following day.

1 . New section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, ^- Editorial correction of History 2. (Register 93, No. 20).

No. 39). A Certificate of Compliance must be transmitted to OAL 1-25-93 or 4. Certificate of Comphance as to 1-20-93 order transmitted to OAL 5-26 -93 and

emergency language will be repealed by operation of law on the following day. filed 7-8-93 (Register 93, No. 28).

[The next page is 126.3.]

Page 126.2(a) Register 97, No. 18; 5-2-97

Title 17

State Department of Health Services

§ 10390

•

§ 1 0377.8. Manufacturers of Active Ingredient Components
of Human Prescription Drugs.

(a) In addition to the regulations in this article, manufacturers of any
active ingredient component of a human prescription drug shall comply
with the following sections of Code of Federal Regulations, title 21. part
2 i 1 (revised as of April 1 , 1992), except that all references to "drug prod-
uct" shall apply to active ingredient components: sections 21 1.25 (Per-
sonnel qualifications), 21 1.28 (Personnel responsibilities), 21 1.42 (De-
sign and construction features), 21 1.44 (Lighting). 21 1.46 (Ventilation,
air filtration, air heating and cooling). 21 1.48(a) [first sentence] and (b)
(Plumbing). 21 1.50 (Sewage and refuse). 21 1 .52 (Washing and toilet fa-
cilities). 21 1.56 (Sanitation). 21 1.58(Maintenance). 2 11. 63 (Equipment
design, si/e. and location), 211.65 (Equipment construction), 211.67
(Equipment cleaning and maintenance), 211.68 (Automatic, mechani-
cal, and electronic equipment). 211.142 (Warehousing procedures),
21 1.150 (Distribution procedures), 211. 180(a), (c). (d), and (f) (General
requirements), 211.182 (Equipment cleaning and use logs), 211.196
(Distribution records), 21 1.204 (Returned drug products), and 21 1.208
(Drug product salvaging).

(b) In the event that it is impossible for a manufacturer of a biological
dmg to comply with both this section and the federal regulations for the
manufacture of biologic drugs, this section shall not apply to the extent
that it conflicts with a federal regulation specifically applicable to the bi-
ological drug product in question.

NOTI-.: Authority cited: Sections 102, 208, 26202 and 26209. Health and Safety
Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.

History

3. Editorial correction of History 2. (Register 93, No. 20).

4. Certificate of Compliance as to 1-20-93 order including amendment of newly
desienated subsection (a) and new subsection (b) transmitted to OAL 5-26-93
and filed 7-8-93 (Register 93, No. 28).

§ 10380. Labeling, Misbranding (26240).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10381. Label Non-Prescription Drugs.
Pregnancy/Nursing.

(a) Any drug not subject to Section 26660 of the Health and Safety
Code which is intended for systemic absorption into the human body
shall include on the label the following statement:

"Caution: If pregnant or nursing a baby, consult your physician or
pharmacist before using this product."

(b) Section 10381(a) shall not apply if such drug:

(1 ) Is intended for poison control purposes.

(2) Is labeled with information regarding use in pregnancy and nursing
which is substantially similar to the statement required by Section
10381(a).

(3) Meets both of the following:

(A) It is intended to benefit the embryo, fetus or nursing infant during
the period of pregnancy or lactation.

(B) It is labeled with specific directions for use during the period of
pregnancy or lactation pursuant to federal or state requirements.

(4) Is not intended to be systemically absorbed.

(5) Is oxygen intended for emergency use.

(c) Any drug manufactured and labeled after 1 1-18-82 shall be mis-
branded if the information required by this section is not disclosed on the
label.

NoTH: Authority cited: Sections 208 and 26202. Health and Safety Code. Refer-
ence: Sections 26400. 26630 and 26638, Health and Safety Code.

History
1. New section filed 10-19-81; effective thirtieth day thereafter (Register 8 L No.
43).

2. Kdilorial collection of subsection (c) (Register 82. No. 3).

§ 1 0385. Labeling Requirements (26241 ).

History

L Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10386. Manufacturer of Finished Dosage Form.

The intent of this section is to assure that the advertising and labeling
required by Section 26636(c) of the code provides .sufficient useful infor-
mation to pharmacists, physicians, and other purchasers of prescription
drugs that they may identify certain persons participating in the manufac-
turing of the finished dosage form of such drug(s). These regulations are
in addition to the regulations of other sections of the Sherman Food.
Drug, and Cosmetic Law regarding labeling and advertising require-
ments for drugs.

(a) For the purpose of this section the finished dosage form of a pre-
scription drug is defined as that form of the drug which is or is intended
to be dispensed or administered to the patient and requires no further
manufacturing or processing other than packaging and labeling.

(b) For the purpose of this section only, the term "drug" shall include
only those articles as defined in Section 26010 of the Act which achieve
their principal intended purposes through chemical action within or on
the body of man or other animals or which are metabolized in the
achievement of these purposes.

(c) For the purpose of this section the term "manufacturer" means per-
sons who "manufacture" as that term is defined by Section 26019 of the
Health and Safety Code.

(d) For the purpose of this section the term advertisement shall have
the same definition as Section 26002 of the Health and Safety Code.

(e) The labeling and advertising for any prescription drug, including
those whose label states "distributed by . . ." or similar language, must
contain the name and place of business of the manufacturer who mixed
the final ingredients, and the manufacturer who encapsulated (if in cap-
sule form) or tableted (if in tablet form) the finished dosage form, quali-
fied by such phrases as "final ingredients mixed by . . .." "encapsulated
by. . ..""tableted by . . .," or words of similar or like meaning that express
the facts. The presence of the name and address of only one manufacturer
shall mean that only the named firm mixed the final ingredients and en-
capsulated (if in capsule form) or tableted (if in tablet form) the finished
dosage form.

(f) The requirement for declaration of the name of the manufacturer
of the finished dosage form shall be deemed to be safisfied in the case of
a corporation only by the actual corporate name which may be preceded
or followed by the name of the particular division of the corporation. Ab-
breviations for "Company," "Incorporated," etc., may be used and "The"
may be omitted. In the case of an individual, partnership, or association,
the name under which the business is conducted shall be used. The state-
ment of the place of business shall include the street address, city, state,
and zip code: however, the street address may be omitted if it is shown
in a current city directory or telephone directory.

(g) For the purposes of this section, all products subject to this section
will be deemed to be misbranded if the name and place of business of
each manufacturer as described in the foregoing subsections of this regu-
lation is not included in the labeling on, or within the package from which
the drug is dispensed and in all advertising of such product intended pri-
marily for disseminafion to California practitioners.

NOTE: Authority cited: Sections 208 and 26202. Health and Safety Code. Refer-
ence: Section 26636, Health and Safety Code.

History

1. New section filed 6-28-73; effective thirtieth day thereafter (Register 73. No.
26).

2. Amendment filed 1 2-1 7-85; effecfive thirtieth day thereafter ( Register 85. No.
51).

§ 10390. Forms of Making Required Statements (26242).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

Page 126.3

§ 10395

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 10395. Statements of Ingredients and Proportions
(26243).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56. No. 16.

§ 1 0400. Hoxsey IVlethod for Treatment of Cancer.

(a) The Hoxsey method is a cancer treatment system which employs
the use of the substances potassium iodide, lactated pepsin, red clover
blossoms, cascara sagrada, licorice, burdock root, stillingia root, berberis
root, poke root, echinacea root, prickly ash bark, and buckthorn bark, ei-
ther singly or in combination with each other.

(b) The prescription, administration, sale or other distribution of
Hoxsey agents, or any of the ingredients described in subsection (a) of
this section, whether singly or in any combination, or in any dosage or
guise whatever, in the diagnosis, alleviation, treatment or cure of cancer,
or for treatment of any patient who has or who believes he or she has or
who may have cancer is prohibited, except as provided by Section 1708
of the Health and Safety Code.

(c) No person shall, for the purpose of prescribing, administering, sell-
ing or otherwise distributing any or all ingredients of the Hoxsey formu-
la, make any representation that said Hoxsey method for the treatment of
cancer, or any of the ingredients described in subsection (a) of this sec-
tion, whether singly or in any combination or in any guise whatever, has
any value in arresting or curing cancer.

NOTE: Authority cited: Sections 208 and 1704, Health and Safety Code. Refer-
ence: Section 1704, Health and Safety Code.

History

1. New section filed 10-1-62; effective thirtieth day thereafter (Register 62, No.
21).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85. No.
51).

§ 10400.1. Beta-Cyanogenetic Glucosides ("Laetriles")
Agent for Treatment of Cancer.

(a) The Department of Public Health has carefully considered a docu-
ment entitled "A Report on the Treatment of Cancer with Beta-Cyanoge-
netic Glucosides ('Laetriles')" dated May 20, 1963, and is satisfied be-

yond a reasonable doubt that the findings therein are true. The
Department hereby ratifies and adopts said report as its own and a copy
of same is on file with the California State Department of Public Health
and is available for public inspection at its office located at 2151 Berke-
ley Way, Berkeley, California.

(b) The Department of Public Health hereby finds that beta-cyanoge-
netic glucosides including amygdalin (with or without the addition of
diisopropyl ammonium iodide), and prunasin, commonly known as
"Laetriles," are of no value in the diagnosis, treatment, alleviation or cure
of cancer and that the use of one or more of these agents in early cancer
to the exclusion of conventional treatment might well be dangerous since
treatment with acceptable, modern, curative methods (surgery or radi-
ation) would thereby be delayed potentially until such time as metastases
had occurred and the cancer therefore might no longer be curable. In late
disease palliative effect is lacking. The Department recommends that the
public refrain froin using any of the said agents or any agent, drug, medi-
cine, compound or device substantially similar thereto in the diagnosis,
alleviation, treatment or cure of cancer.

(c) Except as otherwise provided in Section 1708 of the California
Health and Safety Code the prescription, administration, sale or other
distribution of beta-cyanogenetic glucosides including amygdalin (with
or without the addition of diisopropyl ammonium iodide) and prunasin,
commonly known as "Laetriles" or. any substantially similar agent, drug,
medicine, compound or device to any patient who has or who believes
that he has or may have cancer is prohibited; and the Department shall
upon learning of such prescription, administration, sale or other distribu-
tion take appropriate steps to cause such persons so doing to cease and
desist therefrom.

(d) No person shall for the purpose of prescribing, administering, sell-
ing or otherwise distributing beta-cyanogenetic glucosides including
amygdalin (with or without the addition of diisopropyl ammonium io-
dide) or prunasin, commonly known as "Laetriles," make any representa-
tion that said agents have any value in arresting, alleviating or curing can-
cer; and the Department shall upon learning of such representation take
appropriate steps to cause such person to cease and desist from such re-

[The next page is 127.]

Page 126.4

Title 17

State Department of Health Services

§ 10400.6

presentation and shall take such other and further steps as may be appro-
priate to cause such representation to be discontinued.
Non;; Authority cited: Sections 102 and 208. Health and Safety Code. Reference:
Section 1 704. Flcalth and Safety Code.

History
1 . New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
17).

§ 1 0400.2. Bolen Test for Diagnosis of Cancer.

(a) As used in this .section, the Bolen test means the determination of
malignanc}' by the clotting patterns of a drop of blood as described and
defined in the report entitled REPORT. FINDINGS AND RECOM-
MENDATIONS of the CALIFORNIA CANCER ADVISORY COUN-
CIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUB-
LIC HEALTH. 215 1 Berkeley Way, Berkeley 4. California, with respect
to the DIAGNOSIS OF CANCER WITH THE BOLEN TEST dated
April 17. 1963.

(b) Except as otherwise provided in Section 1708 of the Health and
Safety Code, the administration of the Bolen test or any substantially
similar test for the diagnosis of cancer in any patient who has or who be-
lieves that he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpose of administering the Bolen test
make any representation that it has any value in diagnosing cancer.
NoTi:: Authority cited: Sections 208 and 1704, Health and Safety Code. Refer-
ence, Section 1704, Health and Safety Code.

History

1 . New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
17).

2. Amendment fded 12-17-85; effective thirtieth day thereafter (Register 85, No.

51).

§ 1 0400.3. Koch Agents for Treatment of Cancer.

(a) As used in this section, the Koch agents mean those agents de-
scribed and defined in the report entitled REPORT, FINDINGS AND
RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY
COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF
PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4. California, with re-
spect to THE TREATMENT OF CANCER WITH THE KOCH SYN-
THETIC ANTITOXINS — (Malonide, Glyoxylide and Parabenzoqui-
none) dated April 17, 1963, which agents are commonly known as
Malonide, Glyoxylide and Parabenzoquinone and are further commonly
collectively known as the Koch agents.

(b) Except as otherwise provided in Section 1708 of the Health and
Safety Code the prescription, administration, sale or other distribution of
the three Koch agents, as defined in subsection (a) of this section, or any
agents substantially similar thereto, whether singly or in any combina-
tion, or in any dosage or guise whatever, in the diagnosis, alleviation,
treatment or cure of cancer, or for treatment of any patient who has or who
believes that he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpose of prescribing, administering, sell-
ing or otherwise distributing any or all of the Koch agents, make any re-
presentation that the Koch agents, whether singly or in any combination
or in any guise whatever, have any value in arresting, alleviating, or cur-
ing cancer.

NOTK: Authority cited: Sections 208 and 1704, Health and Safety Code. Refer-
ence: Section 1704, Health and Safety Code.

History

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63. No.
17).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No.

51).

§ 1 0400.4. Lincoln Staphage Lysate Agent for Treatment of
Cancer.

(a) As used in this section, Lincoln Staphage Lysate means that agent
described and defined in the report entitled REPORT, HNDINGS AND
RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY
COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF

PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, w ith re-
spect to THE TREATMENT OF CANCER WITH LINCOLN STA-
PHAGE LYSATE, dated April 17, 1963, which agent consists of staphy-
lococcus bacteriophage lysates, alpha and beta is commonly known as
Lincoln Staphage Lysate.

(b) Except as otherwise provided in Section 1708 of the Health and
Safety Code the prescription, administration, sale or other distribution of
Lincoln Staphage Lysate, as defined in subsection (a) of this section, or
any agent substantially similar thereto, in the diagnosis, al Icviation. treat-
ment or cure of cancer, or for the treatment of any patient who has or who
believes that he or she has or who may have cancer is prohibited.

(c) No person shall, for the purpo.se of prescribing, administering, sell-
ing or otherwise distributing Lincoln Staphage Lysate. make any repre-
sentation that it has any value in arresting, alleviating or curing cancer.

NOTE: Authority cited: Sections 208 and 1704, Health and Safety Code. Refer-
ence: Section 1704, Health and Safety Code.

History

1. New section filed 10-3-63; effective thirtieth dav thereafter ( Register 63. No.
17).

2. Amendment filed 1 2-1 7-85; effective thirtieth day thereafter (Register 85. No.
51).

§ 1 0400.5. Mucorhicin Agent for Treatment of Cancer.

(a) As used in this section, Mucorhicin means that agent, consisting of
a mold substrate containing generic forms of Mucor, Rhizopus and vari-
ous strains of penicillium, as described and defined in the report entitled
REPORT, FINDINGS, AND RECOMMENDATIONS of the CALI-
FORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALI-
FORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berke-
ley Way, Berkeley 4, California, with respect to THE TREATMENT OF
CANCER WITH MUCORHICIN, dated April 17, 1963.

(b) Except as otherwise provided in Section 1 708 of the Health and
Safety Code the prescription, administration, sale or other distribution of
Mucorhicin, as defined in subsection (a) of this section, or any agent sub-
stantially similar thereto, in any dosage or guise whatever, in the diagno-
sis, alleviation, treatment or cure of cancer, or for the treatment of any
patient who has or who believes that he or she has or who may have can-
cer is prohibited.

(c) No person shall, for the purpose of prescribing, administering, sell-
ing or otherwise distributing Mucorhicin, make any representation that
Mucorhicin in any dosage or in any guise whatever, has any value in ar-
resting, alleviating or curing cancer.

NOTE: Authority cited: Sections 208 and 1704, Health and Safety Code. Refer-
ence: Section 1704, Health and Safety Code.

History

1. New section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
17).

2. Amendment filed 1 2-1 7-85; effective thirtieth day thereafter (Register 85, No.
51).

§ 10400.6. Anthrone Test for Diagnosis of Cancer.

(a) As used in this section, the Anthrone test means the determination
of the presence or degree of malignancy by the purported determination
of the 24 hour level of chorionic gonadotropin excretion in urine as such
method is described and defined in the report entitled in part REPORT,
FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CAN-
CER ADVISORY COUNCIL with respect to the DIAGNOSIS OF'
CANCER WITH THE ANTHRONE TEST dated August 17, 1964.

(b) Except as otherwise provided in Section 1708 of the Health and
Safety Code, the use of the Anthrone test, as described in subsection (a)
of this section, or any test substantially similar thereto for the diagnosis
of cancer in any patient who has or who believes that he has or who may
have cancer is prohibited.

(c) No person shall, for the purpose of using the Anthrone test in any
guise whatever, make any representation that it has any value in diagnos-
ing cancer.

NOTE: Authority cited: Sections 208 and 1704. Health and Safety Code. Refer-
ence: Section 1704, Health and Safety Code.

Page 127

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§ 10400.7

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1 . New section filed 7-28-65; effective thirtieth day thereafter (Register 65, No.
13).

2. Amendment filed 12- 17-85; effective thirtieth day thereafter (Register 85, No.
51).

§ 1 0400.7. Krebiozen for Treatment of Cancer.

(a) As used in this section Krebio/en means that agent described and
defined in the report entitled REPORT. FINDINGS AND RECOM-
MENDATIONS OF THE CANCER ADVISORY COUNCIL with re-
spect to THE TREATMENT OF CANCER WITH KREBIOZEN dated
May 27. 1964 and the supplementary report of said Council dated Sep-
tember 12, 1967.

(b) Except as otherwise provided in Section 1708 of the Health and
Safety Code, the prescription, administration, sale or other distribution
of Krebiozen, as defined in subsection (a) of this section, or any substan-
tially similar agent, drug, medicine, comi)ound or device to any patient
who has or who believes he or she has or who may have cancer is prohib-
ited.

(c) No person shall, for the purpose of prescribing, administering, sell-
ing or otherwise distributing Krebiozen, make any representation that
said agent has any value in arresting, alleviating or curing cancer.

NOTE: Authority cited: Sections 208 and 1704, Health and Safety Code. Refer-
ence: Section 1704, Health and Safety Code.

History

1 . New section filed 10-27-67; effective thirtieth day thereafter (Register 67, No.

43).

2. Amendment filed 12-17-85; effective thirtieth day thereafter (Reaister 85, No.
51).

§ 1 0401 . Drugs for Use in the Diagnosis, Treatment,

Alleviation or Cure of Cancer in Human Beings.

NOTE; Authority cited: Sections 102, 208 and 1704(a). Health and Safety Code.
Reference: Sections 1707.1-1707.7. Health and Safety Code.

History

1 . New section filed 3-8-68 as an emergency; effective upon filing (Register 68.
No. 10).

2. Amendment filed 4-3-68 as an emergency; effective upon filing. Certificate of
Compliance included (Register 68, No. 14).

3. Amendment of 1st paragraph filed 6-24-68; effective thirtieth day thereafter
(Register 68, No. 24).

4. Amendment of 1st paragraph filed 3-19-70: effective thirtieth day thereafter
(Register 70, No. 12).

5. Repealer filed 12-1785; effective thirtieth day thereafter (Register 85. No. 51).

§ 1 0401 .1 . Investigation of Various Agents for the
Diagnosis or Treatment of Cancer.

Experts wishing to investigate the value of drugs, medicines, com-
pounds or devices in the diagnosis or treatment of cancer under the ex-
emption provisions of Section 1 708 of the Health and Safety Code shall
provide the following information, in 20 copies, to the Department for
approval prior to initiating the investigation.

(a) A sample of the labeling of the drug, medicine, compound or de-
vice which shall include the name, quantity, lot number of the agent and
name of manufacturer and also a statement "Caution: New drug (or medi-
cine or compound or device). Use in the diagnosis, treatment, alleviation
or cure of cancer limited by law to investigational use."

(b) If the animal testing required by subsection (b) of 1708 has been
done by or under the auspices of a person other than the applicant and the
latter wishes to use the results of such testing as a part of his request for
approval of the investigation, a signed authorization for use of the results
from the person or persons responsible for such testing shall be provided.

(c) The written statement signed by the expert shall show what facili-
ties the expert will use for the investigation to be conducted by him; that
the drug, medicine, compound or device will be used solely by him or un-
der his direction for the investigation; and shall contain information iden-
tifying any assistant or agent of the expert who uses the drug, medicine,
compound or device under the direction of the expert. It shall also include
a study plan for the investigation to show that a significant number of
cases and controls are to be studied, the duration of the study and all other

details of the plan; a sworn statement that the agent is to be used solely
for investigational purposes without compensation or profit; and a de-
tailed outline of the training and experience of the expert, this latter re-
quireinent being met by submission of a curriculum vitae and a list of
publications. Criteria for evaluation of effect shall be those adopted by
the Cancer Advisory Council on April 12, 1967.

(d) A copy of the consent form required by subsection (f) of 1708.

(e) An acknowledgment that complete records will be kept.

Note: Authority cited: Sections 208 and 1704(a), Health and Safety Code. Refer-
ence: Sections 1707.1 through 1707.5, Health and Safety Code.

History

1. New section filed 7-30-69; effective thirtieth day thereafter (Register 69, No.
31).

2. Amendment of first paragraph filed 1 2-1 7-85; effective thirtieth day thereafter
(Register85, No. 51).

§ 10401.2. American Board of Oncology.

Note: Authority cited: Section 208, Health and Safety Code. Reference: Section
1708.5, Health and Safety Code (Chapter 11 30, Statutes of 1980).

History

1. New section filed 2-11-81 as an emergency; effecfive upon filing (Regi.ster 81,
No. 7).

2. Order of Repeal of 2-1 1-81 emergency order filed 2-1 1-81 by OAL pursuant
to Government Code Section 11349.6 (Register 81, No. 7).

§ 1 0405. Directions for Use — Exemptions Thereto.

(a) Adequate Directions for Use. "Adequate directions for use" means
directions under which a layperson can use drug or device safely and for
the purposes for which it is intended. Directions for use may be inade-
quate because (among other reasons) of omission, in whole or in part, or
incorrect specification of:

( 1 ) Statements of all conditions, purposes, or uses for which such drug
or device is intended, including conditions, purposes, or uses for which
it is prescribed, recommended, or suggested in its oral, written, printed,
or graphic advertising, and conditions, purposes, or uses for which the
drug or device is commonly used; except that such statements shall not
refer to conditions, uses, or purposes for which the drug or device can be
safely used only under the supervision of a practitioner licensed by law
and for which it is advertised solely to such practitioner.

(2) Quantity of dose (including usual quantities for each of the uses for
which it is intended and usual quantities for persons of different ages and
different physical conditions).

(3) Frequency of administration or application.

(4) Duration of administration or application.

(5) Time of administration or application (in relation to time of meals,
time of onset of symptoms, or other time factors).

(6) Route or method of administration or application.

(7) Preparation for use (shaking, dilution, adjustment of temperature,
or other manipulation or process).

(8) Methods of application or use.

(b) Exemptions From Directions for Use. Drugs and devices subject
to Section 26638 of the code, shall be exempt from the requirements un-
der the following conditions:

( 1 ) Exemptions for Drugs and Devices Shipped Directly to Licensed
Practitioners, Ho.spitals, Clinics, or Public Health Agencies for Profes-
sional Use. Except as provided in subparagraph (3) of paragraph (b) of
this section, a drug or device shipped directly to or in the possession of
a practitioner licensed by law to administer the drug or to use or direct the
use of the device, or shipped directly to or in the possession of a hospital,
clinic, or public health agency, for use in the course of the professional
practice of such a licensed practitioner, shall be exempt from Section
26638 of the code if its meets the conditions of Section 10410 (b) and (c).
Section 10415 (a) (2) and (3) or Section 10415 (b) (2) and (3) of these
regulations.

(2) Retail Exemption for Veterinary Drugs and Prescription Devices.
A drug or device subject to Section 10410 or Section 10415 (b) of these
regulations shall be exempt at the time of delivery to the ultimate purchas-
er or user from Section 26638 of the code if it is delivered by a licensed

Page 128

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Title 17

State Department of Health Services

§ 10405

practitioner in llic course of thie practitioner's professional practice or
upon a prescription or other order lawfully issued in the course of his pro-
fessional practice, with labeling bearing the name and address of such li-
censed practitioner and the directions for use and cautionary statements,
if any, contained in such order.

(3 ) Exemption for New Drugs or Devices. A new drug or device shall
be exempt from Section 26638 of the code:

(A) To the extent to which such exemption is claimed in an effective
application with respect to such dmg or device under Section 26670 of
the code; or

(B) If no application under Section 26670 of the code is effective with
respect to such daig but it complies with Section 26679 of the code and
Section 10440 of the regulations thereunder. No exemptions shall apply
to any other daig or device which would be a new drug or device if its
labeling bore representation for its intended uses.

(4) Exemption for Drugs or Devices When Directions Are Commonly
Known. A drug or device shall be exempt from Section 26638 of the code
insofar as adequate directions for common uses thereof are known to the
ordinary individual.

(5) Exemptions for Inactive Ingredients. A harmless drug that is ordi-
narily used as an inactive ingredient, such as a coloring, emulsifier, exci-
pient, flavoring, lubricant, preservative, or solvent, in the preparation of
other drugs shall be exempt from Section 26638 of the code. This exemp-
tion shall not apply to any substance intended for a use which results in
the preparation of a new drug, unless an effective new drug application
provides for such use.

(6) Exemption for Diagnostic Reagents. A product intended for use in
the diagnosis of disease and which is an in vitro diagnostic product shall
be exempt from Section 26638 of the code if it meets the requirements
of Section 809.10 of Title 21 of the Code of Federal Regulations.

(7) Exemption for Prescription Chemicals and Other Prescription
Components. For use by registered pharmacists in compounding pre-
scriptions or for dispensing in dosage unit form upon prescriptions shall
be exempt from Section 26638 of the code if all the following conditions
are met:

(A) The drug is an official liquid acid or official liquid alkali, or is not
a liquid solution, emulsion, suspension, tablet, capsule, or other dosage
unit form; and

(B) The label of the drug bears;

1. The statement "For prescription compounding"; and

2. If in substantially all dosage forms in which it may be dispensed it
is subject to Section 26662 of the code, the statement "Caution: Federal
law prohibits dispensing without prescription," or "Caution: Not to be
dispensed without a prescription"; or,

3. If it is not subject to Section 26662 of the code and is by custom
among retail pharmacists sold in or from the intrastate package for use
by consumers, "Adequate directions for use" in the conditions for which
it is so sold. Provided, however, that the information referred to in subdi-
vision 3 of this subparagraph may be contained in the labeling on or with-
in the package from which it is to be dispensed.

(C) This exemption shall not apply to any substance intended for use
in compounding which results in a new drug, unless an effective new
drug application covers such use of the drug in compounding prescrip-
tions.

(8) Exemption for Processing, Repacking, or Manufacture. A drug in
a bulk package (except tablets, capsules, or other dosage unit forms) or
a device intended for processing, repacking, or use in the manufacture of
another drug or device shall be exempt from Section 26638 of the code
if its label bears the statement "Caution: For manufacturing, processing,
or repacking"; and, if in substantially all dosage forms in which it may
be dispensed it is subject to Section 26662, the statement "Caution: Fed-
eral law prohibits dispensing without prescription," or "Caution: Not to
be dispensed without a prescription." This exemption and the exemption
under paragraph (7) of this section may be claimed for the same article.
But the exemption shall not apply to a substance, material, or device in-

tended for use in manufacture, processing, or repacking which causes the
finished article to be a new drug, unless:

( A ) An effective new drug application held by the person preparing the
dosage form or daig for dispensing covers the production and delivery
to that person of such substance; or

(B ) If no application is effective with respect to such new drug, the la-
bel statement "Caution: For manufacturing, processing, or repacking" is
immediately supplemented by the words "in the preparation of a new
drug limited by state law to investigational use," and the delivery is made
for use only in the manufacture of such new drug limited to investigation-
al use as provided in Section 10560 of these regulations.

(9) Exemption for Drugs and Devices for Use in Teaching, Research.
and Analysis. A drug or device subject to Sections 10410 and 1041 5 (a)
and (b) of these regulations shall be exempt from Section 26638 of the
code if shipped or sold to, or in the possession of, persons regularly and
lawfully engaged in instruction in pharmacy, chemistry, or medicine not
involving clinical use, or engaged in law enforcement, or research not in-
volving clinical use, or in clinical analysis, or physical testing, and is to
be used only for such instruction, law enforcement, research, analysis, or
testing.

(10) Expiration of Exemptions.

(A) If a shipment or delivery or any part thereof, of a drug or device
which is exempt under the regulations in this section is made to a person
in whose possession the article is not exempt or is made for any purpose
other than those specified, such exemption shall expire, with respect to
such shipment or dehvery or part thereof, at the beginning of that ship-
ment or delivery. The causing of an exemption to expire shall be consid-
ered an act which results in such drug or device being misbranded unless
it is disposed of under circumstances in which it ceases to be a daig or
device.

(B) The exemptions conferred by paragraphs (5), (6), (7), (8), and (9)
of this secUon shall continue until the drugs or devices are used, for the
purposes for which they are exempted, or until they are relabeled to com-
ply with Section 26638 of the code. If, however, the drug is converted,
compounded, or manufactured into a dosage form limited to prescription
dispensing, no exemption shall thereafter apply to the arficle unless the
dosage form is labeled as required by Section 26662 of the code and Sec-
tions 10410 and 10415 (a) and (b) of these regulafions.

(c) Intended Uses. The words "intended uses" or words of similar im-
port in paragraphs (a) and (b) of this section refer to the objective intent
of the persons legally responsible for the labeling of drugs and devices.
The intent is determined by such persons' expressions or may be shown
by the circumstances surrounding the distribution of the article. This ob-
jective intent may, for example, be shown by labeling claims, advertising
matter, or oral or written statements by such persons or their representa-
tives. It may be shown by the circumstances that the article is, with the
knowledge of such persons or their representative, offered and used for
a purpose for which it is neither labeled nor advertised. The intended uses
of an article may change after it has been introduced into intrastate com-
merce by its manufacturer. If, for example, a packer, distributor, or seller
intends an article for different uses than those intended by the person
from whom the packer distributor, or seller received the drug, such pack-
er, distributor, or seller is required to supply adequate labeling in accor-
dance with the new intended uses. But if a manufacturer knows, or has
knowledge of facts that would give one notice, that a drug or device intro-
duced into intrastate commerce by said manufacturer is to be used for
conditions, purposes or uses other than the ones for which it is offered,
the manufacturer is required to provide adequate labeling for such a drug
which accords with such other uses to which the article is to be put.
NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26638 and 26662, Health and Safety Code.

History
1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 5(i, No.

16).

Page 129

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§ 10409

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Amendment filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).

3. Amendment filed 12-1 7-85; effective thirtieth day thereafter (Register 85. No.
51).

§ 10409. Prescription Ophthalmic Devices.

The quality standards for prescription ophthalmic devices shall be the
1972 standards of the American National Standards histitute Z80. 1 and
Z8().2.

NOTI:; Authority cited: Section 2541.3, Business and Professions Code; and Sec-
tion 208, Health and Safety Code. Reference: Section 2541.3, Business and Pro-
fessions Code.

History

1 , New section filed 10-8-76; effective thirtieth day thereafter (Register 76, No.
41).

2. Editorial con-ection of NOTE filed 8-22-84 (Register 84, No. 34).

§ 10410. Exemption for Prescription Devices.

A device which, because of any potentiality for harmful effect, or the
method of its use, or the collateral measures necessary to its use, is not
safe except under the supervision of a practitioner licensed by law to di-
rect the use of such device, and hence for which "adequate directions for
use" cannot be prepared, shall be exempt from Section 26638 of the code
if all the following conditions are met:

(a) The device is in the possession of a person (or agents or employees
of the person) regularly and lawfully engaged in the manufacture, trans-
portation, storage, or wholesale or retail distribution of such device and
is to be sold only to or on the prescription or other order of such practitio-
ner for use in the course of the practitioner's professional practice.

(b) The label of the device (other than surgical instruments) bears:

( 1 ) The statement "Caution: Federal law restricts this device to sale by
or on the order of a ," or "Caution sale of this device is re-
stricted to sale by or on the order of a ." The blanks to be filled

with the word "physician," "dentist," "veterinarian," or with the descrip-
tive designation of any other practitioner licensed by the law of the State
of California; and

(2) The method of its application or use.

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26638 and 26643, Health and Safety Code.

History
1. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No.
51).

§ 10415. Exemption for Prescription Drugs and Veterinary
Drugs.

(a) Exemption for Prescription Drugs. A drug subject to the require-
ments of Section 26660 of the code, shall be exempt from Section 26638
if all the following conditions are met:

( 1 ) The drug is:

(A) In the possession of a person (or agents or employees of the per-
son) regularly and lawfully engaged in the manufacture, transportation,
storage, or wholesale distribution of prescription drugs; or

(B) In the possession of a pharmacy or a public health agency, regular-
ly and lawfully engaged in dispensing prescription drugs; and is to be dis-
pensed in accordance with Section 26662.

(2) The label of the drug bears:

(A) The statement "Caution: Federal law prohibits dispensing without
prescription," or "Caution: Not to be dispensed without a prescription";
and

(B) The recommended or usual dosage; and

(D) If it is fabricated from two or more ingredients and is not desig-
nated conspicuously by a name recognized in an official compendium the
quantity or proportion of each active ingredient and if it is not for oral use
the names of all other ingredients. Provided, however, that the informa-
tion referred to in subdivisions (B), (C), and (D) of this subparagraph may
be contained in the labeling on or within the package from which it is to
be dispensed, and, in the case of ampuls, too small or otherwise unable
to accommodate a label but which are packaged in a container from

which they are withdrawn for dispensing or use, the information referred
to in subdivision (A) of this subparagraph may be placed on the outside
container only.

(3) The labeling of the drug (which inay include brochures readily
available to licensed practitioners) bears information as to the use of the
drug by practitioners licensed by law to administer it: provided, however,
that such information inay be oinitted from the labeling if it is contained
in scientific literature widely disseminated among practitioners licensed
by law to administer the drug.

(b) Exemption for Veterinary Drugs. A drug intended solely for veteri-
nary use which, because of toxicity or other potentiality for harmful ef-
fect, or the method of its use, is not safe for animal use except under the
supervision of a licensed veterinarian, and hence for which "adequate di-
rections for use" cannot be prepared, shall be exempt from Section 26638
of the code if all the following conditions are met:

( 1 ) The drug is in the possession of a person (or agents or employees
of the person) regularly and lawfully engaged in the manufacture, trans-
portation, storage, or wholesale or retail distribution of veterinary drugs
and is to be sold only to or on the prescription or other order of a licensed
veterinarian for use in the course of the veterinarian's professional prac-
tice.

(2) The label of a drug bears:

(A) The statement "Caution: Federal law restricts this drug to sale by
or on the order of a licensed veterinarian," or "Caution: To be sold only
by or on the order of a licensed veterinarian"; and

(B) The recommended or usual dosage; and

(D) The quantity or proportion of each active ingredient if it is fabri-
cated from two or more ingredients and is not designated conspicuously
by a name recognized in an official compendium. Provided, however,
that the information referred to in subdivisions (B), (C), and (D) of this
subparagraph may be contained in the labeling on or within the package
from which it is to be dispensed.

(3) The labeling of the drug (which may include brochures readily
available to licensed veterinarians) bears information as to use of the drug
by licensed veterinarians; provided, however, that such information may
be omitted from the labeling if it is contained in scientific literature wide-
ly disseminated among veterinarians licensed by law to administer such
drug.

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Secfions 26660 and 26662, Health and Safety Code.

History
1 . Amendment filed 1 2-1 7-85; effective thirtieth day thereafter (Register 85, No.
51).

§ 10416. Exemptions for Drugs Dispensed by Licensed
Practitioners.

Note; Authority cited: Sections 102, 208 and 26202, Health and Safety Code.

History

1. New section filed 8-2-72; effective thirtieth day thereafter (Register 72, No.

32).

2. Repealer filed 12-1 7-85; effective thirtieth day thereafter (Register 85, No. 51 ).

§ 10417. Formulary of Inequlvalent Generic Drug Types
and Drug Products for Which Substitution
Poses a Threat to Health and Safety.

(a) The generic drug types or drug products listed in the formulary be-
low have been determined, pursuant to Business and Professions Code
Section 4047.7, to have demonstrated clinically significant biological or
therapeutic inequivalence and which, if substituted in accordance with
Business and Professions Code Section 4047.6, would pose a threat to the
health and safety of patients receiving such medications.

FORMULARY

( 1 ) Generic Drug Types

(2) Drug Products

(b) Any person requesting the inclusion, addition, or deletion of any
generic drug type or drug product to the formulary shall submit such re-

Page 130

(4-1-90)

Title 17

State Department of Health Services

§ 10446

quest to the Department of Health Services in accordance with the fol-
lowing:

( 1 ) Submissions supporting the inclusion, addition, or deletion of any
generic daig type or dmg product to the formulary shall consist of evi-
dence of adequate and well-controlled investigations, including clinical
investigations, by experts qualified by scientific training and experience,
on the basis of which it could be fairly and responsibly determined by the
Director that a generic drug type or drug product demonstrates, or does
not demonstrate, clinically significant biological or therapeutic inequi-
valence and which, if substituted for another drug product under the pro-
visions of Section 4047.6 of the Business and Professions Code would
pose a threat to the health and safety of patients receiving prescription
medication.

(2) Submissions shall adequately identify all daig products involved
by name of manufacturer, lot number(s), and dosage form(s) and should
demonstrate the condition(s) of use (e.g., duration, frequency, etc.) of
any such drug product where substitution poses a threat to the health and
safety of the patient.

(3) Submissions shall be made in triplicate to Food and Drug Branch,
Department of Health Services, Sacramento, CA 95814.

(4) Any information submitted shall be considered to be public infor-
mation.

NOTE: Authority cited: Section 4047.7, Business and Professions Code. Refer-
ence: Sections 4047.6 and 4047.7, Business and Professions Code.

History

1 . New section filed 3-14-76 as an emergency; effective upon filing (Register 76,
No. 20).

2. Certificate of Compliance filed 9-8-76 (Register 76, No. 37).

3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No.
51).

§ 1 0420. Label Requirements (26254).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

NEW DRUGS

§10425. Applications.

(a) Each new drug application submitted for filing with the Depart-
ment shall be in duplicate. If any part of the application is in a foreign lan-
guage, an accurate and complete English translation shall be appended
to that part.

(b) An application shall not be accepted for filing if only one copy is
submitted or if it is incomplete on its face in that:

(1) It does not contain all the matter required by clauses (1), (2), (3),
(4) and (6), of Section 26670 of the code.

(2) It does not state the conditions under which the drug or device is
to be used; or

(3) The specimen of labeling proposed for use upon or within the retail
package does not expressly or by reference to a brochure or other printed
matter prescribe, recommend, or suggest the use of the drug or device un-
der such conditions.

(c) The date on which an application is received by the Department
shall be considered to be the date on which the application is filed, and
the Department shall notify the applicant of such date. If the applicant
withdraws the application, it shall be considered as not having been filed.

(d) The applicant may file an amendment to an application which has
been filed and is pending before the Department, but in that case the un-
amended application shall be considered as having been withdrawn and
the amended application shall be considered as having been filed on the
date on which the amendment is received by the Department. The De-
partment shall notify the applicant of such date.

(e) After an application has become effective with respect to a drug or
device the applicant may file a supplemental application with respect
thereto setting forth any proposed change in the condifions under which

the dnjg or device is to be used in the labeling thereof, in any circum-
stance relating to its production, or in any other information contained in
the effecUve applicafion. Such supplemental applicafion may omit state-
ments in the effective application concerning which no change is pro-
posed.

NOTE; Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Section 26670. Health and Safety Code.

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Amendment filed 6-27-60; effective 30th day thercafier (Register 60, No. 1 5).

3. Amendment filed 12-17-85; effective thirtieth day thereafter (Reaister 85, No.
51).

§ 1 0430. Notification of Applicant (26289).

History
1 . Repealer filed 1 2-17-85; effective thirtieth day thereafter (Register 85, No. 5 1 ).

§ 10435. Insufficient Information in Application (26290).

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Amendment filed 6-27-60; effecfive 30th day thereafter (Register 60, No. 1 5).

3 . Repealer filed 1 2- 1 7-85; effecti ve thirtieth day thereafter (Register 85, No. 5 1 ).

§ 1 0437. Suspension of Effective Application (26290.5).

History

1 . New section filed 6-27-60; effecfive 30th day thereafter (Register 60, No. 15).

2. Repealer filed 1 2-1 7-85; effective thirtieth day thereafter (Register 85, No. 5 1 ).

§ 1 0438. Untrue Statements in Applications (26290) (e) and
26290.5 (2).

History

1 . New section filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).

2. Repealer filed 1 2- 1 7-85; effective thirtieth day thereafter (Register 85, No. 51).

§ 10440. Exemptions from Section 26670.

A shipment or other delivery of a new drug or device is exempt from
the operadon of Secfion 26670 of the code if:

(a) The exemption is claimed pursuant to Section 26679 of the code,
and

(b) The condifions of Tifie 21, Code of Federal Regulations, Part 312
are safisfied for drugs or the condifions of Tifie 2 1 , Code of Federal Regu-
lations, Part 812 are safisfied for devices, or the condifions of Title 21,
Code of Federal Regulafions, Part 813 are safisfied for devices which are
intraocular lenses.

Note: Authority cited: Sections 208, 26202 and 26679, Health and Safety Code.
Reference: Section 26679(e), Health and Safety Code.

History

1. Amendment filed 6-27-60; effective thirtieth day thereafter (Register 60, No.
15).

2. Amendment filed 12-17-85; effecfive thirtieth day thereafter (Register 85, No.
51).

§ 10445. Exemptions from Section 26288 of the Code
(26292 (2) (3)).

History
1. Repealer filed 9-1-78; effecfive thirtieth day thereafter (Register 78, No. 35).

§ 1 0446. Exemptions for Dental Laboratories.

(a) Dental laboratories which manufacture dental prostheses shall be
exempt from the licensing provisions of Secfion 26685 of the Health and
Safety Code unfil such fime that the health hazards, if any, have been
idenfified and effecfive procedures for their prevenfion have been estab-
lished by the Department after consultation with the California State
Board of Dental Examiners, the dental profession and the dental labora-
tory industry.

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Secfion 26693(g), Health and Safety Code.

Page 131

§ 10450

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History
\ . New section filed 6-12-70; effective thirtieth day thereafter (Register 70, No.

24).
2. Editorial coiTection filed 8-22-84 (Register 84, No. 34).

§ 1 0450. Form of Guaranty (26297).

History

1 . Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Repealer filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 5 1 ).

§ 1 0455. Expiration of Guaranty (26301 ).

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Repealer filed 1 2- 1 7-85; effective thirtieth day thereafter (Register 85, No. 5 1 ).

§ 1 0460. Presentation (26341 ).

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Repealer filed 9-1-78; effecUve thirtieth day thereafter (Register 78, No. 35).

Article 3. Food Regulations

§ 10750. Label Requirements for Foods and Dietary
Supplements.

(a) Any food or dietary supplement, as defined in Title 17, California
Code of Regulations, Division 1, section 10200, that contains any
amount of a substance listed in Table 10750 A shall comply with the fol-
lowing;

( 1 ) The label of foods and dietary supplements that have a total surface
area available to bear labeling of 12 square inches or more shall bear the
following notice in the manner prescribed in paragraph (a)(2) of this sec-
tion:

NOTICE: This product contains (name of substance(s) and common
name(s) if different). Read and follow directions carefully. Do not use
if you have or develop diarrhea, loose stools, or abdominal pain be-
cause (insert common name) may worsen these conditions and be
harmful to your health. Consult your physician if you have frequent di-
arrhea or if you are pregnant, nursing, taking medication, or have a medi-
cal condition.

(2) The notice required by paragraph (a)(1) of this section shall:

(A) Be enclosed by a 0.5 point box rule with 2.5 points of space around
the notice,

(B) Utilize at least one point leading,

(D) Be all black or one color type, printed on a white or other neutral
contrasting background,

(E) Utilize single easy to read type style such as Helvetica Regular and
upper and lower case letters,

(F) Be in type size no smaller than 8 point,

(G) The word "NOTICE" shall be in all upper case letters, and

(H) The sentence "Do not use if you have or develop diarrhea, loose
stools, or abdominal pain because (insert common name) may worsen
these conditions and be harmful to your health." shall be underhned and
highlighted by bold or extra bold type, such as Helvetica Black.

(3) Foods and dietary supplements in small packages that have a total
surface area available to bear labeling of less than 12 square inches shall
include the notice required by paragraph ( a)( 1 ) in the format specified in
(a)(2) in a package insert or a tag attached to the package and bear the fol-
lowing label notice in the manner prescribed in paragraph (a)(4) of this
section:

NOTICE: Do not use if you have or develop diarrhea, loose stools,
or abdominal pain because (insert common name) may worsen these
conditions and be harmful to your health. See package insert (or at-
tached tag) for additional information.

(4) The notice required by paragraph (a)(3) of this section shall:

(A) Be enclosed by a 0.5 point box rule with 2.5 points of space around
the notice,

(B) Ulihze at least one point leading.

(D) Be all black or one color type, printed on a white or other neutral
contrasting background,

(E) Utilize single easy to read type style as Helvetica Regular and up-
per and lower case letters.

(F) Be in type size no smaller than 6 point,

(G) The word "NOTICE" shall be in all upper case letters, and

(H) The sentence "Do not use if you have or develop diarrhea, loose
stools, or abdominal pain because (insert common name) may worsen
these conditions and be harmful to your health." shall be underlined and
highlighted by bold or extra bold type, such as Helvetica Black.

(b) Tills section does not apply to foods and dietary supplements con-
taining the leaf gel or leaf juice of aloe (A I oeferox Mill, or Aloe vera (L.)
N.L. Burm.) or concentrations thereof, providing that the food or dietary
supplement does not contain another substance listed in Table 10750 A.

Table 10750 A-Listed Substances

Common Name Plant Part

aloe also known as latex

cape aloe

aloe also known as latex

aloe vera

buckthorn berry

cascara also known as bark

cascara sagrada

frangula also known as bark

buckthorn

rhubarb root also known as
as Chinese rhubarb

senna also known as leaf

Alexandria senna or or pod

Tinnevelly senna

senna also known as leaf

sicklepod senna or pod

Botanical Name

Aloe ferox Mill.

Aloe vera (L.) N.L.Burm.,
also known as Aloe
barbadensis Mill, or Aloe
vulgaris Lamk.

Rhamnus catharticus L.

Rhamnus purshianus DC.
also known as Rhamnus
purshiana DC. or Frangula
purshiana (DC.) JG Cooper

Rhamnus frangula L. also
known as Frangula alnus
Mill.

Rheum officinale Baill.,
Rheum palmatum L., Rheum
rhaponticum L., or Rheum
tanguticum, Maxim, ex
Balf.

Senna alexandrina P. Mill,
also known as Cassia senna
L., Cassia angustifoUa
Vahl. Cassia acutifolia
Del., or Senna
angustifoUa (Vahl) Batka

Senna obtusifolia (L.) Irwin
and Bameby also known as
Cassia obtusifolia (L.)

senna leaf Senna tora (L.) Roxb. also

or pod known as Cassia tora (L.)

NOTE: Authority cited: Sections 100275, 1 10065 and 1 10100, Health and Safety
Code. Reference: Sections 110175, 110290, 110660, 110705, 110760, 110765
and 1 10770, Health and Safety Code.

History

1. New secfion filed 10-15-96; operative 1-1-97 (Register 96, No. 42). A Certifi-
cate of Compliance must be transmitted to OAL by 5-1-97 or emergency lan-
guage will be repealed by operation of law on the following day. For prior histo-
ry, see Register 78. No. 35.

2. Editorial correction of subsection (b) and Table 10750 A (Register 97, No. 18).

3. New section refiled 4-29-97 as an emergency; operative 5-2-97 (Register 97,
No. 18). A Certificate of Compliance must be transmitted to OAL by 9-2-97
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 4-29-97 order, including amendments, trans-
mitted to OAL 8-28-97 and filed 10-9-97 with changes in label "Notice" effec-
tive 3-1-98 (Register 97, No. 41).

5. Editorial correction of subsection (a)(2)(E) and Table (Register 98, No. 9).

Page 132

Title 17

State Department of Health Services

§ 10826

•

§ 1 0755. Truth of Labeling (26456).

History
1. Repealer filed 9-1-78: effective thirtielh day thereafter (Register 78, No. 35).

ADULTERATION

§ 10760. Metal Coated Dragees and Ornaments (26470 (2)).

History
1. Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 0765. Toxic Substances— Use of (26470 (2)).

History
1 . Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10770. Secondhand Use of Barrels.

(a) No wooden barrel or keg that has ever been used as a container for
other than food products may be re-used for the storage and/or convey-
ance of any food product.

(b) Barrels or kegs that have been used as containers for food products
may be re-used for storage and/or conveyance of other food products.
Provided: they are thoroughly cleaned and are in a sanitary condition at
the time of re-use.

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Section 26524, Health and Safety Code.

History
1 . Editorial correction of section heading and new NOTE filed 8-22-84 (Register
84, No. 34).

§ 1 0775. Custard Fillings for Pastry (26470 (4)).

History
1. Repealer filed 6-23-72; effective thirtieth day thereafter (Register 72, No. 26).

§ 1 0780. Containers, Cadmium Plated (26470 (6)).

History
1. Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 0785. Packing Materials (26470 (6)).

History
1. Repealer filed 9-2-78; effective thirtieth day thereafter (Register 78, No. 35).

§10786. Apricot Kernels.

(a) Apricot kernels sold or distributed into food channels are mis-
branded unless the package or container is conspicuously labeled: "Apri-
cot kernels may be toxic; very low quantities may cause reactions."

(b) Subsection (a) does not apply to:

( 1 ) Firms selling bulk apricot kernels for processing into macaroon
paste or marzipan where the firms furnish to the Department upon its re-
quest, documentation acceptable to the Department, of its intended use
as macaroon paste or marzipan, and the apricot kernels are clearly la-
beled:

"Not suitable for food use without further processing."

(2) Fresh apricots or to apricot kernels added to canned apricots as an
optional flavor agent.

NOTE: Authority cited: Section 26202, Health and Safety Code. Reference: Sec-
tions 26400 and 26520, Health and Safety Code.

History

1. New section filed 6-23-77; effective thirtieth day thereafter (Register 77. No.
26).

2. Amendment filed 9-24-85; effecfive thirtieth day thereafter (Register 85, No.
39).

§ 1 0790. Candy, Trinkets in, Prohibited (26472 (b)).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10795. Blending and Dilution of Certified Coal Tar Colors
(26472 (c)).

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

LABELING, MISBRANDING

§ 1 0800. Labeling, Misbranding (26490 (1 )).

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).

§ 10805. Required Statements, When Exempt (26491).

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

§ 1 081 0. Prominence of Required Statements (26492).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter ( Register 78. No. 35).
For prior history, see Register 56, No. 16.

§ 10815. Prepackaged Candy and Cookies, Retail Sale of
Food from Bulk Containers (Label Exemptions)
(26492).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10820. Exemption upon Proper Labeling.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10825. Conformity to Definitions and Standards of
Identity (26493).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10826. Temporary Permits for Intrastate Shipment of

Experimental Packs of Food Varying from the
Requirements of Definitions and Standards of
Identity.

(a) To obtain a temporary permit for intrastate shipment of experimen-
tal packs of food varying from the requirements of definitions and stan-
dards of identity, a person shall file with the Department a written appli-
cation in triplicate containing the following:

(1) Name and address of the applicant.

(2) A statement of whether or not the applicant is regularly engaged
in producing the food involved.

(3) A reference to the applicable definition and standard of identity
(citing applicable section of regulations).

(4) A full description of the proposed variation from the standard.

(5) The basis upon which the food so varying is believed to be whole-
some and nondeleterious.

(6) The amount of any new ingredient to be added; the amount of any
ingredient, required by the standard, to be eliminated; any change of con-
centration not contemplated by the standard; or any change in name that
would more appropriately describe the new product under test. If such
new ingredient is not a commonly known food ingredient, a description
of its properties and basis for concluding that it is not a deleterious sub-
stance.

(7) The purpose of effecting the variation.

(8) A statement of how the variation is of potential advantage to con-
sumers.

(9) The labeling proposed to be used for the food so varying.

(10) The period during which the applicant desires to introduce such
foods into intrastate commerce, with a statement of the reasons support-
ing the need for such period.

(11) The probable amount of such food that will be distributed.

(12) The areas of distribution.

(13) The address at which such food will be manufactured.

(b) The applicant for a permit described in (a) shall provide the Depart-
ment, upon request, with samples of the food varying from the standard
and any additional information deemed necessary by the Department.

(c) If the Department concludes that the variation may be advanta-
geous to consumers and will not result in failure of the food to conform

Page 133

§ 10830

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

to any provision of the act except Section 26556, a permit siiall be issued
to tlie applicant for intrastate shipment of such food. The terms and condi-
tions of the permit shall be those set forth in the application with such
modifications, restrictions, or qualifications as the Department may
deem necessary and state in the permit.

(d) The terms and conditions of the permit may be modified at the dis-
cretion of the Department or upon application of the permittee during the
effective period of the permit.

(e) The Department may revoke a permit for cause, which shall include
but not be limited to the following:

( 1 ) That the permittee has introduced a food into intrastate commerce
contrary to the terms and conditions of the permit.

(2) That the application for a permit contains an untrue statement of
a material fact.

(3) That the need therefor no longer exists.

(0 During the period within which any permit is effective, it shall be
deemed to be included within the terms of any guaranty or undertaking
otherwise effective pursuant to the provisions of Section 26300 of the act.

(g) If an application is made for an extension of the permit, it shall be
accompanied by a description of experiments conducted under the per-
mit, tentative conclusions reached, and reasons why further experimental
shipments are considered necessary.

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence; Section 26513, Health and Safety Code.

History

1. New section filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Amendment filed 9-24-85; effective thirtieth day thereafter (Register 85, No.
39).

§ 1 0830. Designation of Ingredients (26495).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

§ 10835. Listing Ingredients in Order of Predominance
(26495 (2)).

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10840. Dietary Food Labeling (26496 (1)).

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 60, No. 15.

§ 10841. Label Statements Relating to Emergency Food
Packs.

Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference;
Section 26467, Health and Safety Code.

History

1 . New section filed 1 1-22-61 ; effective thirtieth day thereafter (Register 61, No.
23).

2. Repealer filed 9-24-85; effective thirtieth day thereafter (Register 85, No. 39).

§ 10842. Saccharin Warning Labeling.

(a) The saccharin warning labeling requirements of the Federal Sac-
charin Study and Labeling Act, Public Law 95-203, 1977, and the com-
pliance guidelines promulgated under authority of that act, shall be appli-
cable to all saccharin containing products in intrastate commerce in this
State.

(b) These labeling requirements and guidelines shall apply only to
products introduced into intrastate commerce after the effective date of
this section.

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Section 26206, Health and Safety Code.

History

1. New secdon filed 6-15-78; effective thirtieth day thereafter (Register 78, No.
24).

2. Editorial correction of NOTE filed 8-22-84 (Register 84, No. 34).

§ 10845. Artificial Flavoring or Coloring, Chemical
Preservatives (26496 (2)).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 0850. Form of Guaranty (26521 ).

History
1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 0855. Expiration of Guaranty (26525).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10860. Exemptions from Labeling Requirements (26542).

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 10862. Adoption of Federal Requirements.

Subchapter B, Title 2 1 , Code of Federal Regulations and amendments
thereto shall be included as the requirements of this Department.
NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26203, 26205-26209, 26438, 26510 and 26559, Health and Safety
Code.

History

1, New section filed 7-12-78; effective thirtieth day thereafter (Register 78, No.
28).

2. Editorial correction of NOTE filed 8-22-84 (Register 84, No. 34).

§ 1 0865. Presentation (26565).

History
1. Repealer filed 9-1-78; effecdve thirtieth day thereafter (Register 78, No. 35).

•

Article 3.1. Food Additives Regulations

History

1. Repealer of Article 3.1 (Sections 11000.1 through 11025.1, not consecufive)
filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior
history, see Register 62, No. 15.

Article 3.5. Foods Under Agricultural Code
Regulations

History

1. Repealer of Article 3.5 (Secfions 11350 through 11367, not consecutive) filed
9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior histo-
ry, see Registers 66, No. 20; and 67, Nos. 20, 40, 43, 46 and 48.

Article 3.6. Poultry Meat and Poultry
Products

§ 1 1 375. Sources of Poultry Meat.

NOTE: Authority cited: Section 26540, Health and Safety Code. Reference: Sec-
tions 26540 and 26541, Health and Safety Code.

History

1. New Article 3.6 (Sections 11 375 through 1 1378) filed 6-24-68; effecfive thir-
tieth day thereafter (Register 68, No. 24).

2. Editorial correction renumbering former Section 11375 to new Section 19043
filed 4-13-84 (Register 84, No. 15).

§ 1 1 376. Conditions for Use.

NOTE: Authority cited: Sections 208, 27010 and 27040, Health and Safety Code.
Reference; Sections 27010 and 27040, Health and Safety Code.

History
1. Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

§ 1 1 377. Methods for Treating.

NOTE: Authority cited; Sections 208, 27010 and 27040, Health and Safety Code.
Reference; Sections 27010 and 27040, Health and Safety Code.

History
1 . Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

•

Page 134

Title 17

State Department of Health Services

§ 12001

§ 1 1 378. Disposal of Unfit Poultry Meats.

NOTl:: AiKhority cited: Sections 208. 27010 and 27040. Health and Safety Code.
Reference: Sections 27010 and 27040, Health and Safety Code.

History
I . Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

Article 4. Horse Meat Regulations

History
1 . Repeaierof Article 4 (Section 1 1400) filed 9-1-78; effective thirtieth day there-
after (Register 78. No. 35).

Article 3.7. Raw Milk and Raw Milk
Products

§ 1 1380. Required Health Warning on Labels of Raw Milk
and Raw Milk Products.

(a) Raw Milk and raw milk products shall bear the following warning
on the principal display panel or panels of the label:

WARNING

Raw (unpasturized) milk and raw milk dairy products may contain dis-
ease-causing micro-organisms. Persons at highest risk of disease from
these organisms include newborns and infants; the elderly; pregnant
women; those taking corticosteroids, antibiotics or antacids; and those
having chronic illnesses or other conditions that weaken their immunity.

(b) The warning shall appear within a heavy borderline in a color
sharply contrasting to that of the background. The signal word "WARN-
ING" shall appear in capital letters of ten point type or greater. The re-
maining text of the warning shall be printed in capital letters of six point
type or greater. All characters in the warning message shall be in a sans
serif type style.

(1) "[R]aw" means unpasteurized;

(2) "[R]aw milk product" means any food which contains raw milk,
and shall include, but not be limited to, cheese (except when ripened or
cured at least 60 days pursuant to sections 37975 and 38001 of the Food
and Agricultural Code), cream, butter and kefir.

(d) Raw milk or raw milk products packaged in recyclable glass con-
tainers which are sold only at the location where the raw milk or raw milk
product is produced (including containers which are delivered directly
from the point of production to a retail customer by agents or employees
of the production facility), and which have a principal display panel only
on the container cap, may instead have attached to the container a tag con-
taining the warning message set forth in subsection (a), provided that the
tag will stay attached to the container and remain readable under custom-
ary conditions of storage and transportation, excluding intentional re-
moval after purchase by, or delivery to, the retail customer. The tag shall
be attached in a conspicuous location on the container. The warning mes-
sage portion of the tag shall be subject to all other requirements of this
section. The tag may, to the extent authorized by law, contain any other
information desired by the production facility. For purposes of this sub-
section, a "tag" can be of any shape, material, and design, so long as the
warning message is conspicuous and easily readable.

(e) Any raw milk or raw milk product which does not bear a label meet-
ing the requirements of this section is misbranded.

(0 This section does not apply to raw milk and raw milk products pro-
duced and packaged before February 21, 1991.

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26400 and 26550, Health and Safety Code.

History

1. New section filed 2-11-91 as an emergency; operative 2-11-91 (Register 91,
No. 12). A Certificate of Compliance must be transmitted to OAL by 6-1 1-91
or emergency language will be repealed by operation of law on the following
day.

2. Repealer of 2-1 1-91 order and adoption of new section filed 5-9-91 as an emer-
gency; operative 5-9-91 (Register 91, No. 25). A Certificate of Compliance
must be transmitted to OAL by 9-6-91 or emergency language will be repealed
by operation of law on the fo//owing day.

3. Certificate of Compliance as to 5-9-91 order transmitted to OAL 9-3-91 and
filed 9-30-91 (Register 92, No. 4).

Article 5. Cold Storage Regulations

§ 1 1 600. Cold Storage Regulations.

Noti;: Authority cited: Section 208, Health and Safety Code. Reference: Section
208, Health and Safety Code.

History
1. Repealer filed 8-1-85; effecfive thirtieth day thereafter (Register 85, No. 31).

§ 11 601 . Cold Storage Licenses.

(a) Cold Storage licenses shall be valid for a two-year period from date
of issue and are not transferable. The fee for the license is $100.00.

(b) Application for a Cold Storage license shall be made on State De-
partment of Health form #EH-7.

(d) The licensee shall immediately notify the Department of any
change in the information which was submitted on the license applica-
tion.

NOTE: Authority cited: Sections 208 and 22 1 , Health and Safety Code. Reference:
Secfion 221, Health and Safety Code.

History
1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No.
30).

Article 5.5. Low Acid Frozen Foods in
Hermetically Sealed Containers, Regulations

NOTE: Authority cited: Secdons 208 and 28182, Health and Safety Code. Refer-
ence: Sections 28165-28186, Health and Safety Code.

History

1. Repealer and new Article 5.5 (Sections 11800, 11810, 11820, 11830, 11840,
11850, 11860, and 11870) filed 12-20-55; effective thirtieth day thereafter
(Register 55, No. 18).

2. Repeaierof Article 5.5 (Sections 1 1800-1 1870, not consecutive) filed 3-21-84;
effective thirtieth day thereafter (Register 84, No. 12).

Article 6. Bakery Sanitary Regulations

§ 1 2001 . Custard and Cream Fillings for Pastry (28208).

(a) Perishable bakery products shall include, but are not limited to,
products such as cream-filled pies, pumpkin pies, cakes, pastries, cus-
tard, meringues and cheese cake, which consist in whole or in part of milk
or milk products, eggs, synthetic fiUings or any ingredients capable of
supporting rapid and progressive growth of infectious or toxicogenic mi-
croorganisms.

(b) Perishable bakery products shall be kept, displayed, transported or
maintained at or below 45° Fahrenheit. This Section shall not apply to
products during reasonable periods of preparation or handling not to ex-
ceed two hours.

(d) Uncut pumpkin, sweet potato, yam and squash pies baked in the
shell or so prepared that the fiUing reaches a temperature of at least 140
F, for 5 minutes and which are packaged individually at the point of pro-
duction to prevent contamination, may be considered not to be a perish-
able product and refrigeration is not required. When packaged, the above
pies shall be labeled "Refrigerate after opening."

(e) Uncut citrus meringue pies having a filling of 4.5 pH or lower, and
packaged individually at the point of production to prevent contamina-
tion may be considered not to be a perishable product and refrigerator is

Page 134.1

§ 12001 BARCLAYS CALIFORNIA CODE OF REGULATIONS Title 17

not required. When packaged, citrus meringue pie shall be labeled "Re- 2. Amendment of subsections (d) and (e) filed 10-25-72; effective thirtieth day

fricerate after opening." " thereafter (Register 72. No. 44).

h Marshmallow topping, or other fillina or topping products, with a ^- Amendment of subsection (b) filed 1 1-24-75; effective thirtieth day thereafter

■ r / \ , , ''■,,,,, • (Register 75, No. 48).

sugar-water ratio 01 at least 2.1 to 1 are not perishable and do not require ^ cj-, •, ,• fKir^T^r^A-i n c/i /t> •. o/i m oq\

^. . ^ ^ 4. Editorial conection of NOTE filed 7-12-84 (Register 84, No. 28).

refrigeration. ^ Repealer of Section 12000 (number and section heading only) filed 8-1-85; ef-

NOTE: Authonty cited: Sections 102, 208 and 28214, Health and Safety Code. fective thirtieth day thereafter (Register 85, No. 31).
Reference Section 28208, Health and Safety Code.

History

1. New section filed 6-23-76; effective thirtieth day thereafter (Register 72, No.
26).

[The next page is 135.

Page 134.2 Register 2007, No. 26; 6-29-2007

Title 17

State Department of Health Services

§ 12104

•

Article 6.1 . Local Enforcement of the

Sherman Food, Drug and Cosmetic Law As

It Relates to Retail Food Establishments

§12100. Definitions.

(a) Retail food establishment means any room, building, vehicle,
place, or portion thereof, maintained, used, or operated for or in conjunc-
tion with, the retail sale of food or preparation of food and includes, but
is not limited to:

( 1 ) "Retail Food Production and Marketing Establishment" as defined
in Section 28802 of the Health and Safety Code.

(2) "Bakery" as defined in Section 28190 of the Health and Safety
Code.

(3) "Roadside Stand" as defined in the California Administrative
Code, Title 17, Section 13650.

(4) "Restaurant" as defined in Sections 26595(c) and 28522 of the
Health and Safety Code.

(5) "Itinerant Restaurant" as defined in Sections 26595(c) and 28523
of the Health and Safety Code. (6) "Vehicle" as defined in Sections
26595(c) and 28524 of the Health and Safety Code.

(7) "Mobile Food Preparation Units" as defined in the California Ad-
ministrative Code, Title 17, Section 13601.

(8) "Vending Machines" as defined in Section 28525 of the Health and
Safety Code.

(b) Menu misrepresentation means any false statement on a menu.

NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Sections 26460, 26581 and 26590, Health and Safety Code.

History

1. New Article 6.1 (Sections 12101-121 10) filed 4-21-78; effective thirtieth day
thereafter (Register 78, No. 16).

2. Editorial correction of NOTE filed 7-12-84 (Register 84, No. 28).

§ 1 21 01 . Application for Participation.

Application for participation shall be made by letter from the local
health department to the Director of the Department of Health.

NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Section 26581, Health and Safety Code.

History
1. New NOTE filed 7-12-84 (Register 84, No. 28).

§ 12102. Local Enforcement Authorization.

(a) A local department authorized as a local retail food enforcement
program by the Department shall enforce Department regulations and the
following chapters, articles and sections of Division 21 of the Health and
Safety Code pertaining to the preparation, handling and sale of foods in
retail food establishments.

( 1 ) Definitions and General Provision (Chapter 1 ).

(A) Short title and definitions (Article 1) Sections 26000, 26001,
26002, 26004, 26006, 26007, 26008, 26011, 26012, 26013, 26014,
26015, 26016, 26017, 26018, 26019, 26023, 26024,26025, 26026,
26028 and 26029.

(B) General provisions (Article 2) Sections 26050 through 26052.

(2) Administration (Chapter 2).

(A) Generally (Article 1) Section 26214.

(B) Inspection and sampling (Article 3) Sections 26230 through
26235.

(3) Guarantees (Chapter 3) Sections 26300 through 26307.

(4) Packaging, labeling and advertising (Chapter 4).

(A) Generally (Article 1) Sections 26400, 26401, 26402, 26405,
26406, 26407 and 26408.

(B) Fair packaging and labeling (Article 2) Sections 26430, 26431,
26432, 26436 and 26439.

(5) Food (Chapter 5).

(A) Generally (Article 1) Section 26500.

(B) Enrichment of food and food products (Article 2.5) Sections
26516, 26517 and 26518.

(D) Misbranded food (Article 4) Sections 26550 through 26569.7.

(E) Potentially hazardous foods (Article 5) Section 26570.

(F) Frozen products (Article 5.5) Section 26575.

(G) Local enforcement (Article 6) Sections 26580 through 26590.
(H) Hamburger and imitation hamburger (Article 7) Sections 26595

through 26599.

(6) Penalties and Remedies (Chapter 8)

(A) Penalties (Article 1) Sections 26801 and 26802.

(B) Proceedings (Article 2) Sections 2681 1, 26812 and 26813.

(D) Injunctions (Article 4) Sections 26850 and 26851.

Note; Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Sections 26583 and 26590, Health and Safety Code.

History
1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12103. Laboratory Examinations.

(a) A local health department shall be able to make the following labo-
ratory examinations in order to qualify for local enforcement of retail
food establishments.

(1) Examination of Fresh Meats shall be in accord with the methods
of analysis of the Association of Official Analytical Chemists (AOAC)
and supplements thereto for the following:

(A) Fat content of ground and chopped beef and pork sausage.

(B) Presence of preservatives including sulfite, borates, nitrite and ni-
trate.

(D) Presence of vegetable protein or other extenders.

(2) Examination of Alcoholic Beverages.

(A) Determine alcoholic proof by AOAC methods.

(B) Micro analytical examination to determine and identify insects
and other filth adulteration.

(3) Filth Examination of Various Foods.

(A) Presence of insects by macro or micro analytical methods.

(B) Presence of rodent urine by the AOAC method of analysis.

(D) Verification of foreign material by microscopic and macroscopic
examination.

(b) Laboratory examinations shall be performed in a Public Health
Laboratory or a laboratory designated by the local health department and
approved by the Department.

(c) Laboratory examinations shall be performed by the professional
staff employed in the laboratory designated by the local health depart-
ment and approved by the Department.

(d) The laboratory personnel shall complete Department approved
training.

NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Section 26583, Health and Safety Code.

History
1. New NOTE filed 7-12-84 (Register 84, No. 28).

§12104. Personnel Training.

(a) Local health department personnel shall complete state approved
training in the following areas:

(1) Enforcement of statutes and regulations relating to mislabeling,
false advertising and adulteration of foods in retail food establishments.

(2) Observation and recording of violative condifions in narrative re-
ports that can be used for legal actions.

(3) Determining alcoholic proof of liquor products for mislabeling and
candling of full or partly filled liquor bottles to determine adulteration.

(4) Procedures for voluntary condemnation and destruction of viola-
tive food products.

Page 135

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§ 12105

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(5) Procedures for the embargo of violative food products and the re-
lease of an embargo.

(6) Collection of representative official samples of violative food and
potential adulterants.

(7) Completing official sample receipt forms and memorandum of in-
struction for laboratory examinations.

(8) Procedures for the forfeiture, condemnation and destruction of
food found to be adulterated or misbranded.

(9) Preparation of statements of facts for referrals of violative condi-
tions to the district attorney.

NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Section 26590, Heahh and Safety Code.

History
1 . New NOTE filed 7-12-84 (Register 84, No. 28).

§ 1 21 05. Staff Qualifications.

The minimum qualifications for professional staffing by local health
departments to carry out the local enforcement of the Sherman Food,
Drug, and Cosmetic Law and Department regulations relative to retail
food establishments shall be a registered sanitarian.
NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Section 26590, Health and Safety Code.

History
1. New NOTE filed 7-12-84 (Register 84, No. 28).

§ 12106. Reporting Requirements.

Each local health department shall submit quarterly reports to the De-
partment that summarize enforcement activities for retail food establish-
ments.

Note: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Section 26590, Health and Safety Code.

History
1 . New NOTE filed 7-12-84 (Register 84, No. 28).

§ 1 21 07. Enforcement Authority for Menu
IVIisrepresentation.

(a) Menu is a form of advertising. A local health department autho-
rized by the Department to enforce only menu misrepresentation shall
enforce the following sections of the Health and Safety Code:

(1) Advertising (Chapter 4, Article 3) Sections 26460 and 26461.

(2) Penalties (Chapter 8, Article 1) Sections 26801 and 26802.

(3) Proceedings (Chapter 8, Article 2) Sections 2681 1 and 26812.

(4) Injunctions (Chapter 8, Article 4) Sections 26850 and 2685 1 .
NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Sections 26460, 26461 and 26581, Health and Safety Code.

History
I. New NOTE filed 7-12-84 (Register 84, No. 28).

§ 12108. Personnel Training.

(a) Personnel from local health departments who are assigned to en-
force the Sherman Food, Drug, and Cosmetic Law as it relates only to
menu misrepresentation in retail food establishments shall participate
and complete state approved training as required in Section 12104 or
meet the following training requirements:

( 1 ) Enforcements of statutes and regulations relating to false advertis-
ing in food menus that are used in retail food establishments.

(2) Recording violative conditions in narrative reports of observation
that can be used for legal action.

(3) Preparation of statements of facts for referrals or violative condi-
tions to the district attorney.

NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Sections 26583 and 26590, Health and Safety Code.

History
I. New NOTE filed 7-12-84 (Register 84, No. 28).

§ 1 21 09. Staff Qualifications.

The minimum qualifications for staffing by local health departments
to enforce the Sherman Food, Drug, and Cosmetic Law as it relates to
menu misrepresentation shall be at the level of a registered sanitarian.

NOTE: Authority cited: Sections 208, 26202 and 26590, Health and Safety Code.
Reference: Section 26590, Health and Safety Code.

History
I. New NOTE filed 7-12-84 (Register 84, No. 28).

§ 12110. Reporting Requirements.

A local health department authorized by the Department to enforce
only menu misrepresentation shall submit semiannual reports to the De-
partment that summarize enforcement activities.

NOTE: Authority cited: Sections 208. 26202 and 26590, Health and Safety Code.
Reference: Section 26590, Health and Safety Code.

History
1 . New NOTE filed 7-12-84 (Register 84, No. 28).

Article 7. Food Sanitation Regulations

§ 12200. Vegetable Juice, Preparation and Sale of Fresh
(28281-28282).

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12205. Premises.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12210. Materials.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12215. Extracting Machines.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§ 1 2220. Storage and Sale.

History

1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12225. Employees.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§ 12230. Revocation of Permit.

History
1 . Repealer filed 1 1 -20-85; effective thirtieth day thereafter (Register 85, No. 47).

SANITATION IN FOOD PLANTS

§ T1 7-1 2235. Light, Ventilation, and Plumbing (28281 ).

NOTE: Authority cited: Sections 208 and 28281, Health and Safety Code. Refer-
ence: Section 28281, Health and Safety Code.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12240. Water Supply.

NOTE: Authority cited: Secdons 208 and 28281, Health and Safety Code. Refer-
ence: Section 28281, Health and Safety Code.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§ T1 7-1 2245. General Plant Sanitation; Floors, Walls,
Ceilings, Etc.

The floors, walls, ceilings, partitions, posts, doors and other parts of
all preparation and processing areas shall be of such materials, construc-
tion and finish that they may be readily and thoroughly cleaned. The
floors in all areas where water is used in the operation are to be so con-

Page 136

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Title 17

State Department of Health Services

§ 12280

stmcted and of such material as to be watertight and they shall be main-
tained in such condition as to stay watertight. All areas used for edible
products shall be separate and distinct from those used for inedible prod-
ucts, such as fish meal reduction plants.

NOTI-: Authority cited: Section 208, Health and Safety Code. Reference: Section
28282. Health and Safety Code.

History

1. Editorial correction of section heading and new NOTE filed 7-3-84 (Reeister
84. No. 27).

History

] . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47 ).

§ 12270. Tagging Insanitary Equipment.

NOTE: Authority cited: Sections 208 and 28282, Health and Safety Code. Refer-
ence: Section 28282, Health and Safety Code.

History

1 . Repealer filed 1 1 -20--85; effective thirtieth day thereafter (Register 85, No. 47).

§ 12250. Areas, Equipment, and Operations to Be Sanitary.

(a) Areas, equipment and utensils used for preparing, storing or other-
wise handling any food product and all other parts of the establishment
shall be kept clean and in a sanitary condition. Areas in which any food
product is prepared, processed, stored or handled, including walls, ceil-
ings, and overhead structures of such areas, shall be kept as reasonably
free from moisture as is practicable. In such areas there shall be no drip-
ping from any source, including ceilings and overhead structures, that
may contaminate the product.

(b) Equipment and utensils used for preparing, processing or other-
wise handling any food product shall be of such materials and construc-
tion that they can be readily and thoroughly cleaned. Pipelines used to
convey fluid or semi-fluid products shall be so constructed that they can
be readily and thoroughly cleaned.

(c) Operations and procedures involving the preparation, storing or
handling of any food product shall be strictly in accord with good sanitary
practice.

NOTI-;; Authority cited: Section 208, Health and Safety Code. Reference: Section
28282, Health and Safety Code.

History
1. New NOTE filed 7-3-84 (Register 84, No. 27).

§ 12255. Use of Poisonous Insecticides and Rodenticides.

(a) Every practical precaution shall be taken to keep establishments
free from flies, rats, mice and other vermin. If necessary, rodent-proof
rooms shall be provided for materials which might become contaminated
by these pests.

(b) The use of insecticides, or rodenticides, toxic to humans, in areas
where any food products, not adequately protected, is being stored or
handled is prohibited.

(c) Poisonous insecticides and rodenticides may be used under build-
ings, wharves, outbuildings, or similar places, or where adequately pro-
tected packaged products are stored; only, if adequate precautions are
taken to eliminate the possibility of said poisons being accidentally
spilled, or carried, by any means, to areas where these poisons are prohib-
ited. These poisons are to be adequately protected from possible contact
by children, or domestic animals, and are to be plainly and distinctly la-
beled for identification by adults.

Note; Authority cited: Section 208, Health and Safety Code. Reference: Section
28282(a), Health and Safety Code.

History
1 . Editorial correction of section heading and new NOTE filed 7-3-84 (Register
84, No. 27).

§ 1 2260. Empty Container Storage.

Empty cans, jars, lids, covers, barrels, drums, etc., must be clean when
filled with food products.

NoTE: Authority cited: Section 208, HeaUh and Safety Code. Reference: Section
28282, Health and Safety Code.

History

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§ 12265. Bactericidal Treatment of Utensils and Equipment
in Food Processing Establishments (28282(c)).

NOTE: Authority cited: Sections 208 and 28282, Health and Safety Code. Refer-
ence: Section 28282(c), Health and Safety Code.

§12275. Personal Hygiene.

(a) The employees of the establishment who handle any food product
shall keep their hands clean; and, after visiting the toilet room or urinals,
shall wash their hands before handling any food product or implement
used in the preparation of the product.

(b) Outer clothing and gloves worn by persons who handle any food
product shall be clean and of material that can be readily cleaned.

(c) Such practices as spitting on the floor and using empty cans, jars,
or other containers as drinking cups, or for purposes other than those
originally intended, are forbidden.

(d) Care shall be taken to prevent the contamination of food products
with perspiration, hair, cosmetics, medicaments and the like. Adequate
head coverings must be worn by all men and women while engaged in
the preparation or handling of any food product.

(e) Smoking by any person shall not be permitted while preparing or
handling any food product or while handling empty cans, jars, lids, bar-
rels, drums or other receptacles used for food products.

(f) The use of fingernail polish by any person preparing, processing,
or handling any food product without gloves whereby the product might
become contaminated, is prohibited.

(g) No clothing, shoes, boots, aprons, etc. shall be kept or stored in any
area where any food product is prepared, processed, or handled; except.
in or on facilities specifically provided for this purpose.

NOTE; Authority cited: Section 208. Health and Safety Code. Reference: Sections
28282(d), 28291 and 28293, Health and Safety Code.

History
1. Editorial correction of section heading and new NOTE filed 7-3-84 (Register
84, No. 27).

§12280. Sanitary Facilities.

Adequate sanitary facilities and accommodations shall be furnished
by every food packing establishment. Of these the following are specifi-
cally required:

(a) Dressing rooms, and toilet and urinal rooms shall be sufficient in
number and conveniently located. These rooms shall be well lighted, suf-
ficiently ventilated to insure sanitary conditions, vented to the outside,
and meet all requirements as to sanitary construction and equipment. All
doors entering such rooms shall be self-closing. All windows shall be
screened. Such rooms shall be separate from areas in which food prod-
ucts are prepared, stored, or handled. The walls, ceiling, partitions, and
other parts of all dressing rooms, toilet rooms, lavatory rooms and urinal
rooms shall be of light color and of such construction as to be easily and
adequately cleaned. Where five or more persons of both sexes are
employed, separate facilides shall be provided for each sex.

(b) Sanitary washing facilities, including running hot and cold water,
soap and individual towels, shall be provided, and shall be placed in or
near toilet and urinal rooms and also at other places in the establishment
as may be essential to insure cleanliness of all persons handling any food
product.

(d) Toilet soil lines shall be kept separate from industrial waste lines
to a point outside the buildings. Drainage from toilet bowls and urinals
shall not be discharged into grease salvage basins, or into open disposal
systems.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
28287, 28288, 28289 and 28290, Health and Safety Code.

Page 137

§ 12285

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Title 17

History
1. Edilorial correction of section heading and new NOTE filed 7-3-84 (Register
84. No. 27).

§ 12285. Surroundings of Food Packing Establishments
(28298).

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§ 12290. Labeling Exemption (28322).

History

1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 2295. Form of Affidavit.

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
WALNUT SHELLING

§ 12300. Purchase of Walnut Meats from Producers, Etc.
(28336).

History

1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§12302. Walnut Shelling Licenses.

NOTE: Authority cited: Sections 208 and 221 , Health and Safety Code. Reference:
Section 221, Health and Safety Code.

History

1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No.
30).

2. Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§ 12305. Production Record Specifications.

History
1 . Repealer filed 1 1 -20-85; effective thirtieth day thereafter (Register 85, No. 47).

§ 1 231 0. Bill of Sale Specification.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§ 1 231 5. Condition of Walnut Meats.

History
I . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

Article 8. Cannery Inspection Regulations

ACIDIFIED FOOD PRODUCTS PACKED IN HERMETICALLY

SEALED CONTAINERS SUBJECT

TO pH CONTROL

§12400. Applicability.

Low acid (high pH) foods or acid foods containing low acid ingredi-
ents to an extent where a food poisoning hazard may exist when placed
in hermetically sealed containers, and which are not processed by steam
under pressure must be packed under the supervision of the Department
of Public Health. This includes several types or classes of food products,
among which are the following: vegetables in acidified brine or oil, vege-
table juice cocktails, and various formulated products.

§12405. Acid Requirements.

(a) All products subject to Section 12400 found to have a pH greater
than 4.6 will be restrained.

(b) The pH of low-acid foods may be lowered by the addition of any
edible organic food acid such as citric or acetic. Allowance must be made
for the fact that certain acids, such as acetic, are quite volatile and rapidly
lose their strength when heated in open containers. The Department of
Public Health must be consulted to determine the strength and amount of
acid to be used for each type of pack and the control measures that are
necessary.

Note: For illustration purposes only, the following examples are cited: On the ba-
sis of 60 percent solids in a final acidified artichoke pack, the following brines are
found to furnish the required pH of less than 4.6:

( 1 ) Unblanched, 0.6 percent citric acid (80 ounces per 100 gallons)

(2) Water blanched, 0.5.^ percent citric acid (71 ounces per 100 gallons)

(3) Acid blanched in a 1 percent citric acid solution for six minutes, 0.24 percent
citric acid (32 ounces per 100 gallons)

(c) Acidified vegetables froin a batch previously inspected and re-
leased by the Department of Public Health may be repacked in a packing
medium of an edible vegetable oil without official reinspection only
when adequate records are maintained clearly showing the batch number
of the original batch and the date of release thereof and the batch number
of the repacked vegetable.

§ 12410. Titration by Inspectors.

(a) Samples of the acid blanching solutions and brining solution shall
be collected, one sample of each to be taken at the beginning of each
day's run subsequently at about two-hour intervals during the day. These
samples are to be titrated daily by the state cannery inspector.

(b) When the blanching or brining solution is changed, or more acid
added, the batch number must be changed. A batch is understood to mean
all material blanched at one time in a given solution.

§ 12415. Low Acid Ingredients in Acid Foods.

Some foods such as vegetable juice cocktails are made by mixing por-
tions of low acid vegetables with products possessing a safe level of acid-
ity, with a resulting potential food poisoning hazard. The control of acid-
ity for this type of product is based on the examination of the finished
product, and is determined directly as pH, which must be below 4.6. Sam-
ples of the finished product are to be submitted to the laboratory as re-
quested.

§12420. Formulated Products.

By "formulated products" is meant the class of foods that is com-
pounded from a number of ingredients according to a definite formula,
and these ingredients when so compounded do not have a pH low enough
to render them commercially sterile when processed without steam under
pressure. The control of acidity for this type of product is based on the
examination of the finished product, and is determined directly as pH,
which must be below 4.6. Samples of the finished product are to be sub-
mitted to the laboratory as requested.

§12425. Test Equipment.

All plants packing food products regulated under Sections 1 24 1 5 and
12420 shall have and maintain in proper working condition for the use
of the state cannery inspector pH determination equipment of the glass
electrode type. All plants packing vegetables in acidified brine shall have
complete titrating equipment, consisting of burette, standardized alka-
line solution, indicator solution, pipettes, and titrating flasks or beakers.
All of the above must be kept in clean workable condition at all times.

§ 12430. Samples to Laboratory.

(a) Samples of the finished product, whether brine packed or oil
packed from an acid blanch, are to be submitted to the laboratory as re-
quested.

(b) Cans should be labeled to show the following: product, date of pack
and code number.

§ 12435. Production Records.

Production records shall be kept and a coding system inaugurated as
specified by the inspection service. The production record shall show the
cooking time and temperature for each batch, also number of containers
per batch.

§ 12440. Inspectors' Reports.

A daily report is to be submitted to the Department of Public Health
covering the results of the state cannery inspector's titrations on all
blanching solutions and/or bines; also a report of his pH determinations
to be certain that the acidification procedures are in order.

Page 138

Title 17

State Department of Health Services

§ 12481

§12445. Releases.

Batches of foods subject to pH control are not to be released by the
state cannery inspector until authorization is received from the San
PYancisco Office.

CONDUCT OF CANNERIES

§12450. Responsibility of Canners.

It is the responsibility of every person, group, or organization engaged
in the commercial, semicommercial, cooperative, or noncommercial
community (church, school, or otherwise) canning or preservation of
low-acid foods in hermetically sealed containers, among other things, to
achieve commercial sterility in all units packed.

§ 1 2451 . Cannery Licenses.

(a) Cannery licenses will be valid for a two-year period from date of
issue and are not transferable. The fee for the license is $100.00.

(b) Application for a Cannery license shall be made on State Depart-
ment of Health form #EH-153.

(d) The licensee shall immediately notify the Department of any
change in the information which was submitted on the license applica-
tion.

NOTE: Authority cited: Sections 208 and 221 , Health and Safety Code. Reference:
Section 221, Health and Safety Code.

History
1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No.
30).

§ 12455. Official Sterilization Processes.

All products except those under pH control as defined in Section
12400 through 12445 must meet specific requirements as to initial tem-
perature, process time and temperature, as determined for each product.
The Department of Public Health shall be contacted for the latest official
sterilization requirements. (See Sections 12790 through 12975.)

§12460. Initial Temperature.

The term "initial temperature" as used herein designates the average
temperature of the can contents at the time steam is turned on for the pro-
cess. Just prior to the start of the process, the contents of the container
used for checking the initial temperamres should be shaken or stirred and
the temperature determined. This container should be representative of
the coldest cans in the retort load and should have an initial temperature
equal to or greater than the initial temperature specified under "Official
Sterilization Process." "Initial temperature" should not be confused with
"closing temperature."

§12465. Cleanliness of Materials.

All raw material must meet full requirements as to purity, wholesome-
ness, cleanliness and suitability for canning purposes. To this end the
packer must supply any and all necessary equipment, and additional help
and measures designed to insure the quality of the product.

§ 1 2470. Record of Cooks.

Each licensed retort operator shall keep a record of the cooks as re-
quired by the State Board of Public Health.

(a) The original and a duplicate of the production record must be kept
by filling in accurately in complete detail the form approved by the De-
partment of Public Health. Each entry in the record must be made by the
operator at the time the specific retort operation is observed and not co-
pied afterward. It must be in legible handwriting and be signed by the op-
erator or operators.

(b) Chart of recording thermometer must show full time and tempera-
ture as required, otherwise the product will be restrained.

(c) Each production record and recording thermometer chart shall be
stamped, initialed and numbered by a state cannery inspector before use
and must be accounted for.

(d) The cook or batch number and size of cans involved must be re-
corded by the canner in each respective curve of all temperature charts.

(e) Production records and charts must be scaitinized and checked by
a state cannery inspector before product is released for shipment.

§12475. Coding.

(a) Each plant must submit and have approved a code to appear legibly
on the cover of each container. This code will show the plant where
packed, year packed, the product contained therein, day code, and period
code. The period shall be changed every two and one half hours or less.
This time interval may be extended to three hours if a petition is filed with
the Department demonstrating that adequate consumer protection is pro-
vided under those conditions when potentially hazardous products are re-
quired to be removed from retail market. If a container such as a glass
bottle be used and the cap or cover be too small to permit the coding to
be embossed or ink-stamped thereon, it shall be permissible to legibly
perforate or ink-stamp the required code on the label, provided the label
is securely affixed to the container.

History

1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No.

34).

§12480. Requirements.

(a) All products must be free from adulteration and misbranding in ac-
cordance with Chapter 3 of Division 21 of the Health and Safety Code,
and the United States Food, Drug and Cosmetic Act. The product must
not be in violation of any state or county law. The net weight or other in-
formation as required by law must appear correctly upon labels.

(b) Any number of cans deemed necessary shall be cut and examined
at any time by representatives of the Department of Public Health.

(c) Plants and equipment must comply with necessary requirements as
to cleanliness and sanitation and conform to any and all state require-
ments.

(d) Officials of plants must insure the cooperation of all plant person-
nel.

(e) Packers must realize and faithfully fulfill their own responsibilities
and obligations to produce a sound, wholesome, and safe product.

(f) All packers must fulfill their obligations with respect to mainte-
nance of cannery inspection service according to Article 2 of Chapter 8
of Division 21 of the Health and Safety Code.

§ 12481. Examination of Can Closures and Can Closure
Machines.

(a) Visual Examination. During regular production runs, a constant
watch shall be maintained for gross maladjustments such as deadheads,
cut-overs, and other similar double seam defects. Maintaining this con-
stant check may be accomplished in several ways, depending on the type
of closing machine, line speeds, and general equipment layout. It may
best be performed by training the closing machine operator to recognize
irregularities by visual examination. However, an adequate check pro-
gram can be maintained through use of other trained personnel.

The operator, can closure supervisor, or other qualified personnel shall
visually examine, at intervals of not more than thirty minutes, the top
seam of a randomly selected can from each seaming station, and shall re-
cord his observations. Additional visual seam inspections shall be made
immediately after a can-jam in a closing machine, or after start-up of a
machine following a prolonged shut-ndown. All pertinent observations
shall be recorded. If irregularities are found, the action taken shall be
noted.

(b) Tear-down Examination. Tear-down examinations shall be made
at a frequency of at least one can per seaming station every four hours or
each major fraction thereof. Such examinations shall be made as soon as
possible after starting up following a shut-down, waiting only long
enough for the machine to "warm up." Cans for visual inspection shall
be taken during this warm-up period. The results of the tear-down ex-
aminations shall be recorded.

(c) General Observations. Following are some of the various factors
which influence double seam quality and which shall be examined in the
course of the can seam examination:

Page 139

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

( 1 ) Condition of the seaming equipment — whether or not the mechani-
cal operation and adjustment of the closing machine give the proper seam
contours.

(2) Can material — variations in tinplate thickness.

(3) Can size — roll contours change vv'ith can size to accommodate vari-
ations in plate thickness.

Other pertinent observations shall also be recorded indicating the pres-
ence or absence of such defects as cut-overs, droops, etc.
NOTE: Authority cited: Section 28440, Healtli and Safely Code. Reference: Sec-
tions 28310-28322, Health and Safety Code.

History

1 . New section filed 3-1 3-67; effective thirtieth day thereafter (Register 67, No.
11).

§ 12482. Required and Optional Seam Measurements.

(a) Optical System (use of seam scope or projector)

Required Optional

Body hook Width (length, height)

Overlap Cover hook

Tightness (observation for wrinkle) Countersink

Thickness

(b) Micrometer Measurement System

Required Optional

Cover hook Overlap (by calculation)

Body hook Countersink

Width (length, height) Thickness

Tightness (observation for wrinkle)

Regardless of whether or not a seam scope or seam projector is used,
the double seam shall be torn down for examination.

(c) Two measurements shall be made for each double seam character-
istic if a seam scope or seam projector is used. If a micrometer is used,
three measurements shall be made at points approximately 120 apart, ex-
cluding the side seam. The high and low measurements must fall within
limits considered to be normal for the conditions.

With regard to measurement limits, the canner shall follow the work-
ing limits recommended by the can supplier.

Overlap length can be calculated by the following formula:

The theoretical overlap length = CH-i-BH+T = W

where CH = coverhook

BH = body hook

*T = cover thickness, and

W = seam width (height, length)

*In general practice, 0.010 may be used for the tinplate thickness.

(d) Records shall be kept on all seam examinations. The form of such
records shall be the choice of the canning company, but the records must
show the frequency of visual and tear-down inspections, and the mea-
surements made. It is suggested that sample forms be obtained from the
can supplier.

For the purposes of State inspection, records of seam examinations
must be filed and held for inspection by the State Department of Public
Health.

NOTE: Authority cited: Section 28440, Health and Safety Code. Reference: Sec-
tions 28310-28322, Health and Safety Code.

History
1. New section filed 3-13-67; effective thirtieth day thereafter (Register 67, No.
11).

§ 12485. Standards for Water Used in Fish Canneries.

Waters used in fish canning operations within canneries shall conform
to the following standards:

(a) Water satisfactory without treatment.

(1) For whole fish handling operations:

(A) Not subject to contamination with human fecal discharges.

(B) Maximum of 7 E. coll organisms per cc.

(2) For cut fish handling operations:

(A) Not subject to contamination with human fecal discharges.

(B) Maximum of 7 E. coli organisms per cc.

(b) Waters satisfactory after treatment:

(1) For whole fish handling operations:

(A) Not subject to gross contamination with human fecal discharges
before treatment.

(B) Maximum of 3 E. coli organisms per cc. after treatment.

(2) For cut fish handling operations:

(A) Not subject to gross contamination with human fecal discharges
before treatment.

(B) Maximum of 3 E. coli organisms per cc. after treatment.

(D) The treatment shall include filtration or the equivalent as one of
the steps of the treatment process.

Samples for bacteriological analysis shall be analyzed by an approved
method set forth in the latest edition of the APHA manual entitled "Stan-
dard Methods for the Examination of Water and Sewage." Those meth-
ods shall be employed which give the most specific reliable means of
measuring organisms having their origin in the intestines of man and oth-
er warm-blooded animals.

GENERAL SANITARY REQUIREMENTS FOR FOOD
PACKING ESTABLISHMENTS

§ 12490. Establishments and Premises in or on Which

Food Products Are Prepared, Handled, Stored,
or Packed Shall Be Maintained in a Sanitary
Condition.

The following general requirements shall be complied with:

(a) Light.

There shall be light of good quahty and well distributed wherever the
food product may become contaminated.

(b) Ventilation.

There shall be ventilation sufficient to insure sanitary conditions.

There shall be efficient drainage and plumbing systems for the prem-
ises. All closed drains shall be properly installed with approved traps and
vents.

§12495. Water Supply.

Potable water supply for plant use shall be clean, and bacterially suit-
able with adequate facilities for its distribution in the plant and its protec-
tion against contamination and pollution. In those cases where ocean wa-
ter is used in the handling of a food product, such as in fish canneries, the
ocean water must meet the bacteriological and quality standards for such
water as set forth in Section 12485 of these regulations.

In cases where nonpotable water is used, there shall be no cross con-
nection between the nonpotable supply line system and the potable water
supply line system. Any nonpotable supply line system shall be painted
a color to distinguish it from any potable water supply line system.

§ 12500. Floors, Walls, Ceilings, Etc.

The floors, walls, ceiling, partitions, posts, doors, and other parts of all
preparation and processing areas shall be of such materials, construction
and finish that they may be readily and thoroughly cleaned. The floors
in all areas where water is used in the operation are to be so constructed
and of such material as to be water tight and they shall be maintained in
such condition as to stay water tight. All areas used for edible products
shall be separate and distinct from those used for inedible products, such
as fish meal reduction plants.

Page 140

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State Department of Health Services

§ 12555

§ 12505. Use of Poisonous Insecticides and Rodenticides
in Food Processing Establishments.

(b) The use of insecticides or rodenticides, toxic to humans, in areas
where any food product, not adequately protected, is being stored or han-
dled is prohibited.

§ 12510. Animals in Plant.

Every practical precaution shall be taken to exclude dogs, cats, birds,
or other animals and fowl from food establishments.

§12515. Sanitary Facilities.

Adequate sanitary facilities and accommodations shall be furnished
by every food packing establishment. Of these, the following are specifi-
cally required:

(a) Dressing rooms, and toilet and urinal rooms shall be sufficient in
number and conveniently located. These rooms shall be well lighted, suf-
ficiently ventilated to insure sanitary conditions, vented to the outside,
and meet all requirements as to sanitary construction and equipment. All
doors entering such rooms shall be self-closing. All windows shall be
screened. Such rooms shall be separate from areas in which food prod-
ucts are prepared, stored, or handled. The walls, ceilings, partitions, and
other parts of all dressing rooms, toilet rooms, lavatory rooms and urinal
rooms shall be of light color and of such construction as to be easily and
adequately cleaned. Where five or more persons of both sexes are
employed, separate facilities shall be provided for each sex.

(b) Sanitary washing facilities, including running hot and cold water,
soap, and individual towels, shall be provided, and shall be placed in or
near toilet and urinal rooms and also at other places in the establishment
as may be essential to insure cleanliness of all persons handling any food
product.

(d) Toilet soil lines shall be kept separate from industrial waste lines
to a point outside the buildings. Drainage from toilet bowls and urinal
shall not be discharged into grease salvage basins, or into open disposal
systems.

§ 12520. Areas, Equipment, and Operations to Be Sanitary.

(a) Areas, equipment, and utensils used for preparing, storing or other-
wise handling any food product and all other parts of the establishment
shall be kept clean and in sanitary condition.

Areas in which any food product is prepared, processed, stored or han-
dled, including walls, ceilings, and overhead structures of such areas
shall be kept as reasonably free from moisture as is practicable. In such
areas there shall be no drippings from any source including ceilings and
overhead structures that may contaminate the product.

(b) Equipment and utensils used for preparing, processing, or other-
wise handling any food product shall be of such materials and construc-
tion that they can be readily and thoroughly cleaned. Pipe lines used to
convey fluid or semifluid products shall be so constructed that they can
be readily and thoroughly cleaned.

(c) Operations and procedures involving the preparation, storing, or
handling of any food product shall be strictly in accord with good sanitary
practice.

§ 12525. Personal Hygiene.

(a) The employees of the establishment who handle any food product
shall keep their hands clean and, after visiting the toilet room or urinals,
shall wash their hands before handling any food product or implement
used in the preparation of the product.

(b) Outer clothing and gloves worn by persons who handle any food
product shall be clean and of material that can be readily cleaned.

(c) Such practices as spitting on the floor and using empty cans, jars,
or other containers as drinking cups, or for purposes other than those
originally intended, are forbidden.

(d) Care shall be taken to prevent the contamination of food products
with perspiration, hair, cosmetics, medicaments, and the like. Adequate
head coverings must be worn by all men and women, while engaged in
the preparation or handling of any food product.

(e) Smoking by any person shall not be permitted while preparing or
handling any food product or while handling empty cans, jars, lids, bar-
rels, drums or other receptacles used for food products.

(f) Tlie use of fingernail polish by any person preparing, processing,
or handling any food product without gloves whereby the product might
become contaminated, is prohibited.

(g) No clothing, shoes, boots, aprons, etc. shall be kept or stored in any
area where any food product is prepared, processed, or handled, except
in or on facilities specifically provided for this purpose.

§12530. Surroundings.

The outer premises of every food handling establishment embracing
docks, storage areas, and areas where cars and vehicles are loaded and
unloaded, and the driveways, approaches, yards, etc. shall be properly
drained and kept in a clean and orderly condition. The accumulation of
any material in which flies or other insects or vermin may breed or which
will afford rodent harborage is forbidden. No nuisance which might con-
tribute to insanitation shall be allowed on the premises of any food pack-
ing establishment.

§ 12535. Employment of Diseased Persons.

No food packing estabhshment shall knowingly employ in any depart-
ment where any food product is prepared or handled, any person affected
with a communicable disease.

§ 12540. Empty Container Storage.

Empty cans, jars, covers, lids, barrels, drums, etc. must be clean when
filled with food products.

§ 12545. Tagging Insanitary Equipment.

When the use of any equipment, which is unclean or insanitary, would
lead to contaminaUon of the food product, an inspector may attach a quar-
antine tag to it. No equipment or utensils so tagged shall again be used
until made acceptable. Such tag so placed shall not be removed by any
person other than an employee of the Department of Public Health.

RECANNING OF FOOD PRODUCTS

§12550. Recanning.

It is not permissible to recan for sale any low acid canned food product
for which the State Board of Public Health requires a specific retort pro-
cess, without first obtaining written permission from the Department of
Public Health. Such recanning must be done under the supervision of a
duly authorized Inspector of the Department of Public Health.

SPOILAGE IN CANNED FOOD PRODUCTS

§12555. Reporting Spoilage.

Spoilage in any canned products packed under inspection must be re-
ported in writing to the nearest office of the Department of Public Health,
or to any Cannery Inspector in person.

All swells, springers and flippers found in the warehouse must be in-
cluded in the report.

Page 141

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Title 17

§12560. Segregation,

When swells or other evidence of spoilage in excess of one-half of one
percent, (5 cans per 1 ,000), are found in any warehouse lot, such spoilage
must be segregated from the normal cans, and the entire lot, including flat
cans, held pending immediate notification of the Department of Public
Health. No samples of such material shall be drawn for any purpose until
authorization has been granted by the Department of Public Health.

§12565. Examination.

All of the above must be held in a safe and separate place in the ware-
house pending examination and recommendation by a representative of
the Department of Public Health as to the disposition thereof.

§12570. Monthly Reports.

History
1. Repealer filed 9-1-78: effective thirtieth day thereafter (Register 78, No. 35).

§ 1 2575. Sale to Salvage Company.

A report must be made to the Department of Public Health before any
canned products packed under the supervision of the Department of Pub-
lic Health are sold to a salvage company. The material must be inspected
and released by a representative of the Department of Public Health be-
fore the shipment is made.

§12580. Application.

This regulation is applicable only to warehouse stocks of low acid
canned foods which are packed under supervision of the Department of
Public Health, and does not apply to material from the cook room dam-
aged or spoiled because of mechanical defects.

VENTING OF CANNED FOOD PRODUCTS

§ 12585. Venting of Canned Food Products.

It is not permissible to vent and reprocess for sale any low acid canned
food for which the State Board of Public Health requires a specified retort
process.

BUCKLED CANS

§12590. Tolerance per Batch.

(a) Wherein 10 percent or more of a particular batch is found to be in
buckled condition, the entire batch (both buckled and normal appearing
cans) shall be restrained.

Note: By "buckled condition" is meant those cans with strained ends caused by
excessive internal pressure during processing or cooling, resulting in one or both
ends having elevated or wavy areas such that tiiey have become unsatisfactory for
retail trade.

(b) Batches wherein less than 10 percent of the number of cans are
buckled, only that material showing buckled condition shall be restrained
and the normal appearing cans may be released.

(c) Buckled cans shall be reformed as soon as possible after the cans
have been restrained. The reforming of the cans must be done before any
arrangements can be made to submit the material to a flip vacuum test.
Note: The reforming consists of forcing the distorted top or bottom back to its
normal position. Ends slightly distorted may be reformed by thumb pressure
whereas ends more severely distorted or strained may be reformed with the closing
machine chuck or other suitable tool. Reforming the ends might have some effect
upon the vacuum of the cans and as a consequence flip testing should not follow
the reforming operation until approximately 30 days have elapsed.

(d) If swells develop during the holding period, they are not to be de-
stroyed, but submitted to the laboratory for examination.

§ 12595. Supervision of Flip Testing.

Flip testing shall be done in the presence of a State Cannery Inspector.
Workable zero, or the minimum external vacuum is to be at such a point
that cans with 1 1/2" internal vacuum, or more, are segregated from cans
with less than 1 1/2" internal vacuum.

§ 12600. Segregation of Flip-Tested Cans,

The segregation of flip-tested cans shall be into three lots, namely:

(a) Normal appearing cans

(b) Cans showing 1 1/2" or more internal vacuum

(1) All swells which do not show obvious cause of spoilage shall be
submitted to the laboratory for examination immediately upon instruc-
tions from the State Cannery Inspector.

(2) All leaks and cans punctured at the time of flip test shall be de-
stroyed.

§ 1 2605. Holding After Flip Test.

All material, including normal appearing and buckled cans, not de-
stroyed or submitted to the laboratory must remain under the original re-
straining order until official release has been authorized in writing.

(a) Such restrained material shall be segregated and marked to distin-
guish: (1) normal appearing cans, (2) cans with 1 1/2" or more internal
vacuum, (3) cans with less than 1 i/2" internal vacuum.

§ 12610. Cans Having Less Than 1 1/2" Internal Vacuum.

After the flip test representative samples of cans having less than
1 1/2" internal vacuum shall be submitted for laboratory examination.

(a) If laboratory findings on samples containing less than 1 1/2" inter-
nal vacuum indicate no spoilage, the remainder of the cans in the batch
restrained containing less than 1 1/2" vacuum may be released for man-
ufacturing purposes or disposed of directly through channels such as ho-
tels or restaurants for immediate consumption. The canner must notify
the Department of Public Health to whom this lot is sold. The material
flip testing 1 1/2" or more vacuum and the normal cans may be released
for retail trade.

(b) If laboratory findings on samples containing less than 1 1/2" inter-
nal vacuum indicate the product not to be commercially sterile, all such
cans are to be destroyed in the presence of the State Cannery Inspector.

§ 12615. Cans Having 1 1/2" or More Internal Vacuum.

In the event no cans in the lot are found with internal vacuum less than
1 1/2," representative samples of the lot having I 1/2" or more of internal
vacuum shall be submitted for laboratory examination.

(a) If laboratory findings on samples containing 1 1/2" or more internal
vacuum indicate no spoilage, the remainder of the cans having flip tested
1 1/2" or more internal vacuum may be released for retail distribution.
Normal cans restrained in such lots may also then be released for ship-
ment through retail trade channels.

(b) If laboratory findings on samples having 1 1/2" or more internal
vacuum indicate the product not to be commercially sterile, all such cans
shall be destroyed in the presence of the State Cannery Inspector. In this
event, samples will then be taken from the lot of normal appearing cans
to be submitted for laboratory examination.

§12620. Normal Cans; No Spoilage.

If laboratory findings on samples of normal appearing cans indicate no
spoilage, the remainder of the normal appearing cans may then be re-
leased for retail trade distribution.

Note; Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Sections 28432 and 28440, Health and Safety Code.

History
1. New NOTE filed 8-1-84 (Register 84, No. 31).

§12625. Normal Cans; Spoilage.

If laboratory findings on samples of normal appearing cans indicate
the product not to be commercially sterile, all such cans are to be de-
stroyed in the presence of the State Cannery Inspector.

§ 12630. Overfills and Hydrogen Swells.

That material found to be abnormal due to overfilling or due to the ac-
cumulation of hydrogen from chemical action may be recanned under the
inspection of the Department of Public Health, based on laboratory ex-
aminations of representative samples. See Sections 12550 and 12585 of
these regulations.

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§ 12670

«? 12635. Sampling.

All samples submitted to the laboratory must be selected by the Stale
Cannery Inspector.

§ 1 2640. Decision to Flip Test.

The Department of Public Health shall determine for each restrained
lot whether both normal appearing cans and buckled cans must be flip

tested.

DISPOSAL OF UNFIT CANNED FOODS

§ 12645. Prevention of Salvage of Unfit Canned Foods.

All unfit food products in hermetically sealed containers that are de-
stroyed in public or private dumps must be destroyed by any method suit-
able to the Department of Public Health; thus preventing the salvage of
food unfit for human consumption.

EXPERIMENTAL AND TRIAL PACKS

§12650. Applications.

Applications must be made to the Department of Public Health, in
writing, for permission to put up experimental trial packs of any low acid
food products. Applications must include complete details of the pro-
spective pack: formula, product, size of pack, size of cans, number of
cans, packing medium, initial temperature, time and temperature of pro-
cess, pH of pack, processing equipment, proposed labels, proposed use
of the finished pack. Experimental packs not so authorized will be re-
strained.

§12652. Exemption.

The above does not apply to a commercial cannery equipped with or
having access to a qualified research department if no commodides
packed on an experimental basis will be distributed in commerce.

FISH— DELIVERY, HANDLING, AND INSPECTION OF

§ 12655. General Rules.

(a) The term "decomposed" as used herein shall mean fish that are "in
whole or in part diseased, contaminated, filthy, putrid, or decomposed or
otherwise unfit for food."

(b) The Department of Public Health shall require the seller of raw fish
and the canning organizafion involved in each sale to comply with the
provisions of Chapter 3 of Division 21 of the Health and Safety Code pro-
hibiting the manufacture, production, preparation, compounding, pack-
ing, selling, offering for sale or keeping for sale of any decomposed fish.
The responsibility for maintaining an effective inspection service and of
eliminating decomposed fish from the canned product shall rest upon the
Department of Public Health, Bureau of Food and Drug Inspections, and
the executive head of each canning organization.

(c) The inspector in charge at the plant shall require that all cannery
operations be carried on under clean and sanitary condifions and require
the immediate disposal of decomposed fish, fish offal and bait chum.

(d) The term "inspector" as used in these reguladons shall mean a duly
authorized "state cannery inspector."

§ 12660. Standards for Inspection of Raw Fish.

(a) Inspection of raw fish shall be strict and uniform and shall be de-
signed and carried out to the end that fish unsuitable for canning shall be
rejected in the raw state insofar as possible.

(b) The standards to be used in the examinadon and judging of fish
shall be such as will make the resultant product conform to the Food,
Drug and Cosmedc Act of the United States and to the California Health
and Safety Code, Chapter 3 of Division 21.

Note: The Department will not reject cooked fish because of its color or quality,
unless such color or quality indicates decomposition as defined in subsection (a)
hereof.

(d) Split, mashed, or broken fish shall be condemned if deemed by the
inspector to be necessary for the prevention of acceptance of decom-
posed fish.

(e) The canner shall, promptly on arrival of each boat-load of fish,
notify the Department of Public Health, and no canner shall receive fish
into its plant until authorizadon is given by the inspector.

(f) Raw tuna in the round, shall be inspected by the examination of
each raw, defrosted fish at the time they are eviscerated. "Defrosted"
shall mean that each fish is thawed out to the point that odors are readily
detectable. Raw tuna, not in the round, received dressed, eviscerated,
gilled, headed or loins or pieces received frozen, shall be inspected in a
manner satisfactory to the Department of Public Health at such places
and times as may be directed by the inspector to prevent the canning of
decomposed fish. Cooked fish, frozen cooked fish or fish pieces, shall be
inspected at such places and times as may be directed by the inspector to
insure compliance v^'ith the law and these regulations.

(g) Raw sardines and mackerel shall, when offered for delivery, be in-
spected in the boat or at the hoist or at any other point selected by the in-
spector in charge of the district in order to insure the most effective in-
spection at each plant. There may be more than one place of inspection.

History
1 . Amendment filed 9-30-60; effective thirtieth day thereafter (Register 60, No.
21).

§12665. Inspection Service — Tuna.

(a) The inspection of all fish for canning purposes shall be under the
direction of the Chief of the Bureau of Food and Drug Inspections of the
Department of Public Health. The inspector on duty at each plant shall
observe that all operations are carried out in a sanitary manner and in a
manner to prevent the canning of decomposed fish, and shall immediate-
ly report to his superior any unusual or objecdonable practice.

(b) In order to facilitate and expedite the administration and enforce-
ment of the aforemendoned acts and these reguladons each canner may
select sufficient personnel from his own employees who shall be trained
by an inspector of the bureau to examine fish. The supervising inspector
shall notify each canner in wridng the names of employees of each com-
pany who are approved by the bureau as fish examiners.

(c) The detailed examination of the fish shall be made by an inspector
or an approved cannery fish examiner under the supervision of an inspec-
tor. The inspector shall specify the number of cannery fish examiners re-
quired, in accordance with the condition of fish in process from time to
dme. and the canner immediately shall supply the number so specified,
referring any difference of opinion in this regard to the inspector in
charge of the district. The approved cannery fish examiners shall at all
dmes be under the direction of the inspector in charge at the plant while
they are performing the duty of examining fish. The inspector in charge
at the plant may call upon the cannery management for an approv ed sub-
stitute whenever any authorized cannery fish examiner is, in the opinion
of the inspector, doing his work unsadsfactorily. In the event such substi-
tudon is not immediately made, an inspector shall be assigned to replace
him until an approved subsdtute is available. Tlie canner involved shall
not receive or pack any fish undl a proper substitute or an inspector is
available. All costs shall be assessed against the canner involved.

(d) The inspector in charge of the district shall have full authority over
the acdvides of his subordinates while assigned to the respective canner-
ies.

§12670. Raw Fish Reports.

(a) The inspector shall make a written record of each boat load on a
printed form. The records shall state total quantity of fish and include
such evidence as the inspector may be able to obtain as to the method of
handling.

(b) The bureau shall have free access to the records of each cannery
which bear directly on the problem ol" fish and cannery inspection.

Page 143

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

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(c) Condemned tuna shall be weighed by the canner in the presence of
the inspector and the inspector's report shall show accurately the weight
of condemned fish. The inspector shall keep separate weight records of
fish rejected by the canner because of quality or condition other than de-
composition.

§12675. Fishing Vessels.

(a) Decks and holds of all boats and \essels catching tuna, mackerel,
or sardines and transporting them to a cannery shall be kept in a clean and
sanitary condition. The requirement for cleaning vessels and boats shall
be enforced regardless of the size or type of the vessel or boat and shall
be uniform throughout the State.

(b) Each vessel shall keep a written log which shall be available to the
inspection service. Records of net boats shall show the time of each set.

(c) No decomposed chum may be used for bait or in taking mackerel.
All bait or chum used must be fresh (not over 24 hours old) unless it be
salted or frozen.

(d) High seas fishing boats, whether net or bait, shall keep a record of
their catch and their methods of handling fish, including hold and water
temperature.

(e) The Department of Public Health or its authorized agent may re-
quire interested parties, including members of the laboratory staff, to ap-
pear when undue quantities of fish have been condemned. Inquiry shall
be made of the fishermen to determine the methods used in fishing and
handling. An endeavor shall be made to explain to the fishermen the
proper method of handling raw fish to prevent the recurrence of the loss.
Representatives of the United States Food and Drug Administration and
other interested parties may be admitted to the inquiry.

§ 12680. Disposal of Condemned Fish.

(a) When a boat load of tuna or mackerel has been condemned as unfit
for canning, the inspector shall notify the supervising inspector who shall
take such action as is necessary to prevent delivery of the rejected fish to
any other plant.

(b) When a boat load of sardines has been condemned and the canner
to whom delivery was offered can not receive the fish for reduction pur-
poses, the inspector shall take the necessary steps to prevent the canning
of these fish by any other canner.

(c) In all cases the inspector shall serve notice upon the captain of the
boat whose fish are condemned that they shall not be used or sold for can-
ning purposes.

(d) The inspector shall take such action as may be necessary to insure
that fish which are condemned for canning purposes shall not be used for
canning.

§12685. Sampling Canned Tuna.

(a) The supervising cannery inspector in charge of the district shall de-
termine whether or not sample cans of the final product shall be taken for
examination. He shall base his decision upon the condition of the boat
load and the report of the inspector. If the boat load of fish is in a prime
state of preservation at the time of packing, confirmed by inspecUon in
the plant, no samples need be taken.

(b) Sampling shall be carried out according to rules promulgated by
the Department of Public Health and the minimum quantities of samples
shall be as follows:

A lot of less than 200 cases 48 cans

200 to 1,000 cases 96 cans

1,000 to 2,000 cases 192 cans

2,000 to 5,000 cases 288 cans

5,000 to 10,000 cases 576 cans

Over 10,000 cases 960 cans

Not more than one can should be taken from any one case in sampling.

MACKEREL, HORSE, LABELING EXEMPTION

§ 12690. Horse Mackerel.

{Treacherous symmetricus) may be labeled as "Jack mackerel" pro-
viding that the word "jack" shall be prominently printed in the same size,
style and color letters as the word "mackerel" which it modifies; and in

addition, that the scientific name Treacherous symmetricus be included
on the label; also no written or oral representation on the label or in con-
nection with the sale of the product in invoicing or elsewhere implying
that this fish is California mackerel or Pacific mackerel {Pneumatopho-
rus diego) or any fish other than Treacherous symmetricus.

§ 12695. Sanitary Boat Certificates.

Hi. STORY
1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§12700. Supervision of Cleaning.

History
1 . Repealer filed 9-1-78: effective thirtieth day thereafter (Register 78. No. 35).

§12705. Method of Cleaning.

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

INSPECTION LEGEND

§12710. Application.

Any packer desiring to use the inspecUon legend on labels for products
packed under the provisions of Chapter 8 of Division 21 of the Health and
Safety Code shall make a formal written application therefor to the Board
of Public Health.

§12715. Permission.

Upon receipt of written permission from the Board of Public Health
the following statement may be placed on the labels of only those prod-
ucts packed in compliance with the provisions of the Laws Relating to
Cannery Inspection.

§12720. Official Wording.

The official wording of the legend is as follows: Sterilized under the
supervision of and according to the regulations of the California State
Department of Public Health.

RETORT EQUIPMENT AND OPERATION

§ 12725. Notification of Intention to Install Retorts.

Every person, firm, company, organization, association, or corpora-
tion in the State of California desiring to install a retort to be used for the
sterilization of low-acid food products in accordance with the provisions
of Secuons 28410 and 2841 1 of the Health and Safety Code, prior to in-
stallation of such equipment, shall nofify the Department of Public
Health.

§12730. Obtaining Approval.

Approval shall be obtained from the Department of Public Health be-
fore any retort equipment is installed or before previously installed
equipment may be used for processing commercial products under in-
specUon.

Note: Upon request diagrams of minimum installations for discontinuous retorts
may be obtained from the Department of Public Health.

§ 1 2735. Types of Retorts.

(a) Horizontal. Still and rotary retorts

(b) Verfical. Still retorts

Installations and operafions of continuous pressure cookers are not
sufficiently standardized at the present time to permit making regulations
governing their installations and operafion. However, such installations
shall be subject to the approval of the Department of Public Health.

§ 1 2740. Definition of Terms.

(a) Inspector. "Inspector" means a duly authorized representative of
the Department.

(b) Vent. A "vent" is a valve-controlled opening into a retort, used for
the eliminafion of air during the coming-up fime.

(c) Retort Bleeder. A "retort bleeder" is an opening of at least one-
eighth inch into a retort which is open during the entire process for the

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§ 12745

removal of air that may enter the retort with the steam or through a leaky
air valve.

(d) Thermometer Bleeder. A "thermometer bleeder" is a one-six-
teenth inch or larger opening into a thermometer well or pocket. This
bleeder is open during the entire process to ensure a continuous tlow of
steam from the retort past the thermometer bulb in order that the tempera-
ture shown will be the same as that in the retort.

(e) Coming-Up Time (Lag). The "coming-up time" is the time which
elapses between the turning on of the steam and the time when the retort
reaches the processing temperature.

(0 Process. The term "process" designates the heat treatment ex-
pressed in terms of temperature and time given the product after the con-
tainer is permanently sealed, in order to destroy spoilage microorgan-
isms.

(g) Plug-Cock Valves. An approved type of "plug-cock valve" is one
which permits an unrestricted flow of air through the valve.
NOTH: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 28440, Health and Safety Code.

History
1 . Kditorial coiTcction of subsection (a) and new NOTE filed 8-1- 84 (Resister 84,

No. 31).

§ 12745. Required Equipment for All Types of Retorts

When Sterilizing Food in Tin or in Glass Jars
with Closures Such That They May Be
Processed in Steam.

(a) Recording Thermometer.

( 1 ) The temperature chart shall be easily readable to 1 degree F and
shall be graduated in not to exceed 2 degrees F divisions within the range
of plus and minus 10 degrees F of the official process to be used. All
charts shall have a working scale of not less than three inches. Written
permission from the Department shall be obtained for the use of old
equipment with charts having a working scale of less than three inches.
All replacements or new installations shall conform to a minimum three-
inch working scale.

(2) No temperature chart shall be used in a recording thermometer un-
less it is a chart manufactured specifically for use in the recording ther-
mometer installed on the retort.

(3) It shall be unlawful to use charts with the temperahire indicated in
code.

(4) Every recording thermometer shall bear the name plate of the origi-
nal manufacturer having the serial number assigned by the manufacturer,
and the manufacturer's chart number die stamped thereon.

(5) Any recording thermometer found by a cannery employee or In-
spector to be faulty in its operation shall be promptly adjusted or replaced
by a properly functioning instrument.

(6) Any recording thermometer requiring repair of the thermal system
shall be repaired by the manufacturer or a servicing organization accred-
ited by the manufacturer.

(7) Documentary evidence of proper calibration may be required for

any repaired recording thermometer when returned by the manufacturer
or accredited servicing organization.

(8) All recording thermometers shall be so placed with respect to light
that they are conveniently readable.

(b) Indicating Mercury Thermometer.

( 1 ) The divisions shall be easily readable to 1 degree F and shall not
exceed 20 degrees F per inch of graduated scale. It shall be unlawful to
use mercury thermometers with the temperatures indicated in code.

(2) All mercury thermometers shall be placed in respect to light so that
they are conveniently readable.

( 1 ) Every retort shall have a pressure gauge of the Bourdon type in
which the operating mechanism is a complete unit independent of the
case. Every gauge shall be equipped with a compensating hair spring.

(2) The minimum diameter of the dial shall be four inches.

(3) The range of the pressure scale shall preferably be 0 to 30 pounds,
but a range of 0 to 60 pounds may be used.

(4) Any retort pressure gauge found to be inaccurate either by a can-
nery employee or by an Inspector shall be replaced by a properly func-
tioning instrument.

(d) Valves for Removal of Condensate.

(1) Condensate shall not be allowed to accumulate in horizontal re-
torts.

Note: This may be prevented by the installation of a one-half inch or larger valve
in the bottom of the retort to be left open sufficiently to remove the condensate.

(2) To assure that condensate will not accumulate in a retort during the
process, a one-eighth inch or larger petcock or valve shall be installed or
a hole drilled in the drain or bottom of the retort and it shall remain open
during the entire processing time.

(e) By-Pass Around Diaphragm Control Valve on Steam Inlet.
Each diaphragm control valve shall be equipped with a by-pass to al-
low for hand control in case of an emergency.

(f) Steam Inlet.

(1) Horizontal Retorts:

(A) For retorts more than 20 feet in length, the steam shall enter the
spreader pipe near the center of the retort. For retorts less than 20 feet in
length, the steam may enter the spreader pipe either at the center or at the
end. If steam enters at the end, the spreader pipe shall be no smaller than
the steam inlet.

(B) The retort shall be equipped with an adequately perforated pipe ex-
tending throughout the entire length of the bottom of the retort with per-
forations arranged so that the steam is directed up and into the load of
cans. The ends of the steam spreader shall be closed.

(2) Vertical Retorts:

(A) If steam is admitted into the bottom of the retort, it shall be directed
up into the load of cans. Any other position of the steam inlet must be ap-
proved by the department.

The recommended number of holes to be used in steam spreaders is given in the
followins table:

Size

3/4

Holes

Inch

Inches

Pipe

3/16

7/32

1/4

Size of Steam Supply Inlet

11/4

11/2

Inch

Pipe

112

2 1/2

Inch

Pipe

185

265

135

195

105

145

(g) Retort Bleeders.

( 1 ) For Horizontal Retort:

(A) A horizontal retort shall be equipped with bleeders along the top
of the retort not more than eight feet apart and there shall be one within
approximately one foot of each end of the retort. These bleeders shall be
kept wide open during the entire process.

( B ) Any bleeder at least one-eighth inch in size on a thermometer well
may be considered to comply with this requirement when the well is in
the top of the retort and located at the proper place.

(2) For Vertical Retort:

(A) A vertical retort shall be equipped with a bleeder at the end of the
retort opposite the steam inlet. This bleeder shall be wide open during the
entire process. In the case of very small retorts (less than 30-inch diame-
ter and less than four feet in depth) a three-thirty-second inch bleeder
may be used.

(h) Thermometer Bleeders. Bleeders for All Thermometers on All
Types of Retorts. A one-sixteenth-inch or larger bleeder hole shall be
kept open for the free escape of steam, on all thermometer fittings unless

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thermometer bulbs are set wholly within the shell of retort proper. The
bleeders shall be so located as to provide a full flow of steam past the sen-
sitive part of the thermometer bulb.

(i) Vents for Removal of Air From Retorts During Coming-Up Period.
Vents shall be installed and operated in such a way that all the air is re-
moved from the retort before timing of the process is started.
NOTf-.: See the venting systems described under Sections 12760 and 12765 of
these regulations.

(J) Stacking Equipment for Use in Horizontal and Vertical Retorts.

( 1 ) Stacking equipment (baskets, trays, gondolas, etc.) for all types of
containers in discontinuous retorts, when cans or jars are stacked in a ver-
tical position, shall be preferably of strap iron. When perforated sheet
metal baskets are used, the perforations in the bottoms shall be at least
one-inch holes on one-and-three-fourths-inch centers or their equiva-
lent, unless other equipment has been approved.

(2) If dividers are used, they shall be of wide mesh material, such as
fish nets or onion sacks, or of strap iron or sheet metal having perforations
at least the equivalent of one-inch holes on one-and-three-fourths-inch
centers. Close meshed cloth dividers are not permitted.

NOTK: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 28411, Health and Safety Code.

History

1. Amendment fded 7-1-66; effective thirtietli day thereafter (Register 66, No.
20).

2. Editorial correction of subsections (a)(1), (a)(5) and (c)(4) fded 8-1-84 (Regis-
ter 84, No. 31).

§ 12750. Additional Equipment Suggested but Not

Required by the Department of Public Health.

(a) The use of an additional thermometer on each retort is advised to
serve primarily as a check instrument, preferably located adjacent to the
temperature recorder bulb.

(b) An automatic temperature controller is recommended.

(c) A safety valve of such size and capacity that it meets with the re-
quirements of any board of mechanical engineers or any safety code in
the State of California, and/or the California Industrial Accident Com-
mission. It is recommended that the safety valve discharge be equal to or
greater in capacity, than the retort steam supply line.

§ 12755. Venting of Retorts for Removal of Air, General
Considerations.

(a) Vents (except drains when used as vents) shall be in the opposite
side or end of the retort from that at which the steam is admitted.

(b) Vent valves shall be of the gate or plug cock type, preferably quick
acting, except where otherwise specified.

Note: a globe valve of one pipe size larger than the minimum vent requirement
may be substituted for a gate valve.

(c) for the most efficient operation of a retort, cans shall be so stacked,
and the stacking equipment shall be of a type such that the air can be re-
moved rapidly enough to permit a uniform distribution of heat through-
out the retort at the time processing temperature is attained. Anything
which interferes with the free flow of steam through any part of a retort
load makes this requirement more difficult to meet.

NOTli: Use of the drain as a vent in conjunction with venting from the top of the
retort is permissible and several combinations of top and bottom vents are de-
scribed. However, it is more desirable to use venting systems which do not involve
the use of the drain.

Various anangements of vents may be used to obtain uniform heat distribution
throughout a retort. The following vent arrangements and cycles of operation have
been found to give satisfactory heat distribution. Every retort shall be equipped
with one of these installations or some other arrangement of vents which is equally
satisfactory. If venting systems other than those described here are desired, or if
shorter coming-up times are to be used, the approval of the Department of Public
Health shall first be obtained. A special investigation may be required in order to
determine the conditions under which such equipment may be used.

If equipment now in use approximates, but does not exactly conform to one of
the prescribed venting systems, the Department of Pubhc Health should be con-
sulted before any expensive change of equipment is undertaken. Full details con-
cerning the present installation should be furnished to the department.

Conditions such as boiler capacity and size of steam inlets vary in different
plants and modifications of the venting procedure may be necessary in some in-
stances to permit reaching the temperature specified within the recommended
time. When this seems necessary, an investigation will be made by the Department

of Public Health and modifications of the equipment or venting procedure will be
suggested in accordance with conditions found. When a change in procedure is
suggested, this new procedure will then become the approved method of venting
the retorts in question at that plant.

§ 12760. Venting of Horizontal Retorts for Removal of Air.

Note: The following venting specifications are for discontinuous horizontal re-
torts not exceeding five and one-half feet inside diameter, and are based on data
from tests made with round cans in strap iron trays. There is evidence to indicate
that the use of perforated sheet metal trays may necessitate supplementary retort
venting or modifications in the stacking of cans.

(a) System A. Venting Through Multiple One-Inch Vents Discharg-
ing Directly to the Atmosphere.

(2) Operation. The vent valve shall be wide open when steam is ad-
mitted to the retort, and shall remain wide open for at least five minutes
after steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 225 degrees F, or at least seven minutes
to at least 220 degrees F.

(3) If vent pipes are to be extended beyond the valves, the extensions
shall be of at least one pipe size larger than the vent pipes entering the
retort.

(b) System B . Venting Through the Drain Valve and Through Multiple
One-Inch Vents Discharging Directly to the Atmosphere.

(2) In addition, the retort shall be equipped with a drain of not less than
three-inch pipe size for retorts up to 15 feet in length or of not less than
four-inch pipe size for retorts over 15 feet in length.

Note: The drain valve may be either globe or gate type.

(3) Operation. The vent valves and the drain valve shall be wide open
when steam is admitted to the retort.

(4) The drain valve shall remain wide open for at least two minutes af-
ter steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 210 degrees F.

(5) The one-inch vent valves shall remain wide open for at least five
minutes after steam is turned on, and until the mercury thermometer on
the retort indicates a temperature of at least 220 degrees F.

(6) If vent pipes are to be extended beyond the valves, the extensions
shall be of at least one pipe size larger than the vent pipes entering the
retort.

Note: The drain may be extended beyond the valve with pipe the same size as the
valve.

( 1 ) Equipment. A retort shall be equipped with unrestricted one-inch
pipes, approximately one foot in length, one for each five feet — or frac-
tion thereof — of retort length, approximately symmetrically placed
along the top of the shell, uniformly separated, not more than seven feet
apart, and connected into a manifold. There shall be one of the above
vents within two and one-half feet of each end of the shell. The manifold
shall be of 2 1/2-inch pipe size for retorts up to 15 feet in length, and of
three-inch pipe size for retorts over 15 feet in length. Venting shall be
controlled by a vent valve in a pipe leading from, and of a size not smaller
than that of the manifold.

(2) Operation. The vent valve shall be wide open when steam is ad-
mitted to the retort, and shall remain wide open for at least six minutes
after steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 225 degrees F or at least eight minutes
to at least 220 degrees F.

Page 146

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Title 17

State Department of Health Services

§ 12760

(3) If the vent valve is connected into a discharge pipe or system for
removal of steam from the building, the header shall be sufficiently large
so that venting will not be impaired.

(d) System D. Venting Through the Drain Valve and Through Multi-
ple One-Inch Vents Discharging Through a Manifold.

( 1 ) Equipment. A retort shall be equipped with unrestricted one-inch
pipes approximately one foot in length, one for each five feet — or frac-
tion thereof — of retort length, approximately symmetrically placed
along the top of the shell, uniformly separated, not more than seven feet
apart and connected into a manifold. There shall be one of the above vents
within two and one-half feet of each end of the shell. The manifold shall
be of 2 1/2-inch pipe size for retorts up to 1 5 feet in length, and of three-
inch pipe size for retorts over 15 feet in length. Venting shall be con-
trolled by a vent valve in a pipe leading from, and of a size not smaller
than that of the manifold.

(2) In addition, the retort shall be equipped with a drain of not less than
three-inch pipe size or retorts up to 15 feet in length or of not less than
four-inch pipe size for retorts over 15 feet in length.

NOTl-: The drain valves may be either gate or globe type.

(3) Operation. The vent valve and drain valve shall be wide open when
steam is admitted to the retort.

(4) The drain valve shall remain wide open for at least three minutes
after steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 210 degrees F.

(5) The vent valve shall remain wide open for at least five minutes after
steam is turned on, and until the mercury thermometer on the retort indi-
cates a temperature of at least 220 degrees F.

(6) If the vent valve is connected into a discharge pipe or system for
removal of steam from the building, the header shall be sufficiently large
so that venting will not be impaired.

(e) System E. Venting Through the Water Spreader.

( 1 ) Equipment. The water spreader shall be of not less than 1 1/2-inch
pipe size for retorts less than 15 feet in length, with the water inlet con-
nected through the shell so that the spreader pipes extend in both direc-
tions from a tee in the water inlet. The water inlet to which the spreader
is connected shall be of not less than two-inch pipe size. The vent pipe
shall be of at least two-inch pipe size and shall be connected into the wa-
ter inlet without any restriction in pipe size.

The water spreader shall be of not less than two-inch pipe size for re-
torts from 15 to 30 feet in length with the water inlet connected through
the shell so that the spreader pipes extend in both directions from a tee
in the water inlet. The water inlet to which the spreader is connected shall
be of not less than 2 1/2-inch pipe size. The vent pipe shall be of at least
2 1/2-inch pipe size and shall be connected into the water inlet without
any restrictions in pipe size.

If the water enters at or near one end of the retort the water spreader
shall be at least as large as the water inlet.

For retorts over 30 feet in length, the Bureau of Food and Drug Inspec-
tions, Cannery Inspection Section, shall be consulted for the proper vent-
ing requirements.

(2) The water spreader shall have holes of not less than three-six-
teenths-inch diameter distributed uniformly along the length of the
spreader pipe, and of sufficient number so that their aggregate area is not
less than that of a two-inch pipe (3.34 square inches) for retorts up to 1 5
feet in length, or not less than that of a 2 1/2-inch pipe (4.75 square in-
ches) for retorts having lengths of 1 5 to 30 feet.

(3) Operation. The vent valve shall be wide open when steam is ad-
mitted to the retort, and shall remain wide open for at least five minutes
after steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 225 degrees F; or the vent valve shall
remain wide open for at least seven minutes to at least 220 degrees F.

(4) If the vent valve is connected into a discharge pipe or system for
removal of steam from the building, the header shall be sufficiently large
so that venting will not be impaired.

(5) The following table indicates the minimum number of holes per-
missible in water spreaders when used for venting:

Number of Holes in Spreader Pipe

Drill

Size

Indies

3/16

7/3

1/4

For 1 I /2-Inch
Pipe Outlet
(2.02 Sq. In.)

74
54
42

For 2-Inili
Pipe Outlet
(J.J4 Sq. In.)

121

For: I/2-hirh
Pipe (hille!
14.75 Sq. III.)

173
127
97

(f) System F. Venting Through the Drain Valve and Through the Wa-
ter Spreader.

( 1 ) Equipment. The water spreader shall be of not less than 1 1/2-inch
pipe size for retorts less than 15 feet in length, with the water inlet con-
nected through the shell so that the spreader pipe extends in both direc-
tions from a tee in the water inlet. The water inlet to which the spreader
is connected shall be of not less than two-inch pipe size. The \ent pipe
shall be of at least two-inch pipe size and shall be connected into the w a-
ler inlet without any restriction in pipe size.

The water spreader shall be of not less then two-inch pipe si/e for re-
torts from 15 feet to 30 feet in length with the water inlet ct)nnected
through the shell so that the spreader pipe extends in both directit)ns fremi
a tee in the water inlet. The water inlet to which the spreader is connected
shall be of not less than 2 1/2-inch pipe size. The vent pipe shall be of at
least 2 1/2-inch pipe size and shall be connected into the water inlet with-
out any restrictions in pipe size.

If the water enters at or near one end of the retort the water spreader
shall be of at least the same size as the water inlet.

For retorts over 30 feet in length, the Department of Public Health shall
be consulted for the proper venting requirements.

(2) The water spreader shall have holes of not less than three-six-
teenths-inch diameter distributed uniformly along the length o'i the
spreader pipe, and of sufficient number so that their aggregate area is not
less than that of two-inch pipe (3.34 square inches) for retorts up to 15
feet in length, or not less than that of a 2 1/2-inch pipe (4.75 square in-
ches) for retorts having lengths of 1 5 to 30 feet.

Note: See table in subsection (e)(5) for number and size of holes required.

(3) In addition, the retort shall be equipped with a drain of not less than
three-inch pipe size for retorts up to 15 feet in length or of not less than
four-inch pipe size for retorts over 15 feet in length. The drain valve may
be either globe or gate type.

(4) Operation. The vent valve and the drain valve shall be wide open
when steam is admitted to the retort.

(5) The drain valve shall remain wide open for at least two minutes af-
ter steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 2 1 0 degrees F.

(6) The vent valve shall remain wide open for at least five minutes after
steam is turned on, and unfil the mercury thermometer on the retort indi-
cates a temperature of at least 220 degrees F.

(7) If the vent valve is connected into a discharge pipe or system for
removal of steam from the building, the header shall be sufficiently large
so that venting will not be impaired.

(g) System G. Venfing Through a Single 2 1/2-Inch Top Center
Vent — for Retorts Less Than 15 Feet Long.

(1) Venting may be accomplished by the u.se of a single 2 1/2-inch un-
restricted vent located at the top of the shell, provided this vent is within
two feet of the center of the retort.

(2) Operation. The vent valve shall be wide open when steam is ad-
mitted to the retort, and shall remain wide open for at least four minutes
after steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 220 degrees F.

Page 147

(4-1-90)

§ 12765

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

If the vent valve is connected into a tlischarge pipe or system for re-
moval of steam from the building, the header shall be sufficiently large
so that venting will not be impaired.

(h) System H. Venting Through the Drain Valve and Through a Single
I 1/2-hich Top Center Vent for Retorts Less Than 15 Feet Long.

( 1 ) Venting may be accomplished by the use of the drain valve in con-
junction with a single unrestricted 1 1/2-inch vent located at the top of
the shell, provided the vent is within two feet of the center of the retort.

(2) In addition, the retort shall be equipped with a drain of not less than
four-inch pipe size.

(3) Operation. The vent valve and the drain valve shall be wide open
when steam is admitted to the retort.

(4) The drain valve shall remain wide open for at least two minutes af-
ter steam is turned on, and until the mercury thermometer on the retort
indicates a temperature of at least 210 degrees F.

(5) The vent valve shall remain wide open for at least five minutes after
steam is turned on, and until the mercury thermometer on the retort indi-
cates a temperature of at least 220 degrees F.

(6) If the vent valve is connected into a discharge pipe or system for
removal of steam from the building, the header shall be sufficiently large
so that venting will not be impaired.

§ 12765. Venting of Vertical Retorts for Removal of Air.

(a) The following specifications apply for venting vertical retorts not
larger than approximately 42 inches diameter by 96 inches high, when
the following equipment is used:

( 1 ) Strap-iron or adequately perforated metal baskets.

(2) Vents located in or near the top of the retort.

(3) At least a one-inch steam line into the bottom of the retort and ar-
ranged so that steam is directed up into the load of cans.

(4) Raised supports for retort baskets so constructed that no baffling
effect occurs. Baffle plates are not permitted.

If dividers are used, they shall be of wide mesh material, such as fish
nets or onion sacks, or of strap iron or sheet metal having perforations at
least the equivalent of one-inch holes on one and three-fourths-inch
centers. Close meshed cloth dividers are not permitted .

(b) System I. Venting Through a Single 1 1/2-Inch Overflow Pipe.

(1) Venting of a vertical retort may be accomplished through a
1 1/2-inch overflow pipe if it is connected to the retort within at least 10
inches of the top of the shell. The overflow pipe shall have not more than
eight feet of 1 1/2-inch pipe beyond the valve. If the vent pipe discharges
into a manifold, the manifold shall be sufficiently large so that venting
will not be impaired.

(2) Operation. The vent valve shall be wide open when steam is turned
on, and it shall remain wide open for at least four minutes after steam is
turned on and also until the mercury thermometer reaches a temperature
of at least 2 1 8 degrees F or for at least five minutes to at least 2 1 5 degrees
F.

( 1 ) Venting of a vertical retort may be accomplished through a single
unrestricted one-inch vent located in the lid of the retort. This vent shall
be equipped with a one-inch gate valve and shall discharge into the atmo-
sphere, with not more than four feet of one-inch pipe beyond the valve.

(2) The vent valve shall be wide open when steam is turned on, and it
shall remain wide open for at least five minutes after steam is turned on
and also until the mercury thermometer reaches a temperature of at least
230 degrees F or for at least seven minutes to at least 220 degrees F.
NOTE: Authority cited; Sections 208 and 28440. Health and Safety Code. Refer-
ence: Section 28411. Health and Safety Code.

History

1. New NOTE filed 8-1-84 (Register 84, No. 31).

Page 148

(4-1-90)

Title 17

State Department of Health Services

$ 12780

§ 12767, Diagrams of Venting Systems.

Vtnting through muitipl* 1-in, vcnti discharging
cTifActly to otmosphor*

/•tr> <fOtf t^l** l-in tf^nf

1}C iiRl

Sfram fitrfodtr

=^g

SYSTEM B

Venting through the drain and multiple 1-in.

vsntt discharging directly to atmosphere

SYSTEM C

Venting through multipio 1-in. venti ditcharging

througii a manifold to otmo*phere

ISC

31=

S'»om tO'*»t/f

SYSTEM D

Venting through drain ond multiple l-ln. vents

ditcharging through a monifold to atmoiphere

O0t*^m>^

SYSTEM E
Venting through water spreader

Inht'*

St*am aprr<K/rr-

=V^

SYSTEM F
Venting through drain ond water spreader

tinrrr tpr**J*r

•try— iofoj/rf

=^S:

SYSTEM G

Venting through a single 2'/2-in. top vent (For

retorts not exceeding 15 ft. in length)

Diagrams Reprinted from "Food Industries" Vol. 16, Page 93. Febru-
ary, 1944

NOTI-.: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 28440, Health and Safety Code.

History
1. New NOTE filed 8-1-84 (Register 84, No. 31).

RETORTS, FOR FOODS IN GLASS

§ 12770. Notification of Intention to Install Retorts.

Every plant desiring to install a retort to be used for the sterilization of
low acid food products in accordance with the provisions of Sections
28410 and 2841 1 of the Health and Safety Code, prior to installation of
such equipment, shall notify the Department of Public Health.

§12775. Obtaining Approval.

Approval shall be obtained from the Department of Public Health be-
fore any retort equipment is installed, or before previously installed retort

f/ltn ittfyt

■2/ff^ gat* tM*»

SYSTEM H
Venting through drain and a single IVs-in. top
vent (For retorts not exceeding 15 ft. in length)

1 1

"/Jit^ f€>*r>mMft

irrrotirr

SYSTEM I
Venting through a
MV^oin. ovemew

SYSTEM J
Venting through a
Single Mn. top vent

S'^tf^^ $ff^Q^^^

=\S

Strom ti!*9a/fr

"Vgf

equipment may be used for processing commercial products under in-
spection. Every plant must be properly equipped to satisfy all require-
ments of the department.

§12780. Equipment Required.

Every horizontal steam operated discontinuous retort to be used for the
sterilization of food products packed in glass containers must have the
following as minimum equipment:

(a) Gauge water glass or series of petcock water level indicators.

(Gauge water glass is recommended.)

Note: Automatic pressure control is recommended to prevent waste of com-
pressed air.

(b) Pressure regulating valve in the overflow line. It shall be the same
size as, or larger than, the water supply line.

(d) Recording thermometer

Page 149

(4-1-90)

§ 12785

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) No temperature chart shall be used in a recording thermometer un-
less it is a chart manufactured specifically for use in the recording ther-
mometer installed on the retort.

(3) It shall be unlawful to use charts with temperature indicated in
code.

(5) Any recording thermometer found by a cannery employee or State
Cannery Inspector to be faulty in its operation shall be promptly adjusted
or replaced by a properly functioning instrument.

(6) Any recording thermometer requiring repair of the thermal system
shall be repaired by the manufacturer or a servicing organization accred-
ited by the manufacturer.

(7) Documentary evidence of proper calibration may be required for
any repaired recording thermometer when returned by the manufacturer
or accredited servicing organization.

(8) All recording thermometers shall be so placed with respect to light
that they are conveniently readable.

(e) Indicating mercury thermometer.

(1 ) The divisions shall be easily readable to 1 degree F and shall not
exceed 20 degrees F. per inch of graduated scale. It shall be unlawful to
use mercury thermometers with the temperature indicated in code.

(2) All mercury thermometers shall be placed in respect to light so that
they are conveniently readable.

(f) Pressure gauge.

(2) The minimum diameter of the dial shall be four inches.

(3) The range of the pressure scale shall preferably be 0 to 30 pounds
but a range of 0 to 60 pounds may be used.

(4) Any retort pressure gauge found to be inaccurate either by a can-
nery employee or by an Inspector shall be replaced by a properly func-
tioning instrument.

(g) Proper circulating equipment to insure agitation of the water during
come-up and process time. In horizontal retorts this may be accom-
plished with a recirculating pump. In vertical retorts this may be accom-
plished by providing for a continuous supply of compressed air through
the steam distributor cross during these periods. The bypass line around
the air control valve, providing a continuous supply of air, shall be at least
one-eighth inch inside diameter.

(h) Adequately perforated steam distributor pipe extending the length
of horizontal retorts or forming a cross throughout the width of the bot-
tom of vertical retorts or any other approved methods.

(i) Bottom drain.

(j) A safety valve of such size and capacity that it meets with the re-
quirements of any Board of Mechanical Engineers or any Safety Code in
the State of California, and/or the California Industrial Accident Com-
mission. It is recommended that the safety valve discharge be equal to or
greater in capacity than the retort steam supply line.
NOTE: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence; Section 2841 1, Health and Safety Code.

History

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No.
20).

2. Editorial correction of subsections (d)(1), (f)(4) and new NOTE filed 8-1-84
(Register84, No. 31).

§12785. Installation of Equipment.

(a) The gauge water glass or series of petcocks shall be installed in
such a position as to determine the water level during the process. If a
gauge water glass is used, a mark indicating the height of the top row of
jars shall be placed on the gauge water glass. If a series of petcocks is
used, the petcock above the level of the top row of jars must be open at
all times during the process and the free flow of water shall be visible to
the retort operator.

(b) Steam and air shall be admitted at the bottom of the retort. Water
may be admitted at the top, or bottom, or both.

Note: It is recommended that all pipe connections be equipped with check valves
where there is a common entrance for steam, water, and air.

(c) Steam and air shall be admitted into the bottom center of the retort
through a perforated pipe or cross extending the length of the horizontal
retort or throughout the width of a vertical retort, and in which the perfo-
rations are so arranged as to produce equal turbulence and distribution
throughout the length of the pipe or cross. The extreme ends of the perfo-
rated steam distributor pipe or cross shall be closed; other inethods of
producing turbulence and proper distribution of heat are subject to ap-
proval.

(d) Each diaphragm control valve shall be equipped with a bypass to
allow for hand control in case of an emergency.

(e) In horizontal retorts a suction manifold shall be installed in the bot-
tom of the retort to remove the water for circulation. The number of water
inlets to the suction manifold shall be dependent upon the length of the
retort with a minimum of one for each eight linear feet of retort length.
The inlets shall be spaced at approximately equal intervals. The com-
bined area of the inlets shall equal the area of the manifold. The manifold
shall be connected to a recirculating pump operating at a sufficient rate
to completely recirculate the water in not more than seven minutes. The
water shall re-enter the top of the retort through the perforated water
spreader.

Any other type of manifold or suction installation will be subject to the

approval of the Department.

Note: It is recommended that the switch operating the pump be equipped with a
signal light, preferably red, or other warning device, so that the operator can see
at all times that the pump is properly functioning.

(f) In horizontal retorts the mercury thermometer bulb, recording ther-
mometer bulb and temperature controller bulb shall be located within the
shell of the retort, and in such a position that they are beneath the surface
of the water throughout the process.

(g) In vertical retorts the recording thermometer bulb and temperature
controller bulb shall be installed at the bottom of the retort beneath and
away from the steam inlet.

(h) In vertical retorts the mercury thermometer shall be so installed as
to permit continuous circulation of the heating medium past the bulb dur-
ing the process.

Note: This may be accomplished by inserting the thermometer in a gradually
sloped shallow and closed extension of the retort.

(i) The bottom of the overflow ouflet shall be above the level of the top
of the jars in the retort.

(j) All recording thermometers, mercury thermometers, pressure
gauges and gauge water glasses must be so placed in respect to light that
they are easily readable.

NOTE: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 2841 1, Health and Safety Code.

History
1. Editorial correction of subsection (e) and new NOTE filed 8-1-84 (Register 84,

No. 31).

§12790. General.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12795. Animal Food Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

Page 150

(4-1-90)

Title 17

State Department of Health Services

§ 12976

§ 12800. Asparagus Sterilization Processes.

History
1 . Repealer filed 9-1-78; et'feetive thirtieth day thereafter (Register 78. No. 35).

§ 12805. Beans, Dry: Sterilization Processes.

History
1. Repealer filed 9-1-78; effeeiive thirtieth day thereafter (Register 78, No. 35).

§ 1 281 0. Beans, Green and Wax, Whole or Cut:
Sterilization Processes.

History
1 . Repealer filed 9-1-78; effeetive thirtieth day thereafter (Register 78. No. 35).

§ 12815. Beans, Lima and Soy: Sterilization Processes.

History
1. Repealer filed 9-1-78; effeetive thirtieth day thereafter (Register 78, No. 35).

§ 12820. Bean Sprouts: Sterilization Processes.

History
1. Repealer filed 9-1-78; effeetive thirtieth day thereafter (Register 78. No. 35).

§ 12825. Beets: Sterilization Processes.

History
1 . Repealer filed 9-1-78; effeetive thirtieth day thereafter (Register 78, No. 35).

§ 12830. Broccoli: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12835. Brussels Sprouts: Sterilization Processes.

History
1. Repealer filed 9-1-78; effeetive thirtieth day thereafter (Register 78. No. 35).

§ 12840. Cabbage: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).

§ 12845. Carrots: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12850. Carrot Juice: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12855. Carrots and Peas: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).

§ 12860. Cauliflower: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12865. Celery: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12870. Chili Products: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12875. Corn: Sterilization Processes.

History
1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12880. Corn Meal Mush: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12885. Fish Products: Sterilization Processes.

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12890. Hominy: Sterilization Processes.

History

1 . Repealer filed 9-1-78; effeetive thirtieth day thereafter (Register 78, No. 35).

§ 12895. Lentils in Unthickened Sauce: Sterilization
Processes.

History
1 . Repealer filed 9-1-78; effeetive thirtieth day thereafter ( Regi.ster 78. No. 35).

§ 12900. Mushrooms: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12905. Mushroom Sauce — Spaghetti Sauce: Sterilization
Processes.

History
1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12910. Olives: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12915. Parsnips: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12920. Peas: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12925. Potatoes: Sterilization Processes.

History
1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12930. Potatoes, Sweet: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12935. Poultry Meat — Turkey: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12940. Pumpkin: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12945. Ravioli: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12950. Spaghetti: Sterilization Processes.

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12955. Spinach, Packing and Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12960. Tamales, Cup: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12965. Vegetables, Chopped: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).

§ 1 2970. Vegetables for Salad: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 12975. Vegetables, Strained: Sterilization Processes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter ( Register 78. No. 35).

§12976. Cookroom Personnel.

In order to facilitate and expedite the administration and cnforcemcnl
of these regulations, each canner shall select sufficient qualified person-

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nel from his own employees who. to the satisfaction of the State Cannery
Inspector, shall see that these regulations are followed.
NOTH: Authority cited: Sections 102, 208, 2()202. 26501 and 28440, Health and
Safety Code.

History

1 . New Sections 1 2976 through 1 2984 filed 8- 16-71 : effective thirtieth day there-
after (Register 71. No. 34).

§ 1 2977. Posting of Cooks

Official cooks for all low acid products being packed must be conspic-
uously posted near the retorts.

NOTH: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 28440, Health and Safety Code.

History
1. New NOTK filed 8-1-84 (Register 84, No. 31).

§12978. Marking Containers.

Each can. glass jar. or other food container, basket, truck, car or crate
containing unretorted material to be processed in still retorts shall be
plainly and conspicuously marked with a heat sensitive indicator which
will visually indicate to all cookroom peisonnel whether or not each unit
has been retorted. The marking of each individual food container with an
indicator to indicate process staais is desirable.

NOTI-: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 28440. Health and Safety Code.

History

1 . New NOTE filed 8-1-84 (Register 84. No. 31).

§12979. Time Limits.

Not more than two hours shall elapse between the time the first can is
closed, and the time steam is admitted to the retort containing that batch
or cook. except

(a) tuna which may be held for a maximum of three hours after closing,
and

(b) canned ripe olives and acidified food products packed under pH
control for which the time limitation does not apply. In the event this time
limit is exceeded, the cans or jars may be processed but shall be quaran-
tined by the inspector until the Department has determined they are free
from spoilage.

NOTE: Authority cited: SecUons 208 and 28440. Health and Safety Code. Refer-
ence: Section 28440, Health and Safety Code.

History

1. Editorial correction filed 8-1-84 (Register 84, No. 31).

§ 12980. Double Door Retorts.

No uncooked containers may be placed in a double door retort before
the rear door has been closed. Deviations will be allowed only if prior ap-
proval has been obtained from the Department.

NOTE: Authority cited: Sections 208 and 28440. Health and Safety Code. Refer-
ence: Section 28440. Health and Safety Code.

History

1. Editorial correction filed 8-1-84 (Register 84. No. 31).

§ 1 2981 . Retort Markers.

A distinctive marker must be hung over the still retort opening when
the retort contains unprocessed containers. It must be placed so that the
door or lid cannot be locked before the marker is removed. A retort must
not be locked until the operator indicates that it is ready for the process
to start. Deviations will be allowed only if prior approval has been ob-
tained from the Department.

NOTE: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Secfion 28440, Health and Safety Code.

History
1. Editorial correction filed 8-1-84 (Register 84, No. 31).

§ 1 2982. Care of Containers.

Any container which falls on the floor jnust be immediately picked up.
Any container removed for inspection must be promptly returned. Any
container of unproven status with regard to processing must be punc-
tured.

NOTE: Authority cited: Sections 208 and 28440. Health and Safety Code. Refer-
ence: Section 28440, Health and Safety Code

History
1. Editorial coirection filed 8-1-84 (Register 84, No. 31).

§12983. Blanching.

In the canning of leafy vegetables, all of the product which has been
blanched must be canned and the containers clo,sed within thirty minutes
after shut down in order to prevent incipient spoilage before processing.
If this period is exceeded, the product may be canned, but must be quar-
antined by the inspector until the Department has determined they are
free from spoilage. All such material shall be carefully segregated so rep-
resentative samples may be sent to the laboratory.
NOTE: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 28440, Health and Safety Code.

History

1. Editorial correction filed 8-1-84 (Register 84. No. 31).

§ 12984. Posting Regulations.

These regulations covering operation procedures must be conspicu-
ously posted in all cookroom areas where they can be read and under-
stood.

NOTE: Authority cited: Sections 208 and 28440, Health and Safety Code. Refer-
ence: Section 28440, Health and Safety Code.

History
1 . New NOTE filed 8-1-84 (Register 84, -No. 31).

Article 9. Olive Oil Regulations

§ 13500. Olive Oil Regulations.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
208, Health and Safety Code.

History
1. Repealer filed 8-1-85; effective thirtieth day thereafter (Register 85, No. 31).

Article 10. Mobile Food Preparation Units

§ 13600. Order Promulgating Standards.

Under the authority of Section 28694.5 of the Health and Safety Code,
the following regulations establishing definitions and minimum stan-
dards of operation and construction for mobile food preparation units and
commissaries which service mobile food preparation units are hereby
promulgated.

NOTE: Authority cited for Article 10: Secdon 28694.5, Health and Safety Code.
Reference: Sections 28590-28650, Health and Safety Code.

History
l.Repealerand new Article 10 (Sections 13600-1 3609) filed 12-22-69; effective

thirtieth day thereafter (Register 69, No. 52).

§13601. Definitions.

(a) "Mobile food preparation unit" means any wheeled vehicle upon
which ready-to-eat food is cooked, wrapped, packaged, processed, or
portioned for service, sale or distribution. This section does not apply to
a "bakery delivery vehicle" as defined in Section 28524 of the Health and
Safety Code or a vehicle used only for the sale or delivery of fresh meat,
fish, poultry, or produce.

(b) "Mechanical refrigerafion" means a unit which extracts heat from
an area by means of liquefication and evaporation of a fluid by means of
compressor or flame, or by means of a thermoelectric device. Acceptable
mechanical refrigerafion shall also include cold plates.

History
1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by
Building Standards Commission 11-10-72. (Register 72, No. 49).

§13602. Exterior Requirements.

(a) The name and address of the person operating the mobile food
preparafion unit shall be plainly indicated on each side of the exterior of
the vehicle in letters of contrasfing colors at least three inches high with
a minimum 3/8 inch-wide stroke. Any of the following three methods are
acceptable:

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§ 13604

( 1 ) The name, street address, and city of the person in whose name the
license is issued. Listing of the phone number is optional with the owner
or operator of the vehicle.

(2) The name of the owner or operator, or his business name and city,
providing they are listed in the telephone directory.

(3) The name of the operator or owner of the vehicle, or his business
name, and the address of the commissary from which the vehicle is serv-
iced.

(b) Entrance doors to food preparation areas shall be self-closing and
kept closed when not being used.

(c) Compressor units that are not an integral part of equipment, auxilia-
ry engines, generators, etc.. shall be installed in an area that is completely
separated from food preparation and food storage and which is accessible
from outside the unit for proper cleaning and maintenance. The food
preparation and storage area shall be so constructed so as to be rodent
proof.

(d) The exterior of the mobile food preparation unit and the surround-
ing area, as relating to the operation of the unit, shall be maintained in a
sanitary condition by the operator of the unit. No attachment (such as a
can opener) shall be mounted on the exterior of the mobile food prepara-
tion unit. Adequate waste containers shall be furnished for the use of cus-
tomers. These containers shall be of easily cleanable construction and
furnished with a tight-fitting cover and shall be kept clean.

History

1. Amendment of subsections (a) and (d) filed 11-28-72; effective thirtieth day
thereafter. Approved by Building Standards Commission November 10. 1972
(Register 72, No. 49).

§13603. Interior Requirements.

(a) At least a two-compartment metal sink equipped with hot and cold
running water with dual integral metal drainboards, installed with at least
1/8 inch per foot slope toward the sink, and fabricated with a minimum
of 1/2 inch lip or rim to prevent the draining liquid from spilling onto the
floor shall be provided. The dimensions of each compartment shall be at
least 1 2 inches wide, 1 2 inches long, and 1 0 inches deep. Each drainboard
shall be at least the size of one of the sink compartments.

If multi-use eating and drinking utensils are used, the sink shall have
three compartments; each compartment with a minimum size of 12" x
12" X 10." The drainboards shall be at least 12" x 12." Drainboards for
a three-compartment sink shall comply with the requirements of drain-
boards for a two-compartment sink.

The sink shall be equipped with a mixing faucet and shall be provided
with a swivel spigot capable of servicing any sink compartment individu-
ally as desired.

(b) Hand washing facilities, including a lavatory supplied with hot and
cold running water with a mixing type faucet, hand washing detergent or
soap and single-service sanitary towels in permanently installed dis-
pensing devices shall be provided and maintained in each mobile food
preparation unit. The hand washing facilities shall be separate from the
utensil washing sinks. The lavatory basin must have a minimum dimen-
sion of 9" x 9" in width and 5 inches in depth. The hand washing facilities
shall be separated from the utensil washing sinks by a metal guard with
a height of at least three inches, and extending from the back edge of the
drainboard to the front edge of the drainboard, the comers of the barrier
to be rounded. No separation barrier is required if the distance between
the hand washing sink and the utensil drainboards is two or more feet.
Mobile food preparation vehicles in operation and built before the effec-
tive date of the regulations adopted December 5, 1969, may be accepted
without separate hand wash basins until January 1, 1975, at which time
they must comply with the regulations or discontinue operation.

(c) Floors, walls, and ceilings shall be constructed so that the surfaces
are impervious, smooth and cleanable. Floor surfaces shall provide em-
ployee safety from slipping. The juncture of the floors and walls shall be
covered with the floor surface extending up the wall at least four inches.
In all mobile food preparation units constructed after the effective date
of these regulations there shall be a clear, unobstructed height over the

aisle-way portion of the unit of at least 76 indies from floor to ceiling.
and a minimum of 30 inches of unobstructed horizontal aisle space.

(d) Construction joints and seams shall be sealed to provide smooth,
easily cleanable surfaces. Soldered joints and seams shall be smooth to
the touch. Silicone sealant or equivalent waterproof compounds shall be
acceptable, providing they prevent the entrance of liquid waste or ver-
min.

(e) All equipment shall be so installed as to be easily cleaned, prevent
vermin harborage and provide adequate access for service and mainte-
nance. Equipment shall be spaced apart for easy cleaning or shall be
sealed together. Food equipment and machinery set apart from adjacent
equipment or machinery, or the clearance between the top of the counter,
or the bottom of a piece of equipment with a rigid utility connection, shall
provide a minimum width of three inches of unobstructed space for sani-
tary maintenance beneath the counter equipment or the sides of adjacent
equipment. Food equipment or machinery of a size and weight that can
be easily picked up and moved by one person, and with a flex connection
need not comply with minimum leg height requirement. No threads, nuts,
or rivets shall be exposed where they interfere with cleaning. Should such
threads, nuts, or rivets interfere with cleaning they shall be capped.

On existing mobile food preparation units and equipment with ex-
posed threads, nuts, screws, or rivets that can be cleaned with the usual,
easily available cleaning equipment such as brushes, brooms, mops,
cleaning cloths, or with steam, or flushing with water, shall be acceptable
if maintained in a clean and sanitary condition.

(f) All equipment shall be sealed to the floor to prevent moisture from
getting under the equipment or it shall be raised at least six inches off the
floor by means of an easily cleanable leg and foot.

(g) Equipment, including the interior of cabinet units or compart-
ments, shall be constructed so as to have smooth, easily accessible, and
easily cleanable surfaces (free from channels, crevices, flanges, ledges,
or other cleaning obstructions). Unfinished wooden surfaces are not per-
mitted. Food contact surfaces shall be constructed of metal, high pressure
laminated plastics, or laminated hardwood. These surfaces must be kept
free of cracks, cuts, and other obstructions which would interfere with
proper cleaning.

(h) All utensils shall be designed and constructed so as to be easily
cleanable and shall be made of nontoxic materials.

(i) Space around pipes, conduits, or hoses that extend through cabi-
nets, floors, or outer walls shall be sealed. The closure shall be smooth
and easily cleanable.

(j) Light bulbs, tubes, etc., shall be covered with a completely enclosed
plastic safety shield or its equivalent. Light fixtures shall be installed so
as to not constitute a hazard to personnel or food materials.

(k) Waste receptacles shall be provided inside of the vehicle. They
shall be constructed so as to be smooth, nonabsorbent and easily clean-
able, and kept clean.

(/) No smoking signs and signs directing proper hand washing shall be
posted in the food preparation area.

(m) The interior of the mobile food preparation unit and all equipment
and utensils in the unit shall be kept clean and in good repair and free of
vermin.

History
1. Amendment filed 11-28-72; effective thirtieth day thereafter. Appnncd by

Building Standards Comjnission November 10, 1972 (Register 72. No. 49).

§13604. Temperature Requirements.

(a) Adequate mechanical refrigeration space shall be provided and
each refrigerator shall be equipped with an easily readable thermometer.
Wooden shelves are not permitted in the refrigerator. Readily perishable
food shall be kept at 45 Fahrenheit, or below, at all times (except as pro-
vided in Subsection (b)). Readily perishable packaged food arranged for
display and self-service may be held on an ice bed. Mobile units man-
ufactured prior to the effective date of this Section are not required to
have mechanical refrigeration space provided adequate nonmechanical
refrigeration has been installed.

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) Adequate space shall be provided to maintain readily perishable
food which is kept hot at a temperature of 140 Fahrenheit, or higher, and
a suitable thermometer to test the internal temperature of food, accurate
to plus or minus 2 Fahrenheit, must be axailable for measuring the tem-
perature of the hot food. All readily perishable food which is not refriger-
ated shall be kept at 140 Fahrenheit, or higher, at all times.

History

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by
Building Standards Commission November 10, 1972 (Register 72, No. 49).

2. AmendmenI of subsection (a) filed 1 1-24-75; effective thirtieth day thereafter
(Register73, No. 48).

§13607. Service Openings.

(a) Service openings shall be limited to 216 square inches each. The
service openings may not be closer together than 18 inches. They shall
be self-closing with a screen of not less than 16 mesh per inch, or a solid
closing device. With the exception of the service openings the entire food
preparation and food storage area shall be enclosed with a solid, easily
cleanable material. The counter surface of the service openings shall be
smooth and easily cleanable.

History

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by
Building Standards Commission November 10, 1972 (Register 72. No. 49).

§13605. Ventilation.

Mechanical exhaust ventilation equipment shall be provided over all
cooking equipment as required to effectively remove cooking odors,
smoke, steam, grease and vapors. The ventilation shall be adequate to
provide a reasonable condition of comfort for employees. Grease filters
or other means of grease extraction are required and shall be of steel con-
struction, or other approved material, and shall be readily accessible for
cleaning. Every joint and seam shall be substantially tight. No solder
shall be used, except for sealing a joint or seam. Every hood shall be so
designed and installed to provide for thorough cleaning of the entire
hood. When grease gutters are provided they shall drain to a collecting
receptacle fabricated, designed, and installed to be readily accessible for
cleaning. All ducts in the exhaust system shall have a slope of at least two
inches per lineal foot. All seams in this duct work shall be substantially
tight to prevent the accumulation of grease. The ducts shall have suffi-
cient clean-outs to make the ducts readily accessible for cleaning. Make-
up air shall be provided at the rate of th;U exhausted. It may be accom-
plished from screened service openings, vents in the ceiling, or
mechanically through an air-conditioning system, but not through open
doors or openable windows.

History

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by
Building Standards Commission November 10, 1972 (Register 72, No. 49).

§13606. Storage.

(a) Spare tires, related automotive equipment, or special tools relating
to the mechanical operation of the mobile food preparation unit shall not
be stored in the food preparation or food storage areas.

(b) A separate cabinet or drawer shall be installed for the storage of in-
secticides or other poisonous substances, if such substances are used. All
poisonous chemicals shall be kept in this cabinet, or drawer in their origi-
nal containers, and in a manner that offers no contamination hazard to
food or utensils.

(c) Suitable facilities shall be provided for the storage of linens, uni-
forms, and other related linens. Suitable facilities such as a cabinet or
drawer shall be provided for the storage of personal belongings. All per-
sonal belongings shall be kept in the space provided.

(d) All pressure cylinders shall be securely fastened to a rigid structure
of the vehicle. All liquefied petroleum equipment shall be installed to
meet fire department standards and other laws that are applicable. A
minimum 5 B.C.-rated fire extinguisher to combat grease fires shall be
installed on the interior of each mobile food preparation unit in a readily
accessible place.

(e) Adequate and suitable space shall be provided for the orderly stor-
age of food and food service materials.

(f) Single-service utensils shall be stored in their original enclosed
package, in a clean, dry area. They shall be kept in an approved, enclosed
dispenser for customer use. Straws shall be wrapped or dispensed from
approved, enclosed dispensers. An enclosed dispenser shall protect the
lip-contact portion of the eating and drinking utensil from contamina-
tion.

HlSTOR\'
1. Amendment of subsections (b), (d) and (0 filed 11-28-72; effective thirtieth
day thereafter. Approved by Building Standards Commission November 10,
1972 (Register 72, No. 49).

§13608. Power Supply.

Whenever the vehicle is in service, adequate electrical power shall be
provided to operate the approved exhaust, lighting, and refrigeration sys-
tems, or any other accessories and appliances that may be installed on a
mobile food preparation unit.

History
1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by

Building Standards Commission November 10, 1972 (Register 72, No. 49).

§ 13609. Water Supply, Plumbing.

(a) A water supply tank of sufficient capacity to furnish an adequate
quantity of potable water for food preparation, cleaning, and hand wash-
ing purposes shall be provided (minimum 30 gallons). Hose connection
valves shall be at least five feet above the ground and be kept covered
with a protective screw-type cap, which is attached to the vehicle. The
water supply shall meet health department requirements of potability as
specified in Chapter 7 (commencing with Section 4010) of Part 1, Divi-
sion 5 of the Health and Safety Code. The water system shall be of such
materials and designed and constructed so water or air can be introduced
without the water becoming contaminated. The water system shall deliv-
er at least one gallon per minute to each sink basin in the unit.

(b) A hot water heater with a minimum capacity of three gallons, or an
instantaneous heater capable of producing water of 1 20 Fahrenheit inter-
connected with the potable water supply, shall be provided and shall op-
erate independently of the vehicle engine and/or generator. Hot and cold
water, under pressure, shall be provided at hand washing and utensil
sinks units from mixing faucets.

(c) The liquid waste tank shall have a capacity at least 50 percent great-
er than the fresh water tank, and shall receive and be adequate to hold
melting ice water resulting from one day's operation.

(d) All tanks, lines, couplings, valves, or any other plumbing shall be
designed, installed, maintained, and constructed of materials that will not
contaminate the water supply, food, utensils, or equipment.

(e) Water and waste storage tanks shall be installed so as to be easily
drained, flushed, and cleaned with an easily accessible outlet. Breather
tubes or overflow pipe openings shall be protected from the entrance of
dust, insects, and other contamination. All waste lines shall be connected
to the waste tank with watertight seals.

(f) The water supply tank shall be filled and the waste storage tank
shall be emptied only at the commissary or other facilities approved by
the health officer.

(g) Toilet facilities for the use of the food service personnel shall be
available within 100 feet of the vehicle whenever it is stopped to conduct
business for more than a one-hour period.

(h) Mobile food preparation units may be connected to an approved
water supply and sewerage disposal system. Such units shall be equipped
with a hose or other approved connection to attach to the water system.
This connection shall be used for no other purpose and shall be protected
from contaminafion at all times. In order to avoid confusion, all water
connections shall be green in color. Waste lines shall be a color other than
green.

History
1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by

Building Standards Conrniission November 10, 1972 (Register 72, No. 49).

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{j 13650

•

Article 10.1. Commissaries Servicing
Mobile Food Preparation Units

§ T1 7-1 361 1 . General Requirements.

(a) The requirements of this article shall be the minimum requirements
for commissaries which service mobile food preparation units in the
State of California.

Ncm-: Autlioritv cited for Article 10.1 : Section 28694.5. Health and Safely Code.
Reference: Sections 28590 through 28650, Health and Safety Code.

History

1. New Article 10.1 ( T17-1361 1 through TI7-13616) filed 12-22-69; effective
thirtieth day thereafter (Register 69, No. 52).

2. Approved hy State Building Standards Commission 2-1.3-70 nunc pro tunc
(12-22-69) (Register 70, No. 8).

§ 13612. Waste Handling and Disposal.

(a) Each commissary which services mobile food preparation units,
shall have on the premises adequate facilities for:

(1 ) Handling liquid waste from the mobile unit being serviced. Such
facility shall be constructed so that waste can be handled in a safe and san-
itary manner.

(2) Handling and disposing of garbage and rubbish which originates
on the mobile unit. Tlic waste receptacles shall be constructed so as to be
easily cleaned and securely covered.

§ 13613. Water Supply and Plumbing.

(a) Each commissary which services mobile food preparation units
shall have potable water available for filling the water tanks of mobile
units. Such watering facilities shall be constructed so as to minimize the
possibility of contaminating the water being loaded.

(b) The hose used for filling water tanks shall be constructed of a non-
toxic material (NSF approval recommended). It shall be green in color
and shall be used for no other purpose. At all times the hose shall be kept
at least four feet above the ground.

(d) Potable water supply shall at all times be protected from potential
backtlow.

History
1. Amendment of subsections (b) and (d) filed 1 1-28-72; effective thirtieth day
thereafter. Approved by Building Standards Commission November 10, 1972
(Register 72, No. 49).

§ T1 7-1 361 4. Electrical Hook-Up Facilities.

(a) Each commissary which services mobile food preparation units
shall have available sufficient, suitable electrical outlets for mobile units
which require electrical service. These outlets shall be constructed to
comply with the applicable provisions of Part , Title 24, California Ad-
ministrative Code.

§ T1 7-1 361 5. Toilet and Lavatory.

(a) Each commissary which services mobile food preparation units
shall have available suitable toilet and lavatory facilities for the use of the
operators of the mobile units. These facilities shall be provided with hot
and cold running water with mixing faucets, or tempered (1 10°-1 15°F)
running water, soap and sanitary towels in permanently installed dis-
pensing devices. Toilet facilities shall be kept clean and in good repair.

(b) If toilet facilities are used by five or more people of different sex,
separate facilities for each sex shall be provided. The ratio of toilets to
employees shall be as required in Section B-1 105, Part 2, Title 24, Cali-
fornia Administrative Code, and one additional toilet and lavatory facil-
ity shall be provided for each additional 60 mobile unit operators of the
same sex on the premises at any one time.

History

1. Amendment filed 11-28-72; effective thirtieth day thereafter. Approved by

Building Standards Commission November 10, 1972 (Register 72, No. 49).

§ 11 7-1 361 6. Facilities for Food Storage.

(a) Each commissary which services mobile food preparation units
shall have adequate facilities for storing all food and supplies which arc
loaded on the mobile units. No food or food in a container shall be .stored
directly on the floor. They shall be stored at least six inches abo\c the
floor, or under such other conditions as are approved by the State Health
Department. "Other conditions" that may be acceptable are storage of
foods on moveable pallets with a minimum height of five inches.

(b) Perishable food shall be stored in devices which maintain the tem-
perature of the food at 45 Fahrenheit, or below, or 140 Fahrenheit, or
above, at all times. These devices shall be equipped with thermometers
which are located so as to be easily read.

History

1 . Amendment of subsection (a) filed 1 1-28 72; effective thirtieth day thereafter.
Approved by Building Standards Commission November 10. 1972 (Register
72, No. 49).

2. Amendment of subsection (b) filed 1 1-24-75; effective thirtieth day thereafter
(Register 75, No. 48).

Article 1 0.2. Requirements for the Sale of
Imitation Hamburger in Restaurants

§13620. Definitions.

(a) "Wallboard" means any permanent sign used to display or describe
food items for sale in a restaurant.

(b) "Placard" means any non-permanent sign used to display or de-
scribe food items for sale in a restaurant.

Note: Authority cited: Secfions 208, 26202 and 26596, Health and Safety Code.
Reference: Section 26596, Health and Safety Code.

History

1 . New Article 1 0.2 (Sections 1 3620 and 1 362 1 ) filed 1 0- 11 -74; effective thirtieth
day thereafter (Register 74, No. 41 ).

2. Editorial con-ection of NOTE filed 8-1-84 (Register 84, No. 31).

§ 13621 . Wallboard and Placard Requirements in
Restaurants Without Menus.

Restaurants serving imitation hamburger containing more than 1 0 per-
cent added protein and water or other extenders or binders shall post an
ingredient statement on a wallboard or placard.

(a) The ingredients shall be listed in descending order of predomi-
nance by weight.

(b) The term "imitation hamburger," or any other term which accurate-
ly informs the customer of the nature of the product and its ingredients,
shall be stated in letters at least one (1 ) inch in height (72 point letters)
in bold-face type in colors which contrast with the wallboard or placard.

(c) The wallboard or placard shall be posted in a permanent place, con-
spicuous to the customers, in each room or area where food is served.
Note: Authority cited: Sections 208, 26202 and 26596, Health £uid Safety Code.
Reference: Section 26596, Health and Safety Code.

History
1. New NOTE filed 8-1-84 (Register 84, No. 31).

Article 10.3. Requirements for Roadside

Stands, Food Establishments Open to the

Outside Air, and Retail Dairies

§13650. Definitions.

(a) "Roadside Stand" means a food establishment which has one or
more sides open to the outside air during hours of business, which sells
produce or shell eggs or both, and where no more than ten percent of the
floor space of the food sales and storage area is devoted to packaged
foods.

(b) "Food Establishment Open to the Outside Air" means a food estab-
lishment which has one or more sides open to the outside air during hours
of business, and where over ten percent of the floor space is de\ cited to
the storage and sale of packaged foods to consumers.

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

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(c) "Retail Dairy" means a food establishment of which milk or milk
products to be sold directly to the consumer constitute over 50 percent
of the volume of sales. Processing and packaging facilities as defined in
Sections 32505 and 32513 of the California Food and Agricultural Code
shall not be considered part of the retail dairy.

(d) "Retail Sales Area of Grower-Seller Premises" means the retail
sales area operated by a grower or producer only for the sale of his own
produce or shell eggs or both directly to the consumer. These products
must be grown or produced on property owned, rented, or leased by the
grower or producer, and on which the sales area is located.

(e) "Employee" means any person working in an establishment gov-
erned by the provisions of this Article.

(f) "Food Preparation" means any operation by which the form, flavor,
or consistency of food is changed. It includes, but is not limited to, cook-
ing, seasoning, cutting, and grinding.

(g) "Milk and Milk Products" means those food items which are de-
fined in Sections 32510-32512 of the California Food and Agricultural
Code. Division 1 5, Part 1 . Chapter 1 . Milk and milk products will be con-
sidered to be packaged foods.

(h) "Packaged Foods" means foods in a package, as defined in Section
26023 of the California Health and Safetj Code. The package shall con-
form to the applicable provisions of Chapter 4 of Division 21 (commenc-
ing with Section 26400) of the California Health and Safety Code. The
packaging of such products shall be done at a facility approved by the lo-
cal health officer. Processing and packaging facilities as defined in Sec-
tions 32505 and325 1 3 of the California Food and Agricultural Code shall
be exempt from this requirement.

(i) "Potentially Hazardous Food" means any food which consists in
whole or in part of ingredients capable of supporting rapid and progres-
sive growth of infectious or toxicogenic microorganisms, including, but
not limited to, milk or milk products, eggs, meat, poultry, fish or shel-
lfish. It does not include food that has been processed and packaged so
as to prevent the growth of pathogenic microorganisms, or any un-
cracked shell eggs.

(j) "Produce" means any fruit or vegetable in its raw or natural state.

(k) "Produce Preparation" means any operation by which the form,
flavor or consistency of the produce is changed. It includes, but is not lim-
ited to, cooking, seasoning, cutting, trimming, and grinding.

{/) "Trimming" means the removal of part of the produce, such as outer
leaves, stems, stalks, roots, and tops.

(m) "Utensil" means any kitchenware, cuflery, container, implement,
wrapper or other equipment with which food comes in contact during
storage, display, preparation, sale, or through use by an employee or con-
sumer.

NOTIi: Authority cited: Sections 208 and 28802.5, Health and Safety Code. Refer-
ence: Section 28802.5 Health and Safety Code.

History

1. New Article 10.3 (Sections 13650 through 13653) filed 8-1-75; effective thir-
tieth day thereafter (Register 75, No. 31).

2. Editorial correction relettering subsections (a) and (c)-(k) filed 7-3-84 (Regis-
ter 84, No. 27).

§ 13651. Structural and Operational Requirements.

NOTE: Authority cited: Sections 208 and 28802 5, Health and Safety Code. Refer-
ence: Section 28802.5, Health and Safety Code.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

§13652. Health Requirements.

(a) All employees shall wear clean washable outer garments and shall
keep their hands clean at all times while engaged in handling food, bever-
ages, or utensils. All employees shall wash their hands and arms with
soap or detergent and water before commencing work after using toilet
facilities, before returning to work, and at such other times as are neces-
sary to prevent contamination of food. Legible signs shall be posted in
each toilet room directing attention to this requirement.

(b) When information as to the possibility of disease transmission is
presented to the local health officer, he shall investigate conditions and
take appropriate action. The health officer may, after investigation and
for reasonable cause, require any or all of the following measures to be
taken:

( 1 ) The immediate exclusion of such employee or owner from the af-
fected food establishment;

(2) The immediate closing of the establishment until in the opinion of
the health officer no further danger exists;

(3) Medical examination of the owner and employees, with such labo-
ratory examination as may be indicated, or should such examination or
examinations be refused, the immediate exclusion of the refusing owner
or employee from that or any other food establishment operation until a
medical or laboratory examination shows that he is not affected with, or
a carrier of, any disease in a communicable form.

NOTE; Authority cited: Sections 208 and 28802.5, Health and Safety Code. Refer-
ence: Section 28802.5, Health and Safety Code.

History

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§ 13653. Enforcement and Inspection.

NOTE: Authority cited: Sections 208 and 28802.5, Health and Safety Code. Refer-
ence: Section 28802.5. Health and Safety Code.

History
1 . Repealer filed 1 1-20-85; effective thirtieth day thereafter (Register 85, No. 47).

Article 10.4. Ventilation Standards for
Retail Food Establishments

§ 13670. Adoption of the 1976 Uniform Mechanical Code.

Chapter 4-20 of Title 24, California Administrative Code, shall be the
commercial hood and kitchen ventilation standards for retail food estab-
lishments as defined in Title 17, California Administrative Code, Section
12100(a).

Note; Authority cited: Sections 208, 28694, 28694.5 and 28863, Health and Safe-
ty Code. Reference: Sections 28196, 28545 and 28826, Health and Safety Code.

History

1 . New Article 1 0.4 (Sections 1 3670-1 367 1 ) filed 9-1 8-80; effective thirtieth day
thereafter (Register 80, No. 38).

§13671. Building Plan Approval.

(a) Building plans for new construction or remodeling of kitchen ven-
tilation systems in retail food establishments shall be submitted for re-
view and approval to either the local health officer or a duly authorized
registered sanitarian.

(b) Construction or installation shall not begin without prior written
approval that the building plan complies with the requirements of Section
13670.

Note: Authority cited: Sections 208, 28694. 28694.5 and 28863, Health and Safe-
ty Code. Reference: Sections 28196, 28545, 28826 and 28865, Health and Safety
Code.

Article 10.5. Raw Oysters

§ 13675. Raw Gulf Oysters: Labeling, Written Warnings
and Additional Requirements.

(a) For purposes of this article, the following definitions shall apply:

(1) "Dealer" means a person who shucks, packs, re-packs, processes,
labels, re-labels, ships, re-ships, holds or otherwise sells shellfish.
"Dealer" does not include persons solely engaged in retail activities as
defined in the Health and Safety Code, Section 1 13875.

(2) "Gulf oyster" means any oyster harvested from the states of Alaba-
ma, Florida, Louisiana, Mississippi, or Texas.

(3) "Half-shell oyster" means any oyster from which one shell has
been removed.

(4) "MPN" (Most Probable Number) means a statistical estimate of the
number of bacteria per unit volume determined from the number of posi-
tive results in a series of fermentation tubes.

Page 156

Title 17

State Department of Health Services

§ 13675

(5) "Non-dclcctablc level" means that the MPN of Vibrio vulnificus
bacteria is less than 3 MPN per gram of product as determined by the Vi-
brio vulnificus testing method in the U.S. Food and Drug Administration
Bacteriological Analytical Manual. 8th Edition, 1995. pages 9.01-9.27.
hereby incorporated by reference.

(6) "Offers" means making raw oysters available to any person,
whether the raw oysters are subject to purchase, exchange, or transfer, or
are provided without charge.

(7) "Orders" means requesting or selecting raw oysters for consump-
tion on the premises of a retail food facility, or requesting or selecting raw
oysters for consumption off the premises.

(8) "Oyster treatment process" means a process that has been deter-
mined by the state shellfish control authority havingjurisdiction. the U.S.
Food and Daig Administration, or a recognized process authority to con-
sistently reduce the level of Vibrio vulnificus to a non-detectable level.

(9) "Recognized process authority" means the person(s) or organiza-
tion(s) recognized by the state shellfish control authority or the U.S. Food
and Drug Administration as having expert knowledge of oyster treatment
processes, and having adequate facilities for making such determina-
tions.

( 10) "Retail food facility" means "retail" as defined in section 1 13875
of the Health and Safety Code and "food facility" as defined in section
1 1 3785 of the Health and Safety Code.

(11) "Shellfish Control Authority" means the State, or other regulatory
authority, or its designated agents responsible for the enforcement of
laws or regulations governing shellfish growing and harvesting areas,
shellfish handling facilities and dealer activities including harvesting,
transporting, storing, handling, processing, packing, and repacking of
shellfish.

(12) "Shellstock oyster" means any oyster in both shells.

(13) "Shucked oyster" means any oyster from which both shells have
been removed and which has been packed in a container by a dealer.

( 14) "Tent cards" means free-standing print displays or a printed dis-
play in a supporting stand designed for placement on dining tables or
food service counters.

(b) Every retail food facility that offers raw Gulf oysters shall provide
a written warning to any person who orders raw oysters, as provided in
this section.

( 1 ) The written warning shall be worded in English and Spanish as fol-
lows:

WARNING

THIS FACILITY OFFERS RAW OYSTERS FROM THE GULF
OF MEXICO. EATING THESE OYSTERS MAY CAUSE SE-
VERE ILLNESS AND EVEN DEATH IN PERSONS WHO
HAVE LIVER DISEASE (FOR EXAMPLE ALCOHOLIC CIR-
RHOSIS), CANCER OR OTHER CHRONIC ILLNESSES THAT
WEAKEN THE IMMUNE SYSTEM. If you eat raw oysters and
become ill. you should seek immediate medical attention. If you are
unsure if you are at risk, you should consult your physician.

AVISO IMPORTANTE

ESTA FACILIDAD OFRECE OSTRAS CRUDAS DEL GOLFO

DE MEXICO. A COMER ESTAS OSTRAS CRUDAS PUEDEN

CAUSAR UNA ENFERMEDAD GRAVE Y HASTA LA MUER-

TA EN LAS PERSONAS QUE PADECEN DE ENFERME-

DADES DEL IIIGADO (POR EJEMPLO, CIRROSIS AL-

COHOLICA), CANCER U OTRAS ENFERMEDADES

CRONICAS QUE DEBILITAN EL SISTEMA INMUNOLOGI-

CO. Si usted come ostras crudas y se enferma, debe buscar atencion

medica inmediatamente. Si usted cree estar en peligro, debe consultar

a un medico.

(2) Where raw oysters are purchased by a consumer over a counter, or
where they are offered for safe by a sign, tag, or menu board, the sign
bearing the warning set forth in subsection (b)( 1 ) shall be prominently

placed so that it is likely to be read by consumers prior to ordering raw
oysters. The warning signs shall meet the following specifications:

(A) Be square in shape and no smaller than 10 inches on a side ( 100
square inches) or be rectangular in shape and no smaller than 1 1 inches
high by 8.5 inches wide (93.5 square inches).

(B) Be printed in black ink on a white background, dark blue ink on
a yellow background or other ink that is of high contrast from the color
of the background material.

(D) The word "Warning" and the words "Aviso Importante" shall be
in all bold, upper case letters and underlined and be no smaller than 35
point type face.

(E) Tlie first two sentences of the English and the Spanish version shall
be in bold letters and be no smaller than 30 point type face. The remaining
sentences of the English and the Spanish version shall be no smaller than
25 point type face.

(3) Where raw oysters are ordered directly from a server, at a dining
table, or where a warning sign posted pursuant to subsection (b)(2) is not
clearly legible from any location where the consumer orders raw oysters,
the warnings shall be printed on all menus in which raw oysters are listed,
or on tent cards located on each dining table. For menus, the warning may
be shortened to contain the headers and the first two sentences of the En-
glish and Spanish statements as set forth in subsection (b)( 1 ) and shall be
prominently placed on the menu so that it is likely to be read by consum-
ers prior to ordering raw oysters. Tent cards shall contain the complete
warning statements as set forth in subsection (b)( 1 ) and be prominently
placed on the dining tables so that they are likely to be read by consumers
prior to ordering raw oysters. Both menu warning statements and tent
card warning statements shall meet the following specifications:

(A) Be printed in black ink on a white background, dark blue ink on
a yellow background or other ink that is of high contrast from the color
of the background material.

(B) The word "Warning" and the words "Aviso Importante" shall be
in all bold, upper case letters and underlined.

(4) Menu warning statements shall meet the following additional spec-
ifications:

(A) Be no smaller than 10 point type face.

(B) Be enclosed by a box rule with no less than 1/8" of space around
the notice.

(5) Tent card warning statements shall meet the following additional
specifications:

(A) Be square in shape and no smaller than 4 inches on a side (16
square inches) or be rectangular in shape and no smaller than 3 inches
high by 5 inches wide (15 square inches).

(B) The word "Warning" and the words "Aviso Importante" and the
first two sentences of the English and Spanish version shall be in no
smaller than 12 point medium or bold type face, and the remaining sen-
tences shall be no smaller than 10 point type face.

( 1 ) Refuse to accept any container of raw shellstock oysters, half-shell
oysters, or shucked oysters, if the container does not have a tag or label
affixed that prominently and clearly bears the statement "Harvested in

", "Product of ". or

words of similar meaning (to be filled in with the name of the state or for-
eign country in which the raw oysters were harvested). For containers of
raw oysters that have any oyster harvested from a state bordering on the
Gulf of Mexico, this paragraph is safisfied when the container bears a tag
or label affixed that prominently and clearly bears the statement "Har-
vested from the Gulf of Mexico", or "Product of the Gulf of Mexico".

(2) Refuse to accept raw shellstock oysters unless each container con-
tains a tag or label that prominently and clearly bears all of the follow ing:

(A) The harvest date of the oysters.

Page 156.1

§ 13676

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(B) The bed name or lease number assigned by the shellfish control au-
thority to the harvest area.

(C) The state abbreviation and certification number assigned by the
shellfish control authority to the harvester, or original dealer.

(3) Refuse to accept raw shucked oysters unless each container of oys-
ters bears a label that prominently and clearly states all the following:

(A) The sell-by-date, date-shucked, date-packed, or similar date of
the shucked oysters.

(B) The state abbreviation and certification number assigned by the
shellfish control authority of the state or foreign country to the harvester
or original dealer.

(C) The harvest date of raw Gulf oysters. This requirement is satisfied
when each shipment of raw oysters is accompanied by an invoice that
specifies the harvest date of the oysters.

(D) That raw Gulf oysters, which have not been subjected to an oyster
treatment process, be cooked before eating.

(4) Refuse to accept any container of raw half-shell oysters unless
each container of oysters bears a tag or label that prominently and clearly
states the information required in subparagraphs (c)(3)(A), (B), and (C).

(5) Refuse to accept any container of raw shellstock, half-shell, or
shucked Gulf oysters harvested during April through October, and such
oysters shall be deemed adulterated, unless:

(A) The oysters have been subjected to an oyster treatment process and
are prominently and clearly tagged or otherwise labeled with the in-
formation required by subsection (i); and

(B) The dealer or retail food facility has on file a current copy of the
letter from the department verifying the use of an oyster treatment pro-
cess in accordance with subsection (h).

(d) Warnings under subsection (b) are not required for raw shellstock,
half-shell or shucked Gulf oysters whenever the retailer has received a
copy of a current verification letter from the dealer pursuant to subsection
(h) and tags or labels as required by subsection (i) demonstrating that the
oysters have been subjected to an oyster treatment process.

(e) In order to be eligible to receive verification by the department that
oysters supplied by the dealer are subjected to an oyster treatment pro-
cess, a dealer shall submit a written request for verification pursuant to
Section 13676. A verification issued by the department shall be valid for
two years from the date of issue unless revoked or suspended.

(f) A dealer who has received a verification pursuant to Section 13676
shall notify the department in writing prior to making any changes to the
oyster treatment process, or any changes to the Hazard Analysis and Crit-
ical Control Point (HACCP) plan required by Title 21, Code of Federal
Regulations. Part 123.

(g) A dealer who has received a verification pursuant to Section 1 3676
shall notify the department, within seven days, of any new information
known to the dealer pertaining to the effectiveness of the oyster treatment
process.

(h) A dealer who has received verification pursuant to Section 13676
shall provide a copy of the letter from the department granting the current
verification to every dealer and retail food facility in California to whom
the dealer sells or provides shellstock, half-shell, or shucked raw Gulf
oysters. Every dealer and retail food facility that offers shellstock, half-
shell, or shucked raw Gulf oysters for which verification pursuant to Sec-
tion 13676 has been granted, shall retain and make available for inspec-
tion by the department and local health agencies a copy of the current
verification letter provided by the dealer. A retail food facility shall retain
the copy of the verification for one year after the date that the verification
expires.

(i) A dealer who has received verification pursuant to Section 13676
shall affix to each container of raw Gulf oysters processed to reduce Vi-
brio vulnificus to a non-detectable level, a tag or label pursuant to subsec-
tions (c)(2). (c)(3), and (c)(4), as required. In addition to requirements of
subsections (c)(2), (c)(3), and (c)(4), such tag or label shall clearly and
prominently bear the phrase "PROCESSED TO REDUCE VIBRIO
VULNIFICUS TO NON-DETECTABLE LEVELS", followed by a lot
number traceable to the dealer's processing records. Use of the phrase

"PROCESSED TO REDUCE VIBRIO VULNIFICUS TO NON-DE-
TECTABLE LEVELS", or words of similar meaning on tags or labels of
raw unprocessed oysters, or on tags or labels of processed raw oysters
from other than a dealer who has a current verification from the depart-
ment is unlawful, and causes the oysters to be misbranded.
NOTE; Authority cited: Sections 100275, 1 10065. 110105, 110430, 112165 and
11.1710, Health and Safety Code. Reference: Sections 110175, 110545,
1 12165(c), 112195, 1 12200 and 1 13980, Health and Safety Code.

History

1. New section filed 12-31-90 as an emergency; effective 12-31-90 operative
3-1-91 pursuant to subsection (g) (Register 91, No. 8). A Certificate of Com-
pliance must be transmitted to OAL by 4-30-91 or emergency language will be
repealed by operation of law on the following day.

2. Repealer and new section filed 3-1-91 as an emergency, operative 3-1-91
(Register91, No. 14). A Certificate of Compliance must be transmitted to OAL
by 7-1-91 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 3-1-91 order including amendment of section
transmitted to OAL 7-1-91 and filed 7-23-91 (Register 91. No. 45).

4. Hditorial correction of printing errors in section (Register 91, No. 45).

5. Amendment of section heading, section and NOTE filed 6-6-97 as an emergen-
cy, operative 6-6-97 (Register 97, No. 23). A Certificate of Compliance must
be transmitted to OAL by 1 0-6-97 or emergency language will be repealed by
operation of law on the following day.

6. Hditorial correction of HISTORY 3 (Register 97, No. 46).

7. Certificate of Compliance as to 6-6-97 order, including amendment of subsec-
tion (g)(1), transmitted to OAL 10-1-97 and filed 1 1-13-97 (Reaistcr 97, No.
46).

8. Amendment of section heading, section and Noth filed 4-14-2003 as an emer-
gency; operative 4-14-2003 (Register 2003, No. 16). A Certificate of Com-
pliance must be transmitted to OAL by 8-12-2003 or emergency language will
be repealed by operation of law on the following day.

9. Certificate of Compliance as to 4-14-2003 order transmitted to OAL
8-1 1-2003 and filed 9-23-2003 (Register 2003, No. 39).

§ 1 3676. Request for Verification.

(a) A request for verification by the department that oysters supplied
by a dealer are subjected to an oyster treatment process shall include all
of the following:

( 1 ) The name and address of the dealer;

(2) A copy of the shellfish certificate or license issued by the Shellfish
Control Authority having jurisdiction;

(3) A description of the process used to treat the oysters and the proce-
dures used to ensure that oysters harvested during April through October
and shipped to California are subjected to the treatment.

(4) A report by the Shellfish Control Authority or a recognized process
authority, accompanied by the concurrence of the U.S. Food and Drug
Administration verifying that the process used consistently reduces the
level of Vibrio vulnificus to a non-detectable level.

(5) Signature, under penalty of perjury, of the individual requesting
verification attesting to the accuracy of the information provided in the
request for verification.

(b) Requests for verification shall be deemed complete when the in-
formation specified in subsection (a) has been received in writing by the
department. Initial requests for verification may be submitted at any time
to the department. Requests for renewals shall be submitted to the depart-
ment no later than 60 days prior to the expiration date. Requests for verifi-
cation shall state whether the dealer is requesting an initial verification
or renewal of an existing verification.

(c) The department shall notify the dealer in writing within 15 days of
receipt of a request for verification of one of the following:

(1) The request for verification is complete and shall be evaluated by
the department, or

(2) The request for verificafion is incomplete and not accepted for
evaluation. The department's written notification shall describe the spe-
cific information or documentation that is deficient.

(d) Within 60 days of the receipt of a complete request for verification,
the department shall notify the dealer of one of the following:

(1) That the oyster treatment process has been verified, or

(2) That the request has been reviewed and denied for failure to estab-
lish that each oyster harvested during April through October and sold or
distributed in California will be subjected to an oyster treatment process.

Page 156.2

Title 17

State Department of Health Services

§ 13701

The department shall provide a written description in the notification of
the basis for the denial.

(e) Written notification by the department to dealers requesting verifi-
cation shall be deemed to occur on the date that the notification is post-
marked.

(f) The department shall deem a request for verification abandoned by
a dealer requesting verification who fails to respond or to supply informa-
tion or documents within 30 days of notification by the department.

(g) The time periods for processing a request for verification from the
date of receipt by the department are as follows:

( 1 ) The median time for processing a request is 45 days.

(2) The minimum time for processing a request is 20 days.

(3) The maximum time for processing a request is 60 days.

(h) The department may revoke or suspend a verification granted pur-
suant to Section 1 3675(e) and this section for any failure of the dealer to
ensure the use of the oyster treatment process as described in the request
for verification, for any failure of the oyster treatment process to reduce
Vibrio vulnificus to non-detectable levels, or for any violation by the
dealer of this article. The department shall inform the person of any de-
nial, revocation, or suspension in writing, stating the reasons for the de-
nial, revocation, or suspension.
NOTK: Authority cited: Section 15376, Government Code; and Sections 100275,

1 10065, 1 10105. 1 10430 and i 12165(a), Health and Safety Code. Reference: Sec-
tions 110435, 110545, 110660, 112165(e), 112195. 112200 and 1 13980. Heallli
and Safety Code.

History

1 . New section filed 4-14-2003 as an emergency; operative 4-14-2003 (Register
2003. No. 16). A Ccrtiiieate of Compliance mu.st be transmitted to OAL by
8-12-2003 or emergency language will be repealed by operation ol law on the
following day.

2. Certificate of Compliance as to 4-14-2003 order transmitted to OAL
8-1 1-2003 and filed 9-23-2003 (Register 2003, No. 39).

Article 1 1 . Frozen Food Locker
Regulations

§ 13700. Frozen Food Locker Regulations.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
208, Health and Safety Code.

History
1. Repealer filed 8-1-85; effective thirtieth day thereafter (Register 85, No. 31).

§ 13701 . Licenses for Frozen Food Locker Plants.

(a) Licenses for Frozen Food Locker Plants will be valid for a two-
year period from date of issue and are not transferable. The fee for the
license is $30.00.

[The next page is 157.]

Page 156.3

Title 17

State Department of Health Services

§ 15440

(b) Application for a Frozen Food Locker Plant license shall be made
on State Department of Health form #EH-6.

(d) The licensee shall immediately notify the Department of any
change in the information which was submitted on the license applica-
tion.

NOTt-:: Authority cited: Sections 208 and 22 1 , Health and Safety Code. Reference:
Section 221, Health and Safety Code.

History
1 . New section filed 7-2 1 -76; effective thirtieth day thereafter (Reeister 76, No.
30).

Subarticie 2.

Article 12. Hazardous Substances
Regulations

NOTE: Authority cited for Article 12: Sections 102 and 208, Health and Safety
Code. Reference: Sections 28740 through 28755, 28778 and 28779, Health and
Safety Code.

History

1. New Article 12 (Sections 14001-14003, 14010-1401. 14061-14063,
14101-14103, 14105, 14107 and 14108) filed 7-23-62; effective thirtieth day
thereafter (Register 62, No. 15).

2. Repealer of Article 12 (Sections 14001-14108, not consecutive) filed 9-1-78;
effective thirtieth day thereafter (Register 78, No. 35). Group 2. Definitions and
Standai'ds

Group 2. Definitions and Standards

Article 13. Food Standards

§ 15200. Order Promulgating Standards.

History
1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15205. General Regulations.

NOTK: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1 . Repealer filed 3- 1 8-85; effective thirtieth day thereafter (Register 85, No. 1 2).

§ 15210. Examinations and investigations — Samples.

NOTH: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1 . Repealer filed 3-1 8-85; effective thirtieth day thereafter (Register 85, No. 12).

§ 15215. General Methods for Water Capacity and Fill of
Containers.

History
1 . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 5220. General Statements of Substandard Quality and
Substandard Fill of Container.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

FLOURS AND RELATED PRODUCTS

Subarticie 1. Flour and Cereal Products

History
1. Repealer of Part I (Sections 15225-15300, not consecutive) filed 9-1-78; ef-
fective thirtieth day thereafter (Register 78, No. 35). For prior history, see Reg-
i.sters 67, No. 40, and 56, No. 16.

Corn Flour and Related
Products

History
1. Repealer of Part 2 (Sections 15305-15375. not consecutive) filed 9 1-78; ef-
fective thirtieth day thereafter. (Register 78. No. 35 ) For prior history , see Reg-
isters 78, No. 10; 77, No. 48; 67. No. 40; and 56. No. 16.

Subarticie 2A. Rice and Related Products

History'

1. Repealer of Part 2A (Section 15376) filed 9-1-78; effective thirtieth day there-
after (Register 78, No. 35). For prior history, see Register 60, No. 15.

Subarticie 3. Bakery and Bakery Products

History
1 . Repealer of Part 3 (Sections 15380-15403, not consecutive) filed 9 -1-78; ef-
fective thirtieth day thereafter (Register 78, No. 35). For prior history, sec Reg-
isters 78, No. 10; 77, No. 48; 67. No. 40; 61, No. 23; 60, No. 15; and 56, No. 16.

Subarticie 4. Alimentary Pastes

§ 15405. Macaroni Products: Identity; Label Statement of
Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 67, No. 40.

§ 15410. Enriched Macaroni Products: Identity; Label
Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

§ 15415. Milk Macaroni Products: Identity; Label Statement
of Optional Ingredients.

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15420. Whole Wheat Macaroni Products: Identity; Label
Statement of Optional Ingredients.

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15425. Wheat and Soy Macaroni Products: Identity;
Label Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 1 6.

§ 15430. Vegetable Macaroni Products: Identity; Label
Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effecdve thirtieth day thereafter (Register 78. No. 35).
For prior history, see Register 56, No. 16.

§ 15435. Noodle Products: Identity; Label Statement of
Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).
For prior history, see Register 67, No. 40.

§ 15440. Enriched Noodle Products: Identity; Label
Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 1 6.

Page 157

(4-1-90)

ii 15445

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 15445. Wheat and Soy Noodle Products: Identity; Label
Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56. No. 16.

§ 15450. Vegetable Noodle Products: Identity; Label
Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

§ 15455. Oriental Style Noodles, Chinese Style Noodles,
Japanese Style Noodles, Korean Style
Noodles: Identity; Label Statement of
Ingredients.

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History

1. Amendment filed 6-27-60; effective thirtieth day thereafter (Register 60, No.
15).

2. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§ 15460. Tagliarini: Identity; Label Statement of Optional
Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15465. Use of Secondhand Boxes for Alimentary Pastes.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

PROCESSED VEGETABLE PRODUCTS

Subarticlel. Canned Vegetables

History
1 . Repealer of Part 1 (Sections 15470-15525, not consecutive) filed 9-1-78; ef-
fective thirtieth day thereafter (Register 78, No. 35). For prior history, see Reg-
isters 68, No. 14; 60, No. 15; and 56, No. 16.

Subarticie 2. Canned Vegetable Other Than
Those Specifically Regulated

History
1 . Repealer of Part 2 (Sections 15530 and 1 553 1 ) filed 9-1-78; effective thirtieth
day thereafter (Register 78, No. 35). For prior history, see Registers 68, No. 4;
60, No. 15; and 56, No. 16.

PROCESSED TOMATO PRODUCTS

Subarticie 3. Canned Tomatoes

History
1. Repealer of Part 1 (Secfions 15535-15545, not consecufive) filed 9-1-78; ef-
fective thirtieth day thereafter (Register 78, No. 35). For prior history, see Reg-
ister 68, No. 14.

Subarticie 4. Tomato Products

History
1. Repealer of Part 2 (Sections 15550-15570, not consecufive) filed 9-1-78; ef-
fective thirtieth day thereafter (Register 78, No. 35). For prior history, see Reg-
isters 60, No. 15; and 56, No. 16.

Subarticie 5. Tomato Products, Mold
Filament Tolerance

§ 15575. Tomato Catsup, Puree, and Paste.

A mold tolerance of 40 percent of the microscopic fields is not to be
exceeded in cases of tomato catsup, puree, and paste.
NOTI:: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Section 26523, Health and Safety Code.

History

1. New NOTE filed 7-3-84 (Register 84, No. 27).

§ 15580. Tomato Juice.

The mold tolerance in case of tomato juice should not exceed 20 per-
cent of the microscopic fields.

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Section 26523, Health and Safety Code.

History
1. New NOTE filed 7-3-84 (Register 84, No. 27).

§ 15585. Comminuted Tomato Products.

Comminuted tomato products exceeding mold count tolerances speci-
fied in Section 15575 and Section 15580 cannot be used as ingredients
of manufactured foods such as tomato soup, spaghetti sauce, etc.
NOTE; Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Section 26523, Health and Safety Code.

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. New NOTE filed 7-3-84 (Register 84, No. 27).

PROCESSED FRUIT PRODUCTS

Subarticie 1. Canned Fruit

History
1. Repealer of Part 1 (Sections 15590-15713, not consecutive) filed 9-1-78; ef-
fective thirtieth day thereafter (Reeister 78, No. 35). For prior history, see Reg-
isters 67, No. 23; 60, No. 15; and 56. No. 16.

Subarticie 2. Fruit Preserves and Jellies

History
1. Repealer of Part 2 (Secfions 15715 and 15716) filed 9-1-78; effecUve thirtieth
day thereafter (Register 78, No. 35). For prior history, see Registers 67, No. 23;
60, No. 15; 57, No. 11; and 56, No. 16.

Subarticie 3. Fruit Butters

History
1. Repealer of Part 3 (Sections 15717, 15718 and 15719) filed 9-1-78; effecfive
thirtieth day thereafter (Register 78, No. 35). For prior history, see Registers 67,
No. 23; and 56, No. 16.

Subarticie 3.5. Citrus Products

History
1 . Repealer of Part 3.5 (Sections 1 5721-15723, not consecufive) filed 9-1-78; ef-
fective thirtieth day thereafter (Register 78, No. 35). For prior history, see Reg-
ister 68, No. 43.

Subarticie 4. Carbonated Beverages

History
1 . Repealer of Part 4 (Secfion 15726) filed 9-1-78; effecfive thirtieth day thereaf-
ter (Register 78, No. 35). For prior history, see Register 68, No. 20.

Page 158

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Title 17

State Department of Health Services

§ 15861

DRESSINGS FOR FOODS

Subarticle 1 . Dressings for Salads

History
Repealer olPart 1 (Sections 15735-15750, not consecutive) filed 9-1-78; ef-
fective thirtieth day thereafter (Register 78, No. 35). For prior histoiy, see Reg-
isters 68. No. 36: 60. No. 15: and 56, No. 16.

SEA FOODS AND SEA FOOD PRODUCTS

2. Amendment filed 3-18-85: effective thirtieth day thereafter (Register 85, No
12).

Subarticle 1. Canned Shrimp

NOTt;; Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1. Repealer of Part 1 (Sections 15755-15757) filed 3-18-85: effective thirtieth
day thereafter (Register 85, No. 12). For prior history, see Register 66, No. 20.

Subarticle 2. Canned Oysters

NOTH: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202. Health and Safety Code.

History
1 . Repealer of Part 2 (Sections 1 5760 and 1 5765) filed 3-1 8-85: effective thirtieth

day thereafter (Register 85, No. 12). For prior history, see Registers 66, No. 37

and 54, No. 16.

Subarticle 3. Raw Oysters

Note; Authority cited: Sections 208 and 26202. Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1. Repealer of Part 3 (Sections 15770-15820, not consecufive) filed 3-18-85; ef-
fective thirtieth day thereafter (Register 85, No. 12). For prior history, see Reg-
ister 56, No. 16.

Subarticle 4. Sea Food Cocktails

§ 15825. Sea Food Cocktails.

Sea food cocktails are the food products prepared by immersing the
clean, cooked, edible portions of sea food ingredients in a suitable acidi-
fied sauce.

(a) Sauce. A suitable cocktail sauce may be made from catsup or other
acidulated tomato product with or without the addition of pieces and/or
sodium benzoate. A sufficient amount of vinegar or other food acid shall
be added to bring the pH of the sauce to 3.70 or lower. This pH shall be
checked by the packer for every batch of sauce.

(b) "Meat" Ingredient.

( 1 ) The sea food ingredient of sea food cocktails must represent not
less than 30 percent of the weight of the finished product.

(2) If such ingredient consists wholly of the "meat" of one type of sea
food such as crab meat, shrimp, oyster, etc., the product may be named
after that ingredient.

(3) If a mixture of two sea food ingredients are used the product may
be so named to indicate this fact, stating first the name of the sea food in-
gredient present in greatest quantity.

(4) If a mixture of more than two sea food ingredients is used in sub-
stantial quantities the product may be labeled "mixed sea food cocktail"
or the names of the three or more sea food ingredients may be stated in
the order of their predominance by weight.

NOTH: Authority cited: Secdons 208 and 25610, Health and Safety Code. Refer-
ence: Sections 25610 and 25612, Health and Safety Code.

History
1. Amendment filed 8-16-71; effective thirtieth day thereafter (Register 71, No.
34).

Subarticle 5. Canned Tuna Fish

NOTIi: Authority cited: Sections 208 and 26202. Health and Safety Code. Refer-
ence: Sections 26051 and 26202. Health and Safety Code.

History
1 . Repealer of Part 5 (Sections 1 5826 and 1 5827 ) filed 3-1 8-85; effective thirtieth

day thereafter (Register 85, No. 12). For prior history, .see Register 60, No. 15.

Subarticle 1.

EGGS AND EGG PRODUCTS

§15830. Eggs.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15835. Liquid Eggs, Mixed Eggs, Liquid Whole Eggs,
IVIixed Whole Eggs: Identity.

History

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No.
20).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15840. Frozen Eggs, Frozen Whole Eggs, Frozen Mixed
Eggs: Identity.

History

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No.
20).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15845. Dried Eggs, Dried Whole Eggs; Identity.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 66, No. 20.

§ 15850. Egg Yolks, Liquid Egg Yolks, Yolks, Liquid Yolks:

History

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
16).

2. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No.
20).

3. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15855. Frozen Yolks, Frozen Egg Yolks: Identity.

History

1. Amendment filed 7-1-66; effective thirtieth day thereafter (Register 66, No.
20).

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15856. Egg Whites, Liquid Egg Whites, Liquid Egg
Albumen; Identity.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 66, No. 20.

§ 15857. Frozen Egg Whites, Frozen Egg Albumen;
Identity.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15860. Dried Egg Yolks, Dried Yolks; Identity.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 66, No. 20.

§ 1 5861 . Dried Egg Whites, Egg White Solids, Dried Egg
Albumen, Egg Albumen Solids; Identity.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).
For prior history, see Register 66, No. 20.

Page 159

(4-1-90)

§ 15865

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

COCOA PRODUCTS

§ 15865. Cacao Nibs, Cocoa Nibs, Cracked Cocoa:
Identity; Label Statement of Optional
Ingredients.

History

1. Amendment filed 8-17-56: effective thirtieth day thereafter (Register 56, No.
16).

2. Repealer filed 9-1-78: effective thirtieth day thereafter (Register 78, No. 35).

§ 15870. Chocolate Liquor, Chocolate, Baking Chocolate,
Bitter Chocolate, Cooking Chocolate,
Chocolate Coating, Bitter Chocolate Coating;
Identity: Label Statement of Optional
Ingredients.

History
1. Repealer filed 9-1-78: effecUve thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56. No. 16.

§ 15875. Breakfast Cocoa, High Fat Cocoa: Identity; Label
Statement of Optional Ingredients.

History
1 . Repealer filed 9-1-78: effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

§ 15880. Cocoa, Medium Fat Cocoa: Identity; Label
Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).

§ 15885. Low-Fat Cocoa: Identity; Label Statement of
Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15890. Sweet Chocolate, Sweet Chocolate Coating:
Identity; Label Statement of Optional
Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

§ 15895. Milk Chocolate, Sweet Milk Chocolate, Milk
Chocolate Coating, Sweet Milk Chocolate
Coating: Identity; Label Statement of Optional
Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).
For prior history, see Register 56, No. 16.

§ 15900. Skim Milk Chocolate, Sweet Skim Milk Chocolate,
Skim Milk Chocolate Coating, Sweet Skim Milk
Chocolate Coating: Identity; Label Statement
of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15905. Buttermilk Chocolate, Buttermilk Chocolate

Coating: Identity; Label Statement of Optional
Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 15910. Mixed Dairy Product Chocolate, Mixed Dairy
Product Chocolate Coating: Identity; Label
Statement of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 591 5. Sweet Chocolate and Vegetable Fat (Other Than
Cacao Fat) Coatings: Identity; Label Statement
of Optional Ingredients.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78. No. 35).

§ 15920. Sweet Cocoa and Vegetable Fat (Other Than

Cacao Fat) Coatings: Identity; Label Statement
of Optional Ingredients.

History
I. Repealer filed 9-1-78; effecfive thirtieth day thereafter (Register 78. No. 35).

FLAVORING EXTRACTS
§ 15925. Distinction Between "Extract" and "Flavor."

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence; Sections 26051 and 26202, Health and Safety Code.

History
1. Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

Subarticlel. Extracts

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1. Repealer of Part 1 (Secdon 15930) filed 3-1 8-85; effective thirtieth day thereaf-
ter (Register 85, No. 12). For prior history, see Registers 78, No. 35 and 54, No.
16.

Subarticle 2. Flavors

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Secnons 26051 and 26202, Health and Safety Code.

History
1. Repealer of Part 2 (Sections 15935-15970, not consecutive) filed 3-18-85; ef-
fecfive thirtieth day thereafter (Register 85, No. 12). For prior history, see Reg-
ister 54, No. 16.

Subarticle 3. Labeling

§15975. Labeling Defined.

Note: Authority cited: Secfions 208 and 26202, Health and Safety Code. Refer-
ence: Secfions 26051 and 26202, Health and Safety Code.

History

1 . Repealer filed 3-1 8-85; effecfive thirtieth day thereafter (Register 85, No. 1 2).

§ 15980. Where Label Statements Must Appear.

All required information shall appear on the main display panel of the
bottle and carton. If more than one panel is used for display, the required
information shall appear on each. This statement applies to the name of
the product, list of ingredients when required, declaration of artificial
color, added preservative, name and address of the manufacturer, distrib-
utor or packer, and the statement of the quantity of contents.

§ 15985. Name and Address of Manufacturer or
Distributor.

Note: Authority cited: Secfions 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1 . Repealer filed 3-18-85; effecfive thirtieth day thereafter (Register 85, No. 12).

§ 15990. Quantity of Contents Statement.

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1 . Repealer filed 3-18-85; effective thirtieth day thereafter (Register 85, No. 12).

§15995. Listing of Ingredients.

NOTE; Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1. Repealer filed 3-18-85; effecfive thirtieth day thereafter (Register 85, No. 12).

Page 160

(4-1-90)

Title 17

State Department of Health Services

§ 16113

•

§16000. Artificial Coloring.

NOTI-.: Aiithoritv cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 2b()5 1 and 26202, Health and Safety Code.

History
1 . Repealer filed 3-1 8-85; effective thirtieth day thereafter (Register 85, No. 12).

§16005. Artificial Flavoring.

NOTt;: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History

1 . Repealer filed .VI 8-85: effective thirtieth day thereafter (Register 85, No. 12).

§ 16010. Chiemical Preservatives.

NOTi:: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
1 . Repealer filed 3-1 8-85; effective thirtieth day thereafter (Register 85, No. 12).

§ 1 601 5. Guaranty Statements.

NOTH: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26051 and 26202, Health and Safety Code.

History
I . Repealer filed 3-1 8-85; effective thirtieth day thereafter (Register 85, No. 1 2).

§16020. Misleading Containers.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

SIRUP STANDARDS

§16025. Definitions.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16030. Sirup.

History
I . Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16035. Sugar-Cane Sirup.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16040. Sorgiium Sirup.

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16045. Maple Sirup.

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16050. Sugar Sirup.

History
1. Repealer filed 9-1-78; effective thutieth day thereafter (Register 78, No. 35).

§16055. Imitation Sirups.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 6060. Labeling of Sirups.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

VINEGAR STANDARDS

§ 16065. Vinegar, Cider Vinegar, Apple Vinegar.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 16070. Distilled Vinegar, Spirit Vinegar, Grain Vinegar.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 16075. Wine Vinegar, Grape Vinegar.

History
1. Repealer filed 9-1-78; effective thutieth day thereafter (Register 78, No. 35).

§ 1 6080. Malt Vinegar, Beer Vinegar.

History

1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16085. Spices.

History'
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. ^5}.

§ 1 6090. Labeling of Vinegars.

Historv
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§16095. Adulteration.

HIST0R^'
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 1 61 00. Imitation Vinegar.

History
1. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

MISCELLANEOUS FOOD PRODUCTS

Subarticle 1. Olives, Ripe, Sold in Bulk

§ 16105. Manner of Holding Bulk Ripe Olives.

All bulk lipe olives shall be held in kegs or barrels in a brine .solution
containing as a minimum 2 1/2 percent salt (10 degrees salometer).
NOTE: Authority cited: Sections 208, 26202 and 26209, Health and Safety Code.
Reference: Sections 26050, 26209 and 26520, Health and Safety Code.

History
1. New NOTE filed 7-3-84 (Register 84, No. 27).

§ 1 61 1 0. Label Stipulations of Bulk Ripe Olives.

All barrels or kegs containing ripe olives shall have a label affixed
thereto bearing the following statement:

The Contents of This Keg or Barrel

Shall Not be Held or Preserved in Closed or

Sealed Glass Jars or Tins

NOTE: Authority cited: Sections 208 and 26202, Health and Safety Code. Refer-
ence: Sections 26050 and 26520, Health and Safety Code.

History

1. New NOTE filed 7-3-84 (Register 84, No. 27).

Subarticle 2. Canned Whole and Pitted
Ripe Olives

§16112. Definitions.

(a) The term "Canned Ripe Olives" refers to olives of the "ripe type"
or the "green-ripe type."

(1 ) "Ripe type" olives are those which have been treated and oxidized
in processing to produce a typical dark brown to black color.

(2) "Green-ripe type" olives are those which have not been oxidi/ed
in processing and which range in color from yellow-green; green-yellow
or other greenish casts; and which may be mottled.

Note; Authority cited: Sections 208, 26202 and 26510, Health and Safety Code.
Reference: Section 26510, Health and Safety Code.

History

1. New Part 2 (Sections 16112, 161 13 and Table 1) filed 12-15-83; effective thir-
tieth day thereafter (Register 83, No. 51 ).

2. Editorial conection of subsection (a)(2) printing error (Register 84. No. 8).

§16113. Labeling.

(a) Cans of Ripe Olives shall bear a label which meets all of the label-
ing requirements set forth in Article 4. Sections 26550 thru 265(i2 of the
California Health and Safety Code and in addition, shall bear all of the
following information:

Page 161

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§ 16113

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1) A statement of the drained weight. (b) Cans ofRipeOHves with counts per pound between two size ranges

(2) A size designation according to one of the seven sizes set forth in shall be labeled as the lesser or smaller size.

Table 1 . NOTI-:: Authority cited: Sections 208. 26202 and 265 1 0. Health and Safety Code.

(3 ) A cut or imprint which represents the approximate size of the fruit Reference: Sections 26556 and 26557, Health and Safety Code,
designated as set forth in Table 1 .

TABLE 1. SIZE— CANNED WHOLE AND PITTED RIPE OLIVES

DESia^TION

COUNT PER
POUND

ILLUSTRATION

APPROXIMATE
DIAMb'ftat RANGE
ILLUSTRA'm) (nm)

SMALL

128 - 140

16 - 17

MEDItM

106 - 121

17 - 19

LARGE

91 - 105

19 - 20

EXTRA
LARGE

65 - 88

20 - 22

TABLE 1. (CONTINUED)

•

DESIGNATION

COUNT PER
POUND

ILLUSTRATION

APPROXIMATE

DIAMETER RANGE

ILLUSTRATtU (nm)

JUMBO

51 - 60

22 - 24

COLOSSAL

41 - 50

24-26

SUPER
COLOSSAL

26 - 40

26 and over

Illustration has been reduced for printing purposes.

Page 162

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Title 17

State Department of Health Services

§ 17005

Article 13.1. Actionable Defect Levels for
Processed Foods

§ 16200. General Provisions.

A manufacturer shall not mix a lot of a food containing defects exceed-
ing the actionable level with another lot of food containing fewer defects
than the actionable level. Such mixing renders the food actionable re-
gardless of the defect level of the final food.

NOTH: Authority cited: Sections 208. 26202 and 26203, Health and Safety Code.
Reference: Sections 26203, 26520 and 26523, Health and Safety Code.

History

1. New Article 13.1 (Sections ]6200-16201)filed5-30-78;effective thirtieth day
thereafter (Register 78, No. 22).

2. Amendment filed 3-18-85; effective thirtieth day thereafter (Register 85, No.

12).

§ 16201. Heat Processed Canned Peaches: Actionable
Defect Levels for Insects.

(a) Definitions.

(1) Standard Peach Unit means:

(A) A single whole peach, or

(B) A peach half, or

equal in weight to a fraction of the drained weight according to can size

as follows:

Drained Weight

or Drained

Weight Fraction

Equivalent to

One Standard

Can Size Peach Unit

8 oz. - 211x304 1/3

No. 300 - 300x407 1/6

No. 303 - 303x406 1/6

No. 2 - 307x409 1/8

No. 2 1/2-401x411 1/10

No. 10 - 603x700 1/40

No. 10 - 603x700 solid pack or preheated pie pack 1 .5 oz.

Larger than above sizes 1 .5 oz.

1 . The method of ascertaining drained weight shall be the method used
for the USDA Quality Grade Standards for canned foods.

(2) Insect infested means a standard peach unit having embedded or
clinging insects or insect fragments.

(b) Actionable levels for peaches which are principally peeled by
hand, such as white peaches, are reached at any time when:

( 1 ) More than five percent of standard peach units by count are insect
infested, or

(2) More than twenty percent of the cans contain one or more free
floating whole insect larvae, or the larval parts equivalent to a whole lar-
va, or any free floating part of any adult insect.

( 1 ) More than one percent of standard peach units by count are insect
infested, or

(2) More than two percent of the cans contain one or more free floating
whole insect larvae, or the larval parts equivalent to a whole larva, or any
free floating part of any adult insect.

(d)Sampling Requirements.

(1) The minimum number of standard peach units and the minimum
number of cans selected from a single manufacturer's lot for evaluation
of compliance shall be determined according to can size as follows:

Minimum

Number of Mininnim

Standard Number

Can Size Peacli Units of Cans

8 oz.- 21 1/304 100 50

No. 300 - 200x407 100 25

No. 303 - 303x406 ] 00 25

No. 2 - 307x409 1 25 25

No. 2 1/2 - 401x41 1 200 25

No. 10 - 603x700 200 8

All Larger Cans 200 2

NOTE; Authority cited: Sections 208. 26202 and 26203, Health and Safety Code.
Reference: Sections 26523 and 26524, Health and Safety Code.

History
1. Nev.- NOTE filed 7-3-84 (Register 84, Nv). 27).

Article 14.

Wine Standards and Prohibited
Practices

§ 17000. Order Promulgating Regulations and Standards.

NOTE: Authority cited for Article 14: Sections 26540 and 26540.2, Health and
Safety Code. Reference: Sees. 26540.2 and 26542.1, Health and Safety Code.

History

1. Repealer of Article 14 (Sections 17000 through 17105) and new Article 14
(17000, 17001. 17005, 17010, 17015, 17075, 17076. 17090, 17100. 17105 and
17116) filed 9-23-69; effective thirtieth day thereafter (Register 69, No. 39).
For prior history, see Register 66, No. 20.

2. Repealer filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35).

§ 17001 . Adoption and Application of Regulations and
Standards.

(a) Application. The Treasury Department regulations adopted and the
exceptions and additional provisions in this Article shall be applicable to
all the wine produced, imported, botfled, offered for sale or sold within
the state for beverage use, or any other purpose, except as hereinafter pro-
vided. The production, the importation, or sale within this state of any
product as, or under the designation of wine, which fails to conform to
the applicable standard described herein, except for distillation into wine
spirits or industrial or nonbeverage purposes is hereby prohibited.

(b) Except as otherwise provided in this Article, the definitions and
standards of identity and quality for wine and their amendments, now or
hereafter promulgated by the U. S. Treasury Department, Internal Reve-
nue Service, in Title 27 C.F.R., Part 4, Subparts B and C, Part 1 9, Subpart
N, Part 23 1 , Subpart F and Part 240, Subparts O, P, Q, R, S, T, V, W, X,
Z, and ZZ, are the definitions and standards of identity and quality for
wine in the State of California.

Note: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code.
Reference: Section 26515, Health and Safely Code.

History
1. Amendment filed 3-14-85; effective thirtieth day thereafter (Register 85, No.
11).

§ 1 7005. standards of Identity and Quality for Wine
Produced in California or Elsewhere.

(a) The standards herein established are minimum standards for wine
of the several classes and types defined.

(b) Prohibited Wine. Wine derived from raisins, dried grapes, dried
berries, and other dried fruit, and imitation or substandard wine, shall not
be produced, imported, or sold in this state except for distillation into
wine spirits or for industrial or nonbexerage purposes.

(c) Cellar Treatment. Cellar treatment shall conform to the methods
and materials authorized for treatment of wine by the Alcohol, Tobacco
and Firearms Division of the Internal Revenue Service as well as the Cali-
fornia Pure Foods Act and the Federal Food, Drug, and Cosmetic .Act and
the regulations adopted thereunder. In case of conflict between Federal
and State laws or regulations the California law or regulation shall take
precedence.

Page 163

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§ 17010

IJARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTH: Authority cited: Sections 208, 26202 and 26213, Health and Safety Code.
Reference: Section 26515, Health and Safety Code.

History
1 . Repealer of subsection (d) filed 3-1 4-85; effective thirtieth day thereafter (Reg-
ister 85. No. 11).

§ 17010. Provisions Applicable to Wine Produced in
California.

The following provisions shall apply lo wines produced in California:

(a) Sugar Use. No sugar, or material containing sugar, other than pure
condensed grape must, and no water in excess of the minimum amount
necessary to facilitate normal fermentation, may be used in the produc-
tion or cellar treatment of any grape wine except:

( 1 ) In the production of sparkling wine (where sugar or liquid sugar
may only be used in the traditional secondary fermentation and dosage),

(2) Carbonated and special natural wine; provided, however, that spar-
kling and carbonated wine or the residuum thereof may be reconverted
into still wine, and such wine and special natural wine or the residuum
thereof may be distilled into wine spirits if the unfermented sugar has not
been refermented.

(3 ) Natural grape wine produced outside of the State of California with
the use of sugar pursuant to applicable federal regulations may be
blended with grape wine produced in California pursuant to these regula-
tions only for the purpose of producing sparkling wine and carbonated
wine. The resultant blend shall not be entitled to the appellation of origin
"California" or any geographical subdivision thereof.

(b) Sweetness Limitation.

( 1 ) The Brix saccharometer test, using a saccharometer calibrated at
20° C and made in the presence of the alcohol content provided herein
shall be:

(A) Not less than 5.5 degrees for Angelica, Muscatel, Port and White
Port.

(B) Not less than 3.5 degrees for Tokay (as a dessert wine).

(2) The reducing sugar content (per 100 milliliters at 20" C and calcu-
lated as dextrose) for sherries shall be as follows:

Minimiini Maxivium

Dry Sherry 0.0 gram 2.5 grams

Sherry 2.5 grams 4.0 grams

Sweet, Golden, Cream or

Mellow Sherry 4.0 grams

(c) Fixed Acidity. The minimum titratable fixed acidity per 1 00 millili-
ters at 20" C for grape wine (except wine used solely for blending, medic-
inal or industrial purposes) calculated as tartaric acid, shall be as follows:

red table wine 0.4 gram

white table wine 0.3 gram

all other wine 0.25 gram

NOTE: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code.
Reference: Section 26515, Health and Safety Code.

History

1 . Amendment of subsection (b)(1) (C) and ( D) filed 6-1 2-70; effective thirtieth
day thereafter (Register 70, No. 24).

2. Amendment filed 1 1-29-79; effective thirtieth day thereafter (Register 79, No.
48).

3. Amendment of NOTE filed 3-21-84 (Register 84, No. 12).

§ 17015. Wines Bearing the Appellation of Origin

"California" or a Geographical Subdivision
Thereof.

(a) A grape wine shall be entitled to the appellation of origin "Califor-
nia" or a geographical subdivision thereof only if:

(1) 100 percent of its volume is derived from fermented juice of fruit
grown within California; except that wine spirits produced in California
from residues of wines, which contain grapes grown outside of Califor-
nia, may be used in the production of wines bearing the appellation of ori-
gin "California" or subdivisions thereof, subject to all of the following
limitations:

(A) The wine shall not derive more than 1 percent of its volume from
fruit grown outside California.

(B) The non-California portion shall be derived solely from residue
wine spirits.

(C) Grapes, juice, concentrate, wine or other distilling material shall
not be iinported into California for distilling of wine spirits for use under
this Section, and

(2) It has been fully produced and finished within the State of Califor-
nia, and

(3) It conforms to the requirements of these regulations: provided, that
no wine shall be entitled to an appellation of origin in violation of Section
25236 or Section 25237 of the California Alcoholic Beverage Control
Act.

NOTE: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code.
Reference: Section 26515, Health and Safety Code.

History

1. Ainendment filed 8-10-78; effective thirtieth day thereafter (Register 78, No.
32).

2. New NOTE filed 3-21-84 (Register 84, No. 12).

§17075. Labeling.

(a) Certificate. The permittee responsible for labeling shall, upon re-
quest of the Department, furnish adequate proof that a valid certificate of
label approval for all labels has been obtained from the U. S. Treasury
Department and that such certificate is unrevoked at the time the wine is
offered for sale; provided a wine shall not be deemed to be mislabeled,
if its label fails to conform to the federal requirements only in those par-
ticular respects which are specifically authorized in this Article.

(b) Service Containers. The prescribed mandatory information re-
quirement shall not apply to containers used solely for service purposes,
where such containers are filled on retail premises just before sale and for
immediate use thereon.

Note: Authority cited: Sections 208, 26202 and 26515, Health and Safety Code.
Reference: Section 26515, Health and Safety Code.

History
1. Amendment filed 3-14-85; effective thirtieth day thereafter (Register 85, No.
11).

§ 17076. Combination Wines.

History
1. Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85. No. 11).

§ 1 7090. Advertising of Wine.

History
1. Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

§17100. Sanitation.

History
1 . Repealer filed 3-14-85; effecfive thirtieth day thereafter (Register 85, No. 1 1 ).

§17105. Enforcement.

History
1 . Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 1 1 ).

§ 1 71 1 6. Constitutionality.

History
1 . Repealer filed 3-14-85; effective thirtieth day thereafter (Register 85, No. 11).

Article 15. Distilled Spirits Standards

§ 18000. California Brandy.

(a) A grape brandy shall be entitled to the appellation "California"
only if:

( 1 ) 100% of its volume is derived at the time of distillation from grapes
grown within the State of California or from California wine and

(2) It has been fully distilled within the State of California.

NOTE: Authority cited: Sections 208 and 26514, Health and Safety Code. Refer-
ence: Section 26514, Health and Safety Code.

History
1. Repealer of Article 15 (Sections 18000-18135, not consecutive) filed 9-1-78;

effective thirtieth day thereafter (Register 78, No. 35). For prior history, see

Page 164

(4-1-90)

Title 17

State Department of Health Services

§ 19020

2. New Article 15 (Section 18000) filed 1 1-29-79; effective thirtieth day thereaf-
ter (Register 79. No. 48).

?. Amendment filed 8-14-81 ; effective thirtieth day thereafter (Register 81, No.

Article 16. Processed Pet Food
Regulations

§ 19000. Order Promulgating Standards.

NOTf/. Authority cited: Sections 208. 27010 and 27040, Health and Safety Code.
Reference: Sections 27010 and 27040. Health and Safety Code.

History

1 . Repealer and new Article 16 (Sections 19000 through 19040. not consecutive)
filed 8-10-70: effective thirtieth day thereafter (Register 70. No. 33). For prior
history, see Registers 60, No. 3, and 64. No. 1 1 .

2. Repealer filed 9-27-85; effecfive thirtieth day thereafter (Register 85. No. 40).

{j 1 9001 . Intent of Regulations.

NOTlv. Authority cited: Sections 208. 27010 and 27040. Health and Safety Code.
Reference: Sections 27010 and 27040, Health and Safety Code.

History
1 . Repealer filed 9-27-85; effective thirtieth day thereafter (Register 85, No. 40).

§19005. Definitions.

(a) "Complete food" means a nutritionally adequate pet food com-
pounded by a specific formula to be fed as the sole ration and capable of
maintaining life and/or promoting normal reproduction in healthy pets
without any additional substance being consumed except water, based
upon the recommendations of recognized authority in the field of animal
nutrition.

(b) "Balanced food" means a pet food having all known required nutri-
ents in a proper amount and proportion based upon the recommendations
of recognized authority in the field of animal nutrition for a given set of
physiological animal requirements.

(c) "Edible" as used in this article is to be construed as food fit to be
eaten by dogs, cats, or other domestic animals.

(d) "Meat" means the clean, wholesome flesh derived from slaugh-
tered mammals and is limited to that part of the striated muscle which is
skeletal or that which is found in the tongue, in the diaphragm, in the
heart, or in the esophagus; with or without the accompanying and overly-
ing fat, and the portions of skin, sinew, nerve and blood vessels which
normally accompany the flesh. The term "meat" when applied to the cor-
responding portions of mammals other than cattle, swine, sheep and
goats shall be used in qualified form, for example, "horsemeat."

(e) "Meat by-products" is the non-rendered, clean, wholesome parts
of the carcass of slaughtered mammals such as lungs, spleens, kidneys,
brains, liver, stomach, bone, blood, and intestines free of their contents.
It does not include skin, horns, teeth and hoofs. The term "meat by-prod-
ucts" when applied to the corresponding portions of mammals other than
cattle, swine, sheep and goats shall be used in qualified form, as, for ex-
ample, "horsemeat by-products."

(f) "Poultry" means the eviscerated carcass of slaughtered poultry, ex-
clusive of the head, feet and feathers.

(g) "Poultry parts" means the clean, wholesome parts of dressed poul-
try characterized by large portions of bone such as necks, backs, and
wings exclusive of feet, heads, viscera and feathers.

(h) "Poultry by-products" means the non-rendered, clean parts of car-
casses of slaughtered poultry such as heads, feet, and viscera free from
fecal content and foreign matter, except in such trace amounts as might
occur unavoidably in good factory practice.

(i) "Giblet" means the edible heart, Hver, and gizzard of poultry.

(j) "Fish" means the fish and/or any part offish used as a pet food in-
gredient with or without removal of entrails, head, tail and fins, except
as provided in paragraph (k) of this secfion.

(k) "Fish by-products" means the heads, fins, tail ends, bones, skin
and viscera of fish.

(/) "Fish meal" means the dried ground whole fi.sh or fish cuttings, ei-
ther or both, with or without extraction of part of the oil.

(m) The common names and definitions of other ingredients used in
the processing of pet foods shall be those recognized in the Official Publi-
cation of Feed Control by the Association of American Feed Control Of-
ficials (AAFCO) Incorporated and/or the U.S. Department of Agricul-
ture.

NOTE: Authority cited: Sections 208 and 27040. Health and Safety Code. Refer-
ence: Section 27040, Health and Safety Code.

History
1 . Amendment filed 9-27-85; effective thinieth day thereafter (Register 85, No.
40).

§ 1 901 0. Chemical Analysis.

(a) All canned pet food shall comply with the following analysis:

(1) Crude protein content — a minimum of 7 1/2 percent

(2) Crude fat content — a minimum of 2 percent

(3) Crude fiber content — a maximum of 1 1/2 percent

(4) Moisture content — a maximum of 78 percent or the natural mois-
ture content of the constituent ingredients of the product, whichever is
greater.

(b) All semi-moi.st pet food shall comply with the following analysis:

( 1 ) Crude protein content — a minimum of 1 2 percent

(2) Crude fat content — a minimum of 5 percent

(3) Crude fiber content — a maximum of 5 percent

(4) Moisture content — a maximum of 65 percent

(1) Crude protein content — a minimum of 18 percent

(2) Crude fat content — a minimum of 4 percent

(3) Crude fiber content — a maximuin of 10 percent

(4) Moisture content — a maximum of 18 percent

Note: Authority cited: Sections 208 and 27040(a), flealth and Safety Code. Ref-
erence: Sections 27033 and 27040, Health and Safety Code.

History
1. Editorial correcfion adding NOTE filed 4-13-84 (Register 84, No. 15).

§19015. Exemptions.

(a) Treats, candy and special diet for pets are exempt from the mini-
mum and maximum requirements of the chemical analysis but shall com-
ply with Section 19025, of this Article.

(b) A processed pet food consisting endrely of gravy, sauce, broth or
juice, when so labeled, is exempt from the requirements of paragraphs
(a), (b), and (c) of Secfion 19010 and paragraph (b) of Section 1 9025 of
this Article.

NOTE: Authority cited: Sections 208 and 27040(a), Health and Safety Code. Ref-
erence: Sections 27033 and 27040(a), Health and Safety Code.

History
1. Editorial correction filed 4-13-84 (Register 84, No. 15).

§19020. Required Verifications.

(a) Prior to offering a processed pet food for sale in California, each
pet food manufacturer shall submit in triplicate to the Department, the
following:

( 1 ) A complete list of the pet food ingredients by their common or usu-
al name, and in order of their predominance by weight. The percentage
of each ingredient derived from mammals, poultry, or fish shall be stated
for each formula when the product is as defined in Section 19025, para-
graphs (i), (j), (k), and (/) of this Article.

(2) copies of each label for all processed pel foods.

(b) Manufacturers of processed pet foods shall, upon request, supply
verification of formulas, and/or flavor ingredients or claims to the State
Department of Public Health.

NOTE: Authority cited: Sections 208 and 27040, Health and Safety Code. Refer-
ence: Sections 27031, 27032, 27033, 27034 and 27040(a) and (d). Health and
Safety Code.

Page 165

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§ 19025

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History
I. Kditorial con-ection filed 4-13-84 (Register 84, No. 15).

§ 19025. Labeling and Restrictions.

(a) The words "dog food," "cat food," or similar designations shall ap-
pear conspicuously upon the principal display panels of the pet food la-
bels.

(b) The following shall appear on the label:
"Guaranteed Analysis"

Crude protein — minimum %

Crude fat — minimum '7f

Crude fiber — maximum %

Moisture — maximum 9f

Additional guarantees, if any, shall follow crude fiber.

(c) The ingredients used in the manufacture of the processed pet food
shall be listed in the ingredient statement on the label by their common
or usual name as defined in Section 1 9005 of this Article in their descend-
ing order of predominance by weight. When water is added in the prepa-
ration of a processed pet food, a statement of that fact, for example, "suf-
ficient water has been added for processing," may appear at the
conclusion of the ingredient list.

(d) No product or any of its wrappers, packaging or other containers
shall bear any false or misleading marking, label or other labeling, and
no statement, word, picture, design, or de\ ice which gives a false indica-
tion of origin, quality or flavor. No product shall be wholly or partly en-
closed in any wrapper, packaging or other container that is so made,
formed, or filled as to be misleading.

(e) All labels shall also comply with the provisions of Sections 27031 ,
27032, 27033. and 27034 of the California Health and Safety Code and
the U.S. Fair Packaging and Labeling Act.

(0 A processed pet food shall not be labeled a specific flavor unless
a sufficient amount of that ingredient is used to impart such characteristic
flavor and/or odor to the finished product which is detectable by a recog-
nized test method, or is one the presence of which provides a characteris-
tic distinguishable by the pet. Any flavor designafion on a pet food label
must either conform to the name of its source as shown in the ingredient
statement or the ingredient statement shall show the source of the flavor.

(g) The terms "fit for human food," "fit for human consumpfion," or
any similar terms are prohibited on the labels or in advertisements of a
processed pet food.

(h) The name of the processed pet food shall not be derived from one
or more ingredients of a mixture to the exclusion of other ingredients and
shall not be one representing any components of a mixture of a pet food
product unless all components or ingredients are included in the name ex-
cept as specified in paragraphs (f), (i), (j)' (k) and ( 1) of this secdon; pro-
vided, that if any ingredient or combination of ingredients is intended to
impart a disdnctive characterisdc to the product which is significant to
the purchaser, the name of that ingredient or combinadon of ingredients
may be used as a part of the name of the pet food if:

( 1 ) the ingredient or combinadon of ingredients is present in sufficient
quandty to impart a disdncdve characteristic to the product;

(2) it does not constitute a representation that the ingredient or combi-
nadon of ingredients is present to the exclusion of other ingredients; and

(3) it is not otherwise false or misleading.

(i) When an ingredient or a combinadon of ingredients derived from
mammals, poultry, or fish consdtutes 95% or more of the total weight of
all ingredients of a pet food mixture, the name or names of such ingredi-
ent(s) may form a part of the product name of the pet food, provided that
where more than one such ingredient is part of the product name, then all
such ingredient names shall be in the same size, style, and color print on
the front panel of the label, in their descending order of predominance by
weight.

(j) When an ingredient or a combination of ingredients derived from
mammals, poultry, or fish constitutes 50% or more of the total weight of
all ingredients of a pet food mixture, the name or names of such ingredi-
ent(s) may form a part of the product name of the pet food, when the prod-

uct name also includes a descriptive term "with gravy," "with sauce," or
similar connotation which will fully describe the contents of the pet food
mixture. All such ingredient name(s) shall be in descending order of pre-
dominance by weight. The ingredient name(s) shall be in the same size,
style, and color print on the front panel of the label and the descriptive
term shall follow immediately after or below the ingredient name(s) in
conspicuous size lettering in the same style and color print.

(k) When an ingredient or a combination of ingredients derived from
mammals, poultry, or fish, constitutes 25% or more of the total weight
of all ingredients of a pet food mixture, the name or names of such ingre-
dient or ingredients may form a part of the product name of the pet food
only if the product name also includes a primary descriptive term such
as "balls," "cakes," "loaf," "croquettes," or "stew," so that the product
name describes the contents of the product in accordance with an estab-
lished law, custom, or usage, or so that the product name is not mislead-
ing. All such ingredient names and the primary descriptive term shall be
in the same size, style and color print.

(/) A product shall not be described on the label or in advertising as "all
meat" or " 1 00% meat" or "all tuna" or "all chicken" or otherwise repre-
sented as being composed wholly of a named ingredient if it contains oth-
er added ingredients such as the by-products of meat, poultry, or fish.
However, for the purpose of this provision, water sufficient for process-
ing, required denaturing agents, and trace amounts of preservatives and
condiments shall not be considered ingredients.

(m) Terms such as "burger," "chunk," "patty," "cube," "loaf," "cro-
quette" and other of similar import, shall not be used to describe a product
or an ingredient thereof which does not have substantially the shape or
form so represented when it is sold to the retail purchaser.

(n) The names of ingredients shall not be used in advertising, labeling,
brand or trade name, or otherwise, so as to misrepresent direcdy or by im-
plications the identity of an ingredient or the composition of a processed
pet food.

(o) A vignette, graphic, or pictorial representation of a product on a
processed pet food label shall not misrepresent the contents of the pack-
age.

(p) Inspection Legend. Upon receipt of written permission from the
Department, the following statement may be placed on the labels or can
end of pet food packed in compliance with the provisions of the Laws Re-
lating to Cannery Inspection: "STERILIZED UNDER THE SUPERVI-
SION OF AND ACCORDING TO THE REGULATIONS OF THE
CALIFORNIA STATE DEPARTMENT OF HEALTH SERVICES."
NOTE: Authority cited: Sections 208 and 27040(a), (b) and (d). Health and Safety
Code. Reference: Sections 27031, 27032, 27034 and 27040, Health and Safety
Code.

History
1. Editorial correction filed 4-13-84 (Register 84, No. 15).

§ 19030. Manufacturing Requirements.

(a) Pet food ingredients used to manufacture a processed pet food shall
be sound, clean, and wholesome and shall conform to the provisions of
the California Pure Pet Food Act of 1969.

(b) All stomachs, intestines, and/or other such by-products, which are
used in the manufacture of processed pet food, shall be thoroughly
washed and inspected for fecal or foreign contamination.

(c) Meat meal, meat and bone meal, meat scraps, and other similar
meat products may be used only if they have been produced in a plant ap-
proved by a federal, state, or municipal inspection agency.

(d) All processed pet food packed in hermetically sealed containers
shall be processed in such a manner as to achieve commercial sterility in
all units packed.

(e) All processed pet food not packed in hermetically sealed containers
shall be processed so as to render the product free of salmonella, or other
pathogenic microorganisms which are transmissible to man or animal.
NOTE: Authority cited: Sections 208 and 27040(c), Health and Safety Code. Ref-
erence: Sections 27030 and 27040(c), Health and Safety Code.

•

Page 166

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Title 17

State Department of Health Services

§ 30007

History

1. Kditorial coixection adding NOTE filed 4-13-84 (Register 84, No. 15).

§ 19035. Magnet to Remove Ferrous Material.

(a) All pet food processors are hereby required to install between the
cooker and the filling machine a magnetic separator with a holding power
of not less than 1 25 pounds per square inch to remove ferrous material.
The magnetic exposure area shall be not less than 6 inches by 10 inches.

( 1 ) The magnet shall be so installed that the material to be processed
shall pass the magnet in a relatively thin stream.

(2) If an electro-magnet is used it shall be fitted with a trap to prevent
any material already removed from passing to the filler, in the event of
a power failure. The switch operating an electro-magnet shall be
equipped with a red signal light.

(b) A magnetic separator specified in Section 19035(a) is not required
if it is demonstrated to the Department's satisfaction that equivalent pro-
lection is being provided by the use of other methods or devices.

NOTf-:; Authority cited: Sections 208 and 27040(c), Health and Safety Code. Ref-
erence: Sections 27030 and 27040(c). Health and Safety Code.

History
1. Editorial correction adding NOTE filed 4-13-84 (Register 84, No. 15).

§ 19040. Arsenic and Lead Tolerance in Animal Food.

The tolerance for arsenic in processed pet food is established at 1/20
(0.05) grain per pound and for lead at 1/60 (0.0167) grain per pound.
Note: Authority cited: Sections 208 and 27040(c), Health and Safety Code. Ref-
erence: Sections 27030 and 27040(c). Health and Safety Code.

History
1. Editorial correction adding NOTE filed 4-13-84 (Register 84. No. 15).

§ 19041 . Pet Food Licenses and Certificates.

(a) Licenses and certificates for pet food processors will be valid for
a two-year period from date of issue and are not transferable. The fee for
the license or certificate is $200.00.

(b) Application for a Processed Pet Food license or certificate shall be
made on State Department of Health form #446-129 or #446-130 re-
spectively.

(d) The licensee shall immediately notify the Department of any
change in the information which was submitted on the license or certifi-
cate application.

NOTE: Authority cited: Sections 208 and 22 1 , Health and Safety Code. Reference:
Section 221, Health and Safety Code.

History

1. New section filed 7-21-76; effective thirtieth day thereafter (Register 76, No.
30).

§ 19043. Sources of Poultry Meat.

Only poultry meat or poultry product from state or federally inspected
poultry processing plants may be used in animal foods.

NOTE: Authority cited: Sections 208, 26202, 26510 and 27040, Health and Safety
Code. Reference: Sections 27033, 27040 and 27041, Health and Safety Code.

History
I. Editorial correction renumbering former Section 11 375 to new Section 19043
filed 4-13-84 (Register 84, No. 15).

Group 2. Standards Governing

Certification of Local Vector Control Agency

Personnel

Subchapter 3. Vector Control

(Originally Printed 5-14-49)

Group 1. Standards Governing State Aid to
Local Mosquito Control Agencies

Note: Authority cited: Sections 208 and 402, Health and Safety Code. Reference:
Section 402, Health and Safety Code.

History

1. New § 30001-30053, inclusive, filed 5-3-49 (Register 16, No. 3).

2. Repealer of Group 1 (Articles 1-7, Sections 30001-30053, not consecutive)
filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

Article 1. Definitions

§ 30001 . Certified Technician.

"Certified Technician" means any employee of a vector control
agency who has passed the Department's certification examination as
specified in section 30055 and is required by section 30061 to obtain con-
tinuing education units in order to independently handle, apply, or super-
vise the application of any pesticide as part of such employee's official
duties.

Note; Authority cited: Sections 208 and 402(d). Health and Safety Code. Refer-
ence: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

1. New section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government
Code section 1 1346.2(d) (Register 90, No. 52).

§ 30003. Certified Technician (Limited).

"Certified Technician (Limited)" means any employee of a vector
control agency who has passed the Department's certification examina-
tion as specified in section 30055, but who is exempt under section 30061
from continuing education requirements. A Certified Technician (Lim-
ited) may not handle or apply a pesticide as part of his or her official du-
ties except under the direct supervision of a Certified Technician, or as
permitted under section 30061(d).

NOTE: Authority cited: Sections 208 and 402(d). Health and Safety Code. Refer-
ence: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

1. New section filed 9-25-89 as an emergency; operadve 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government
Code section 1 1346.2(d) (Register 90, No. 52).

§ 30005. Continuing Education Unit.

"Continuing Education Unit (CEU)" means a unit value assigned to
educational activities approved by the Department equal to one unit for
each 50 to 60 minute segment of instruction as determined by the Depart-
ment.

NOTE: Authority cited: Sections 208 and 402(d), Health and Safety Code. Refer-
ence: Secfions 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New secfion filed 11-16-90; operative 11-16-90 pursuant to Government
Code section 1 1346.2(d) (Register 90, No. 52).

§ 30007. In-Service Training.

"In-Service Training" means training given within an agency on sub-
jects directly related to vector control duties.

NOTE: Authority cited: Sections 208 and 402(d). Health and Safety Code. Refer-
ence: Secfions 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History
1. New section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 1-23-90.

Page 167

§ 30009

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90. No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government
Code section 1 1346.2(d) (Register 90, No. .52).

§ 30009. Pesticide Label.

"Pesticide Label" means the written, printed or graphic matter on, or
attached to, the pesticide or device or any of its containers or wrappers.
NOTE: Authority cited: Sections 208 and 402(il), Health and Safety Code. Refer-
ence: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

1 . New section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transinitted to OAL within 120
days or emergency language will be repealed by operation oflaw on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90. No. 52).

3. New secfion filed 11-16-90; operative 11-16-90 pursuant to Government
Code section 1 1346.2(d) (Register 90, No. 52).

§ 3001 1 . Relevant Vectors.

"Relevant Vectors" means those vectors normally included within a
group of vectors falling within the category of each vector control certifi-
cate and which employee of a vector control agency may be expected to
control when working within a particular certificate specialty.
NOTE; Authority cited: Sections 208 and 402(d), Health and Safety Code. Refer-
ence: Sections 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

1 . New section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation oflaw on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operadve 11-16-90 pursuant to Government
Code secfion 1 1346.2(d) (Register 90. No. 52).

§ 30013. Under the Direct Supervision of.

"Under the Direct Supervision of means the act or process whereby
a pesticide is applied by a Certified Technician (Limited) or a Vector
Control Aide acting under the instructions and control of a Certified
Technician who is responsible for the actions of that person and who is
available if and when needed even though such cerfified technician is not
physically present at the time the pesticide is applied. A Certified Techni-
cian shall be physically present during the application of a pesticide when
required by the pesticide label.

NOTE: Authority cited: Sections 208 and 402(d). Health and Safety Code. Refer-
ence: Sections 402(d). 402.1, 403, 2202 and 2805, Health and Safety Code.

History

1 . New section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-1-90 (Register 90, No. 52).

3. New section filed 11-16-90; operative 11-16-90 pursuant to Government
Code secfion 1 1346.2(d) (Register 90, No. 52).

§30015. Vector.

"Vector" means any animal that meets the definifion of secfion 402. 1
of the Health and Safety Code.

NOTE: Authority cited: Sections 208 and 402(d). Health and Safety Code. Refer-
ence: Secfions 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

1. New secfion filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operafion oflaw on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New section filed 11-16-90; operafive 11-16-90 pursuant to Government
Code section 11346.2(d) (Register 90, No. 52).

§ 3001 7. Vector Control Aide.

"Vector Control Aide" means a person who is employed by a vector
control agency but is not cerfified under Section 30055 and may not han-
dle or apply a pesficide as part of his or her official duties except under

the direct supervision of a Certified Technician or as permitted under sec-
fion 30061(d).

NOTE: Authority cited: Sections 208 and 402(d), Health and Safety Code. Refer-
ence: Secfions 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

2. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New secfion filed 11-16-90; operative 11-16-90 pursuant to Government
Code section 1 1 346.2(d) (Register 90, No. 52).

§ 30019. Vector Control Agency.

"Vector Control Agency" means any government agency, including
but not limited to a mosquito abatement district, vector control district,
pest abatement district, environmental health department, or public
health department, which conducts an ongoing program within its juris-
diction to reduce vector populations in order to protect the public health
and well-being.

Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Refer-
ence: Secfions 402(d), 402.1, 403, 2202 and 2805, Health and Safety Code.

History

1 . New section filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operafion oflaw on 1-23-90.

2. Certificate of Compliance for 9-25-89 order transinitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

3. New secfion filed 11-16-90; operative 11-16-90 pursuant to Government
Code secfion 1 1346.2(d) (Register 90, No. 52).

§ 30054. Definitions.

Note: Authority cited: Sections 208 and 402(d), Health and Safety Code. Refer-
ence: Secfions 402(d) and 402.1, Health and Safety Code.

History

1 . Repealer and new article 1 (section 30054) filed 12-19-78; effecfive thirtieth
day thereafter (Register 78, No. 51). For history of prior section, see Register
74, No. 5.

2. Amendment filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

3. Repealer filed 9-25-89 as an emergency; operafive 9-25-89 (Register 89, No.
39). A Certificate of Compliance must be transmitted to OAL within 120 days
or emergency language will be repealed by operation of law on 1-23-90.

4. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

5. Repealer filed 1 1-16-90; operative 1 1-16-90 pursuant to Government Code
1 1346.1(d) (Register 90, No. 52).

Article 2. Certification Examination

§ 30055. Examination Requirements.

Any person employed by a vector control agency as a Cerfified Tech-
nician or Certified Technician (Limited) shall pass, with a score of 70
percent or higher, the Public Health Pest Control Cerfified Technician
Examinafion administered by the Department.

NotE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
402(d), 403, 2202 and 2805, Health and Safety Code.

History

1. Repealer of article 2 (sections 30060-30061) and new article 2 (sections
30055-30059) filed 12-19-78; effective thirtieth day thereafter (Register 78,
No. 51). For history of prior Article, see Register 74, No. 5.

2. Repealer and new secfion filed 9-25-89 as an emergency; operafive 9-25-89
(Register 89, No. 39). A Certificate of Compliance must be ti-ansmitted to OAL
within 120 days or emergency language will be repealed by operation oflaw on
1-23-90.

3. Editorial correcfion of printing error of NOTE (Register 89, No. 49).

4. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

5. Repealer and new secfion filed 1 1-16-90; operative 1 1-16-90 pursuant to Gov-
ernment Code secfion 1 1346.2(d) (Register 90, No. 52).

§ 30056. Examination Content.

(a) The written examination for certification of vector control agency
personnel shall consist of questions covering the following areas:

Page 168

Title 17

State Department of Health Services

§ 30056.4

•

(1) Label and labeling comprehension — factors including:

(A) The general format and terminology of pesticide labels and label-
ing;

(B) The understanding of instructions, warnings, terms, symbols, and
other information commonly appearing on pesticide labels;

(D) Necessity for use consistent with the label.

(2) Safety — factors including:

(A) Pesticide toxicity and hazard to man;

(B) Common exposure routes;

(D) Precautions necessary to guard against injury to applicators and
other individuals in or near treated areas, including medical supervision;

(E) Need for and use of protection clothing and equipment;

(F) Symptoms of pesticide poisoning;

(G) First aid and other procedures to be followed in case of a pesticide
accident; and

(H) Safe and proper procedures for identification, storage, transport,
handling, mixing of pesticides and disposal of pesticides and used pesti-
cide containers, including precautions to prevent access by children.

(3) Environment — The potential environmental consequences of the
use and misuse of pesticides as may be influenced by such factors as cli-
mate and weather, non-target organisms, and drainage patterns.

(4) Vectors — factors such as:

(A) A knowledge of relevant vectors and their distribution;

(B) Recognition of relevant vectors by distinguishing features of the
vector organisms and/or characteristics of damage or other signs;

(D) Pubhc health importance of relevant vectors, including a practical
knowledge of vector-borne disease transmission, as it relates to and in-
fluences control programs; and

(E) Habitats where relevant vectors occur, including a practical
knowledge of those environments.

(5) Pesticides — factors such as:

(A) Types of pesticides;

(B) Types of formulations;

(C) Characteristics of pesticides and formulations, including compati-
bility, synergism, persistence, and animal and plant toxicity;

(D) Hazards and residues associated with use, including applicable
laws and regulations;

(E) Factors which influence effectiveness or lead to such problems as
resistance to pesticides; and

(F) Dilution procedures.

(6) Pesticide application equipment and techniques — factors includ-
ing:

(A) Types of equipment and their uses, advantages, and limitations;

(B) Maintenance of equipment;

(D) Operating procedures and techniques used to apply various formu-
lations of pesticides;

(E) A knowledge of the most effective equipment and technique of
application to use in a given situation;

(F) Relationship of discharge and placement of pesticides to proper
use, unnecessary use, and misuse; and

(G) Prevention of drift and pesticide loss into the environment.

(7) Non-chemical control methods — A practical knowledge of the im-
portance and use of such methods as sanitation, waste management,
drainage, exclusion, trapping, public education, and legal abatement.

(8) Record Keeping — A familiarity with the principles and practices
of biological and operational documentation.

(9) Supervisory Requirements — A practical knowledge of State and
Federal supervisory requirements, including labeling, regarding the
application of restricted materials by a technician's aide.

(10) Laws and Regulations — A basic knowledge of applicable State
and Federal laws and regulations.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
1800-1813 and 2200-2910, Health and Safety Code".

§ 30056.1 . Interpretation of Dates.

For purposes of this Article:

(a) Submission of an application shall be deemed to occur on the date
the application form is received by the Department.

(b) Filing of a completed application shall be deemed to occur when
all information required to be submitted on an application form has been
received by the Department.

(c) V/ritten notifications by the Department to applicants shall be
deemed to occur on the date the notifications are postmarked.

NOTE: Authority cited: Sections 208 and 402. Heahh and Safety Code: and Sec-
tions 15376 and 15378, Government Code. Reference: Sections 15376 and 15378,
Government Code.

History
1. New section filed 4-1 1-85; effective thirtieth day thereafter (Register 85. No.
15).

§ 30056.2. Applications.

(a) To apply for admission to the Public Health Pest Control Certified
Technician Examination, the applicant shall complete an Application for
Admission to the Public Health Pest Control Certified Technician Ex-
amination, FORM EH 173 (2/88). The application form shall include the
applicant's name and job title, the employing agency's name and ad-
dress, and the signatures of the applicant and the agency administrator.
The form shall be completed, signed, and submitted in accordance with
directions printed on or provided with the form.

(b) Within 14 calendar days after submission of an application for ad-
mission to the examination, the Department shall notify the applicant in
writing, through the vector control agency where the applicant is
employed, that the application is complete and accepted for filing, or that
the applicauon is deficient, and what specific information is required to
complete the applicafion. Notification of acceptance shall be in the form
of a copy of the application form, marked "approved," which shall be re-
turned to the applicant. If deficient, the entire application shall be re-
turned to the applicant.

Note: Authority cited: Sections 208 and 402, Health and Safety Code. Reference:
Section 402, Health and Safety Code.

History

1. New section filed 4-1 1-85; effective thirtieth day thereafter (Register 85, No.
15).

2. Amendment filed 9-25-89 as an emergency; operative 9-25-89 (Register 89,
No. 39). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed by operation of law on 1-23-90.

3. Certificate of Compliance for 9-25-89 order ti-ansmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 32).

4. Amendment filed 11-16-90; operative 11-16-90 pursuant to Government
Code section 1 1346.2(d) (Register 90, No. 52).

§ 30056.3. Admission to Examination.

Admission to an examination shall be permitted upon presentation by
the applicant of an approved copy of the application form, as provided
pursuant to Section 30056.2(b).

NOTE: Authority cited: Sections 208 and 402, Health and Safety Code. Reference:
Section 402, Health and Safety Code.

History
1. New section filed 4-1 1-85; effective thirtieth day thereafter (Register 85, No.
15).

§ 30056.4. Notification of Examination Results.

The Department shall notify the applicant in writing, through the vec-
tor control agency where the applicant is employed, of the examination
result and decision on the certification, within 1 1 8 calendiir days after the
filing of a completed application.

NOTE: Authority cited: Sections 208 and 402, Health and Safety Code: and Sec-
tion 15376, Government Code. Reference: Section 15376, Government Code.

Page 169

§ 30056.5

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1 . New section filed 4-1 1-85; effective thirtietli day thereafter (Register 85, No.
15).

§ 30056.5. Processing Times.

The Department's minimum, maximum, and median time periods for
processing a certificate, from the receipt of the initial appHcations to noti-
fication of the final certification decision regarding results of the exami-
nation for certification, based on the Department's actual performance
during the two years immediately preceding the proposal of this regula-
tion, were as follows:

(a) The median time was 54 calendar days.

(b) The minimum time was 50 calendar days.

NOTE: Authority cited: Sections 208 and 402, Health and Safety Code; and Sec-
tion 15376, Government Code. Reference: Section 15376, Government Code.

History

] . New section filed 4-1 1-85; effective thirtieth day thereafter (Register 85, No.

15).

§ 30057. Expiration.

NOTE: Authority cited: Sections 208 and 402, Health and Safety Code. Reference:
Section 402, Health and Safety Code.

History
1. Repealer filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

§ 30058. Denial, Suspension, or Revocation.

(a) The Director may deny, suspend, or revoke any certificate for any
of the following reasons:

( 1 ) Failure to adequately supervise the use of a restricted material.

(2) Failure to obtain a restricted material permit when required.

(3) Failure to comply with any appHcable provision of Divisions 6 or
7 of the Food and Agricultural Code or regulations adopted pursuant to
such provisions.

(4) Failure to record each restricted material use and submit such re-
cord as required by law or regulations.

(5) Making any false or fraudulent record.

(6) Operating in a faulty, careless, or negligent manner.

(7) Failure to qualify by examination.

(b) Any action to deny, suspend or revoke such certificate shall be
heard under the Administrative Procedure Act, Chapter 5 (commencing
with Section 1 1500) of Part 1 of Division 3 of Tide 2 of the Government
Code; provided, however, if the Director finds that the protection of the
public welfare or safety requires immediate action, he or she may, with-
out hearing, temporarily suspend or condition the certificate and shall
forthwith schedule the matter for hearing. The Director may terininate
such temporary suspension or condition upon corrective action as he or
she deems satisfactory to assure compliance with the requirements of the
law and the regulations.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
1800-1813 and 2200-2910, Health and Safety Code.

§ 30059. Records.

NOTE: Authority cited: Sections 208 and 402, Health and Safety Code. Reference:
Section 402, Health and Safety Code.

History
I. Repealer filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

Article 3. Continuing Education

§ 30061. Continuing Education Requirements.

(a) Except as provided in (d), any employee of a vector control agency
who independently handles, applies, or supervises the applicaUon of any
pesticide as part of his or her official dufies shall obtain the following
continuing education units (CEU) within each two year period following
initial date of certification:

(1) Minimum Prerequisite CEU for all specialty certificates:

(A) Pesticide use and safety — ten CEU.

(B) Animal biology and ecology — two CEU.

(2) Additional minimuin CEU for each specialty certificate:

(A) Mosquito Control — six CEU on mosquitoes and two CEU on oth-
er aquatic invertebrates and their control.

(B) Terrestrial Invertebrate Control — six CEU on domestic flies,
fleas, and ticks; two CEU on other terrestrial invertebrate vectors, and
their control.

(b) Failure to attain minimum CEU in any specialty area shall result
in the down-grading of certification in the specialty in which the Certi-
fied Technician is delinquent, to the Certified Technician (Limited) sta-
tus.

(c) Reinstatement to Certified Technician status shall be subject to the
approval of the Department upon proofof minimum CEU and proof of
payinent of all current fees.

(d) The foregoing continuing education requirements are not applica-
ble to the following:

(1) Employees who use insignificant amounts of compounds com-
monly used for pest detection during inspections.

(2) Persons who do not handle, apply, or supervise the application of
any pesticides for public health purposes.

(3) Employees involved only in research and development of public
health pesticides.

NOTE: Authority cited: Sections 208, 2202 and 2805, Health and Safety Code.
Reference: Sections 402(d). 403. 2202 and 2805, Health and Safety Code.

History

1. Repealer of section, and new Article 3 (section 30061 ) filed 12-19-78; effective
thirtieth day thereafter (Register 78, No. 51). For history of former section, see
Register 74, No. 5.

2. Amendment filed 2-5-85; effective thirtieth day thereafter (Register 85, No. 6).

3. Repealer and new section filed 9-25-89 as an emergency; operative 9-25-89
(Register 89, No. 39). A Certificate of Comphance must be transmitted to OAL
within 120 days or emergency language will be repealed by operation of law on
1-23-90.

4. Certificate of Compliance for 9-25-89 order transmitted to OAL 1-22-90 and
disapproved by OAL on 2-21-90 (Register 90, No. 52).

5. Repealer and new section filed 1 1-16-90; operative 11 -16-90 pursuant to Gov-
ernment Code section 11346.2(d) (Register 90, No. 52).

Subchapter 3.1 . Implementation of the

Emergency Mosquito Abatement Funding

Act of 1983

Article 1. General Provisions

§ 30062. Definitions.

The following definitions shall apply to this subchapter:

(a) "Local agency" means a county which has established an emergen-
cy mosquito abatement trust account pursuant to Article 4 (commencing
with Section 25850) of Chapter 8 of Part 2 of Division 2 of Title 3 of the
Government Code; or a mosquito abatement district or vector control dis-
trict which has established an emergency mosquito abatement trust fund
pursuant to Article 5.1 (commencing with Section 23 15) of Chapter 5 of
Division 3 of the Health and Safety Code; or a pest abatement district
which has established an emergency mosquito abatement trust fund pur-
suant to Article 4. 1 (commencing with Section 2877) of Chapter 8 of Di-
vision 3 of the Health and Safety Code.

(b) "Threat to the public health and safety" means the actual or scien-
tifically predictable presence of mosquitoes in such numbers that, in the
judgment of the Department, there is a strong probability that:

(1) Mosquitobome pathogens will be transmitted to humans; or

(2) There will be substantial interference with the normal enjoyment
of life or property by an entire community or neighborhood, or by any
considerable number of persons.

Page 170

Title 17

State Department of Health Services

§ 30072

NOTl-.: Authority cited: Section 25852(e). Government Code; and Sections 208
and 2317(c), Health and Safety Code. Reference: Section 2317(d), Health and
Safety Code; and Section 25852(d), Government Code.

History

1 . Renumbering of former Subchapter 3. 1 to Subchapter 3.2 and new Subchapter
3. 1 ( Ariicles^l-3, Sections 30062-30066, not consecutive) filed 7-27-84 as an
emergency; effective upon filing (Register 84, No. 31). A Certificate of Com-
pliance must be transmitted to OAL within 120 days or emergency language
will be repealed on 1 1-26-84.

2. Repealed by operation of Government Code Section 1 1346.1(2) (Resister 84,

No. 48).

3. Renumbering of former Subchapter 3. 1 to Subchapter 3.2 and new Subchapter
3.1 (Articles 1-3, Sections 30062-30066, not consecutive) filed 1 1-26-84 as
an emergency; effective upon filing (Register 84, No. 48). A Certificate of Com-
pliance must be transmitted to OAL within 120 days or emergency language
will be repealed on 3-26-85.

4. Certificate of Compliance filed 3-21-85 (Register 85, No. 12).

Subchapter 3.2. Importation of Wild
Animals

Article 2. Conditions Governing

Expenditure of the Emergency Mosquito

Abatement Trust Account or Fund

§ 30064. Application for Expenditure.

(a) When a local agency applies to the Department for authority to ex-
pend any portion of the principal of the emergency mosquito abatement
trust account (if the local agency is a county) or emergency mosquito
abatement trust fund (if the local agency is a mosquito abatement district,
vector control district, or pest abatement district) it shall apply for the ex-
penditure in writing, by telephone, or other rapid means, but shall con-
firm in writing within 3 working days.

(b) The application for expenditure shall include the following:

( 1 ) Whether the imminent threat to the public health and safety is due
to either an actual outbreak or to an expected outbreak of mosquitoes, or
both;

(2) The mosquito species involved;

(3) Other areas involved;

(4) The specific control actions proposed;

(5) The approximate dates of the proposed actions;

(6) The name of the person who will supervise the proposed actions
and the vector control certificates or licenses possessed by that person;
and

(7) The amount of the principal proposed to be expended.

Note: Authority cited: Section 25852(e), Government Code; and Sections 208
and 2317(e), Health and Safety Code. Reference: Section 2317(d), Health and
Safety Code; and Section 25852(d), Government Code.

Article 3. Criteria for Determining If a Local

Agency Has Established Adequate
Emergency Mosquito Abatement Procedures

§ 30066. Criteria for Emergency Mosquito Abatement
Procedures.

The emergency mosquito abatement procedures shall be adequate if:
(a) The local agency's program is under the direct supervision of:

( 1 ) A technician certified in mosquito control pursuant to Section 402
of the Health and Safety Code; or

(2) Any person who is licensed in health-related pest control pursuant
to Chapter 1 (commencing with Section 11401) and Chapter 2 (com-
mencing with Section 1 1501) of Division 6 of the Food and Agricultural
Code; and

(b) The Department finds that the proposed emergency mosquito
abatement procedures are proven effective in the reduction of the immi-
nent threat to tha public health and safety.

Note: Authority cited: Sections 208 and 2317(e), Health and Safety Code; and
Section 25852(e), Government Code. Reference: Section 2317(e), Health and
Safety Code; and Section 25852(e), Government Code.

Article 1. General

§ 30070. Purpose and Scope.

These regulations are intended to provide safeguards for the protection
of persons in the State of California from disease hazards associated with
imported wild animals. The regulations apply to all persons, including
but not limited to the following: educational and research institutions,
zoological gardens, schools, colleges, universities, pet stores, animal
care facilities, and laboratories, who import, hold, sell, purchase or pos-
sess any wild animal for which an import permit is required under the pro-
visions of Chapter 14, Division 20, California Health and Safety Code.
NOTE: Authority cited: Sections 102, 208 and 25990.5, Health and Safety Code.
Reference: Sections 25990 through 25994.8, Health and Safety Code.

History

1. New Subchapter 3.1 ( 30070 thj-ough 30086) filed 10-8-70; effective thirtieth
day thereafter (Register 70, No. 41).

2. Renumbering of former Subchapter 3.1 to Subchapter 3.2 and new Subchapter
3.1 (Articles 1-3, Sections 30062-30066, not consecutive) filed 7-24-84 as an
emergency; effective upon filing (Register 84, No. 31). A Certificate of Com-
pliance must be transmitted to OAL within 120 days or emergency language
will be repealed on 1 1-26-84. 3. Repealed by operation of Government Code
Section 11 346. Kg) (Register 84 No. 48).

4. Renumbering of former Subchapter 3.1 to Subchapter 3.2 and new Subchapter
3.1 (Articles 1-3, Sections 30062-30066, not consecufive) filed 1 1-26-84 as
an emergency; effective upon filing (Register 84, No. 48). A Certificate of Com-
pliance must be transmitted to OAL within 120 days or emergency language
will be repealed on 3-26-85.

5. Editorial correction of HISTORY NOTE Nos. 2-4 (Register 84, No. 48).

§30071. Definitions.

For the purposes of these regulations:

(a) "Person" means any person, firm, association, organization, part-
nership, business trust, corporation, or company.

(b) "Department" means the State Department of Health Services.

(c) "Animal" means any wild animal or bird specified by the Depart-
ment under provisions of Chapter 14, Division 20, of the Health and Safe-
ty Code.

(d) "Veterinarian" means a person authorized to practice veterinary
medicine under provisions of Chapter 1 1, Division 2, California Busi-
ness and Professions Code.

(e)"Standards" means the requirements with respect to the quarantine
housing, handling, care, treatment, and transportation of imported ani-
mals.

(f) "Primate" means a nonhuman member of the highest order of mam-
mals, including prosimians, monkeys, and apes as specified in Section
30072.

(g) "Euthanasia" means the humane destruction of an animal accom-
plished by a method that involves instantaneous unconsciousness and
immediate death or by a method that involves anesthesia, produced by
an agent which causes painless loss of consciousness, and death during
such loss of consciousness.

Note: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Secfion 25990.5, Health and Safety Code.

History
1. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

Article 2. Import Permits

§ 30072. Wildlife Admitted by Permit.

No person shall import into or receive in this State any animals of the
following orders, families, and genera specified herein without first ob-
taining a permit and paying to the Department such fees as required under
these regulations.

(a) Birds (Class Aves). Admissible without permit from the depart-
ment.

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§ 30073

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) Mammals (Class Mammalia)

(1) Primates (Order Primates) — Members of the following families,
all genera therein:

Family Lorisiclae, Genus Loris (Slender Loris), Genus Nycticebus
(Slow Loris), GtnwiArciocebus (Golden Potto), Genus Perdicticus (Pot-
to), Genus Galago (Galago), and Genus Euoticiis (Needle-clawed Gala-
go).

Family Callithricidae, Genus Callithrix (Short-tusked Marmoset),
Genus Cebuella (Pygmay Marmoset), (jenus Saguiinis (Long-tusked
Marmoset), and Genus Leontideus (Lion-headed Marmoset).

Family Cebidae, Genus Aotus (Douroucoulis), Genus Callicebus (Titi
Monkey), Genus Cacajao (Ukari), Genus Pithecia (Saki), Genus Chiro-
potes (Red-backed Saki), Gtmxs, Alouattu (Howler Monkey), Genus Ce-
biis (Capuchin), Genus Saimiri (Squirrel Monkey), Gcxwxs Ateles (Spider
Monkey), Genus Brachyteles (Woolly Spider Monkey), Genus Lago-
thrix (Woolly Monkey), and Genus Callimico (Goeldi's Marmoset).

Family Cercopithecidae, Genus Macaca (Macaque), Genus Cynoma-
caca (Celebes Macaque), Genus Cynopithcus (Celebes Crested Ma-
caque), Genus Cercocebus (Mangabey), Genus Chaeropithecus (Ba-
boon), Genus Comopithecus (Hamadryas Baboon), Genus Mandrillus
(Mandrill), Genus Theropithecus (Gelada Baboon), Genus Cercopithe-
ciis (Guenon). Genus Miopithecus (Talapoin Monkey), Genus All enopi-
thecus (Allen's Monkey), Genus Erythrocebus (Patas Monkey). Genus
Presbytis (Langur), Genus Pygathrix (Douc Langur), Genus Rhinopithe-
cus (Snub-nosed Langur), Genus Simias (Mentawi Islands Snub-nosed
Langur), Genus Nasalis (Proboscis Monkey), and Genus Colobus (Colo-
bus Monkey).

Family Pongidae, Genus Hylobates (Gibbon), Genus Symphalangus
(Siamang Gibbon), Genus Pongo (Orangutan), Genus Pan (Chimpan-
zee), and Genus Gorilla (Gorilla).

(2) Carnivores (Order Camivora) — Members of the following fami-
lies, all genera therein unless otherwise noted:

(A) Family Felidae, genus Felis and genus Panthera, consisting of
New World species: F. pardalis (Ocelot). F. wiedii (Margay). F. tigrina
(Little Spotted Cat), F. colocolo (Pampas Cat), F. geoffroyi (Geoffrey's
Cat), F. guigna (Kodkod), F. jacobita (Gato Andina), F. yagouaroundi
(Jaguarundi), and P. onca (Jaguar).

All other members of the family Felidae are admissible without permit
from the Department.

(B) Family Canidae, genus Aopex (Arctic Fox), genus Vulpes (Red or
Kit Fox), genus Urocyon (Gray Fox), and genus Canis, including all spe-
cies other than Canis familiaris (the domestic dog).

All other members of the family Canidae are admissible without per-
mit from the Department.

All other members of the family Procyinidae are admissible without
permit from the Department.

(D) ¥waW.yMusteldae, genus Mephitis (Striped Skunk) and genus Spi-
logale (Spotted Skunk).

All other members of the family Musteldae are admissible without
permit from the Department.

(3) Bats (Order Chiroptera) — Members of all families, all genera
therein.

Note: Reference should also be made to statutory provisions of the California
Fish and Game Code and the joint regulations of the Fish and Game Commission
and the California Department of Agriculture. Where question exists regarding the
importation into and the keeping of live wild birds, mammals, amphibians, rep-
tiles, crustaceans and fish in California, representafives of the Department of Fish
and Game should be consulted.

NOTE: Authority cited: Sections 208, 25990.3 and 25990.5, Health and Safety
Code. Reference; Sections 25990.3 and 25990.5, Health and Safety Code.

History

1. Amendment of subsection (b)(2), designation of (b)(2)(A) and new subsections
(b)(2)(B)-(b)(3) and Note filed 4-28-94; operative 5-30-94 (Register 94, No.
17).

§ 30073. Application for Import Permits.

Import permits for animals listed under Section 30072 shall be issued
only upon written application from the person desiring to import them.
The application shall include but not be limited to the following:

(a) The number, common name, and true scientific name of each spe-
cies (Example reference: Walker, E. P., and others. Mammals of the
World. Baltimore. Johns Hopkins Press, 1975. Volumes 1 and II).

(b) The carrier and probable point of first arrival in this state of each
shipment.

(d) The name and address of the consignee.

(e) The name and address of the consignor.

(1") The place or premise where the animals shall be held in quarantine
pending the completion of such tests, veterinary examinations, and ob-
servation period as may be specified by the department in issuance of im-
port permit. Adequate quarantine facilities must be available and ap-
proved by the department before issuance of the import permit can be
made (See Sections 30077 and 30077.1).

(g) The name and address of the veterinarian who shall conduct the
tests and examinations specified by the department.

(h) For personal pets only, the date of acquisition and name and ad-
dress of supplier.

NOTE: Authority cited: Sections 208, 25990.5 and 25992.3, Health and Safety
Code. Reference: Sections 25992 and 25992.3, Health and Safety Code.

History
1. Amendment of subsection (a) and new Note filed 4-28-94; operative 5-30-94

(Register 94, No. 17).

§ 30073.1 . Determination of Application Completeness and
Notification.

(a) Within 15 calendar days of receipt of an application for a wild ani-
mal importation permit, or a request for permit modification, the Depart-
ment shall inform the applicant in writing either that the application is
complete and accepted for filing, or that it is deficient and identify the ad-
ditional specific informadon necessary for the application to be com-
plete.

(b) The date on which the application is determined complete for fil-
ing, or on which the application is determined deficient shall be the date
on which the Department's written notification to the apphcant is post-
marked.

NOTE: Authority cited: Section 15376, Government Code; and Sections 208 and
25992, Health and Safety Code. Reference: Section 15376, Government Code;
and Section 25992, Health and Safety Code.

History
1. New secdon filed 4-28-94; operative 5-30-94 (Register 94, No. 17).

§ 30073.2. Application Time Periods for Processing a
Permit Based on Actual Performance.

(a) The Department's time periods for processing a wild animal impor-
tation permit application, or a wild animal quarantine facility approval
application, from the receipt of the initial application to the final decision
regarding the permit or approval, are as follows:

(1) The median time for processing is:

(A) 10 calendar days for an importarion permit apphcation.

(B) 90 calendar days for a quarantine facility approval application.

(2) The minimum time for processing is:

(A) 5 calendar days for an importation permit application.

(B) 60 calendar days for a quarantine facility approval application.

(3) The maximum time for processing is:

(A) 15 calendar days for an importation permit application.

(B) 180 calendar days for a quarantine facility approval application.
NoTE: Authority cited: Section 15376, Government Code; and Secfions 208 and
25992, Health and Safety Code. Reference: Secfion 15376, Government Code;
and Secfion 25992, Health and Safety Code.

History
1. New section filed 4-28-94; operafive 5-30-94 (Register 94, No. 17).

Page 172

Title 17

State Department of Health Services

§ 30074.1

•

§ 30074. Issuance of Import Permits.

Issuance of import permits for animals listed under Section 30072 may
be made by the Department upon:

(a) Submission of written application providing the information enu-
merated under Section 30073 not less than seven (7) days preceding the
probable date of shipment, and

(b) if necessary, submission of a written application for Department
approval of the wild animal quarantine facility, completion of an on-site
inspection, and final approval of the quarantine facihty or premise desig-
nated in the permit application, and

(c) payment of the necessary permit fees required under Section
25992.8 of the Health and Safety Code and set forth under Section 30076
of these regulations, and

(d) determination by the Department that the public health and safety
is not endangered, and

(e) approval of the probable point of first arrival into this State.
NOTH: Authority cited: Sections 208, 25990.5, 25992.3 and 25992.8, Health and
Safely Code. Reference: Sections 25990.5, 25992, 25992.3 and 25992.8, Health
and Safety Code.

History
1 . Amendment of first paragraph, subsections (b) and (d) and new Note filed
4-28-94; operative 5-30-94 (Register 94, No. 17).

§ 30074.1. Importation of Animals Under Special Permit.

Permits not requiring the quarantine of imported wild animals may be
issued by the Department under the following special conditions:

(a) Short-Term Exhibition of Captive Born and Raised Nonhuman
Primates Having No Contact With the Public. Animals subject to these
provisions (as specified under Section 30072) may be brought into the
Slate for short-term nonresident exhibition purposes (e.g., circuses) un-
der a short-term exhibition permit issued by the Department upon appli-
cation for the permit and payment of a $ 1 0.00 permit fee per animal. Per-
sons wishing to import or receive nonhuman primates for short-term
exhibition purposes under this subsection shall provide the Department
with documentation of the following:

(1) A health history on the animal, or the parents of animals less than
six months of age, for the 180 days prior to importation, and

(2) The animal(s) are captive bom and raised, and

(3) How the animal(s) will be maintained in a manner approved by the
Department to prevent direct physical contact with the pubhc, and

(4) A veterinary health certificate issued not more than 30 days before
importation certifying that the animal has been examined by a veterinari-
an accredited by the United States Department of Agriculture and is free
of signs of contagious or infectious diseases.

(b) Short-Term Exhibition of Captive Bom and Raised Nonhuman
Primates Having Direct Contact With the Public. Animals subject to
these provisions (as specified under Section 30072) may be brought into
the State for nonresident exhibition purposes under a short-term exhibi-
tion permit issued by the Department upon application for a permit and
payment of a $ 10.00 permit fee per animal. Persons wishing to import or
receive short-term exhibition nonhuman primates into the State where
the ammal(s) will have direct contact with the public shall provide the
Department with documentation of the following:

( 1) A health history on the animal, or the parents of animals less than
six months of age, for the 180 days prior to importation, and

(2) The animal(s) are captive born and raised, and

(3) How the animal(s) will be maintained in a manner approved by the
Department to prevent direct physical contact with the public at all times
except when being exhibited, and

(5) A negative tuberculin skin test performed on the animal(s) not
more than 30 days before importation.

(c) Short-Term Exhibition of Captive Born and Raised Carnivores.
Animals subject to these provisions (as specified under Section 30072)
may be brought into the State for short-term nonresident exhibition pur-
poses (e.g., circuses) under a short-term exhibition permit issued by the
Department upon application for the permit and payment of a $ 1 0.00 per-
mit fee per animal. Persons wishing to bring short-term exhibition carni-
vores into the State shall provide the Department with documentation of
the following:

(1) A health history on the animal, or the parents of animals less than
six months of age, for the 180 days prior to importation, and

(2) The animal(s) are captive born and raised, and

(3) How the animal(s) will be maintained in a manner approved by the
Department to prevent direct physical contact with other animals or the
public, and

(d) Zoological exhibition of specified wild animals.

(1) Animals subject to these provisions as specified under Section
30072 may be brought into the State for exhibition in a zoological collec-
tion accredited by the American Association of Zoological Parks and
Aquariums (AAZPA) under a zoological exhibition permit issued by the
Department upon payment of a $10.00 permit fee per animal. AAZPA
accredited organizations wishing to import or receive specified wild ani-
mals for zoological exhibition purposes under this subsection shall pro-
vide the Department with documentation of the following:

(A) The animal(s) are captive bom and raised, or have been in the pos-
session of the consignee for at least 180 days prior to importation, and

(B) the animal(s) are being imported from an AAZPA-accredited zoo-
logical collection, and

(C) a health history on the animal or the parents of the animals less than
six months of age, for the 180 days prior to importation, and

(D) a veterinary health certificate issued not more than 30 days before
importation certifying that the animal has been examined by a veterinari-
an accredited by the United States Department of Agriculture and is free
of signs of contagious or infectious diseases.

(E) A negative tuberculin skin test performed on all nonhuman pri-
mates not more than 30 days before importation.

(2) Nonhuman primates imported under this subsection shall be kept
in isolation for 30 days immediately following importation. The ani-
mal(s) shall be tested if necessary for enteric pathogens during isolation.
If at the end of the 30 days, the animal(s) are tuberculin skin tested with
negative results, are examined and issued a health certificate by an ac-
credited veterinarian certifying that the animal(s) are healthly and free of
signs of contagious or infectious diseases, the animal(s) may be released
by the Department upon review of isolation records.

(3) Camivores or Chiroptera specified in Section 30072 imported un-
der this subsection shall be kept in isolation for 90 days immediately fol-
lowing importation. If at the end of the 90 days, the animal(s) are ex-
amined and issued a health certificate by an accredited veterinarian
certifying that the animal(s) are healthy and free of signs of contagious
or infectious diseases, the animal(s) may be released by the Department
upon review of isolation records.

(e) Animal Breeding. Animals being moved for breeding purposes as
part of a recognized animal colony established for experimental breeding
of animals in captivity, may be moved for this purpose upon issuance of
a fee exempt permit provided that the conditions specified by the Depart-
ment in the permit are adhered to in full.

(f) Animal(s) permitted entry under subsection 30074. 1 (a) through (e)
shall not be sold, traded, or given away during the permit period without
notification and prior approval by the Department. The duration of the
permit will be determined by the Department at the time of permit issue
and shall not exceed the duration of an exhibitor's itinerary submitted to

Page 173

§ 30075

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

the Department at the time of permit application. The duration of the per-
mit may be extended at the discretion of the Department.
NOTE; Authority cited: Sections 208, 23990.5, 25992.3, 25992.5 and 25992.8,
HeaUh and Safety Code. Reference: Sections 25990.5, 25992.3, 25992.5 and
25992.8, Health and Safety Code.

History
1 . Amendment of section and new Noth filed 4-28-94; operative 5-30-94 (Reds-
ler94. No. 17).

§ 30075. Conditions of Quarantine for Personal Pets.

NOTE: Authority cited: Sections 208, 25990.5 and 25992, Health and Safety
Code. Reference: Sections 25990.5, 25992, 25992.3 and 25992.5, Health and
Safety Code.

History

1. Repealer and new Note filed 4-28-94; operative 5-30-94 (Redster 94, No.
17).

§ 30076. Permit Fees.

(a) Each application for an import permit shall be accompanied by
payment of an import permit fee to the Department. Except as provided
in Section 30074. 1(e), the permit fee charged shall be at the rate of $ 1 0.00
per animal.

(b) If the actual number of animals received in the shipment exceeds
the number enumerated in the application, payment of an additional fee,
for the unpaid animal(s), shall be due at the rate of $10.00 per animal plus
a charge of $10.00 for amending the original permit issued.

(c) If the actual number of animals received is less than the number
enumerated on the application, the person may apply for a refund subject
to such verification and documentation as may be required by the depart-
ment.

(d) No refund shall be allowed for animals found dead on arrival
(DOA), but credit may be allowed for animals DOA against future im-
ports within the following 12 month period. No credit or refund shall be
allowed for animals which die during quarantine or are found diseased
and not fit for release from quarantine.

(e) A previously issued import permit may be amended by the Depart-
ment where necessary upon written request by the permittee provided the
purpose of the amendment does not in the opinion of the Department
jeopardize the intent and purpose of the required quarantine procedure
or the public health. A fee of $10.00 must accompany the written request
for amendment.

NOTE: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Section 25992.8, Health and Safety Code.

History

1. New Note filed 12-26-84 (Register 84, No. 52).

2. Subsection redesignation and amendment of subsections (a), (b) and (e) filed
4-28-94; operative 5-30-94 (Register 94, No. 17).

Article 3. Quarantine Facilities and
Operating Standards

§ 30077. Animal Holding Facility.

(a) Structural. The housing facilities used for quarantine of imported
animals shall be constructed in accordance with the compiled State
Building Code, Part 2, Chapter 2-93, Title 24, California Code of Regu-
lations. All quarantine structures, fixtures, equipment and facilities shall
be maintained so as to be clean, sanitary and in good repair. All quaran-
tined animals shall be contained within the facility.

(b) Storage. Supplies of food and bedding shall be adequately pro-
tected against contamination with zoonotic disease causing organisms.
Refrigeration shall be provided for supplies of perishable food.

(c) Medical Waste Disposal. Animal and food wastes, bedding, debris
and any items present in the quarantine facility while a wild animal quar-
antine is in effect shall be disposed of as medical waste in accordance
with Health and Safety Code, Section 25020, et seq. Disposal facilities
shall be provided and operated as to prevent vermin infestation and mini-
mize orders and diseases hazards.

(d) Handwashing Facilities. Handwashing facilities, such as basins or
sinks, shall be provided to maintain cleanliness among caretakers. Hand-
washing facilities shall include hot and cold running water, soap, paper
towels, and a waste container. Handwashing facilities shall conform to
the State Building Code, Part 5, Title 24, California Code of Regulations.

(e) Drainage. A suitable method shall be provided to rapidly eliminate
excessive water from housing facilities. If drains are used, they shall be
properly constructed and shall be kept in good repair to avoid disease
transmission within the facility. Draining facilities to rapidly eliminate
excessive water from housing facilities shall conform to the State Build-
ing Code, Part 5, Basic Plumbing Regulations, Title 24, California Code
of Regulations.

(f) Local Building Codes, Zoning Codes, Use and Business Permits.
Notwithstanding the provisions of these regulations, the provisions of lo-
cal building codes, zoning codes, and applicable use and business per-
mits shall be complied with by the owner or operator of quarantine facili-
ties as a condition to approval by the Department, provided such
provisions are at least equal to these regulations. Construction shall be in
accordance with Title 24, California Code of Regulations.

NOTE: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Sections 25990.5, 25994 and 25994.3, Health and Safety Code.

History

1. New Note filed 12-26-84 (Register 84, No. 52).

2. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

3. Amendment of section headine and subsection (c) filed 4-28-94; operative
5-30-94 (Register 94, No. 17).^

§ 30077.1. Alternative Housing Facilities.

The use of alternative housing quarantine facilities for special purpose
conditions may be approved by the Department upon written application
provided the public health and safety shall not be endangered. These faci-
lities shall be constructed in accordance with the State Building Code,
Part 2, Chapter 2-93, Title 24, California Code of Regulations.
NOTE: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Sections 25990.5, 25994 and 25994.3, Health and Safety Code.

History

1. New Note filed 12-26-84 (Register 84, No. 52).

2. Amendment filed 12-14-88; operative 1-13-89 (Register 88, No. 53).

3. Amendment of section heading and text filed 4-28-94; operadve 5-30-94
(Register 94, No. 17).

§ 30078. Primary Enclosures.

Primary enclosures shall conform to the following requirements:

(a) They shall be maintained so as to be clean and dry.

(b) They shall provide convenient access to clean food and water.

(c) Primary enclosures shall conform to the State Building Code, Part
2. Chapter 2-93, Title 24, California Code of Regulations.

NOTE: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Sections 25990.5, 25994 and 25994.3, Health and Safety Code.

History

1. New NOTE filed 12-26-84 (Register 84, No. 52).

2. Amendment filed 12-14-88; operafive 1-13-89 (Register 88, No. 53).

§ 30079. Animal Health and Husbandry Standards.

(a) Food.

( 1 ) The food shall be free from contamination, wholesome, and of suf-
ficient quality and nutritive value to meet the known normal daily re-
quirements for the condition and size of the animal.

(2) Food, and food receptacles if used, shall be accessible to all animals
and shall be placed so as to minimize contamination by excreta. Food re-
ceptacles, except self feeders, shall be kept clean and sanitized at least
once a week.

(b) Watering.

(1) All watering receptacles shall be kept clean and shall be sanitized
at least once a week.

(2) Automatic watering devices shall be maintained in accordance
with good husbandry practices. They shall be sanitized when occupancy
in the primary enclosure is changed and at the end of quarantine period.

•

Page 174

Title 17

State Department of Health Services

§ 30081

( 1 ) Cleaning of Primary Enclosures. Excreta sliall be removed from
ihe primary enclosures at least daily, or as often as necessary to prevent
contamination of the animals contained therein and to reduce disease
hazards and odors. When hosing or flushing methods are used for this
purpose, measures shall be taken to prevent animals confined in such en-
closures from being wetted or contaminated involuntarily.

(2) Saniti/ation of Primary Enclosures.

(A) Prior to the introduction of animals into primary enclosures pre-
viously occupied by other animals, such enclosures shall be sanitized in
the manner provided in subparagraph (c)(3) of this subdi vision. (B) Pri-
mary enclosures shall be sanitized often enough to prevent an accumula-
tion of debris or excreta, or a disease hazard: Provided, however, that
such enclosures shall be sanitized at least once every two weeks in the
manner provided in subparagraph (c)(3) of this subdivision.

(3) Sanitizing Procedures. Cages, rooms, vehicles and hard surfaced
pens or runs shall be sanitized either by washing them with hot water ( 1 80
F.) and soap or detergent, as in a mechanical cage washer, or by washing
all soiled surfaces with a detergent solution followed by a safe and effec-
tive disinfectant, or by cleaning all soiled surfaces with live steam.

(d) Housekeeping. Premises (buildings and grounds) shall be kept
clean and in good repair in order to protect the animals from injury and
to facilitate the prescribed husbandry practices set forth in this section.
Premises shall remain free of accumulations of trash.

(e) Pest Control. An effective program for the control of insects, ecto-
parasites, and avian and mammalian pests shall be established and main-
tained.

(f) Employees. A sufficient number of employees shall be utilized to
maintain the prescribed level of husbandry practices set forth herein. Per-
sons well trained and competent in retrieving, restraining and releasing
animals in a humane manner for testing and examination procedures dur-
ing quarantine must be provided. Such practices shall be carried out by
or under the supervision of an animal caretaker who has a background in
animal husbandry or care. Proper safeguards and precautions shall be
practiced by employees so as not to endanger themselves, other persons,
or animals. Outer work clothing, gloves, boots, etc., used in caring for
animals in quarantine shall not be worn outside the quarantine area.

(g) Classification and Separation.

( 1 ) Animals housed in the same primary enclosure shall be maintained
in compatible groups and shall not be housed in the same primary enclo-
sure with other animal species.

(2) Animals entering quarantine on different dates shall not be housed
in the same room, unless the quarantine periods commence with the date
of the last animal(s) admitted to the room (See Section 30081 ).

(h) Veterinary Care.

( 1 ) Programs of disease control and prevention, euthanasia, and ade-
quate veterinary care shall be established and maintained under the su-
pervision and assistance of a veterinarian.

(2) Each animal shall be observed daily by the animal caretaker in
charge or by someone working under his direct supervision. Sick or dis-
eased, injured, lame, or blind animals shall be provided with veterinary
care or humanely disposed of unless such action is inconsistent with the
purposes for which the animals are being imported.

(i) Vehicles.

( 1 ) Vehicles used in transporting animals shall be mechanically sound
and equipped to provide fresh air to all animals being transported, with-
out injurious drafts. The vehicles shall contain the animals and restrict the
entry of other animals and unauthorized persons.

(2) The ability to view the interior of the cargo space is necessary to
observe any animals that may have escaped from their primary enclo-
sures.

(3) The interior of the animal cargo space shall be kept clean.

(4) The animal cargo space and all primary enclosures used in trans-
port shall be cleaned and sanitized in the manner provided in subsection
{c)(3) of this section after each shipment has been transported from the
point of arrival to the quarantine facility. Animals entering quarantine

and those having completed the quarantine shall not be transported con-
currently in the same vehicle.

NOTF: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Reler-
enee: Sections 25990.5. 25994 and 25994.3, Health iind Safety Code.

History
1. New NOTE tiled 12-26-84 (Register 84, No. 52).

§ 30080. Approved Quarantine Facilities.

(a) Approval. Quarantine facilities used to house imported animals are
subject to inspection and approval by representatives of the Department
for such periods of time as the Department deems indicated. Such facili-
ties may be used for housing imported animals only as long as they are
maintained and operated in conformance with standards prescribed in
Sections 30070 through 30086; in Title 42 of the Code of Federal Regula-
tions, Section 71.53; and in "Biosafety in Microbiological and Biomedi-
cal Laboratories", U.S. Department of Health and Human Services, Pub-
lic Health Service, Centers fro Disease Control and National Institutes of
Health, 2nd edition, 1 988; which are hereby incorporated by reference.

(b) Inspection. The department may make such inspection of approved
facilities as it deems necessary to insure compliance with prescribed
standards. Such inspections shall be carried out by department represen-
tatives at any time, normally during but not restricted to working hours.

(c) Notification of Change in Name or Ownership. The department
shall be notified of any change in name, address, management or substan-
tial control or ownership of any approved facility.

NOTE: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Sections 25990.5 and 25992.5, Health and Safety Code.

History
1 . Amendment of subsection (a) and new Non-: filed 4-28-94; operative 5-30-94
(Register 94, No. 17).

Article 4. Quarantine Provisions

§ 30081 . Quarantine.

All imported animals must be maintained for such period of quarantine
as may be required by the Department and under such conditions as pre-
scribed herein:

(a) Quarantine Period and Conditions for Release Therefrom.

(1) Primates. The normal quarantine period required for primates is
that which provides for a physical examination, administration of a tuber-
culin test by a veterinarian upon entry and a repeat physical examination
and tuberculin test 30 days later. Primates may be released from quaran-
tine by the department upon completion of the second tuberculin test pro-
vided that in the judgment of the attending veterinarian:

(A) Both tuberculin tests are negative.

(B) The animals exhibit no visible oral ulcers at the end of quarantine
period.

(C) The animals show no clinical evidence of dysentery or diarrhea.
emesis, emaciation, contagious skin lesions, central nervous system dis-
turbances, jaundice, or abnormal respiratory signs at the end of quaran-
tine period.

(D) There is no evidence of a zoonotic disease traced back to the quar-
antined animals.

(E) In the opinion of the attending veterinarian the animals are healthy.
A summary report by the attending veterinarian, in writing over his sig-
nature, shall be made to the department incorporating 1 ) the results of all
tests, physical examinations, etc., performed and 2) his opinion that the
animals are healthy (See Section 30084).

(2) Carnivores. Carnivores shall be confined in a place and manner ap-
proved by the Department for a 90 day period. A primary enclosure as
defined under Section 2-9302 and set forth under Section 2-9305. Title
24, California Code of Regulations, or an equivalent approved by the De-
partment, is acceptable for confinement. If at the end of quarantine, the
animals are examined and found healthy by a veterinarian, they ma) be
released by the Department upon receipt of such certification in writing
by the attending veterinarian without further restriction.

Page 174.1

§ 30081.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) Imported animals refused release from quarantine shall be handled
in such manner as approved and specified by the department.

(c) Where the quarantine procedures specified herein are not compat-
ible with the objective of a specific research project, the department may
authorize variations from the requirements specified herein provided that
no public health hazard will result from the variations allowed.

(d) Any person importing animals for purposes of sale to any educa-
tional and research institution, zoological garden, laboratory, college or
university, may satisfy the requirements of this section and Sections
30081. 1-30084 by contract with such institution. Such quarantine shall
meet all of the requirements herein with regard to period, observation, re-
porting and other conditions of quarantine.

NOTI:; Authority cited: Sections 208 and 25990.5. Health and Safety Code. Refer-
ence: Sections 25990.5 and 25994.3. Health and Safety Code.

History
1. Amendment filed 12-14-88; operative 1-1 V89 (Register 88, No. 53).

§ 30081 .1 . Tuberculin Test.

The method of tuberculin testing used shall be subject to approval by
the department. Normal variations in site of administration and type and
dilution of tuberculin used for intradermal injection may be accepted by
the department. Tlie use of such testing methods as the patch and multiple
puncture tests will not be accepted.

Article 5. Quarantine Records

§ 30082. Record Keeping.

Adequate records shall be kept by permit number showing daily health
status of each animal in the shipment, together with notation, under veter-
inary supervision, of signs of any illness, deaths, any treatment given, re-
sults of any tests or examinations performed, etc., on all animals in the
shipment.

NOTi-:: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Sections 25990.5 and 25994.3, Health and Safety Code.

History

1. New NOTE filed 12-26-84 (Register 84, No. 52).

§ 30083. Animal Identification.

Identification of animals shall be maintained through use of cage num-
bers, tags on individual animals, or by means of tattoo.
NOTE: Authority cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Sections 25990.5 and 25994.3, Health and Safety Code.

History
1. New NOTE filed 12-26-84 (Reeister 84, No. 52).

Article 6. Quarantine Reporting

§ 30084. Reporting of Tests Results, Physical
Examinations, Illnesses, Deaths.

(a) A written summary report by the attending veterinarian of the re-
sults of all tests, physical examinations, etc., performed shall be made to
the department in writing over a signature of the attending veterinarian.

(b) Deaths or illnesses in quarantined animals shall be immediately re-
ported to the attending veterinarian and then to the Department without
delay. Dead animals shall be handled as biohazardous medical waste and
kept under refrigeration pending necropsy instructions by the attending

veterinarian. A necropsy shall be conducted under strict infection control
precautions by the attending veterinarian or otherwise qualified patholo-
gist, and adequate specimens shall be obtained for diagnostic laboratory
examination to determine the cause of illness or death. Following necrop-
sy, the carcass shall be handled and disposed of as biohazardous waste,
(c) Records shall be maintained by the quarantine facility for a two-
year period and shall be available for department examination upon re-
quest.

NOTE: Authorilv cited: Sections 208 and 25990.5, Health and Safety Code. Refer-
ence: Sections 25990.5. 25994.3 and 25994.5, Health and Safety Code.

History
1. Repealer and new subsection (b) and new Noth filed 4-28-94; operative
5-30-94 (Regi.ster 94. No. 17).

Article 7. Cooperation with Other
Governmental Agencies

§ 30085. Cooperating Agencies.

It is the intent of the department to maintain liaison and to cooperate
fully with other governmental agencies having jurisdiction with regard
to the import, holding, or regulation of animals into the United States and
California as well as within the State. These agencies include:

(a) Foreign Quarantine Program, Center for Disease Control, U.S. De-
partment of Health, Education and Welfare.

(b) Animal Resources Branch, Division of Research Facilities and Re-
sources, National Institutes of Health, U.S. Department of Health, Edu-
cation and Welfare.

(d) Bureau of Customs, U.S. Treasury Department.

(e) Animal Health Division, Agricultural Research Service, U.S. De-
partment of Agriculture.

(f) U.S. Department of Defense.

(g) California Department of Fish and Game,
(h) California Department of Agriculture.

(i) County and city government, including local public health agen-
cies, within the State of California.

Any importation or other acquisition of wild animals under these regu-
lations does not relieve the importer's responsibility for complying with
any applicable health, quarantine, agriculture, customs, license, permit
or any other requirements imposed by the laws or regulations of other
duly authorized federal or State agency or county, city and county, or city
government in California.

Article 8. Exceptions

§ 30086. Exceptions.

The department upon application may grant variances from the re-
quirements of these regulations as it determines are authorized by law
and will not result in hazard to the public health. Such applications, and
variances made thereon, shall be in writing; any variances granted under
this section shall set forth conditions designed to protect the public
health, and shall be granted only for a specified period, not to exceed 6
months.

[The next page is 175.]

Page 174.2

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30100

Subchapter 4. Radiation

Group 1. General

Article 1. Definitions

§ 30100. General Definitions.

As used in subchapter 4:

(a) "Act" means the "Radiation Control Law," Health and Safety
Code, Division 104, Part 9, chapter 8. sections 1 14960 et seq.

(b) "Agreement State" means any state with which the United States
Atomic Energy Commission or Nuclear Regulatory Commission has en-
tered into an effective agreement under section 274b of the Atomic Ener-
gy Act of 1954, Title 42, United States Code, section 2021(b) (formerly
section 274(b)).

(c) "Decommission" means to remove safely from service and reduce
residual radioactivity to alevel that permits release of the property forun-
restricted use and termination of the license.

(d) "Department" means the State Department of Health Services.

(e) "Depleted uranium" means the source material uranium in which
the isotope uranium-235 is less than 0.71 1 weight percent of the total ura-
nium present. Depleted uranium does not include special nuclear materi-
al.

(f) "Hazardous radioactive material", as used in section 33000 of the
California Vehicle Code and 1 14820(e) of the Health and Safety Code
means any "highway route controlled quantity" of radioactive material
as such material is defined in The United States Code of Federal Regula-
tions (CFR), 49 CFR 173.403(/) as printed in FR 13431, March 31, 1983.

(g) "Human use" means the internal or external administration of radi-
ation or radioactive materials to human beings.

(h) "Installation" means the location where one or more reportable
sources of radiation are possessed.

(i) "License," except where otherwise specified, means a license is-
sued pursuant to group 2, Licensing of Radioactive Material.

(j) "Misadministration" means the administration of:

( 1 ) A radiopharmaceutical or radiation from a sealed source other than
the one intended;

(2) A radiopharmaceutical or radiation to the wrong patient;

(3) A radiopharmaceutical or radiation by a route of administration
other than that intended by the prescribing physician;

(4) A diagnostic dosage of a radiopharmaceutical differing from the
prescribed dosage by more than 50 percent;

(5) A therapeutic dosage of a radiopharmaceutical differing from the
prescribed dosage by more than 10 percent; or

(6) A therapeutic radiation dose from a sealed source such that errors
in the source calibradon, time of exposure, and treatment geometry result
in a calculated total treatment dose differing from the final prescribed to-
tal treatment dose by more than 10 percent.

(k) "Other official agency specifically designated by the Department"
means an agency with which the Department has entered into an agree-
ment pursuant to section 1 14990 of the Health and Safety Code.

(/) "Person" means any individual, corporation, partnership, firm, as-
sociation, trust, estate, public or private institution, group, agency, politi-
cal subdivision of this State, any other state or political subdivision or
agency thereof, and any legal successor, representafive, agent, or agency
of the foregoing, other than the United States Nuclear Regulatory Com-
mission, the United States Department of Energy, or any successor there-
to, and other than Federal Government agencies licensed by the United
States Nuclear Regulatory Commission, under prime contract to the
United States Department of Energy, or any successor thereto.

(m) "Personnel monitoring equipment" means devices designed to be
worn or carried by an individual for the purpose of measuring the dose

received by that individual (e.g., film badges, pocket chambers, pocket
dosimeters, film rings, etc.).

(n) "Possess" means to receive, possess, use. transfer or dispose of ra-
dioactive material pursuant to this regulation.

(0) "Possessing a reportable source of radiation" means ha\ing physi-
cal possession of. or otherwise having control of. a reportable source of
radiation in the State of California.

(p) "Radiation" (ionizing radiation) means gamma rays and X-rays;
alpha and beta particles, high-speed electrons, neutrons, protons, and
other nuclear particles; but not sound or radio waves, or visible, infrared,
or ultraviolet light.

(q) "Radiation machine" means any device capable of producing radi-
ation when the associated control devices are operated, but excluding de-
vices which produce radiation only by the use of radioactive material.

(r) "Radioactive material" means any material which emits radiation
spontaneously.

(s) "Registrant" means any person who is registering or who has regis-
tered with the Department pursuant to group 1.5. Registration of Sources
of Radiation.

(t) "Reportable sources of radiation" means either of the following:

( 1 ) Radiation machines, when installed in such manner as to be capa-
ble of producing radiation.

(2) Radioacdve material contained in devices designed and manufac-
tured for the purpose of detecting, measuring, gauging, controlling thick-
ness, density, level, interface location, radiation, leakage or qualitative
or quantitative chemical composition, for producing light or an ionized
atmosphere, possessed pursuant to a general license under provisions of
section 30192.1 of group 2 of this subchapter (Licensing of Radioactive
Materials).

(u) "Research and development" means theoretical analysis, explora-
tion, experimentation or the extension of invesfigative findings and
scientific or technical theories into practical application for experimental
or demonstration purposes, including the experimental production and
testing of models, prototype devices, materials and processes; but shall
not include human use.

(v) "Sealed source" means any radioactive material that is permanent-
ly encapsulated in such manner that the radioacUve material will nt)t be
released under the most severe conditions likely to be encountered by the
source.

(w) "Source of radiation" means a discrete or separate quantity of ra-
dioactive material or a single radiation machine.

(x) "Special nuclear material" means:

(1) Plutonium, uranium 233, uranium enriched in the isotope 233 or
in the isotope 235, and any other material which the Department declares
by rule to be special nuclear material after the United States Nuclear Reg-
ulatory Commission, or any successor thereto, has determined the male-
rial to be such, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing, but does
not include source material.

(y) "Specific license" means a license or the equivalent document is-
sued to a named person by the Department or by the Nuclear Regulatory
Commission or by any other Agreement State.

(z) "This regulation" means: California Code of Regulations, Title 17,
Chapter 5, Subchapter 4.

(aa) "User" means any person who is licensed to possess radioactive
material or who has registered as possessing a reportable source of radi-
ation pursuant to groups 1.5 and 2 of this .subchapter, or who otherwise
possesses a source of radiation which is subject to such licensure or regis-
tration.

(ab) "Worker" means any individual engaged in activities subject to
title 1 7, California Code of Regulations, chapter 5, subchapter 4, and con-
trolled by a user, but does not include the user.

NOTE: Authority cited: Sections 100275 and ILSOOO, Health and Safety Code.
Reference: Sections 114965. 114970. 114985 and 115060. Health and" Satetv
Code.

Page 175

§ 30102

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1. Repealer of group 1 and new group 1 (sections 30100 through 30146) filed
1 1-29-65; effective thirtieth day thereafter (Register 65. No. 23). For prior his-
tories, see Registers 62, No. 1 and 62, No. 8.

2. Repealer and new section filed 1 1-25-85; effective thinieth day thereafter
(Register85. No. 48).

3. Change without regulatory effect of subsection (ac)(2) (Register 88, No. 6).

4. Amendment of subsection (j), relettering of former subsections (p)-(ap) to sub-
sections (q)-(aq), and new subsection (p) filed 9-.5-89; operative 10-5-89
(Regi.ster89, No. 36).

5. New subsection (k) and redesignation of former sections (k) through (aq) to sub-
•sections (/) through (ar) filed" 4-1 9-91; operative 5-19-91 (Register 91. No.
20).

6. Editorial correction of printing error in subsections (qHar) (Reeister 91. No.
30).

7. Change without regulatory effect amending subsection (an) filed 1 1-1-91 pur-
suant to section 100, title 1, California Code of Regulations (Register 92, No.
5).

8. Amendment of section and Note filed 3- -3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted
to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day.

9. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

10. Amendrnent of subsection (a), new subsection (c) and subsection relettering
filed 10-16-95 as an emergency; operative 10-16-95 (Register 95, No. 42). A
Certificate of Compliance must be transmitted to OAL by 2-1 3-96 or emergen-
cy language will be repealed by operation of law on the following day.

1 1 . Certificate of Compliance as to 10-16-95 order, including amendment of sub-
sections (a), (f) and (k) and of NOTt:, transmitted to OAL 2-9-96 and filed
3-25-96 (Register 96, No. 13).

12. Amendment of subsection (q) and Note filed 6-22-2005 as an emergency; op-
erative 6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must
be transmitted to OAL by 10-20-2005 or emergency language will be repealed
by operation of law on the following day.

13. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005. No. 42).

14. Amendment of subsection (a) filed 7-20-2006; operative 8-19-2006 (Regis-
ter 2006, No. 29).

§30102. Registration Requirement.

History

1. Renumbering and amendment of former Section 30102 to Section 30108 filed
1 1-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§30103. Communications.

History

1. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No.
4).

2. Repealer filed 1 1-25-85; effective thirtieth day thereafter (Register 85, No. 48).

Article 2. Exemptions and Enforcement

§30104. Exemptions.

(a) The Department may, upon application by any user, or upon its
own initiative, grant such exemptions from the requirements of this regu-
lation as it determines are authorized by law and will not result in undue
hazard to health, life or property. Applications for exemptions shall spec-
ify why such exemption is necessary.

(b) Before granting an exemption, the Department shall determine that
there is reasonable and adequate assurance that:

( 1 ) the doses to any individual in any controlled area will not exceed
those specified in Section 30265;

(2) the dose to the whole body of any individual in an uncontrolled area
will not exceed 0.5 rem in a year;

(3) The deposition of radioactive material in the body of any individual
will not likely result in a greater risk to the individual than would be ex-
pected from the dose specified in Section 301 04 (b)( 1 ) or (2), as appropri-
ate, based on guidance from such bodies as the International Commission
on Radiological Protection, and the National Council on Radiation Pro-
tection and Measurements; and

(4) there is no significant hazard to life or property.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25815 and 25876, Health and Safety Code.

History
L Renumbering and amendment of former section 30.345 to article 2 (.section
30104) filed 1 1-2.5-85; effective thirtieth day thereafter (Register 85, No. 48).

2. Change without regulatory effect of subsection (b)(3) (Register 87, No. 4).

3. Change without regulatory effect amending subsections (b) and (b)(3) filed
11-1-91 pursuant to section 100, title 1, California CodeofRe2ulations(Re2is-
ter92. No. 5).

§ 30105. Deliberate Misconduct.

(a) A user, applicant for a license or registration, employee of a user
or applicant, or any contractor (including a supplier or consultant), sub-
contractor, employee of a contractor or subcontractor of any user or ap-
plicant for a license or registration, who knowingly provides to any user,
applicant, contractor, or subcontractor, any components, equipment, ma-
terials, or other goods or services that relate to a user's or applicant's acti-
vities subject to this regulation, shall not:

( 1 ) Engage in deliberate misconduct, as defined in subsection (c), that
causes or would have caused, if not detected, a user or applicant to be in
violation of any rule, regulation, or order; or any term, condition, or li-
mitation of any license issued by the Department; or

(2) Deliberately submit to the Department, a user, an applicant, or a
user's or applicant's contractor or subcontractor, information that the
person submitting the information knows to be incomplete or inaccurate
in some respect material to the Department.

(b) A person who violates subsection (a) shall be subject to enforce-
ment action in accordance with the Act.

(c) For the purposes of subsection (a), deliberate misconduct by a per-
son means an intentional act or omission that the person knows:

( 1 ) Would cause a user or applicant to be in violation of any rule, regu-
lation, or order, or any term, condition, or limitation, or any license or
registration issued by the Department; or

(2) Constitutes a violation of a requirement, procedure, instruction,
contract, purchase order, or policy of a user, applicant, contractor, or sub-
contractor.

NOTE: Authority cited: Secfions 100170, 100275, 115000, 115230 and 115235,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 1 15215,
1 15230 and 1 15235, Health and Safety Code.

History

L New section filed 12-29-2005; operative 1-28-2006 (Register 2005, No. 52).

For prior history of former article 2 (section 30105), see Register 85, No. 48.

Group 1.5.

Registration of Sources of
Radiation

Article 1. Registration Procedure

§30108. Registration Requirement.

Every person possessing a reportable source of radiation shall register
with the Department in accordance with the provisions of Sections 301 10
through 30146.

Note: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Section 25815, Health and Safety Code.

History
1. Renumbering and amendment of former Section 30102 to Section 30108 and
designation of new Group 1.5 (Sections 30108-30146, not consecutive) filed
1 1-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§ 301 1 0. Initial Registration.

(a) Every person not already registered who acquires a reportable
source of radiation shall register with and pay the fee as specified in Sec-
tion 30145 to the Department within 30 days of the date of acquisition.

(b) Every person who intends to acquire a radiation machine capable
of operating at a potential in excess of 500 kVp shall notify the Depart-
ment at least 60 days prior to his/her possession of the machine or at least
60 days prior to the commencement of construction or reconstruction of
the room which will house the machine, whichever occurs first. This
equipment shall not be used to treat patients until written approval of pro-

Page 176

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30111

xisions for radiation safety lias been obtained by the user from tlie De-
partment.

(c) Ever\' person who registers or renews a registration shall complete
a separate registration form furnished by the Department for each sepa-
rate installation.

Ncm;: Authority cited: Sections 208 and 2581 1(c), Health and Safety Code. Ref-
erence: Section 258L'S(b). Health and Safety Code.

History

1 . Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80. No.
26).

2. Amendment filed 1 1-2.5-85; effective thirtieth day thereafter (Register 85, No.
48).

.^. Amendment of subsection (a) filed 1 1-1-93 as an emergency; operative
1 1 l-y.'^ (Register 93, No. 45). A Certificate of Compliance must be transmitted
to OAL by 3-1-9J- or emergency language will be repealed by operation of law
on the follow ing day.

4. Certificate of Compliance as to 1 1-1-93 order transmitted to OAL 2-24-94;
disapproved by OAL 4-7-94 (Register 94, No. 27).

5. Amendment of subsection (a) refiled 7-6-94 as an emergency; opcrati\e
7-6-94 (Register 94, No. 27). A Certificate of Compliance must be transmitted
to OAL by 1 1-3-94 or emergency language will be repealed by operation of law
on the following day.

6. Certificate of Compliance as to 7-6-94 order transmitted to OAL 6 30 94 and
filed 7-20-94 (Register 94, No. 29).

§ 301 1 1 . Renewal of Registration.

Every person already registered pursuant to 301 10 shall renew such
registration annually and pay the fee as specified in Section 30145 to the
Department on or before the registration renewal date.
NOTI:: Authority cited: Sections 100275 and 1 1500()(c), Health and Safety Code.
Reference: Section lL5060(b). Health and Safety Code.

HiSTOR't'
1 . Amendment filed 1 1 -25-85; effective thirtieth day thereafter { Register 85, No.

48).

[The next page is 177.]

Page 176.1

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30145

2. Repealer and nevv' section and amendment of NoTt-; filed 1-20-99; operative
2- 1 9-99 ( Register 99, No. 4).

§ 301 1 2. Registration Form.

History
1 . Repealer filed 1 1-25-85; effective thirtieth day thereafter (Register 85. No. 48).

§ 301 1 3. Separate Installations.

History

1 . Repealer filed 11 -25-85; effective thirtieth day thereafter (Register 85, No. 48).

§ 301 1 5. Report of Change.

The registrant shall report in writing to the Department, within 30
days, any change in: registrant's name, address, location of the installa-
tion or receipt, sale, transfer, disposal or discontinuance of use of any re-
portable source of radiation.

Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Section 25815, Health and Safety Code.

History

1 . Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No.
26).

2. Amendment filed 1 1-25-85; effective thirtieth day thereafter (Register 85, No.
48).

§ 301 1 6. Report of Discontinuance.

History
1 . Repealer filed 1 1-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§ 30117. Registration Shall Not Imply Approval.

History
1 . Repealer filed 1 1-25-85; effective thirtieth day thereafter (Register 85, No. 48).

§ 301 1 8. Vendor Obligation.

(a) Any manufacturer, distributor, retailer, agent, or any other person
who sells, leases, transfers or lends a radiation machine to any person
who may be required to register such machine shall notify the Depart-
ment on a form approved by the Department no later than 30 days after
the end of each calendar quarter of:

( 1 ) The names and addresses of persons who have received such ma-
chines.

(2) The manufacturer and model of each such machine.

(3) The date of transfer of each radiation machine.

(4) Other related information as may be required by the Department.

(b) The vendor shall inform the receiver of each machine of the regis-
tration requirements of Section 30108 of these regulations.

Note: Authority cited: Secdons 208 and 2581 1(c), Health and Safety Code. Ref-
erence: Section 25815(b), Health and Safety Code.

History

1 . New section filed 9-4-73 as an emergency; effective upon filing (Register 73,
No. 36). Approved by State Building Standaids Commission 1 1-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Editorial correcfion of NOTE filed 7-12-84 (Register 84, No. 28).

4. Change without regulatory effect of subsection (b) (Register 88, No. 6).

§ 30120. Reportable Sources of Radiation.

History

1. Repealer of Article 4 (Secfion 30120) filed 1 1-25-85; effective thutieth day
thereafter (Register 85, No. 48).

Article 2. Exclusions from Registration

§ 30125. Excluded Material and Devices.

The following devices and materials do not require registration:

(a) Electrical equipment that produces radiafion incidental to its opera-
tion for other purposes, but which does not produce radiation in any area
accessible to individuals such that there is a reasonable likelihood that
any individual will receive a radiation dose to the whole body, head and
trunk, gonads, or lens of the eye or active blood-forming organs in excess
of 0.5 rem in a year.

(b) All radioactive materials except as specified in Section 30192.1.

Note: Authority Cited: Sections 208 and 258 1 1 (c). Health and Safety Code. Ref-
erence: Section 25815(c), Health and Safety Code.

History

1. New NoTi; filed 7-12-84 (Register 84, No. 28).

2. Editorial renumbering of former article 5 to article 2 (Register 85, No. 48).

3. Change without regulatory effect amending subsection (b) filed 1 1-1-91 pur-
suant to secfion 100. dtle 1, California Code of Regulations (Resister 92. No.

5).

§ 30126. Exempt Possessors.

Common and contract carriers are exempt from the requirement to reg-
ister to the extent that they transport or store reportable sources of radi-
ation in the regular course of their carriage for another or storage incident
thereto.

Note: Authority cited: Sections 208 and 2581 1(c), Health and Safety Code. Ref-
erence: Secfion 25815(b), Health and Safety Code.

History
1 . Amendment filed 1 1-25-85; effective thirtieth day thereafter (Reeister 85, No.
48).

Article 3. Records

§ 30130. Radiation Protection Standards.

History
1. Repealer of Section 30130 and renumbering of Article 6 to Article 3 filed
1 1-25-85; effecfive thirtieth day thereafter (Register 85, No. 48).

§ 30131 . Records to be Maintained.

Note: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Secfion 1 15060, Health and Safety Code.

History

1 . Amendment filed 1 1-25-85; effective thirtieth day thereafter (Register 85, No.
48).

2. Repealer of section and amendment of NOTE filed 9-9-97; operative 1 0-9-97
(Register 97, No. 37).

§30140. Violations.

History
1. Repealer of Article 7 (Section .30140) filed 11-25-85; effective thirtieth day
thereafter (Register 85, No. 48).

Article 4. Fees

§ 30145. Registration Fees.

(a) Each radiation machine that is a reportable source of radiation as
defined in section 30100(t), is classified as one of the following:

(1) "High priority radiation machine," a radiation machine, which has
high potential for exposing humans by means of heavy use, high radi-
ation exposure, specialized use for radiosensitive areas of the human
body, or misadjustment or malfunction of radiation safety features. A
high priority radiation machine is further defined as one of the following
machine types, or a machine that is used by any of the following catego-
ries of users:

(A) Orthopedist.

(B) Radiologist or roentgenogoloist.

(D) Hospital.

(E) Medical clinic.

(F) Portable X-ray service (human use).

(G) Fluoroscope used on humans.

(H) Chest photofluorography (mini film unit).

(1) Non-human use particle accelerator with maximum energy capa-
ble of equaling or exceeding 10 MeV.

(J) Non-human use radiation machine used in field radiography, as de-
fined in Section 30336(c).

(2) "Medium priority radiation machine," a radiation machine not cov-
ered by subsections (a)(1), (a)(3) or (a)(4).

(3) "Dental priority radiation machine," a radiation machine used ex-
clusively in dental radiography of human beings.

(4) "Special priority radiation machine," a radiation machine used for
mammography.

Page 177

§ 30145.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) When a radiation machine is equipped with two or more tubes that
can be used separately, each tube shall be considered as a single radiation
machine.

(d) The initial registration period for a reportable source of radiation
being registered by a person who has a reportable source of radiation al-
ready registered with the Department shall be coterminous with the exist-
ing registration.

(e) Any fees collected for a radiation machine for any registration peri-
od shall be transferred to any replacement radiation machine for the re-
mainder of the registration period.

(f) For initial registration or renewal of registration, the fees shall be
$214.00 annually for each high priority radiation machine, $172.00 an-
nually for each medium priority radiation machine, $79.00 annually for
each dental priority radiation machine and, except as provided in section
30145.1, $475.00 annually for each special priority radiation machine.
Where the initial registration period is less than one year pursuant to sub-
section (d), the initial registration fee shall be prorated, based on the
priority classification and number of full months in the initial registration
period in accordance with the following formula:

Initial Registration Fee = A x [B/ (12 Months)]

Where:

A = Annual fee as specified above, dollars per year

B = Number of full months remaining in coterminous period

(g) The total registration fee paid by a registrant for high priority, me-
dium priority, special priority, and dental priority radiation machines,
which are at the same installation, shall not exceed $6,000.00 per year.

(h) A late fee of 25% of the annual fee shall be charged for any registra-
tion fee which is 30 days past due.

(i) Fees required by this section shall be nonrefundable.
NOTE: Authority cited: Sections 100275, 115000, 115060, 115065, 115080 and
115085, Health and Safety Code. Reference: Sections 114980, 115080, 115085
and 1 15165, Health and Safety Code.

History

1. Amendment of subsection (a) filed 7-1-75; effective thirtieth day thereafter
(Register 75, No. 27).

2. Amendment filed 4-30-76; effective thirtieth day thereafter (Register 76, No.
18).

3. Amendment filed 7-3-79 as an emergency; effective upon filing (Register 79,
No. 27).

4. Certificate of Compliance transmitted to OAL 10-26-79 and filed 11-2-79
(Register 79, No. 44).

5. Amendment filed 1 1-25-85; effecfive thirtieth day thereafter (Register 85, No.
48).

6. Change without regulatory effect of subsections (a) and (a)(] )(k) (Register 88,
No. 6).

7. Amendment of subsection (a) filed 4-19-91 ; operafive 5-19-91 (Register 91,
No. 20).

8. Amendment of subsection (a) and Note, and adoption of subsections (d)-(f)
filed 1 1-1-93 as an emergency; operative 1 1-1-93 (Register 93, No. 45). A
Certificate of Compliance must be transmitted to OAL by 3-1-94 or emergency
language will be repealed by operadon of law on the following day.

9. Certificate of Compliance as to 11-1-93 order transmitted to OAL 2-24-94;
disapproved by OAL 4-7-94 (Register 94, No. 27).

10. Amendment of subsection (a) and Note and new subsecdons (d)-(f) refiled
7-6-94 as an emergency; operafive 7-6-94 (Register 94, No. 27). A Certificate

of Compliance must be transmitted to OAL by 1 1-3-94 oremergency language
will be repealed by operation of law on the following day.

1 1 . Certificate of Compliance as to 7-6-94 order transmitted to OAL 6-30-94 and
filed 7-20-94 (Register 94. No. 29).

12. Amendment of section and Note filed 1-20-99; operative 2-19-99 (Register
99, No. 4).

1 3. Amendment of section heading, section and Note filed 6-22-2005 as an emer-
gency; operative 6-22-2005 (Register 2005, No. 25). A Certificate of Com-
pliance must be transmitted to OAL by 1 0-20-2005 or emergency language
will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§ 30145.1. Registration Fee, Mammography Exception.

The fee shall be $282.00 annually for each special priority radiation
machine accredited by an independent accrediting agency recognized
under the federal Mammography Quality Standards Act [42 U.S.C.
263(b)].

NOTE: Authority cited: Sections 100275. 115000(c), 115065, 115080 and
1 15085, Health and Safety Code. Reference: Sections 1 15080 and 1 15085, Health
and Safety Code.

History

1. New section filed 1-20-99; operadve 2-19-99 (Register 99, No. 4).

2. Amendment filed 6-22-2005 as an emergency; operadve 6-22-2005 (Register
2005, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-20-2005 oremergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§30146. Payment of Fee.

Each registration or registration renewal which reports possession of
a radiation machine, and each report of change reporting the receipt of
an additional radiation machine, shall be accompanied by an amount to
pay the fee for the period to the next regularly scheduled registration re-
newal date.

NOTE: Authority cited: Secdons 208 and 2581 1(c), Health and Safety Code. Ref-
erence: Secdon 25817, Health and Safety Code.

History

1. Amendment filed 7-1-75; effective thirtieth day thereafter (Register 75, No.
27).

2. Amendment filed 4-30-76; effective thirtieth day thereafter (Register 76, No.
18).

3. New NOTE filed 7-12-84 (Register 84, No. 28).

Group 2. Licensing of Radioactive
Materials

Article 1. General

§30170. Authority,

NOTE; Authority cited: Sections 102 and 208, Health and Safety Code. Reference:
Sections 25780 and 25800 through 25870, Health and Safety Code.

History

1. Repealer of Article 1 (Sections 30170 through 30173) and new Article 1 (Sec-
tions 30170. 30172 and 30173) filed 1 1-29-65; effective thirtieth day thereafter
(Register 65, No. 23). For prior history, see Registers 62, No. 1 and 62, No. 8.

2. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

Page 178

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30180

§30172. License Requirement.

NOTI.: Authoritv died: Sections 102. 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876,
Health and Safety Code.

History
1. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§30173. Communications.

NOTH: Authority cited: Sections 102. 208 and 2581 1, Health and Safety Code.
Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876,
Health and Safety Code.

History

1. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No.
4).

2. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

Article 2. Definitions

§30175. General Definitions.

NOTH: Authority cited: Sections 102, 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876,
Health and Safety Code.

History

1. Repealer and new section filed 11-29-65; effective thirtieth day thereafter
(Register 65, No. 23). For prior history, see Registers 62, No. 1 and 62, No. 8.

2. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No.
4).

3. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

Article 3. Exemptions

§ 30180. Exempt Persons, Products, Concentrations and
Quantities.

(a) Any person is exempt from this regulation if such person:

( 1 ) Is a common and contract carrier transporting radioactive material
in the regular course of their carriage for another or storage incident
thereto. Such carriers are subject to the provisions of Group 4, Transpor-
tation of Radioactive Material.

(2) Is licensed by the United States Nuclear Regulatory Commission
under Title 10, Code of Federal Regulations, Part 150, Section 150.15,
Continued Commission Regulatory Authority in Agreement States, or
otherwise agreed upon by the Department and the Commission.

(3) Is under a prime contract with the United States Nuclear Regulato-
ry Commission or the United States Department of Energy at a U.S. Gov-
ernment-owned or controlled site, including the transporting of radioac-
tive material to or from such site, the performance of contract services
during temporary interruptions of such transportation; for research in or
development, manufacture, storage, testing or transportation of atomic
weapons or components thereof; or for the use of nuclear devices in U.S.
Government-owned vehicle or vessel; or under a subcontract when it is
jointly determined by the Department and the United States Nuclear Reg-
ulatory Commission that an exemption is appropriate.

(b) The following products are exempt from this regulation:

( 1 ) Timepieces, hands or dials therefor, containing any radioactive lu-
minous material provided these have been distributed as exempt products
in accordance with a United States Nuclear Regulatory Commission li-
cense: and any timepieces, hands or dials therefore containing radium ac-
tivated luminous material.

(2) Automobile lock illuminators containing up to 15 millicuries of tri-
tium or 2 millicuries of promethium 147 per lock.

(3) Compounds or mixtures with rare earth elements containing up to
0.25% by weight of source material.

(4) Glazed ceramic tableware containing up to 20% by weight of
source material in the glaze.

(5) Glassware containing not more than 10 percent by weight source
material; but not including commercially manufactured glass brick, pane
glass, ceramic tile, or other glass or ceramic used in construction;

(6) Glass enamel or glass enamel frit containing not more than 1 0 per-
cent by weight source material imported or ordered for importation into
the United States, or initially distributed by manufacturers in the United
States, before July 25, 1983.

(7) Photographic film, negatives, and prints containing source materi-
al.

(8) Incandescent gas mantles, vacuum tubes, electric lamps, and weld-
ing rods containing thorium.

(9) Any finished product or part fabricated of, or containing, tungsten-
thorium or magnesium-thorium alloys; provided that the thorium con-
tent of the alloy does not exceed 49c by weight.

(10) Finished optical lenses containing up to 30% by weight of tho-
rium, but not including spectacles, contact lenses, or eyepieces of optical
instruments and subject to not altering the finished product by any pro-
cess such as shaping, grinding, or polishing.

(11) Fire detector heads containing up to 0.005 microcuries of uranium
per head.

(12) Electric lamps for illuminating purposes provided that each lamp
does not contain more than 50 milligrams of thorium.

(13) Germicidal lamps, sun lamps and lamps for outdoor or industrial
lighting provided that each lamp does not contain more than two grams
of thorium.

(14) Personnel neutron dosimeters provided that each dosimeter does
not contain more than 50 milligrams of thorium.

(15) Shipping containers utilizing natural or depleted uranium metal
as shielding, if such container is and remains:

(A) Conspicuously impressed with the legend: "CAUTION — RA-
DIOACTIVE SHIELDING— URANIUM" and;

(B) The uranium metal is encased in mild steel or equally fire resistant
metal of minimum wall thickness of one eight inch (3.2 mm).

(16) Counterweights of uranium installed in, or store or handled in
connection with installation in or removal from, aircraft, rockets, projec-
tiles, or missiles, if each such counterweight has been manufactured pur-
suant to an appropriate specific license; and

(A) each counterweight manufactured prior to December 31,1 969 has
been, and remains, impressed, labeled and marked in accordance with the
provisions of that specific license at the time of manufacture;

(B) each counterweight manufactured on or after December 31,1 969
has been impressed with the following legend clearly legible through any
plating or other covering: "DEPLETED URANIUM"; and is durably and
legibly labeled or marked with the identification of the manufacturer, and
the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED."

(17) Precision balances or parts therefor, provided that no such bal-
ance contains more than 1 .0 millicurie of tritium and no balance part con-
tains more than 0.5 millicurie of tritium.

(18) Automobile shift quadrants containing not more than 25 millicu-
ries of tritium.

( 1 9) Marine compasses containing not more than 750 millicuries of tri-
tium gas and other marine navigational instruments containing not more
than 250 millicuries of tritium gas.

(20) Thermostat dials and pointers containing not more than 25 milli-
curies of tritium per thermostat.

(2 1 ) Thorium contained in any finished aircraft engine part containing
nickel-thoria mixture, provided that:

(A) The thorium is dispersed in the nickel-thorium mixture in the form
of finely divided thorium dioxide; and

(B) The thorium content of the mixture does not exceed 4% by weight.

(22) Electron tubes: Provided that each tube does not contain more
than one of the following specified quantities of radioactive material:

(A) 150 millicuries of tritium per microwave receiver protector tube
or 10 millicuries of tritium per any other electron tube;

(B) 1 microcurie of cobalt 60;

(D) 30 microcuries of krypton 85;

(E) 5 microcuries of cesium 137;

(F) 30 microcuries of promethium 147;

Page 179

§ 30181

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

and provided rurthcr. that these have been manufactured and distrib-
uted pursuant to an appropriate specific license.

NOTi;: Electron tubes include spai'k gap tubes, power tubes, gas tubes including
glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, ra-
diation detection tubes and any other completely sealed tube that is designed to
conduct or control electrical cun'ents.)

(23) Synthetic plastic resins containing scandium 46 and designed for
sand consolidation in oil wells provided such resins shall have been man-
ufactured or imported in accordance with a specific license which autho-
rizes their distribution as exempt products.

(24) Intact meters containing radium activated luminous material.

(25) Piezoelectric ceramic containing not more than 2 percent by
weight source material.

(26) Gas and aerosol detectors containing radioactive material and de-
signed to protect life or property from fires and airborne hazards provided
such detectors have been manufactured or imported in accordance with
a specific license which authorizes their distribution as exempt products.

(27) Self-luminous products containing tritium, krypton 85, or prome-
thium 147 provided such products have been manufactured or imported
in accordance with a specific license which authorizes their distribution
as exempt products, and provided further that such products are not used
primarily for frivolous purposes or as toys or adornments.

(28) Ionizing radiation measuring instruments containing, for pur-
poses of internal calibration or standardization, one or more sources of
radioactive material, provided that:

(A) Each source contains no more than one exempt quantity set forth
in section 30235, Schedule A, and

(B) Each instrument contains no more than ten exempt quantities. For
purposes of subsection (b)(28)(A) and (B), an instrument's source(s)
may contain either one type or different types of radionuclides, and an
individual exempt quantity may be composed of fractional parts of one
or more of the exempt quantities in section 30235, Schedule A, provided
that the sum of such fractions shall not exceed unity.

(C) For purposes of subsection (b)(28)(B), 0.05 microcurie of ameri-
cium- 241 is considered an exempt quantity under section 30235, Sched-
ule A.

(29) Spark gap irradiators containing not more than one microcurie of
cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil
burners having a firing rate of at least three gallons per hour (1 1.4 liters
per hour).

(30) Capsules containing one microcurie of carbon-14 urea each, for
in vivo diagnostic use for humans. Persons who use the capsules for re-
search involving human subjects shall possess a specific license issued
pursuant to section 30195.

( 1 ) Any naturally-occurring radioactive material, except source mate-
rial, in concentrations which occur naturally. Unprocessed ore in its natu-
ral form containing source material is exempt. Refining and processing
are not exempt.

(2) Any chemical mixture, compound, solution or alloy containing up
to one-twentieth of one percent (0.05 percent) by weight of source mate-
rial.

(3) Any radioactive material in concentration not exceeding those spe-
cified in section 30237, Schedule C, except that a specific license shall
be required by any person to transfer possession or control of any product
or material into which radioactive material has been introduced in such
concentrations except for transfers to appropriately licensed persons for
analytical test or waste disposal purposes.

(4) Radioactive material in individual quantities each of which does
not exceed the applicable quantity set forth in section 30235, Schedule
A, if not more than 10 such scheduled quantities are possessed at any one
time.

(d) The exemptions contained in subsection (b) shall not authorize any
of the following:

(1) The manufacture of any product listed.

(2) The application or removal of radioactive luminous material to or
from meters and timepieces, or hands and dials therefor.

(3) The installation into automobile locks of illuminators containing
tritium or promethium 1 47 or the application of tritium to balances of pre-
cision or parts therefor.

(4) The chemical, physical, or metallurgical treatment or processing
of thorium-metal alloys.

(5) Human use. or the use in any device or article, except time pieces
and the product specified in subsection (b)(30). which is intended to be
placed on or in the human body.

(6) The chemical, physical, or metallurgical treatment or processing
of uranium counterweights other than repair or restoration of any plating
or other covering.

(e) The exemptions specified in subsections (b)(30). (c)(3) or (c)(4)
shall not authorize the production, packaging, repackaging or transfer of
radioactive material for purposes of commercial distribution, or the in-
corporation of radioactive material into products intended for commer-
cial distribution.

NOTIi: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965. 114970. 115000, 115165 and 115235, Health and
Safety Code.

History

1. Amendment of subsection (c)(1) and new subsecdon {d)(7) fded 10-12-72; ef-
fective thirtieth day thereafter (Register 72, No. 42). For prior history, see Reg-
ister 71. No. 30.

2. Amendment fded 7-7-86; effective thirtieth day thereafter (Register 86. No.
28).

3. Chanee without regulatory effect of subsections (b)( 15) and (c)(2)-(4) (Register
88, No. 6).

4. Change without regulatory effect amending subsections (b)( 1 ), (b)( 17), (b)(28),
and (d)(2) fded 11-1-91 pursuant to section 100, title l.CaUfornia Code of Reg-
ulations (Register 92, No. 5).

5. Editorial correction reinserting inadvertently omitted subsections (c)-(c)(4)
(Register 92, No. 44).

6. Editorial correction of subsection (b)(28)(B) (Register 2003, No. 29).

7. Amendment of section and repealer and new Note fded 7-28-2006; operative
8-27-2006 (Register 2006, No. 30).

§ 301 81 . Persons Exempt.

History

1 . Amendment of subsection (b)(1) fded 1 0- 1 2-72 ; effecd ve thirtieth day thereaf-
ter (Register 72, No. 42).

2. Repealer filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

§ 30182. Other Exemptions.

History
1 . Repealer filed 1 1-25-85; effecUve thirtieth day thereafter (Register 85, No. 48).

Article 4. Licenses

§30190. Types of Licenses.

(a) Department licenses for radioactive material are of two types: gen-
eral and specific.

(b) General licenses provided in this regulation are effective without
the filing of an application with the department or the issuance of licens-
ing documents to particular persons.

(c) Specific licenses are issued to named persons upon approval of an
application filed pursuant to this regulation. A specific license issued by
the department is required by any person to possess any radioactive mate-
rial in this state, except as otherwise provided in Sections 30180, 30181,
30182, 30191,30192, or 30225.

(d) Every specific and general license is subject to all applicable provi-
sions of this regulation and, except as otherwise specified, to the provi-
sions of Group 3 of this subchapter (Standards for Protection Against Ra-
diation).

History
1. Repealer of Article 4 (Sections 30190 through 30205) and new Article 4 (Sec-
tions 30190 through 30198 and 30205) filed 11-29-65; effective thirtieth day
thereafter (Register 65, No. 23). For prior history, see Register 62, No. 1 .

Page 180

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§30192.1

§ 301 91 . General Licenses-Source Material.

(a) A general license is hereby issued to commercial firms, education,
and medical institutions and government agencies, authorizing the pos-
session and use of not more than 1 5 pounds of source material at any one
time, for research, development, educational, commercial or operational
purposes. Persons authorized to possess and use source material, pur-
suant to this general license, may not receive more than a total of 150
pounds of source material in any one calendar year. Any person shall,
with respect to such source material, be exempt from the provisions of
Group 3 of this subchapter, except for Sections 30253, 30254 and
30293(a), unless such person also possesses source material under a spe-
cific license.

(b) A general license described in Section 30191(a) shall not authorize
human use; or the use in any device or article which is intended to be
placed on or in the human body; or the use of any instrument or apparatus
(including component parts and accessories thereto) intended for human
use.

NOTI-;: Authority cited: Sections 100275 and 1 15000, Health and Safety Code.
Reference: Sections 114965, 114970. 114985(g), 115000, 115060. 115165 and
1 15235, Health and Safety Code.

History

1. New NoTH filed 8-22-84 (Register 84, No. 34).

2. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

3. Change without regulatory effect inserting (a) to first paragraph filed 1 1-1-91
pursuant to section 1 00, title 1 , California Code of Regulations (Register 92, No.
5).

4. Amendment of subsection (a) and NOTE filed 9-9-97; operative 1 0-9-97 (Reg-
ister 97, No. 37).

§ 30192. General Licenses — Static Elimination or Ion
Generation Devices.

(a) A general license is hereby issued to any person authorizing pos-
session of radioactive material incorporated in any of the following items
when manufactured pursuant to a specific license which authorizes dis-
tribution to general licensees:

(1) Static eliminators containing sealed sources of up to 500 microcu-
ries of polonium 210 per device.

(2) Air ionization devices containing, as sealed sources, up to 500 mi-
crocuries of polonium 210 or 50 millicuries of hydrogen 3 per device.

(b) Possession of radioactive material listed in this section is exempt
from the requirements of Group 3 of this subchapter except for Sections
30253, 30254, and 30293(a).

NOTH: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970, 114985(g), 115060, 115165 and 115235,
Health and Safety Code.

History

1. Amendment of subsection (c) and new subsection (0 filed 1 1-16-67; effective
thirtieth day thereafter (Register 67, No. 46).

2. Amendment of subsection (c)( 1 ) filed 5-13-66; effective thirtieth day thereafter
(Register 69, No. 20).

3. Repealer of subsections (a)(1)(B) and (a)(1)(C), renumbering of (a)(1)(D) to
(a)(1)(B), new subsection (a)(3) and amendment of subsection (b) filed
7-22-71; effective thirtieth day thereafter (Register 71. No. 30).

4. Repealer of subsections (a)(2) and (b)(2) filed 10-12-72; effective thirtieth day
thereafter (Register 72, No. 42).

5. Amendment of subsection (a)(3) filed 10-1 1-74; effective thirtieth day thereaf-
ter (Register 74, No. 41).

6. Repealer and new section filed 7-7-86; effective thirtieth day thereafter (Regis-
ter 86, No. 28).

7. Amendment of subsection (b) and NOTE filed 9-9-97; operative 10-9-97
(Register 97, No. 37).

8. Kditorial correction restoring inadvertently deleted Histories (Register 97, No.

45).

§ 301 92.1 . General Licenses— Gauging and Controlling.

(a) A general license is hereby issued to commercial and industrial
firms and research, educational and medical institutions, individuals in
the conduct of their business, and government agencies to possess and
use radioactive material when contained in devices designed and man-
ufactured for the purpose of detecting, measuring, gauging or controlling

thickness, density, level, interface location, radiation, leakage, qualita-
tive or quantitative chemical composition or for producing light or an
ionized atmosphere when such devices are manufactured pursuant to a
specific license authorizing distribution to general licensees provided
that each such device:

( 1 ) Is labeled in accordance with the provisions of the specific license
which authorizes distribution of the device;

(2) Bears a label containing the following or substantially similar
statement:

"The receipt, possession, use and transfer of this device. Model .

Serial No. , are subject to a general license or equivalent and the reg-
ulations of the United States Nuclear Regulatory Commission or of a
state with which the United States Nuclear Regulatory Commission has
entered into an agreement for the exercise of regulatory authority. Re-
moval of this label is prohibited.

CAUTION— RADIOACTIVE MATERIAL

(Name of Supplier)"

The model, serial number and name of supplier may be omitted from

this label provided they are elsewhere specified in labeling affixed to

the device; and

(3) Is installed on the premises of the general licensee by a person hav-
ing a specific license which authorized installation of such devices when
required by the label on the device.

(b) Persons who possess a device pursuant to the general license con-
tained in Section 30192.1(a) shall:

( 1 ) Within 30 days of the receipt of any such device, register with the
Department and within 30 days of transfer of any such device, notify the
Department in accordance with the provisions of Group 1.5 of this sub-
chapter (Registration of Radiation Sources).

(2) Not transfer, abandon or dispose of the device, except by transfer
to a person holding a specific license to receive such device.

(3) Transfer the device to another general licensee only;

(A) Where the device remains in use at a particular location. In such
case the transferrer shall give the transferee a copy of this section and any
safety documents identified in the label of the device, or;

(B) Where the device is held in storage in the original shipping con-
tainer at its intended location of use prior to initial use by the general li-
censee.

(4) Assure that all labels affixed to the device at the time of receipt and
bearing the statement, "Removal of this label is prohibited" are main-
tained thereon and comply with all instructions contained in such labels.

(5) Have the device tested for leakage of radioactive material and
proper operation of the on-off mechanism and indicator, if any, at the
time of installation of the device or replacement of radioactive material
on the premises of the general licensee and thereafter at no longer than
six-month intervals or at such longer intervals as may be specified in the
specific license which authorized distribution of the device to general li-
censes. Devices containing only krypton need not be tested for leakage.
Devices containing only tritium or not more than 100 uCi of other beta
and/or gama emitting material or 10 uCi of alpha emitting material and
devices held in storage in the original shipping container prior to initial
installation need not be tested for any reason.

(6) Have the test required by Section 30192.1(b)(5) and all other ser-
vices involving the radioactive material, its shielding and containment
performed:

(A) In accordance with the instructions provided by the label; or

(B) By a person holding an appropriate license therefor.

(7) Maintain records of all tests performed on the devices as required
under this section, including the dates and results of these tests and the
names and addresses of the persons conducting the test.

(8) Upon occurrence of a failure of or damage to, or any indication of
a possible failure of or damage to the shielding or containment of the ra-
dioactive material, or of the on-off mechanism or indicator, immediately
suspend operation of the device until it has been repaired by or disposed
of to a person holding a specific license therefor.

Page 181

§ 30192.2

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(9 ) Within 30 days alter the occurrence of a failure of or damage to the
shielding or containment of radioactive material or the on-off mecha-
nism or indicator or upon the detection of 0.005 microcuries or more of
removable radioactive material, furnish to the Department a complete
description of the device (manufacturer, type, serial number) and a brief
description of the event and the remedial action taken.

(c) Persons who possess a device pursuant to the general license con-
tained in Section 30192.1(a) shall with respect thereto be exempt from
the requirements of Group 3 of this subchapter except for Sections
30253, 30254. and 30293(a).

NoTh: Authority cited: Section.s 100275 and 1 15000. Health and Safety Code.
Reference; Sections 114965, 114970, 114985(h), 115060. 115165, 115230 and
1 1 5235, Health and Safety Code.

Hlstory

1. New section tiled 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

2. Change without regulatory effect of subsection (b)(5) (Register 88, No. 6).

3. Amendment of subsection (c) and NOTE filed 9-9-97; operative 10-9-97 (Reg-
ister 97. No. 37).

§ 30192.2. General Licenses— Aircraft Safety Devices.

(a) A general license is hereby issued to any person to possess and use
tritium or promethium 147 contained in luminous safety devices de-
signed for use in aircraft provided that each such device contains not
more than 10 curies of tritium or 300 millicuries of promethium 147 and
has been manufactured, assembled or imported in accordance with a spe-
cific license authorizing distribution to general licensees.

(b) The general license contained in Section 30192.2(a) does not au-
thorize:

(1) The manufacture, assembly, disassembly, repair or disposal of
such devices.

(2) The use of such devices other than in aircraft.

(3) The possession of promethium 147 in instrument dials.

(c) Persons who possess a device pursuant to the general license con-
tained in Section 30192.2(a) shall, with respect thereto, be exempt from
the requirements of Group 3 of this subchapter except for Sections
30253, 30254, and 30293(a).

NOTti: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970, 114985(g), 115060, 115165, and 115235,
Health and Safety Code.

History

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

2. Amendment of subsection (c) and NOTE filed 9-9-97; operative 10-9-97
(Register97, No. 37).

§ 30192.3. General Licenses — Calibration or Reference
Sources.

(a) A general license is hereby issued to persons who hold either a spe-
cific license issued by the Department for any radioactive material or a
specific license issued by the United States Nuclear Regulatory Commis-
sion for any special nuclear material, to possess americium-241 or pluto-
nium in the form of calibration or reference sources. Calibration or refer-
ence sources shall be manufactured in accordance with the specifications
contained in an appropriate specific license which authorizes distribution
under a general license. Each source possessed pursuant to the general
license or its storage container shall bear a label which includes the infor-
mation required in the following statement:

"The receipt, possession, use and transfer of this source. Model ,

CAUTION— RADIOACTIVE MATERIAL— THIS SOURCE
CONTAINS (AMERICIUM 241 OR PLUTONIUM, whichever is ap-
propriate). DO NOT TOUCH RADIOACTIVE PORTION OF THIS
SOURCE.

(Name of Manufacturer or Importer)

(b) Persons who possess a source pursuant to the general license con-
tained in Section 30192.3(a) shall:

( 1 ) Not have, at any one time, at any one location of storage or use,
more than 5 microcuries of americium-241 and 5 microcuries of pluto-
nium contained in such sources.

(2) Not transfer, abandon or dispose of such sources except by transfer
to a person authorized by a license to receive the source.

(3) With respect to each such source when not in use, store the source
in a closed container adequately designed and constructed to contain any
of the radioactive material in case the source is ruptured or leaks.

(4) Not use such source for any purpose other than calibration of radi-
ation detectors or standardization of other sources.

(c) Persons who possess a source pursuant to the general license con-
tained in Section 30192.3(a) shall with respect thereto be exempt from
the requirement of Group 3 of this subchapter except for Sections 30253,
30254, and 30293(a).

(d) The general license in paragraph (a) of this section does not autho-
rize the manufacture, import, or export of calibration or reference sources
containing americium or plutonium.

NOTE: Authority cited: Sections 100275 and 115000. Health and Safety Code.
Reference: Sections 114965, 114970, 114985(s), 115000, 115060. 115165,
1 1 5230 and 1 1 5235, Health and Safety Code.

History

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

2. Amendment of subsection (c) and NOTE filed 9-9-97; operative 10-9-97
(Register 97, No. 37).

§ 30192.4. General Licenses — Ice Detection Devices.

(a) A general license is hereby issued to any person to possess stron-
tium 90 contained in ice detection devices provided that each device con-
tains not more than 50 microcuries of strontium 90 and each device has
been manufactured or imported in accordance with a specific license
which authorizes distribufion under a general license.

(b) Persons who possess a device pursuant to the general license con-
tained in Section 30192.4(a) shall:

( 1 ) Assure that all labels affixed to the device at the time of receipt and
which bear a statement that prohibits removal of the labels are maintained
thereon;

(2) Upon occurrence of damage, discontinue use of the device until it
has been inspected, tested for leakage and repaired by a person holding
a specific license authorizing such testing or repair.

(c) Persons who possess a device pursuant to the general license con-
tained in Section 30192.4(a) shall, with respect thereto, be exempt from
the requirements of Group 3 of this subchapter except for Sections
30253, 30254 and 30293(a).

(d) This general license does not authorize the manufacture, assembly,
disassembly or repair of ice detecdon devices containing strontium 90.
NOTE: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970, 114985(g), 115060, 115165, 115230 and
1 15235, Health and Safety Code.

History

1. New section filed 7-7-86; effecfive thirtieth day thereafter (Register 86, No.
28).

2. Amendment of subsection (c) and NOTE filed 9-9-97; operative 10-9-97
(Register 97, No. 37).

§ 30192.5. General Licenses — In Vitro Testing.

(a) A general Hcense is hereby issued to any physician, veterinarian,
clinical laboratory or hospital to possess and use radioactive material in
prepackaged units described in Section 30236, Schedule B, Table 1, for
in vitro clinical testing.

(b) The general hcensee shall not possess or use radioactive material
pursuant to the general license contained in this section: ( 1 ) Except as pre-
packaged units which are labeled in accordance with the provisions of a
specific license is.sued by the United States Nuclear Regulatory Commis-
sion or a state with which the United States Nuclear Regulatory Commis-

Page 182

Title 17 Radiation — Radiologic Technology — Nuclear Medicine Technology § 30192.5

sion has entered into an agreement for the exercise of regulatory author- cians, veterinarians, clinical laboratories or hospitals and only for in \ itro

ity, and clinical or laboratory tests not involving internal or external administra-

(2) Unless the prepackaged unit bears a label or is accompanied by a tionofthe material orthe radiation therefrom to human beings or animals,

package insert containing the following or a substantially similar state- The receipt, possession, use and transfer of this material is subject to reg-
nient: ulations and general license of the United States Nuclear Regulatory

"This radioactive material may be received and used only by physi-

[The next page is 183.]

Page 182.1 Register 2006, No. 30; 7-28-2006

•

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30194.2

•

Commission or ihc state with which the Commission has entered into an
agreement Tor the exercise of regulatory authority."

(c) Persons who possess radioactive material pursuant to the general
license contained in Section 30192.5(a), shall with respect thereto be ex-
empt from the requirements of Group 3 of this subchapter except for Sec-
tions 30253. 30254. and 30293(a).

NOTK: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965. 114970, 114985(g), 115000, 115060. 115165,
1 15230 and 1 15235, Health and Safety Code.

History

1. New section filed 7-7-86; effective thirtieth day thereafter (Recister 86, No.
28).

2. Amendment of sub.seetion (c) and NOTI-: filed 9-9-97; operative 10-9-97
(Register 97. No. 37).

§ 30192.6. General Licenses — Depleted Uranium.

(a) A general license is hereby issued to any person to possess and use
depleted uranium contained in industrial products or devices for the pur-
pose of providing a concentrated mass of the product or device when such
products or devices are manufactured pursuant to a specific license au-
thorizing distribution to general licensees.

(b) Persons who possess depleted uranium pursuant to the general li-
cense contained in Section 30192.6(a) shall:

( 1 ) Within 30 days of receipt of any such product or device, register
with the Department and within 30 days of transfer of any such device,
notify the Department in accordance with provisions of Group 1 .5 of this
subchapter;

(2) Not introduce such depleted uranium into any chemical, physical
or metallurgical treatment or process except a treatment or process for re-
pair or restoration of any plating or other covering of the depleted ura-
nium;

(3) Maintain procedures designed to establish physical control over
such depleted uranium to prevent unauthorized use or transfer;

(4) Not transfer, abandon or dispose of such depleted uranium except
by transfer to a person holding a specific or general license to receive
such material.

(c) Persons who possess depleted uranium pursuant to the general li-
cense contained in this section shall with respect thereto be exempt from
the requirements of Group 3 of this subchapter except for Section 30253,
30254, and 30293(a).

NOTE: Authority cited: Sections 100275 and 115000. Health and Safety Code.
Reference: Sections 114965. 114970. 11498.5(2), 115060. 115165. 115230 and
1 15235. Health and Safety Code.

History

1 . New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

2. Amendment of subsection (c) and NOTE filed 9-9-97; operative 10-9-97
(Register 97, No. 37).

§ 30193. Application for Specific Licenses and
Amendments.

NOTE: Authority cited: Sections 102, 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876,
Health and Safety Code.

History
1. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§ 30194. Approval of Applications and Specific Terms and
Conditions for Licenses.

(a) An application for a new specific license or for renewal or amend-
ment of an existing license will be approved if the Department deter-
mines that:

(1) the applicant or his specified personnel are qualified by reason of
training and experience to use radioactive material of the kinds and quan-
tities and for the purposes requested, in such a manner as to provide rea-
sonable and adequate assurance of protection to health, life, and proper-
ty;

(2) the applicant's equipment, facilities, proposed uses and procedures
are such as to provide reasonable and adequate assurance of protection
to health, life, and property;

(3) the issuance of the license will not jeopardize the health and safety
of the public;

(4) the applicant satisfies all applicable requirements of the Act and
regulations thereunder.

(b) Prior to issuing, amending or renewing a license pursuant to the
provisions of this subchapter, the Department may inspect at any reason-
able time the place of business, or premises and facilities of any applicant
in order to verify information contained in the application or to obtain ad-
ditional information for the purpose of completing the application.

(c) No license or any right under a licen.se shall be assigned or other-
wise transferred unless approved in adsance by the Department.

(d) Each licensee shall restrict possession of licensed material to the
locations and conditions of the use authorized in the license.

(e) Each .specific license shall expire on the expiration date specified
as a condition of the license. However, the license shall continue to be
valid if a timely application for renewal is filed. An application for re-
newal shall be timely if filed at least 30 days prior to the expiration date.
The existing license shall not expire until the department has taken final
action on the timely filed application for renewal.

(f) Applications and documents submitted shall be made available for
public inspection except where the applicant identifies portions of the
application as "trade secret" and the Department finds that the informa-
tion is "trade secret" pursuant to provisions of the Public Records Act and
Evidence Code Section 1 060.

(g) As provided by Section 30195.1, certain applications for specific
licenses filed under Group 2 shall contain a proposed decommissioning
funding plan or a certification of financial assurance for decommission-
ing. In the case ofrenewal applications submitted before January 1, 1996.
the submittal of a proposed decommissioning funding plan or a certifica-
tion of financial assurance for decommissioning may foil ow the renewal
application but shall be submitted on or before January 1, 1996.
NOTE: Authority cited: Sections 1001 10. 100275 and 1 15000. Health and Safety
Code. Reference: Sections 114965. 114970. 115060. 115165. 115230 and
1 15235, Health and Safety Code.

History

1. Amendment filed 7-8-87; operative 8-7-87 (Register 87. No. 29).

2. New subsection (g) filed 10-16-95 as an emergency; operative 10-16^-95 (Reg-
ister 95. No. 42). A Certificate of Compliance must be transmitted to OAL by
2-1 3-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-16-95 order, including amendment of
Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96. No. 13).

§ 301 94.1 . Criteria for Authorizing Multiple Locations of
Use.

Criteria for authorizing more than one location of use on a specific li-
cense shall be as follows:

(a) All locations shall be under the same business entity.

(b) The radiation protection program required by section 20.1 101 of
Title 10. Code of Federal Regulations, Part 20 as incorporated by refer-
ence in secfion 30253 shall demonstrate that use of radioactive materials
at each location shall be in accordance with this regulation.

(c) A single location where licensing and compliance records will be
maintained for Department review shall be designated.

(d) The nature of radioactive materials use and the operations shall be
the same at all locations.

NOTE: Authority cited: Sections 100275 and 115000. Health and Safety Code.
Reference: Secfions 114965, 114970, 115060 and 115165. Health and Safety
Code.

History

1. New section filed 6-22-2005 as an emergency; operative 6-22-2005 (Register
2005. No. 25). A Certificate of Compliance must be transmitted to OAL by
10-20-2005 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005. No. 42).

§30194.2. Amendment Requests.

To amend an existing license, a licensee shall submit a written request
to the Department containing:

Page 183

§ 30195

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(a) The licensee's name and license number as shown on the specific
license.

(b) The nature and scope of the request.

(d) If the request proposes to increase the maximum possession limit
specified on the license, the request shall include the fee specified in sec-
tion 30231(c).

NOTH: Authority cited: Section.s 100275 and 1 15000. Health and Safety Code.
Referenee: Sections 114965, 114970. 115060 and 115165. Health and Safety
Code.

History

1 . New section filed 6-22-2005 as an emergency; operative 6-22-2005 (Register
2005, No. 25). A Certificate of Compliance must be transmitted to OAL by
1 0-20-2005 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§ 30195. Special Requirements for Issuance of Specific
Licenses.

In addition to the requirements set forth in Section 30194, specific li-
censes for certain specialized uses will be issued only if the following
conditions are met:

(a) For human use of radioactive material in institutions:

( 1 ) The institution has a formally-constituted and officially-recog-
nized medical radiation safety committee, which should include a repre-
sentative of the institution's administration and at least three individuals
who are knowledgeable in the areas of human use of radioactive material
and of radiation safety, and which shall evaluate all proposals for, and
maintain surveillance over, all uses of radioactive material within the in-
stitution.

(2) The institution has a radiation safety officer, who is a member of
the radiation safety committee, and who is qualified by reason of training
and experience to oversee the radiation safety aspects of radioactive ma-
terial use in the institution.

(3) The institution's application includes a detailed statement of quali-
fications, duties, authority, and responsibility of the radiation safety
committee and the radiation safety officer.

(4) The institution had adequate facilities for the cUnical care of pa-
tients.

(5) Each person to be designated as an individual radioactive material
user is a physician and furnishes clear evidence of substantial training and
experience in the kinds of uses proposed, including handling and admin-
istration of the radioactive material and the appropriate clinical manage-
ment of patients.

(b) For human use of radioactive material by individuals:

( 1 ) The applicant is a physician and furnishes clear evidence of having
substantial training and experience in the kinds of uses proposed, includ-
ing the handling and administration of the radioactive material and the
appropriate clinical management of patients.

(2) The applicant demonstrates access to adequate hospital facilities
for the patients, where appropriate.

(c) For use of multiple quantities of types of radioactive material for
research and development or for processing for distribution:

(1) The applicant has a radiation safety committee of at least three
members which must evaluate all proposals for, and maintain surveil-
lance over, all uses of radioactive material. Committee members shall be
knowledgeable and experienced in pertinent kinds of radioactive materi-
al use and in radiation safety.

(2) The applicant has a radiation safety officer, who is a member of the
radiation safety committee, and who is supported by a staff of a size and
degree of competence appropriate to deal with radiation safety problems
that might be encountered.

(3) The applicant furnishes a detailed statement of the qualifications,
duties, authority, and responsibilities of the radiation safety committee
and of the staff radiation safety group.

(d) For distribution of devices to persons generally licensed under Sec-
tions 30192.1 and 30192.6:

( 1 ) The applicant submits sufficient information relating to the design,
manufacture, prototype testing, quality control procedures, labeling, pro-
posed uses and conditions of use, and potential radiation hazards of each
device to provide reasonable assurance that:

(A) the radioactive material contained in the device will not be lost;

(B) no individual will receive a radiation dose to the whole body or ma-
jor portion thereof, head and trunk, lens of the eye, gonads, or active
blood-forming organs in excess of 0.5 rem in a year, under ordinary cir-
cumstances of use;

(D) the radioactive material within the device would not be accessible
to unauthorized individuals.

(2) The applicant submits a sample of the labels to be affixed to the de-
vice which include instructions and precautions for safe operation, and
indicates the manner in which the labels will be affixed and their location
on the device. Each such label shall bear the statement, "Removal of this
label is prohibited."

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25855 and 25876, Health and Safety Code.

History

1 . Repealer and new subsection (e) filed 10-12-72; effective thirtieth day thereaf-
ter (Register 72, No. 42).

2. Repealer of subsection (e) filed 7-7-86; effective thirtieth day thereafter (Regis-
ter 86, No. 28).

3. Change without regulatory effect amending subsection (d) filed 1 1-1-91 pur-
suant to section 100. title 1, California Code of Regulations (Register 92, No.

5).

§ 30195.1 . Special Requirements for Issuance of Specific
Licenses — Financial Surety for
Decommissioning.

(a) The regulations governing financial assurance for decommission-
ing in Title 10, Code of Federal Regulations, Section 30.35, as revised
January 1, 1996, including Appendix A, B and C to Part 30 of Title 10,
Code of Federal Regulations, referenced in such Secfion 30.35, are here-
by incorporated by reference with the following exceptions:

(1) Subsection 30.35(g) is not incorporated by reference.

(2) The phrase "byproduct material" shall include all "radioactive ma-
terial" as defined in Title 17, California Code of Regulations, Section
30100, except source material which shall be governed by subsection (b).

(3) The date "January 1, 1996" is substituted for the date "July 27,
1990."

(4) Any reference to the United States Nuclear Regulatory Commis-
sion or any component thereof shall be deemed to be a reference to the
Department.

(5) Any reference to Title 10, Code of Federal Regulations section
30.37 shall be deemed to be a reference to Section 30194.

(6) The date "January 1 , 1 998" is substituted for the date "November
24, 1995."

(b) The regulations governing financial assurance for decommission-
ing in Title 10, Code of Federal Regulafions, Secdon 40.36, as revised
January 1, 1996, including Appendix A to Part 40 of Title 10, Code of
Federal Regulations, referenced in such Section 40.36, is hereby incor-
porated by reference with the following exceptions:

(1) Subsection 40.36(f) is not incorporated by reference.

(2) The date "January 1, 1996" is substituted for the date "July 27,
1990."

(3) Any reference to the United States Nuclear Regulatory Commis-
sion or any component thereof shall be deemed to be a reference to the
Department.

(4) Any reference to Title 10, Code of Federal Regulations Section
40.43 shall be deemed to be a reference to Section 30194.

(5) The date "January 1, 1998" is substituted for the date "November
24, 1995."

Page 184

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30205

( 1 ) Persons authorized to possess no more than 1 .000 times the quanti-
ty specified for each licensed material specified in Appendix B to Part 30
ol" Title 10. Code of Federal Regulations;

(2) Persons authorized to possess hydrogen-3 contained in hydrogen
gas in a sealed source;

(3) Persons authorized to possess radioactive noble gases in sealed
sources with no radioactive daughter product with half-life greater than
30 days; or

(4) Persons authorized to possess no more than 1 0 mCi of source mate-
rial in any form and source material in any quantity in a non-dispersible
form.

NOTH; Authority cited: Sections 100275, 1 15000. and II 5091. Health and Safety
Code. Reference: Sections 114965, 114970, 115060. 115091. 115092 and
1 15235. Health and Safety Code.

History

1. New section filed 7-7-86; effective thirtieth day thereafter (Resister 86, No.
28).

2. Amendment of subsection (c) filed 7-12-89; operative 8-1 1-89 (Resister 89,
No. 28).

3. Renumbering of former section 30 195.1 to new section 301 95.3 and new section
filed 10-16-95 as an emergency; operative 10-16-95 (Register 95. No. 42). A
Certificate of Compliance must be transmitted to OAL by 2-1 3-96 or emergen-
cy language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 10-16-95 order, including amendment of sub-
section (c)( 1 ) and Note, transmitted to OAL 2-9-96 and filed 3-25-96 (Regis-
ter 96, No. 13).

5. Amendment of subsections (a) and (b). new subsections (a)(5). (a)(6). (b)(4) and
(b)(5). and amendment of NOTE filed 9-9-97; operative 10-9-97 (Register 97,

No. 37).

§ 30195.2. Special Requirements for Issuance of Specific
Licenses — Emergency Plans.

(a) The regulations governing application for specific licenses in Title
10. Code of Federal Regulations. Section 30.32. Subsection (i), as re-
vised January 1, 1994, including section 30.72 of Title 10. Code of Feder-
al Regulations, referenced in such Subsection (i), are hereby adopted by
reference with the following exceptions:

( 1 ) The phrase "radioactive material" as defined in Title 1 7, California
Code of Regulations, Section 30100 is substituted for the phrase "bypro-
duct material."

(2) Any reference to the Nuclear Regulatory Commission or any com-
ponent thereof shall be deemed to be a reference to the Department.

(b) In addition to the requirements set forth in §§ 30194, 30195,
30195. 1 and 301 95.3, specific licenses shall be issued only if the require-
ments specified in Subsection (a) are met.

NOTH: Authority cited: Sections 100275 and 115000. Health and Safety Code.
Reference: Sections 114965. 114970. 115060, 115230. and 1 1 5235, Health and
Safety Code.

History

1 . New section filed 10-16-95 as an emergency; operative 1 0-1 6-95 (Register 95,
No. 42). A Certificate of Compliance must be transmitted to OAL by 2-13-96
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 10-16-95 order, including amendment of Note.
transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96, No. 13).

§ 30195.3. Special Requirements for Issuance of Specific
Licenses for Use of Sealed Sources in
Industrial Radiography.

(a) The definitions of sections 30100 and 30330 apply to this section.

(b) An applicant for a specific license for the use of sealed sources in
industrial radiography shall submit:

( 1 ) A description of the applicant's training program that meets the re-
quirements of section 30333(a) and (b). Copies of typical examinations
and correct ansv^ers shall be submitted. Instructors shall, at a minimum,
meet the requirements of section 30333.05(a)(1). Instructor qualifica-
tions shall be submitted;

(2) If the applicant proposes to be a radiation safety training provider,
the information required by section 30331(a)(3) through (a)(5) and the

fee required by section 3033 1 (a)(6) in addition to any fee required by sec-
tion 30230. This information shall be clearly identified as being sub-
mitted for compliance with section 3033 1 ;

(3) Procedures for verifying and documenting the certification status
of radiographers and ensuring that the certification of each radiographer
remains valid;

(4) A description of the applicant's overall organizational structure as
it applies to the radiation safety responsibilities in radiography using
sealed sources, including specified delegation of authority and rcspcmsi-
bility;

(5) Operating and emergency procedures that meet the requirements
of section 30333.1;

(6) A description of the internal inspection system u.scd to assure that
radiographers and radiographer's assistants comply with Department
regulaUons and license conditions and the applicant's operating and
emergency procedures as required by section 30333(e);

(7) The name(s) and qualificaUon(s) of the individual(s) designated as
the radiation safety officer (RSO) and potential designees responsible for
ensuring that the licensee's radiation safety program is implemented in
accordance with Department regulations and license conditions and the
applicant's operating and emergency procedures. The designated RSO
shall, at a minimum, meet the requirements specified in section
30333.07. Potenfial designees shall, at a minimum, meet the require-
ments specified in section 30333.05; and

(8) The location and a description of the locadon of each field station
and permanent radiographic installation.

NOTE: Authority cited: Sections 114975. 115000, 131050, 131051 and 131200,
Heahh and Safety Code. Reference: Sections 1 14965, 1 14970, 1 15()6(). 1 15165
and 1 15235, Health and Safety Code.

History

1. Renumbering of former section 30195.1 to new section 30195.3 filed 10 16 95
as an emergency; operative 10-16-95 (Register 95. No. 42). A Certificate of
Compliance must be transmitted to OAL by 2-13-96 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 10-16-95 order, including amendment of Noti;,
transmitted to OAL 2-9-96 and filed 3-25-96 (Register 96. No. 13).

3. Amendment of section heading, section and Nori-; filed 4-1 1-2008; operative
5-11-2008 (Register 2008, No. 15).

§ 30196. Issuance of Specific Licenses.

NOTE: Authority cited: Secfions 102, 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876,
Health and Safety Code.

History
1. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§ 30197. Specific Terms and Conditions of Licenses.

NOTE: Authority cited: Sections 102. 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876,
Health and Safety Code.

History

1. Amendment filed 1 1-16-67; effective thirtieth day thereafter (Register 67, No.
46).

2. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§30198. Expiration of Licenses.

NOTE: Authority cited: Sections 102, 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25805, 25815, 25855, 25875 and 25876,
Health and Safety Code.

History
1. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§ 30205. Modification, Suspension, Revocation and
Termination of Licenses.

(a) All licenses shall be subject to modification, suspension, or revoca-
tion by regulafions or orders issued by the department.

(b) Any license may be modified, suspended, or revoked by the depart-
ment:

( 1 ) for any material false statement in the application or in any required
report;

(2) because of conditions revealed by any means which would warrant
refusal to grant such a license on an original application; or

(3) for violafion of any terms and conditions of the Act, of the license,
or of any relevant regulation or order of the department, including non-

Page 185

§ 30210

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

payment of license fee pursuant to Sections 30230-30232 of this regula-
tion.

(c) Prior to the institution of proceedings to modify, suspend, or revoke
a license, facts or conduct which may warrant such action shall be called
to the attention of the licensee in writing and the licensee shall be ac-
corded reasonable opportunity to demonstrate or achieve compliance,
except in cases of willful violation or those in which the public health or
safety requires otherwise.

(d) A specific license may be terminated by mutual consent between
the licensee and the department.

NOTE: Authority cited: Sections 208 and 258 11(d), Health and Safety Code. Ref-
erence: Sections 25801 . 25802. 258 1 5. 25875 and 25876, Health and Safety Code.

HlSTOI^Y

1. Amendment of subsection (b)(3) filed 10-12- 72; effective thirtieth day thereaf-
ter (Register 72, No. 42).

2. New NOTK filed 8-22-84 (Register 84, No. 34).

Article 5. Transfer of Material

§ 30210. Authorization for Transfer.

(a) A licensee may transfer radioactive material only to persons listed
below and only following acceptance of such transfer:

( 1 ) the Department;

(2) any person who is exempt from this regulation to the extent per-
mitted under such exemption; or

(3) any person licensed or authorized to receive the material by the
United States Nuclear Regulatory Commission, the Department, or any
other Agreement State.

(b) This section does not authorize the commercial distribution of ra-
dioactive material other than those items listed in Section 30192 through
30192.6, except when such distribution is authorized by a specific h-
cense.

NOTE: Authority cited: Secfions 102, 208 and 258 11, Health and Safety Code.
Reference: Sections 25801, 25802, 25815. 25855, 25875 and 25876, Health and
Safety Code.

History

1. Repealer of Article 5 (Section 30210 and 3021 1) and new Article 5 (Section
30210) filed 1 1-29-65; effecfive thirtieth day thereafter (Register 65, No. 23).
For prior history, see Register 62, No. 1 .

2. Amendment filed 1 1-16-67; effecfive thirtieth day thereafter (Register 67, No.
46).

3. Amendment filed 5-13-69; effective thirtieth day thereafter (Register 69, No.
20).

4. Amendment filed 7-8-87; operafive 8-7-87 (Register 87, No. 29).

§30210.1. Verification Required.

(a) Before transferring radioactive material to a licensee, the licensee
transferring the material shall verify license authorization for the receipt
of the type, form and quantity of radioactive material to be transferred.

(b) The transferrer shall utilize methods of verification and maintain
records of verification required by subsection (a) as specified in
10CFR30.41 (38FR33968).

NOTE: (1) Authority cited: Sections 208 and 2581 1, Health and Safety Code. Ref-
erence: Sections 25801, 25802, 25811, 25815, 25855, 25875 and 25876, Health
and Safety Code.

(2) Copies of Title 10, Code of Federal Regulations — Energy, are for
sale by the Superintendent of Documents, U.S. Government Printing Of-
fice, Washington, D.C. 20402.

History

1. New section filed 7-7-86; effecfive thirtieth day thereafter (Register 86. No.
28).

2. Change without regulatory effect of NOTE (Register 88, No. 6).

§ 30210.2. Labeling Requirements for the Manufacture,
Preparation or Transfer for Commercial
Distribution of Drugs Containing Radioactive
Material for Human Use as Authorized by a
Specific License.
(a) A person applying for a specific license to manufacture, prepare or

transfer for commercial distribution radioactive dmgs for human use

shall satisfy the following labeling requirements:

( 1 ) A label shall be affixed to each transport radiation shield of a radio-
active drug to be transferred for commercial distribution. The label shall
include:

(A) The radiation symbol and the words, "CAUTION, RADIOAC-
TIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL";

(B) The name of the radioactive drug or its abbreviation; and

(C) The quantity of radioactivity at a specified date and time. For ra-
dioactive drugs with a half-life greater than 100 days, the time may be
omitted.

(2) A label shall be affixed to each syringe, vial, or other container used
to hold a radioactive drug to be transferred for commercial distribution.
The label shall include:

(A) The radiation symbol and the words, "CAUTION, RADIOAC-
TIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL",
and

(B) An identifier that ensures that the syringe, vial, or other container
can be correlated with the information on the transport radiation shield
label.

NOTE: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970. 115060, 115165 and 115235, Health and
Safety Code.

History
1. New secfion filed 10-13-99; operative 1 1-12-99 (Register 99, No. 42).

Article 6. Enforcement

§ 30220. Violations.

NOTE: Authority cited: Sections 102, 208 and 25811, Health and Safety Code.
Reference: Secfions 25801, 25802, 25815, 25855, 25875 and 25876, Health and
Safety Code.

History

1. Repealer of Article 6 (Sections 30215 through 30217) and new Article 6 (Sec-
tion 30220) filed 1 1-29-65; effective thirtieth day thereafter (Register 65, No.
23). For prior history, see Register 62, No. 21.

2. Repealer filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

Article 7.

Reciprocal Recognition of
Licenses

§ 30225. Persons Licensed by Other Agencies.

(a) Any person who holds a specific license issued by the United States
Nuclear Regulatory Commission, or by any other Agreement State or by
any state that has been either provisionally or finally designated as a Li-
censing State by the Conference of Radiation Control Program Directors,
Inc., other than this State, may conduct activities of the kind therein au-
thorized within this State for a period not in excess of 1 80 days in any cal-
endar year without obtaining a specific license from the department, pro-
vided that the following conditions are satisfied:

( 1 ) The person maintains an office for directing the licensed activity,
and at which radiation safety records are normally maintained, in a loca-
tion under jurisdiction of the agency which issued the specific license.

(2) The license does not limit the authorized activity to specified in-
stallations or locations.

(3) The person provides written notice to the department at least 3 days
prior to engaging in such activity. Such notice shall indicate the location,
specific time period, and type of proposed possession and use within this
state, and shall be accompanied by a copy of the pertinent license. If, for
a specific case, the 3-day period would impose an undue hardship on the

Page 186

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30231

person, the person may make application to the department to proceed
sooner.

(4) The person complies with all applicable regulations of the depart-
ment and with all the terms and conditions of the license, except such
terms and conditions which may be inconsistent with said regulations.

(5) The person supplies such other information as the department may
request.

(6) The person pays a fee in accordance with section 30230(0 to the
Department prior to the engagement of activities within the state.

(h) Any person who holds a specific license issued by the United States
Nuclear Regulatory Commission, or by any other Agreement State or by
any state that has been either provisionally or finally designated as a Li-
censing State by the Conference of Radiation Control Program Directors.
Inc.. other than this State, authorizing the holder to install or service a de-
vice described in section 30192.1(a) shall be issued a general license to
install or service such device in this State, provided that the following
conditions are satisfied:

( 1 ) The person files a report with the department within 30 days after
the end of each calendar quarter in which any device is transferred to or
installed in this State identifying each device recipient by name and ad-
dress, the type of device transferred or installed, and the quantity and type
of radioactive material contained in each device.

(2) The device has been manufactured and labeled and is installed and
serviced in accordance with applicable provisions of the specific license.

(3) The person assures that any labels required to be affixed to the de-
vice under regulations of the authority which licensed manufacture of the
device are affixed and bear a statement that "Removal of this label is pro-
hibited."

(4) The person furnishes to each device recipient in this State to whom
he or she transfers such a device or on whose premises he or she installs
the device, a copy of Group 1.5 of this subchapter, of section 30192.1(a)
and (b) of this regulation, and of sections 30253, 30254, 30293(a)(2) and
30295 of Group 3 of this subchapter.

(c) The department may withdraw, limit, or qualify its acceptance of
any license specified in secdons 30225(a) or (b) upon determining that
such acfion is necessary to protect health or to minimize danger to life or
property.

NOTH: Authority cited: Sections 100275, 1 15000 and 1 15060. Health and Safety
Code. Reference: Sections 114965, 114970. 114985, 114990. 115060. 115065,
115090. 115093, 115105, 115110, 115120, 115165, 1 15230 and 115235. Health
and Safety Code.

History

1. Repealer of article 7 (section 30220) and new article 7 (section 30225) filed
1 1-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior his-
tory, see Register 62, No. 21.

2. Amendment of subsection (a) filed 7-22-71; effective thirtieth day thereafter
(Register 71, No. 30).

3. Amendment of subsection (a) filed 10-12-72; effective thirtieth day thereafter
(Rcgi.ster 72, No. 42).

4. New NoTH filed 8-22-84 (Register 84, No. 34).

5. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

6. New subsection (a)(6) and amendment of Noth filed 10-23-91; operative
1 1-22-91 (Register 92, No. 5).

7. Amendment of section and Note filed 10-15-2001; operafive 11-14-2001
(Register 2001, No. 42).

8. Amendment of subsection (a)(6) filed 6-22-2005 as an emergency; operative
6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be trans-
mitted to OAL by 10-20-2005 or emergency language will be repealed by op-
eration of law on the following day.

9. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

Article 8. License Fees

§ 30230. License Fees.

(a) Except as provided in subsection (b), each applicant for a specific
license pursuant Lo the provisions of this group shall include with the ap-
plication a nonrefundable fee, which is equal to the annual fee as set forth
in section 3023 1 . and if the specific license is granted, the application fee
shall constitute the annual fee for the first year of the license.

(b) Each applicant for a specific license for commercial distribution of
sealed sources or devices containing sealed sources, who requests evalu-
ation of the information submitted pursuant to section 3()195(d)( 1 ) and
(d)(2). shall include with the application, a nonrefundable fee, which is
equal to the annual fee, and a nonrefundable evaluation fee as set forth
in section 30231. If the specific license is granted, the fee equal to the
annual fee shall constitute the annual fee for the first year of the license.

(c) Each licensee shall pay an annual fee. as set forth in section 3023 1 .
on or before the anniversary of the effective date of the license.

(d) Each licensee, who applies for an amendment to a specific license
that increases the maximum possession limits of the license shall include
with the request submitted pursuant to section 301 94.2, an additional fee
for each such amendment, as set forth in section 30231(c).

(e) Each licensee authorized pursuant to section 301 95(d) to commer-
cially distribute sealed sources or devices containing sealed sources
shall, in addition to the annual fee specified in section 30231(a). pay:

(1) The evaluation fees specified in secfion 30231(f)( 1 ) through (3),
specific to the type of evaluation, when a request for evaluation is sub-
mitted to the Department; and

(2) The annual fee specified in section 30231(f)(4).

(0 Each person authorized to conduct activities within the state pur-
suant to section 30225(a) shall pay a fee as specified in section 3023 1 (e).
NOTH: Authority cited: Sections 100275. 1 15000, 1 15060 and 1 15065, Health and
Safety Code. Reference: Sections 114965, 114970. 114980 and 115165. Health
and Safety Code.

History

1. Amendment filed 8-1-62; effective thirtieth day thereafter f Register 62. No.
16).

2. Renumbering from article 9 to article 8. filed 1 1-29-65 (Regi.ster 65. No. 23).

3. New NoTh filed 8-22-84 (Register 84, No. 34).

4. New subsection (d) and amendment of Noth filed 10-23-91; operative
1 1-22-91 (Register 92, No. 5).

5. Amendment of section and Note filed 6-22-2005 as an emergency; operative
6-22-2005 (Register 2005, No. 25 ). A Certificate of Compliance must be trans-
mitted to OAL by 10-20-2005 or emergency language will be repealed by op-
eration of law on the following day.

6. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005. No. 42).

§30231. Fee Schedule.

(a) The annual fee shall be calculated in accordance with the following
formula and shall not exceed $25,000.00 for any one license:

Annual fee (rounded to the nearest dollar) = A-f-(AxBxC)

Where:

A = [Sum of the license fee specified in subsection (b)( 1 ), the fee for
unsealed sources specified in subsection (b)(2) and the fee for sealed
sources specified in subsecfion (b)(3) |

B = [Number of authorized use locations minus one as specified in
subsection (b)(4)]

C = [0.2 as specified in subsecfion (b)(4)].

(b) The annual fee for each specific license shall consist of the follow-
ing components:

( 1 ) A fee of $ 1 , 1 1 2.00 for each license;

(2) A fee for the unsealed sources authorized to be possessed at any one
fime by the license provided such unsealed sources have a combined total
strength of over 10 millicuries (mCi), as follows:

Over 10 mCi. but not over 100 mCi $636.00

Over 100 mCi, but not over 500 mCi $1,271 .00

Over 500 mCi, but not over 1 curie (Ci) $2,543.00

Over 1 Ci, but not over 10 Ci $3,814.00

Over 10 Ci, but not over 100 Ci $5,085.00

Over 100 Ci $6,375.00;

(3) A fee for the sealed sources authorized to be possessed at any one

time by the license provided such sealed sources have a combined total

strength of over 100 mCi, as follows:

Over 100 mCi, but not over 1 Ci $636.00

Over 1 Ci, but not over 5 Ci $1,271.00

Over 5 Ci, but not over 10 Ci $2,.543.()()

Over 10 Ci, but not over 100 Ci $3.814.()()

Over 100 Ci, but not over LOOO Ci S5,085.0()

Over 1,000 Ci S6..\57.()(): and

(4) A fee for each location of use greater than one, authorized in a spe-
cific license pursuant to secfion 30194.1, which is determined by multi-

Page 186.1

§ 30232

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

plying ihe number of authorized use locations minus one by the sum of
the values of subsections (b)(1) through (3) and by 0.2.

(c) The amount of additional fee required pursuant section 30230(d),
except as limited by this section, shall be the difference between the cur-
rent annual fee and the total annual fees required for the new limits re-
quested.

(d) Any licensee who fails to pay the annual fee by the anniversary of
the effective date of the license shall immediately cease use of all sources
of radiation by placing the sources in storage until such time as the annual
fee and a late fee of 25 percent of the annual fee has been paid.

(e) The fee for persons authorized to operate under section 30225(a)
shall be equal to the annual fee as specified in subsection (a) for the com-
bined total strength of radioactive material that will be possessed while
in this state. The fees shall be effective for the period in which reciprocity
is granted under section 30225.

(f) The fees required by subsections (b) and (e) of section 30230 shall
be as follows:

( 1 ) $4,270.00 for evaluation of each device and sealed source;

(2) $3,270.00 for evaluation of each device only.

(3) $ 1 ,000.00 for evaluation of each sealed source only; and

(4) $400.00, annually, for each registry certificate maintained by the
Department indicating that the sealed source or device is commercially
manufactured and/or distributed and includes evaluations of modifica-
tions of the source or device identified on the certificate.

(g) Fees required by this section shall be nonrefundable.

NOTE: Authority cited: Sections 100275. 1 15000. 115060 and 115065. Health and
Safety Code. Reference: Sections 114965. 114970, 114980 and 115165. Health
and Safety Code.

History

1. Amendment filed 8-1-62; effective thirtieth day thereafter (Register 62. No.
16).

2. Amendment filed 7-2-82; effective thirtieth day thereafter (Register 82, No.
27).

3. Kditorial correction of Norr-; filed 8-22-84 (Register 84, No. 34).

4. Amendment filed 7-7-86 as an emergency; effective upon filing (Register 86.
No. 28). A Certificate of Compliance must be transmitted to OAL within 120
days or emergency language will be repealed on 1 1-4-86.

5. Certificate of Compliance transmitted to OAL 10-9-86 and filed 11-7-86
(Register 86. No. 45).

6. Amendment filed 3-6-89 as an emergency; operative 3-6-89 (Register 89. No.
10). A Certificate of Compliance must be transmitted to OAL within 120 days
or emergency language will be repealed on 7-5-89.

7. Certificate of Compliance transmitted to OAL 6-12-89 and filed 6-28-89
(Register 89, No. 26).

8. New subsection (e) and amendment of NoTh filed 10-23-91; operative
1 1-22-91 (Register 92. No. 5).

9. Amendment of subsections (a)-(c) and (e) and NoTi; filed 3-1-94 as an emer-
gency; operative 3- 1-94 (Register 94. No. 9). A Certificate of Compliance must
be transmitted to OAL by 6-28-94 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 3-1-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94. No. 28).

1 1 . Repealer and new section and amendment of NoTi-; filed 6-22-2005 as an
emergency; operative 6-22-2005 (Register 2005. No. 25). A Certificate of
Coinpliance must be transmitted to OAL by 10-20-2005 or emergency lan-
guage will be repealed by operation of law on the following day.

12. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005. No. 42).

§ 30232. Fee Limitations.

NOTE: Authority cited: Sections 208. 2581 1 and 25816. Health and Safety Code.
Reference: Sections 25801. 25802, 25815, 25816, 25875 and 25876, Health and
Safety Code.

History

1. Amendment filed 7-2-82; effective thirtieth day thereafter (Register 82, No.
27).

2. Editorial con-ection of NoTi-: filed 8-22-84 (Register 84, No. 34).

3. Amendment filed 7-7-86 as an emergency; effective upon filing (Register 86,
No. 28). A Certificate of Compliance must be transmitted to OAL within 120
days or einergency language will be repealed on 1 1-4-86.

4. Certificate of Compliance transmitted to OAL 10-9-86 and filed 11-7-86
(Register86, No. 45).

5. Amendment filed 3-6-89 as an emergency; operative 3-6-89 (Register 89, No.
10). A Certificate of Compliance must be transmitted to OAL within 120 days
or emergency language will be repealed on 7-5-89.

6. Certificate of Compliance transmitted to OAL 6-12-89 and filed 6-28-89
(Register 89, No. 26).

7. Amendment of subsections (a), (c)-(f) and Notk filed 3-1-94 as an emergency;
operative 3-1-94 (Register 94, No. 9). A Certificate of Compliance must be
transmitted to OAL by 6-28-94 or emergency language will be repealed by op-
eration of law on the following day.

8. Certificate of Compliance as to 3-1-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94. No. 28).

9. Repealer filed 6-22-2005 as an emergency; operative 6-22-2005 (Register
2005, No. 25). A Certificate of Compliance must be transmitted to OAL by
10-20-2005 or emergency language will be repealed by operation of law on the
following day.

10. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

[The next page is 187.]

Page 186.2

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

S 30235

Article 9. Schedules

§ 30235. Schedule A. Exempt Quantities.

Mtcro-

RadionucUde curies

Antimony-122 (Sb»") 100

Antimony-124 (Sb»") 10

Antimony-125 (Sb'") 10

Arsenic-73 (As") 100

Arsenic-74 (As'*) 10

Arsenic-76 (As'«) 10

Arsenic-77 (As") 100

Barium-131 (Ba'=») 10

Barium-133 (Ba'") lo

Barium-140 (Ba'") 10

Beryllium-7 (Be') 100

Bismuth-210 (Bi"'") 1

Bromine-82 (Br") 10

Cadmium-109 (Cd"»») 10

Cadmium-115m (Cd'""') 10

Cadmium-115 (Cd"*) 100

Calcium-45 (Ca") 10

Calcium-47 (Ca*') 10

Carbon-14 (C'<) 100

Cerium-141 (Ce"") 100

Cerium-143 (Ce'**) 100

Cerium-i44 (Ce»**) 1

Cesium-129 (Cs"'») 100

Cesium-lSl (Cs'=") 1,000

Cesium-134m (Cs'^'") 100

Cesium-134 (Cs»") 1

Cesium-135 (Cs«") 10

Cesium-136 (Cs'=»») 10

Cesium-137 (Cs>") 10

Chlorine-36 (Cl»«) 10

Chlorine-38 (Ci="*) 10

Chromium-51 (Cr") 1,000

Cobalt-57 (Co") 100

Cobalt-58m (Co**") 10

Cobalt-58 (Co") 10

Cobait-60 (Co«») I

Copper-64 (Cu«*) 100

Dysprosium-165 (Dy«") 10

Dysprosium-166 (Dy'»«) 100

Erbium-i69 (Er"») 100

Erbium-171 (Er«'«) 100

Europium-1529.2h (Eu»w9.2

h) 100

Europium-152 13 yr (Eu'" 13

yr) 1

Europium-154 (Eu"") 1

Micro-

Radionuclide curies

Europium-155 (Eu'»') 10

Fluorine-18 (F'") 1.000

Gadolinium-153 (Gd'") 10

Gadolinium-159 (Gd»") 100

Gallium-67 (Ga«') 100

Gallium-72 (Ga") 10

Gennanium-71 (Ge^') 100

Gold.198 (Au'") 100

GoId-199 (Au'»«) 100

Hafnium-181 (HP«') 10

HoImium-166 (Ho«««) 100

Hydrogen^ (H^) 1,000

Indium-lll (In"M 100

Indium-113m (In''^*") 100

Indium-114m (In""")..... 10

Indium-115m (In""") 100

Iodine-123 (P") 100

Iodine-125 (I'") 1

Iodine-126 (!•") 1

Iodine-129 (!"») 0.1

Iodine.131 (!•=») 1

Iodine-132 (I>»») 10

Iodme-133 (P^*) i

Iodine.134 (!•»*) 10

Iodine-135 (P^») 10

Iridium-192 (Ir'") 10

Iridium-194 (Ir»»<) 100

Iron-52 (Fe") 10

Iron-55 (Fe") 100

Iron-59 (Fe'») 10

Krypton^ (Kr") 100

Krypton-87 (Kr") 10

Lanthanum-140 (La**") 10

Lead-210 (Pba'") 0.1

LuteHum-177 (Lu'") 100

Manganese-52 (Mn") 10

Manganese-54 (Mn") 10

Manganese-56 (Mn"J 10

Mercury-197m (Hg"^"") 100

Mercury-197 (Hg"»') 100

Mercury-203 (Hg»") 10

Molybdenum-99 (Mo»») 100

Neodymium-147 (Nd'*') 100

Neodymium-149 (Nd'«) 100

Nickel^9 (Ni*») 100

Nickel.63 (Ni*») 10

Page 187

§ 30236

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Micro-
RadionucUde curies

Nickel-65 (Ni8») 100

Niobmm-93m (Nb**^'") 10

Niobium-95 (Nb»*) 10

Niobium-97 (Nb") 10

Osmium-185 (Os'»*) 10

Osmium-191m (Os'»"") 100

Osmium-191 (Os"") 100

Osmium-193 (Os'") 100

Palladium-lOa (Pd'»») 100

PaUadium-109 (Pd'"') 100

Phosphorus-32 (P") 10

Platinum-191 (Pt"") 100

Platinuni-193m {Pt'83'") 100

Platinum-193 (Pt'^^) 100

Platinum-197m (Pt'»^'") 100

Platinum- 197 (Pt"»^) 100

Polonium-210 (Po*'") 0.1

Potassium'42 (K«) 10

Potassium-43 (K") 10

Praseodyniiuin-142 (Pr'«) .... 100

Praseodymium-143 (Pr'") .... loo

Promethium-147 (Pm'*') 10

Promethium-149 (Pm'*») 10

Rhenium-186 (Re»»«) 100

Rhenium-188 (Re*") 100

Rhodium-103m (Rh"^") 100

Rhodium-105 (Rh»«*) 100

Rubidium-81 (Rb*') 10

Rubidium-86 (Rb"") 10

Rubidium-87 (Rb") 10

Ruthenium-97 (Ru»') 100

Ruthenium-103 (Ru*"^) lo

Ruthenium-105 (Ru"») 10

Ruthenium-106 (Ru'o«) 1

Samarium-lSl (Sm'*') 10

Samarium-153 (Sm»") 100

Scandium-46 (Sc") 10

Scandium-47 (Sc*') 100

Scandium-48 (Sc*») 10

Selenium-75 (Se") 10

Silicon-31 (Si'*) 100

Silver-105 (Ag'") 10

Silver-lIOm (Ag'""") 1

Silver-ill (Ag'") 100

Sodium-22 (Na**) i

Sodiuni-24 (Na") 10

Strontium-85 (Sr") 10

Strontium-89 (Sr"") 1

Micro-
Radionuclide curies

Strontium-dO (SrS") 0.1

StTontium-91 (Sr"') 10

Strontium-92 (Sr*'*) 10

Sulphur-35 (S") 100

Tantalum-182 (Ta'") 10

Technetium-96 (Tc»«) 10

Technetium-97m (Tc*""') 100

Technetium-97 (Tc«') 100

Technetium-99m (Tc""'") 100

Technetium-99 (Tc*") 10

Tellurium- 125m (Te'***'") 10

Tellurium-127m (Te'""") 10

Tellurium.127 (Te»»^) 100

Tellurium-129m (Te'*«'") 10

Tellurium.129 (Te"*i 100

Tellurium-131m (Te'^"") 10

Tellurium-i32 (Te'»») 10

Terbium-160 (Tb««») 10

Thallium-200 (Tl"") 100

ThaUium-201 (Tl*««) 100

ThaUium-204 (Tl"<) 10

Thulium-170 (Tm'-'«) 10

Thulium-171 (Tm'^') 10

Tin-113 (Sn»'^) 10

Tin-125 (Sn'") 10

Tungsten- 181 (W>»«) 10

Tungsten-185 (W") 10

Tungsten.187 (W»") 100

Vanadium-48 (V*") 10

Xenon-131m (Xe'»"") 1,000

Xenon-133 (Xe>") 100

Xenon-135 (Xe'") 100

Ytterbium-175 (Yb>") 100

yttrium-87 (Y") 10

Yttrium-90 (Y«») 10

Yttrium-91 (Y"') 10

Yttrium-92 (Y") 100

YttTium-93 (Y") 100

Zinc-65 (Zn") 10

Zinc-69m (Zn®"") 100

Zinc-69 (Zn««) 1,000

Zirconium-93 (Zr") 10

Zirconium-95 (Zr") 10

Zirconium-97 (Zr®') 10

Any radionuclide not listed
above other than alpha

emitting radionuclides.... 0.1

NOTE; Authority cited: Sections 100275 and 1 15000, Health and Safety Code.
Reference: Sections 114965, 114970, 115000, 115060, 115165, 115230 and
1 15235, Health and Safety Code.

History

1. New Schedule A filed 7-22-71; effective thirtieth day thereafter (Register 71,
No. 30). For history of former section, see Register 62. No. 16.

2. Amendment filed 10-12-72; effective thirtieth day thereafter (Register 72, No.
42).

3. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

4. Amendment of Note filed 7-28-2006; operative 8-27-2006 (Register 2006,
No. 30).

§ 30236. Schedule B, Table I, In Vitro Clinical Tests.

Maxinaum Maximum
MiCTOcuries Microcuries

Radionuclide Per Unit Total

Hydrogen 3 50 2,000

Carbon 14 10 2,000

Iron 59 20 200

Selenium 75 lo 200

Cobalt 57 10 200

Iodine 125 or Iodine 131 10 200

Mock Iodine 125
Reference Source

Iodine 129 0.05 —

Americium 241 0.005 —

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815, 25855, 25875 and 25876, Health and
Safety Code.

History
1. New Schedule B filed 7-7-86; effective thirtieth day thereafter (Register 86,

No. 28). For history of former Schedule B, see Registers 72, No. 42, and 67, No.

46.

Page 188

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30237

§30237. Schedule C.

•

Element (atomic number)

Isotope

Column I
Gas-
concentration
([iCi/ml^)

•

Antimony (51 ) Sb'--

Sbl24

Sb'25

Argon (18) Ar^"?

Ar41

Arsenic (33) As^3

As74
As'^'i
As77

Barium (36) Ba^^l

Bal40

Beryllium (4) Be^

Bismuth (83) Bi206

Bromine (35) Br^^

Cadmium (48) Cd^O^

Cdii3

Calcium (20) Ca'*5

Ca47

Carbon (6) C'^

Cerium (58) Cei"*'

Cel43
Cei44

Cesium (55) Cs^^i

Csl34m

Cs»34

Chlorine (17) Cp6

Chromium (24) Cr^l

Cobalt (27) Co57

Co58

Co60

Copper (29) Cu64

Dysprosium (66) Dy'^^

Dyl66

Erbium (68) Eri69

Erl71

Europium (63) Eu''^^

(T/2=9.2 Hrs.)
Eul58

Fluorine (9) p'S

Gadolinium (64) Gd'53

Gdl59

Gallium (31) Ga^2

Germanium (32) Ge^^

Gold (79) Aui96

Aul98
Aul99

Hafnium (72) Hfl8l

Hydrogen (1) H3

Indiuin (49) Inll3m

Inll4m

Iodine (53) l'26

1131
Il32
Il33
jl34

Iridium (77) Irl90

Irl92

Irl94

Iron (26) Fe53

Fe59

Krypton (36) Kr86m

Kr88

Lanthanum (57) La'^O

Lead (82) Pb203

Lutetium (71) Lu''^'^

Manganese (25) Mn52

Mn54
Mn56

Mercury (80) Hgl97m

Hgl97
Hg203

Molybdenum (42) Mo99

Neodymium (60) Ndi47

Ndl49

1 X 10-3
4x 10-'^

4x 10-

Ix Ky-^

9x10-7

2x 10-6

5x 10-6

3x10-9
3 x 10-9
8 X 10-8

1 X 10-8

2 X 10-7

1 X 10-6
3 X 10-6

Column II

Liquid and solid

concentration

(liCi/ml-)

3x 10-4
2x 10-4
1 X 10-3

5x10-3

5xl(H

2x 10-4

8x 10-^

2x10-3

3x10-*

2x 10 2

4x10-^

3 x 10-2

2x10-2

3x10-^

3x10-*

9x 10-3

5x10-^

8x10-3

9x10-4

4x10-4

1 xlO-^

2x10-2

6x10-2

9x10-3

4X 10-3

2x10-2

5x 10-3

1 X 10-3

5x10-4

3x10-3

4x10-3

4x10-*

9x10-^

1 X 10-3

6x10-*

2x'l'a-'3'

8x10-3

2x10-3

8x10-4

4x10-*

2x10-2

5x10-*

2x10-2

7x10-*

3 X 10-2

1 X 10-2

2x10-4

2x10-5

2 x 10-3

6x10-4

7x10-3

1 X 10-3

2x10-3

4x10-4

3x10-*

8x10-2

6x10-*

2x10-4
4X 10-3
1 X 10-3
3X10-*
1 X 10-3
1 X 10-3
2x10-3
3x10-3
2xl(H
2x 10-3
6x10-*
3x10-3

Page 189

§ 30237

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Element (atomic number)

Isotope

Column I

Gas

concentration

(|IC//m/'j

Nickel (28) Ni<'6_

Niobium (columbium)(41 ) Nb'^-"'

Nb97

Osmium (76) Os'^-^

Osl91ni

Osl91
Osl93

Palladium (46) Pd'O-^

Pd'09

Phosphorus (15) ?^-

Platinum (78) Pt''^'

ptl93m
p,197m
p,197

Polonium (84) Po^'O

Potassium (19) K"*-

Praseodymium (59) Pr'^-

p,.143

Promethium (61) Pm'^?

Pml^9

Radium (88) Ra--^

Radon (86) Rn230

Rn222

Rhenium (75) Re'^^

Rel85
Rel88

Rhodium (45) Rh'O^m

RhlOS

Rubidium (37) Rb^S

Ruthenium (44) Ru^''

Rul03
Ru'05
Rul06

Samarium (62) Sm'^^

Scandium (21) Sc^S

Sc'*^
Sc48

Selenium (34) Se^3

Silicon (14) Si31

Silver (47) Agi05

^gllOm

Aglll

Sodium (11) Na^'*

Strontium (38) Sr^^

Sr89
Sr9l
Sr92

Sulfur (16) S^-"^

Tantalum (73) Ta'^^

Technetium (43) Tc99ni

Tc98

Tellurium (52) Tel2--'ni

jel27m

Tei27

ygl29ni

Xei32

Terbium (65) Tb^^g

Thallium (81) TpOO

jl20]
J1202
Jl204

Thulium (69) Tm™

Tml71

Tin (50) Snii3

Snl23

Tungsten (wolfram)(74) W^^l

Wl87

Vanadium (23) V48

Xenon (54) Xei3im

Xel33
Xel35

Ytterbium (70) Yb^''^

Yttrium (39) Y^O

Y91
Y92
Y93

1 X 10-7
1 X 10-8

9x 10-8

4x 10-6
3 X 10-6
Ix 10-6

Column U

Liquid

and solid

concentration

([iCi/ml-)

1 X

0-3

1 X

0-3

0-*

10-2

10-3

10-4

10-3

10-4

10-^

1 X

10-3

1 X

10-2

1 X

10-2

1 X

10-3

10-4

10-3

10-4

10-3

10-4

10-7

10-3

10-^

10-4

10-1

1 X

10-3

10^

10-3

10-4

10-3

1 X

10-^

10-4

10-^

10-2

1 x

10-3

10-4

10-^

10-3

1 X

10-3

10-4

10^

10-8

10-4

1 X

10-1

1 X

10-3

10-4

10-3

10-^

10-4

10-3

10-2

10-3

10-4

10-3

10^

10-^

10-3

10-4

10-^

1 X

10-3'

10-4

10-3

10-4

10^

•

Page 190

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30253

Element (atomic number)

Isotope

Column I

Gas

concentration

(\lCi/mlh

Column II

Liquid and solid

concentration

(\lCi/mr-)

Zinc (30)

Zirconium (40)

Zn65
7n69m

Zn(^^>
Zr95

Zr'"

Beta and/or gamma emitting
radioactive material not
listed above with hall-life
less than 3 years

Note-:: l : Many radioisotopes disintegrate into isotopes which are also radioac-
tive. In expressing the concentrations in Schedule C, the activity stated is that of
the pai'ent isotope and takes into account the daughters.

NOTt;: 2: Where there is involved a combination of isotopes, the limit for the com-
bination should be derived as follows:

Determine for each isotope in the product the ratio between the concentration
present in the product and the exempt concentration established in Schedule C for
the specific isotope when not in combination. The sum of such ratios may not ex-
ceed "1" (i.e. unity).

Example :

Concentration of Isotope A in Product

Concentrate of I.sotopc B in Troduct

l-.xempt concentration of I.sotopc A hxcinpt concentration of Isotope B

' Values are given only for those materials normally used as gases.

- |iCi/gm for solids.

NOTK; Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970, 115000, 115060, 115165, 115230 and
1 15235, Health and Safety Code.

History

1. Amendment filed 7-22-71; effective thirtieth day thereafter (Register 71, No.
30).

2. Change without regulatory effect amending Arsenic and Beryllium and adop-
tion of Noth filed 11-1-91 pursuant to section 100, title 1 , California Code of
Regulations (Register 92, No. 5).

3. Amendment of listings for argon and platinum and amendment of footnote 2 and
NoTK filed 7-28-2006; operative 8-27-2006 (Register 2006, No. 30).

Group 3.

Standards for Protection Against
Radiation

Article 1. General

§ 30250. Authority.

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. Repealer of Article 1 and new Article 1 (30250 through 30255) filed 11-29-65;
effective thirtieth day thereafter (Register 65, No. 23). For former Article 1 , see
Register 62, No. 1.

2. Repealer filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§ 30251 . Purpose.

Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History
1. Repealer filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§ 30252. Scope and Purpose.

(a) Group 3 regulations apply to all persons who possess sources of ra-
diation, except as exempt from the licensing and registration require-
ments or otherwise specifically exempted by the provisions of Group 1
and Group 2 of this subchapter.

(b) The limits in Group 3 do not apply to doses due to background radi-
ation, to exposure of patients to radiation for the purpose of medical diag-
nosis or therapy, or to voluntary participation in medical research pro-
grams.

NOTE: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 2580], 25802, 2581 1 and 25815, Health and Safety Code.

History
1. Repealer and new subsection (b) filed 3-3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted

X 10-

1 X 10--^
7x 10-^
2x 10--
6X 10-^
2x 10-^

X 10^

to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day. For prior history, sec Register 87, No. 28.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6 7-94 and
filed 7-14-94 (Register 94. No. 28).

3. Editorial correction deleting History 1 and amending and redesignating Histo-
ry 2 (Register 94, No. 28).

§ 30253. Standards for Protection Against Radiation.

(a) The regulations governing standards for protection against radi-
ation in title 10, Code of Federal Regulations, part 20, (10 CFR 20) sec-
tions 20.1001 through 20.2402 and Appendices A through G, (January
1, 2005) are hereby incorporated by reference with the following excep-
tions:

(1) Title 10, Code of Federal Regulations, sections 20.1001, 20.1002,
20.1006, 20.1007, 20.1008, 20.1009. 20.1401, 20.1402, 20.1403,
20.1404, 20.1405, 20.1406, 20.2106(d), 20.2302, 20.2401, and 20.2402,
and Appendix D are not incorporated by reference.

(2) Any references to the United States Nuclear Regulatory Commis-
sion (NRC) or any component thereof shall be deemed to be a reference
to State Department of Health Services.

(3) The definition of the term "Byproduct material" in 1 0 CFR 20, sec-
tion 20. 1003 is modified to mean any radioactive material, except special
nuclear material, yielded in or made radioactive by exposure to the radi-
ation incident to, the process of producing or utilizing special nuclear ma-
terial.

(4) The definition of the term "License" in 1 0 CFR 20, section 20. 1 003
is replaced by the definition of the term "License" as defined in section
30100 of this regulation.

(5) The definiUon of the term "Licensed material" in 10 CFR 20, sec-
tion 20.1003 is modified to mean any radioactive material including
source material, special nuclear material, or byproduct material received,
possessed, used, transferred or disposed of under a general or specific li-
cense issued by the NRC, or by any other Agreement State or by any state
that has been either provisionally or finally designated as a Licensing
State by the Conference of Radiation Control program Directors, Inc.
With respect to dose limits and reporting requirements, the term "Li-
censed material" is to be construed broadly in context to include any
source of ionizing radiation subject to the requirements of this regulation.

(6) The definition of the term "Licensee" as defined in 1 0 CFR 20, sec-
tion 20. 1003 is replaced by the definition of the term "User" as set forth
in section 30100 of this regulation.

(7) The definition of the term "Person" as defined in 10 CFR 20, sec-
tion 20. 1 003 is replaced by the definition of the term "Person" as set forth
in secfion 1 14985(c) of the Health and Safety Code.

(8) The definition of the term "Radiation (ionizing radiation)" as de-
fined in 10 CFR 20, secfion 20.1003 is replaced by the definition of the
term "Ionizing radiafion" as set forth in section 1 14985(b) of the Health
and Safety Code.

(9) The definition of the term "Special nuclear materials" as defined
in 10 CFR 20, secfion 20.1003 is replaced by the definition of the term
"Special nuclear material" as set forth in section 1 14985(f) of the Health
and Safety Code.

(b) The terms defined in 10 CFR 20, section 20. 1003, as incorporated
by reference, shall apply to this regulation, except that:

( 1 ) The term "Act" as defined in 10 CFR 20. section 20. 1 003 is limited
to the textual material incorporated by reference in subsection (a) above.
The meaning of the term "Act" elsev/here in this regulation, means the

Page 191

§ 30254

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

"Radiation Control Law." Health and Safety Code, Division 104, Part 9,
chapter 8, sections 1 14960 et seq.

(2) The term "Department" as defined in 10 CFR 20, section 20.1003
is limited to the provisions incorporated by reference in subsection (a).
The meaning of the term "Department" elsewhere in this regulation, is
as defined in section 1 14985(J) of the Health and Safety Code.
NOTt:; Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Section.s 1 14960, 1 14965. 1 14970, 1 14985, 1 14990, 1 15060, 1 15105.
1 151 10, 115 120, 1 15165, 1 I52.W and 1 152.^5, Health and Safety Code.

History

1. Repealer and new section filed 3-.^-94 as an emergency; operative 3-3-94
(Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL
by 7-1-94 or emergency language will be repealed by operation of law on the
follow ing day. For prior history, see Register 86. No. 28.

2. Certificate of Compliance as to .3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

3. Kdittmal correction deleting History 1 and amending and redesignating Histo-
ry 3 (Register94, No. 28)".

4. Editorial coirection of secfion heading (Register 99, No. 8).

5. Amendment of section and NoTh filed 10-15-2001; operative 11-14-2001
(Register 2001, No. 42).

6. Change without regulatory effect amending subsection (a)( 1 ) and repealing sub-
sections (a)( 10)-(!2) filed 8-8-2002 pursuant to section 100, title 1, California
Code of Reeulations (Register 2002, No. 32).

7. Amendmem filed 7-20-2006; operative 8-19-2006 (Register 2006, No. 29).

Article 2. Notices, Instructions, and

Reports to Workers; Inspections and

Investigations

§ 30254. Inspection.

(a) Each user shall afford to the Department or other official agency
specifically designated by the Department, at all reasonable times, op-
portunity to inspect materials, machines, activities, facilities, premises,
and records pursuant to these regulations.

(b) During an inspection, inspectors may consult privately with work-
ers as specified below. The user may accompany inspectors during other
phases of an inspection.

( 1 ) Inspectors may consult privately with workers concerning matters
of occupational radiation protection and other matters related to applica-
ble provisions of Department regulations and licenses to the extent the
inspectors deem necessary for the conduct of an effective and thorough
inspection.

(2) During the course of an inspection any worker may bring privately
to the attention of the inspectors, either orally or in writing, any past or
present condition which he has reason to believe may have contributed
to or caused any violation of the Radiation Control Law, these regula-
tions, or license condition, or any urmecessary exposure of an individual
to radiation from licensed radioactive material or a registered radiation
machine under the user's control. Any such notice in writing shall com-
ply with the requirements of subsection (h) hereof.

(3) The provision of paragraph (b)(2) of this section shall not be inter-
preted as authorization to disregard instructions pursuant to Section
30255(b)(1).

(c) If, at the time of inspection, an individual has been authorized by
the workers to represent them during inspections, the user shall notify the
inspectors of such authorization and shall give the workers' representa-
tive an opportunity to accompany the inspectors during the inspection of
physical working conditions.

(d) Each worker's representative shall be routinely engaged in work
under control of the user and shall have received instructions as specified
in Section 30280(b)(1).

(e) Different representatives of users and workers may accompany the
inspectors during different phases of an inspection if there is no resulting
interference with the conduct of the inspection. However, only one work-
ers' representative at a time may accompany the inspectors.

(f) With the approval of the user and the workers' representative, an
individual who is not routinely engaged in work under control of the user,
for example, a consultant to the user or to the workers' representative,
shall be afforded the opportunity to accompany inspectors during the in-
spection of physical working conditions.

(g) Notwithstanding the other provisions of this section, inspectors are
authorized to refuse to permit accompaniment by an individual who de-
liberately interferes with a fair and orderly inspection. With regard to any
area containing proprietary information, the workers' representative for
that area shall be an individual previously authorized by the user to enter
that area.

(h) Any worker or representative of workers who believes that a viola-
tion of the Radiation Control Law, these regulations or license conditions
exists, or has occurred in work under a license or registration with regard
to radiological working conditions in which the worker is engaged, may
request an inspection by giving notice of the alleged violation to the De-
partment or other official agency specifically designated by the Depart-
ment. Any such notice shall be in writing, shall set forth the specific
grounds for the notice, and shall be signed by the worker or representa-
tive of the workers. A copy shall be provided to the user by the Depart-
ment no later than at the time of inspection except that, upon the request
of the worker giving such notice, his name and the name of individuals
referred to therein shall not appear in such copy or on any record pub-
lished, released, or made available by the Department except for good
cause shown.

(i) If. upon receipt of such notice, the Chief, Radiologic Health
Branch, of the Department, determines that the complaint meets the re-
quirements set forth in subsection (h) hereof, and that there are reason-
able grounds to believe that the alleged violation exists or has occurred,
he shall cause an inspection to be made as soon as practicable, to deter-
mine if such alleged violation exists or has occurred. Inspections pur-
suant to this section need not be limited to matters referred to in the com-
plaint.

(j) No user shall discharge or in any marmer discriminate against any
worker because such worker has filed any complaint or instituted or
caused to be instituted any proceeding under these regulations or has tes-
tified or is about to testify in any such proceeding or because of the exer-
cise by such worker on behalf of himself or others of any option afforded
by this section.

(k) If the Chief, Radiologic Health Branch, of the Department, deter-
mines with respect to a complaint under subsection (h) hereof that an in-
spection is not warranted because there are no reasonable grounds to be-
lieve that a violation exists or has occurred, the complainant shall be
notified in writing of such determination. The complainant may obtain
review of such determination by submitting a written statement of posi-
tion to the Director of the Department, who will provide the user with a
copy of such statement by certified mail, excluding, at the request of the
complainant, the name of the complainant. The user may submit an op-
posing written statement of position with the Director of the Department
who will provide the complainant with a copy of such statement by certi-
fied mail. Upon the request of the complainant, the Director of the De-
partment, or his designee, may hold an informal conference in which the
complainant and the user may orally present their views. An informal
conference may also be held at the request of the user, but disclosure of

Page 192

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30255

the identity of tiic complainant will be made only following receipt of
written authorization from the complainant. After considering all written
or oral views presented, the Director of the Department shall affirm,
modify, or reverse the determination of the Chief, Radiologic Health
Branch, of the Department, and furnish the complainant and the user a
written notification of his decision and the reason therefor.

(/) If the Department determines that an inspection is not warranted be-
cause the requirements of subsection (h) hereof have not been met, it shall
notify the complainant in writing of such determination. Such determina-
tion shall be without prejudice to the filing of a new complaint meeting
the requirements of subsection (h) hereof.

NOTK: Authority cited: Sections 208 and 2581 1. Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Repealer and new section filed 8-19-75 as an emergency; effective upon filing
(Register 75, No. 34). Approved by CAL/OSHA Standards Board 12-16-75.

2. Certificate of Compliance filed 1 1-28-75 (Register 75, No. 48).

3. Amendment of subsections (b)(3) and (d) filed 8-23-76; effective thirtieth day
thereafter (Register 76, No. 35).

4. Amendment of subsections (h), (!) and (k) filed 6-18-87; operative 7-18-87
(Register 87, No. 28).

5. New article 2 heading and amendment of subsection (b)(3) filed 3-3-94 as an
emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance
must be transmitted to OAL by 7-1-94 or emergency language will be repealed
by operation of law on the following day.

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30255. Notices, Instructions, and Reports to Personnel.

(a) Tliis section establishes requirements for notices, instructions, and
reports by users to individuals engaged in work under a license or regis-
tration and options available to such individuals in connection with De-
partment inspections of licensees or registrants to ascertain compliance
with the provisions of the Radiation Control Law and regulations, orders,
and licenses issued thereunder regarding radiological working condi-
tions. The requirements in this section apply to all persons who receive,
possess, use, own or transfer material licensed by or registered with the
Department.

(b) Each user shall:

(1) Inform all individuals working in or frequenting any portion of a
controlled area of the storage, transfer, or use of radioactive materials or
of radiation in such portions of the controlled area; instruct such individu-
als in the health protection problems associated with exposure to such ra-
dioactive materials or radiation, in precautions or procedures to mini-
mize exposure, and in the purposes and functions of protective devices
employed; instruct such individuals in, and instruct them to observe, to
the extent within their control, the applicable provisions of Department
regulations and license conditions for the protection of personnel from
exposures to radiation or radioactive materials occurring in such areas;
instruct such individuals of their responsibility to report promptly to the
licensee or registrant any condition which may lead to or cause a viola-
tion of department regulations or license conditions or unnecessary expo-
sure to radiation or radioactive material, and of the inspection provisions
of Section 30254; instruct such individuals in the appropriate response
to warnings made in the event of any unusual occurrence or malfunction
that may involve exposure to radiation or radioactive materials; and ad-
vise such individuals as to the radiation exposure reports which they may
request pursuant to this section. The extent of these instructions shall be
commensurate with potential radiological health protection problems in
the controlled area.

(2) Conspicuously post a current copy of this regulation, a copy of
applicable licenses for radioactive material, and a copy of operating and
emergency procedures applicable to work with sources of radiation. If
posting of documents specified in this paragraph is not practicable the
user may post a notice which describes the document and states where
it may be examined.

(3) Conspicuously post a current copy of Department Form RH-2364
(Notice to Employees) in a sufficient number of places to permit individ-

uals working in or frequenting any portion of a controlled area to observe
a copy on the way to or from such area.

(4) Conspicuously post any notice of violation involving radiological
working conditions or any order issued pursuant to the Radiation Control
Law and any required response from the user. Department documents
posted pursuant to this paragraph shall be posted within two working
days after receipt of the documents from the Department; the user's re-
sponse, if any, shall be posted within tv/o working days after dispatch by
the user. Such documents shall remain posted for a minimum of five
working days or until action correcting the violation has been completed,
whichever is later.

(5) Assure that documents, notices, or forms posted pursuant to this
section shall appear in a sufficient number of places to permit individuals
engaged in work under the license or registration to observe them on the
way to or from any particular work location to which the document ap-
plies, shall be conspicuous, and shall be replaced if defaced or altered.

(6) Provide reports to any individual of his radiation exposure data and
the results of any measurements, analyses, and calculations of radioac-
tive material deposited or retained in the body of that individual as speci-
fied in this section. The information reported shall include data and re-
sults obtained pursuant to Department regulations, orders, or license
conditions, as shown in records maintained by the user pursuant to De-
partment regulations. Each notificafion and report shall: be in writing; in-
clude appropriate identifying data such as the name of the user, the name
of the individual, the individual's Social Security number; include the in-
dividual's exposure informafion; and contain the following statement:

"This report is furnished to you under the provisions of the California
State Department of Health Services Regulations: Standards for Protec-
tion Against Radiation. You should preserve this report for future refer-
ence."

These reports shall be provided as follows:

(A) At the request of any individual, each user shall advise such indi-
vidual annually of his exposure to radiafion or radioacdve material as
shown in records maintained by the licensee or registrant pursuant to
United States, fitle 10, Code of Federal RegulaUons, part 20, subpart M
as incorporated by reference in section 30253, including the results of
any calculations and analyses of radioacdve material deposited in the
body of the individual.

(B) At the request of an individual formerly engaged in work con-
trolled by the user, the user shall furnish to the individual a report of his
exposure to radiation or radioactive material. Such report shall be fur-
nished within 30 days from the fime the request is made, or within 30 days
after the exposure of the individual has been determined by the user,
whichever is later; shall cover, within the period of time specified in the
request, each calendar quarter in which the individual's activities in-
volved exposure to radiation from radioactive materials licensed by, or
radiation machines registered with the Department; and shall include the
dates and locations of work under the license or registration in which the
individual parUcipated during this period.

(C) When a user is required pursuant to United States, title 10, Code
of Federal Regulations, part 20, subpart M as incorporated by reference
in section 30253 to report to the Department any exposure of an individu-
al to radiation or radioacdve material, the user shall also provide the indi-
vidual a report on his exposure data included therein. Such reports shall
be transmitted at a time not later than the transmittal to the Department.

(D) At the request of an individual who is terminating employment or
assignment to work involving radiation exposure in the user's facility in
a given calendar quarter, the user shall furnish to the individual a written
report of the individual's exposure to radiation or radioactive material re-
ceived during that specifically identified calendar quarter. Such report
shall contain an estimate of exposures if the final reports are not available
at the time of termination. Estimated exposures shall be clearly indicated
as such.

Page 193

§ 30256

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Nori:; Authority cited: Section 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801 , 25802, 2581 1 , 25815, 25826, 25875 and 25876, Health and
Safety Code.

History

1. Renumbering and amendment of former section 30280 to section 30255 filed
3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9). A Certificate
of Compliance must be transmitted to OAL by 7-1-94 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30256. Vacating Installations: Records and Notice.

(a) Each person granted a specific license pursuant to Group 2 of this
Subchapter shall keep records of information important to the decommis-
sioning of a facility in an identified location until the site is released for
unrestricted use by the Department. Before licensed activities are trans-
ferred or assigned in accordance with 30194(c), licensees shall transfer
all records described in this section to the new licensee. In this case, the
new licensee shall be responsible for maintaining these records until the
license is terminated. If records important to the decommissioning of a
facility are kept for other purposes, reference to these records and their
locations may be used. The records shall include the following informa-
tion important to decommissioning:

( 1 ) Records of spills or other unusual occurrences involving the spread
of contamination in and around the facility, equipment, or site. These re-
cords shall include but not be limited to a description of any instances
when contamination remains after any cleanup procedures or when there
is reasonable likelihood that contaminants may have spread to inaccessi-
ble areas, as for example, possible seepage into porous materials such as
concrete. These records shall include any known information on identifi-
cation of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modification drawings of structures and
equipment in restricted areas where radioactive materials are used or
stored, and of locations of possible inaccessible contamination such as
buried pipes which may be subject to contamination. If required draw-
ings are referenced, each relevant document need not be indexed individ-
ually. If drawings are not available, the licensee shall substitute appropri-
ate records of available information concerning these areas and
locations.

(3) Except for areas containing only sealed sources (provided the
sources have not leaked or no contamination remains after any leak) or
any radioactive materials having only half-lives of less than 65 days, a
list contained in a single document and updated every 2 years, of the fol-
lowing:

(A) All areas designated and formerly designated restricted areas as
defined in Title 10, Code of Federal Regulations, Section 20. 1003 incor-
porated by reference pursuant to Title 17, California Code of Regula-
tions, Section 30253;

(B) All areas outside restricted areas that require documentation under
(a)(1);

(C) All areas outside of restricted areas where current and previous
wastes have been buried as documented under Title 10, Code of Federal
Regulations, Section 20.2108 incorporated by reference pursuant to Title
17, California Code of Regulations, Section 30253; and

(D) All areas outside of restricted areas which contain material such
that, if the license expired, the licensee would be required to either decon-
taminate the area to unrestricted release levels or apply for approval for
disposal under Title 10, Code of Federal Regulations, Section 20.2002
incorporated by reference pursuant to Title 17, California Code of Regu-
lations, Section 30253.

(4) Records of the cost estimate performed for the decommissioning
funding plan or of the amount certified for decommissioning, and records
of the funding method used for assuring funds if either a funding plan or
certification is used pursuant to Section 30195.1.

(b) Each person granted a specific license pursuant to Group 2 of this
Subchapter shall, no less than 30 days before vacafing any installation
which may have been contaminated with radioactive material as a result

of his activities, notify the department in writing of intent to vacate. This
notice shall be submitted on form RHB 314 (12/95) entitled "Certificate
of Disposition of Materials" which is incorporated by reference herein
and shall address all requirements specified in Subsection (c).

(c) If a licensee does not submit an applicafion for license renewal un-
der section 30 194, the licensee shall on or before the expiration date spe-
cified in the license:

( 1 ) Terminate use of radioactive material;

(2) Remove radioactive contamination to the extent practicable except
for those procedures covered by Subsection (d) of this section;

(3) Dispose of radioactive material in accordance with applicable reg-
ulafions;

(4) Submit a completed form RHB 314(1 2/95), which certifies infor-
mation concerning the disposition of materials; and

(5) Conduct a radiation survey of the premises where the licensed acti-
vities were carried out and submit a report of the results of this survey,
unless the licensee demonstrates that the premises are suitable for release
for unrestricted use in some other manner. The licensee shall, as appro-
priate:

(A) Report levels of radiation in units of microrads per hour of beta and
gamma radiation at one centimeter and gamma radiation at one meter
from surfaces, and report levels of radioactivity, including alpha, in units
of disintegrations per minute (or microcuries) per 1 00 square centimeters
removable and fixed for surfaces, microcuries per milliliter for water,
and picocuries per gram for solids such as soils or concrete; and

(B) Specify the survey instaiment(s) used and certify that each instru-
ment is properly calibrated and tested.

(d) In addition to the information required under Subsections (c)(4)
and (5), the licensee shall submit a plan for completion of decommission-
ing if the procedures necessary to carry out decommissioning have not
been previously approved by the Department and could increase poten-
tial health and safety impacts to workers or to the public such as in any
of the following cases:

( 1 ) Procedures would involve techniques not applied routinely during
cleanup or maintenance operations; or

(2) Workers would be entering areas not normally occupied where sur-
face contamination and radiation levels are significantly higher than rou-
tinely encountered during operation; or

(3) Procedures could result in significantly greater airborne concentra-
tions of radioacfive materials than are present during operation; or

(4) Procedures could result in significantly greater releases of radioac-
tive material to the environment than those associated with operation.

(e) Procedures with potenUal health and safety impacts shall not be
carried out prior to approval of the decommissioning plan.

(f) The proposed decommissioning plan, if required by Subsection (d)
of this section or by license condition, shall include:

( 1 ) Description of planned decommissioning activities;

(2) Description of methods used to assure protection of workers and
the environment against radiation hazards during decommissioning;

(3) A description of the planned final radiaUon survey;

(4) The information required in (a) (3) and any other information re-
quired by (a) that is considered necessary to support the adequacy of the
decommissioning plan for approval; and

(5) An updated detailed cost estimate for decommissioning, compari-
son of that estimate with present funds set aside for decommissioning,
and plan for assuring the availability of adequate funds for completion
of decommissioning.

(g) The proposed decommissioning plan will be approved by the De-
partment if the Department determines that the decommissioning will be
completed as soon as is reasonable and that the health and safety of work-
ers and the public will be adequately protected.

(h) Upon approval of the decommissioning plan by the Department,
the licensee shall complete decommissioning in accordance with the ap-
proved plan. As a final step in decommissioning, the licensee shall again
submit the information required in Subsection (c)(5) and shall certify the

Page 194

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 3()268

disposition of accumulated wastes from decommissioning by complet-
ing form RHB 314 (12/95).

(i ) If the information submitted under subsection (c)(5) or (h) does not
adequately demonstrate that the premises are suitable for release for un-
restricted use, the Department shall inform the licensee of the appropriate
further actions required for termination of license.

(_] ) Each specific license continues in effect, beyond the expiration date
if necessary, with respect to possession of residual radioactive material
present as contamination until the Department notifies the licensee in
writing that the license is terminated. During this time, the licensee shall:

( 1 ) Limit actions involving radioactive material to those related to de-
commissioning; and

(2) Continue to control entry to restricted areas until they are suitable
for release for unrestricted use and the Department notifies the licensee
in writing that the license is terminated.

(k) Specific licenses shall be terminated by written notice to the licens-
ee when the Department determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive
contamination, if present; and

(3) A radiation survey has been performed which demonstrates that the
premises are suitable for release for unrestricted use; or other information
submitted by the licensee is sufficient to demonstrate that the premises
are suitable for release for unrestricted use.

NoTl-; Authority cited: Sections 100275. 1 1 5000, Health and Safety Code. Refer-
ence: Sections 1 14965, 1 14970, 115060, 1 15230 and 1 15235, Health and Safety
Code.

History

1 . Renumbering of former section 30298 to section 30256 filed 3-3-94 as an emer-
gency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must
be transmitted to OAL by 7-1-94 or emergency language will be repealed by
operation of law on the following day.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

3. Amendment of section heading and section filed 10-16-95 as an emergency;
operative 10-16-95 (Register 95, No. 42 ). A Certificate of Compliance must be
transmitted to OAL by 2-1 3-96 or emergency language will be repealed by op-
eration of law on the following day.

4. Certificate of Compliance as to 10-16-95 order, including amendment of sub-
sections (a), (c)(4) and (f)(3), new (f)(4) and subsection renumbering, and
amendment of subsection (h) and Noth, transmitted to OAL 2-9-96 and filed
3 25-96 (Register 96, No. 13).

5. Amendment of subsection (a) filed 9-9-97; operative 10-9-97 (Register 97,
No. 37).

§ 30257. Bankruptcy Notification.

(a) Each licensee shall notify the Department in writing immediately
following the filing of a voluntary or involuntary petition for bankruptcy
under any chapter or title 1 1 (Bankruptcy) of the United States Code ( 1 1
U.S.C.) by or against:

( 1 ) Any licensee;

(2) An entity (as that term is defined in 1 1 U.S.C. 101 (14)) controlling
the licensee or listing the license as property of the estate; or

(3) An affiliate (as that term is defined in 1 1 U.S.C. 101 (2)) of the li-
cense.

(b) This notification must indicate:

( 1 ) The bankruptcy court in which the petition for bankruptcy was
filed; and

(2) The date of the filing of the pefidon.

NOTI:: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 28501, 28502, 25815, 25860, 25863, 25875 and 25876, Health and
Safety Code.

History

1 . Renumbering of Ibrmer section 30299 to section 30257 filed 3-3-94 as an emer-
gency: operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must
be transmitted to OAL by 7-1-94 or emergency language will be repealed by
operation of law on the following day.

2. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30258. General Definitions.

NOTl:; Authority cited: Sections 208 and 2581 1, Health and Safetv Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876. Health and Safct\ i\)dc.

History

1. Repealerof article 2 and new article 2 (section 30258) filed 1 1-29-65: effccti\e
thirtieth day thereafter (Register 65, No. 23). For former article 2, see Register
62, No. 1.

2. Amendment filed 1-22-76; effective thiiiieth day thereafter (Reeister 76, No.
4).

3. Repealer filed 6-18-87; operative 7-18-87 (Register 87. No. 28).

4. Editorial correction deleting article heading (Register 94. No. 15).

Article 3. Surveys and Tests

§ 30265. Occupational Dose Limits.

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815. 25875 and 25876. Health and Safety
Code.

History

1. Repealer of article 3 and new article 3 (sections 30265 and 30266) filed
1 1-29-65; effective thirtieth day thereafter (Register 65, No. 23). For prior his-
tory' of article 3, see Register 62, No. 1 .

2. Repealer of subsection (c) filed 7-7-86; effective thirtieth day thereafter (Regis-
ter 86, No. 28).

3. Amendment of article heading and repealer of section filed .3-3-94 as an emer-
gency; operative 3-3-94 (Register 94. No. 9). A Certificate of Compliance must
be transmitted to OAL by 7-1-94 or emergency language will be repealed by
operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6 7-94 and
filed 7-14-94 (Register 94. No. 28).

§ 30265.1. Determination of Prior Dose.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 258! 1, 25815, 25875 and 25876, Health and Safety
Code.

History
L New section 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Change without regulatory effect of subsecfion (b) (Register 87, No. 6).

3. Repealer filed 3-3-94 as an emergency; operative 3- 3-94 (Register 94, No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30266. Exposure of Individuals to Concentrations of
Radioactive Material in Controlled Areas.

Note: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815, 25875 and 25876. Health ad Safety
Code.

History

1 . Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 8).

2. Change without regulatory effect of NoTi, (Register 88, No. 6).

3. Repealer and amendment of NoTK filed 3-3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted
to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30268. Permissible Levels of Radiation in Uncontrolled
Areas.

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. Change without regulatory effect adding Noti- (Flegister 87. No. 1 1 ).

2. Change without regulatory effect of subsection (a) (Register 88, No. 6).

3. Editorial correction of prinfing error restoring inadvertantl v deleted His i ( )in 2
(Register92, No. 34).

4. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following da> .

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6 7-94 and
filed 7-14-94 (Register 94, No. 28).

Page 195

§ 30269

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 30269. Concentrations in Effluents to Uncontrolled
Areas.

NOTi;: Authority cited: Sections 208 and 2581 1. Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815, 25875 and 25876. Health and Safety
Code.

History

1 . Change without regulatory effect adding NoTi- (Register 87. No. 1 1 ).

2. Change without regulatory effect of subsection (a) (Register 88. No. 6).

3. Kditorial coiTcction of printing error restoring inadvertently deleted section
(Register 92, No. M).

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30275. Surveys and Tests.

(a) Each user shall make or cause to be made such surveys as are neces-
sary for compliance with all provisions of this regulation.

(b) Upon instruction from the Department or other official agency spe-
cifically designated by the Department, each user shall perform or cause
to have performed, and shall permit the Department or said agency to per-
form, such reasonable tests as the Department or said agency deems nec-
essary for the protection of life, health, or property, including, but not
limited to, tests of:

( 1 ) Sources of radiation.

(2) Facilities wherein sources of radiation are used or stored.

(3) Radiation detection and monitoring instruments.

(4) Other equipment and devices used in connection with utilization
or storage of sources of radiation.

(c) Each sealed source other than sources listed below, shall be tested
for contamination prior to initial use and for leakage at least every six
months:

(1) Hydrogen-3 or krypton-85 sources.

(2) Sealed sources containing licensed radioactive material in gaseous
form.

(3) Source material.

(4) Sources containing radioactive material with a half life of 30 days
or less.

(5) Sources of beta- and/or gamma-emitting radioactive material with
an activity of 100 microcuries or less.

(6) Sources of alpha and/or neutron-emitting radioactive material
with an activity of 10 microcuries or less.

In the absence of a certificate from a transferor indicating that a test has
been made prior to the transfer, the sealed source shall not be put into use
until tested. If there is reason to suspect that a source might have been
damaged, it shall be tested for leakage before further use. Contaminadon
and leak tests shall be capable of determining the presence of 0.005 mi-
crocuries of removable contamination. When any contamination or leak
test reveals the presence of 0.005 microcuries or more of removable con-
tamination the user shall immediately withdraw the source from use and
shall cause it to be decontaminated and repaired or to be disposed of in
accordance with appUcable provisions of Group 2 of this subchapter.
Two copies of a report shall be filed, within 5 days of the test, with the
Department or other official agency specifically designated by the De-
partment, describing the source involved, the test results, and the correc-
tive action taken.

(d) The test sample shall be taken from the surface of the source, or
source holder, or from the surface of the device in which the source is
stored or mounted and on which one might expect contamination to accu-
mulate. Where sealed sources are permanently mounted in devices or
equipment, alternate tests for contamination and leakage may be ap-
proved by the Department.

(e) Tests for contamination and leakage, decontamination, and repair
of sealed sources shall be performed only by persons specifically autho-
rized by the Department to do so in accordance with provisions of Group
2 of this subchapter.

(f) Records of leak tests shall be maintained as specified in United
States, title 10, Code of Federal Regulations, part 20, subpart L as incor-
porated by reference in section 30253..

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815. 25875 and 25876, Health and Safety Code.

History

1. Repealer of article 4 and new article 4 (sections 30275 through 30281) filed
1 1-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former
article 4, see Register 62, No. 1.

2. Change without regulatory effect adding Note (Register 87, No. 1 1 ).

3. Amendment filed 1 1^^-91; operative 12^-91 (Register 92, No. 5).

4. Editorial correction of printing error restoring inadvertantly deleted article
heading (Register 92, No. 34). "

5. Repealer of article heading and amendment of subsection (0 filed 3-3-94 as
an emergency; operative 3-3-94 (Register 94. No. 9). A Certificate of Com-
pliance must be transmitted to OAL by 7-1-94 or emergency language will be
repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30276. Personnel Monitoring.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 258L5, 25875 and 25876, Health and Safety Code.

History

1 . Change without regulatory effect adding Note (Register 87, No. 1 1 ).

2. Amendment of subsection (a), new subsection (b) and subsecfion renumbering
filed 10-10-91; operative 11-9-91 (Register 91, No. 52).

3. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30277. Bio-Assays and Medical Review.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. Amendment filed 9-4-73 as an emergency; effecfive upon filing (Register 73,
No. 36). Approved by State Building Standards Commission 1 1-30-73.

2. Certificate Compliance filed 12-28-73 (Register 73, No. 52).

3. Change without regulatory effect adding Note (Register 87, No. 11).

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30278. Caution Signs and Labels.

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. Amendment filed 11-16-67; effective thirtieth day thereafter (Register 67,
No. 46).

2. Change without regulatory effect adding Note (Register 87, No. 10).

3. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30278.1. Removal of Caution Labels from Empty
Containers.

Each user shall, prior to disposal of an empty uncontaminated contain-
er to unrestricted areas, remove or deface the radioactive material label
or otherwise clearly indicate thai the container no longer contains radio-
active materials.

Note: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815, 25875 and 25876, Health and Safety
Code; and 10 CFR 20. 203 (f)(4) (43 PR 22171).

History
1. New section filed 3-6-87; effective upon filing pursuant to Government Code

Section 11346.2(d) (Register 87, No. 10).

Page 196

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30293

§ 30279. Special Requirements for High Radiation Areas
and Radiation Machines Capable of Producing
High Radiation Areas.

NOTH; Authority cited: Sections 208 and 2581 1 , Health and Safety Code. Refer-
ence: Sections 25801, 25802. 25815, 25875 and 25876, Health and Safety Code.

History

1. Amendment filed 7-22-71; effective thirtieth day thereafter (Resister 71. No.
30).

2. Change without regulatory effect adding Noti-; (Register 87, No. 1 1 ).

3. Repealer filed 3-3-94 as an emergency; operative 3-3-94 (Register 94, No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30279.1. Additional Special Requirements for Very High
Radiation Areas.

Note: ( l ) Authority cited: Sections 208 and 258 1 1 . Health and Safety Code. Ref-
erence: Sections 2580 1 , 25802, 25811, 25875 and 25876. Health and Safety Code.

History

1. New section 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

2. Change without regulatory effect of Note (Register 88, No. 6).

3. Repealer and amendment of Noth filed 3-3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted
to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30280. Notices, Instructions, and Reports to Personnel.

Note: Authority cited: Secfion 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 , 25815, 25826, 25875 and 25876, Health and
Safety Code.

History

1 . Amendment filed 8-19-75 as an emergency; effective upon filing (Register 75,
No. 34). Approved by CAL/OSHA Standards Board 12-16-75.

2. Certificate of Compliance filed 1 1-28-75 (Register 75, No. 48).

3. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86,
No. 28).

4. Change without regulatory effect of subsections (b)(4) and (b)(6)(B) (Register
88, No. 6).

5. Renumbering of former secfion 30280 to new section 30255 filed 3-3-94 as an
emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance
must be transmitted to OAL by 7-1-94 or emergency language will be repealed
by operation of law on the following day.

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30281 . Storage and Control of Radioactive Material.

NOTE: Authority cited: SecUons 208 and 2581 1 , Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25875 and 25876, Health and Safety Code.

History

1. Amendments filed 7-7-86; effective thirtieth day thereafter (Register 86,
No. 28).

2. Repealer filed 3-3-94 as an emergency; operadve 3-3-94 (Register 94, No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30282. Procedures for Opening Packages.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section filed 6-19-73; effective thirtieth day thereafter (Register 73,
No. 25).

2. Change without regulatory effect adding Note (Register 87, No. 11).

3. Repealer filed 3-3-94 as an emergency; operadve 3-3-94 (Register 94, No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14^94 (Register 94, No. 28).

§ 30285. General Requirement.

NOTE: Authority cited: Secfions 208 and 2581 1 , Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25811, 25812 and 25815, Health and Safety Code.

History

1. Repealer of article 5 and new article 5 (sections 30285. 30287. 30288) filed
1 1 -29-65; effective thirtieth day thereafter (Register 65, No. 23). For former
article 5, see Register 62, No. 1.

2. Amendment filed 6-18-87; operative 7-18-87 (Regi.ster 87, No. 28).

3. Repealer of article heading and section f iled 3-3-94 as an emergenc\ : opera-
tive 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be trans-
mitted to OAL by 7-1-94 or emergency language will be repealed by operation
of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7 94 and
filed 7-14-94 (Register 94, No. 28).

§ 30287. Disposal by Release into Sanitary Sewerage
Systems.

NOTF:: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Secfions 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. Change without regulatory effect adding NoTi. (Register 87. No. 1 1 ).

2. Repealer filed 3-.3-94 as an emergency; operative 3-3-94 (Register 94. No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7 94 and
filed 7-14-94 (Register 94, No. 28).

§ 30288. Disposal by Burial in Soil.

History
1. Repealer filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28).

§ 30289. Treatment or Disposal by Incineration.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Secfions 25801, 25802, 25815, 25875 and 25876. Health and Safety (\)de.

History

1. New secfion filed 7-22-71; effective thirtieth day thereafter (Register 71, No.
30).

2. Change without regulatory effect adding Noth (Register 87. No. 1 1 ).

3. Repealer filed 3-3-94 as an emergency; operative .3-3-94 ( Register 94. No. 9).
A Certificate of Compliance must be transmitted to OAL by 7-1-94 or emer-
gency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94. No. 28).

Article 3.1. Records and Notification

§ 30293. Records.

(a) Each user shall keep records showing the receipt, transfer, and dis-
posal of each source of radiation which is subject to licensure or registra-
Uon pursuant to groups 1 .5 and 2 of this subchapter as follows:

( 1 ) The user shall retain each record of receipt of a source of radiation
as long as the source of radiation is possessed and for three years follow-
ing transfer or disposal of the source of radiation.

(2) The user who transferred the source of radiation shall retain each
record of transfer for three years after each transfer unless a specific re-
quirement in another part of the regulations in this subchapter dictates
otherwise.

(3) The user who disposed of the radioactive material shall retain each
record of disposal of the radioactive material until the Department termi-
nates each license that authorizes disposal of the radioactive material.

(b) The user shall retain each record that is required by the regulations
in this subchapter or by license condition for the period specified by the
appropriate regulation or license condition. If a retention period is not
otherwise specified by regulation or license condition, the record shall be
retained until the Department terminates each license that authorizes the
activity that is subject to the recordkeeping requirement.

(c) Records which shall be maintained pursuant to this subchapter may
be the original or a reproduced copy or microform if such reproduced
copy or microform is duly authenticated by authorized personnel and the
microform is capable of producing a clear and legible copy after storage
for the period specified by department regulations. The record may also
be stored in electronic media with the capability for producing legible,
accurate, and complete records during the required retention period. Re-
cords such as letters, drawings, specifications, shall include all pertinent

Page 196.1

§ 30294

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

informalion such as stamps, initials, and signatures. The Hcensee shall
maintain adequate safeguards against tamjiering with and loss of records.

(d) If there is a conflict between the Department's regulations in this
subchapter, license condition, or other written Department approval or
authorization pertaining to the retention period for the same type of re-
cord, the retention period specified in the regulations in this subchapter
for such records shall apply unless the Department, pursuant to 30104,
has granted a specific exemption from the record retention requirements
specified in the regulations in this subchapter.

(e) Prior to license termination, each licensee authorized to possess ra-
dioactive material with a half-life greater than 120 days, in an unsealed
form, shall, if requested by the Department, forward the following re-
cords to the Department:

(1 )Recordsof disposal of licensed material made under Title 10, Code
of Federal Regulations, sections 20.2002, 20.2003. 20.2004, 20.2005, in-
corporated by reference in section 30253; and

(2) Records required by Title 10, Code of Federal Regulations section
20.2103(b)(4), incorporated by reference in section 30253.

(f) If licensed activities are transferred or assigned in accordance with
section 301 94(c), each licensee authorized to possess radioactive materi-
al, with a half-life greater than 1 20 days, in an unsealed form, shall trans-
fer the following records to the new licensee and the new licensee will
be responsible for maintaining these records until the license is termi-
nated:

( 1 ) Records of disposal of licensed material made under Title 10, Code
of Federal Regulations, sections 20.2002, 20.2003, 20.2004, 20.2005, in-
corporated by reference in section 30253; and

(2) Records required by Title 10, Code of Federal Regulations, section
20.2103(b)(4), incorporated by reference in section 30243.

(g) Prior to license termination, each licensee shall, if requested by the
Department, forward the records required by section 30256(a) to the De-
partment.

NOTK: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 1 14965, 1 14970, 115105, 1 151 10, and 1 15235, Health and
Safety Code.

History

1. New article 3.1 (sections 30293 and 30295) and section filed 9-9-97; operative
10-9-97 (Register 97, No. 37). For prior history, see Register 94, No. 28.

§ 30294. Reports of Theft or Loss of Sources of Radiation.

NOTE: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876. Health and Safety Code.

History

1. Amendment of subsections (a) and (c) filed 6-19-73; effective thirtieth day
thereafter (Register 73, No. 25).

2. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76, No.
4).

3. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30295. Notification of Incidents.

(a) Each user shall notify the Department as soon as possible but not
later than four hours after the discovery of an event that prevents immedi-
ate protective actions necessary to avoid exposures to radiation or radio-
active materials that could exceed regulatory limits.

(b) Each user shall notify the Department within 24 hours after the dis-
covery of any of the following events involving radiation or radioactive
materials:

( J ) An unplanned contamination event involving licensed radioactive
material that:

(A) Requires access to the contaminated area by workers or the public,
to be restricted for more than 24 hours by imposing additional radiolog-
ical controls or by prohibiting entry into the area;

(B) Involves a quantity of material greater than five times the lowest
annual limit on intake specified in Appendix B of Title 1 0, Code of Feder-

al Regulations, part 20, incorporated by reference in section 30253 for
the material; and

(C) Has access to the area restricted for a reason other than to allow
isotopes with a half-life of less than 24 hours to decay prior to decontami-
nation.

(2) An event in which equipment is disabled or fails to function as de-
signed when:

(A) The equipment is required by regulation or license condition to
prevent releases exceeding regulatory limits, to prevent exposures to ra-
diation and radioactive materials exceeding regulatory limits, or to miti-
gate the consequences of an accident;

(B) The equipment is required to be available and operable when it is
disabled or fails to function; and

(3) An event that requires unplanned medical treatment at a medical
facility of an individual with spreadable radioactive contamination on the
individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or
any device, container, or equipment containing licensed material when:

(A) The quantity of material involved is greater than five times the
lowest annual limit on intake specified in Appendix B of Title 10, Code
of Federal Reguladons, part 20, incorporated by reference in section
30253 for the material; and

(B) The damage affects the integrity of the licensed material or its con-
tainer.

Each user shall make reports required by subsecUons (a) and (b) by
telephone to the Department. To the extent that the informadon is avail-
able at the time of notification, the information provided in these reports
shall include:

( 1 ) The caller' s name and call back telephone number;

(2) A descripfion of the event, including date and Ume;

(3) The exact locafion of the event;

(4) The isotopes, quantities, and chemical and physical form of the li-
censed material involved; and

(5) Any personnel radiation exposure data available.

(d) Each user who makes a report required by this section shall submit
a written follow-up report within 30 days of the initial report. These writ-
ten reports shall be sent to the Department and include:

(1) A description of the event, including the probable cause and the
manufacturer and model number (if applicable) of any equipment that
failed or malfunctioned;

(2) The exact location of the event;

(3) The isotopes, quantities, and chemical and physical form of the li-
censed material involved;

(4) Date and time of the event;

(5) Corrective actions taken or planned and the results of any evalua-
tion or assessment; and

(6) The extent of exposure of individuals to radiation or to radioactive
materials without identification of individuals by name.

NOTE; Authority cited: Sections 114975. 115000, 131050, 131051 and 131200,
Heahh and Safety Code. Reference: Secfions 1 14965. 1 14970, 1 15105. 1151 10,
and 1 15235, Health and Safety Code.

History

1 . New section filed 9-9-97: operative 10-9-97 (Register 97. No. 37). For prior
history, see Register 94, No. 28.

2. Amendment of secfion and Note filed 4-1 1-2008; operative 5-1 1-2008 (Reg-
ister 2008, No. 15).

§ 30297. Reports of Overexposures and Excessive Levels
and Concentrations.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802. 25815, 25875 and 25876, Health and Safety Code.

History
1. New subsections (c) and (d) filed 5-13-69; effective thirtieth day thereafter
(Register 69, No. 20).

Page 196.2

Title 17 Radiation — Radiologic Technology — Nuclear Medicine Technology § 30297

2. Amendment of subsections (a) and (b) filed 10-12-72; effective thirtieth day 4. Amendment of subsection (a) filed 6-18-87; operative 7-18-87 (Register 87,
thereafter (Register 72, No. 42). No. 28).

3. Amendment of subsection (a) filed 1-22-76; effective thirtieth day thereafter 5. Repealer filed 3-3-94 as an emergency; operative .3-3 94 (Register 94. No. 9).
(Register 76, No. 4). A Certificate of Compliance must be transmitted to OAL by 7- 1 94 or emer-
gency language will be repealed by operation of law on the follow inti da\ .

[The next page is 197.]

Page 196.3 Register 2008, No. 15; 4-11 -ZOOS

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30306

6. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7 14 94 (Register 94, No. 28).

§ 30298. Vacating Installations.

NOTI-: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 23801. 23802, 25815, 25875 and 25876, Health and Safety Code.

History

1. Change without regulatory effect adding Notk (Register 87, No. 1 1).

2. Renumbering of former section 30298 to new section 30256 filed 3-3-94 as an
emergency: operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance
must he transmitted to OAL by 7-1-94 or emergency language will be repealed
by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30299. Bankruptcy Notification.

NOTI-:: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Secfions 28501, 28502, 25815, 25860, 25863, 25875 and 25876, Health and
Safety Code.

History

1. New section filed 4-19-91; operative 5-19-91 (Register9], No. 20).

2. Renumbering of former section 30299 to new section 30257 filed 3-3-94 as an
emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance
must be transmitted to OAL by 7-1-94 or emergency language will be repealed
by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

Article 4. Special Requirements for the Use
of X-Ray in the Healing Arts

§ 30305. General Provisions.

(a)( I ) This article pertains to use of X-rays in medicine, dentistry, os-
teopathy, chiropractic, podiatry, and veterinary medicine. The provi-
sions of this article are in addition to, and not in substitution for, other
applicable provisions of this regulation and of Group 1 of this subchapter.

(2) Any existing machine or installation need not be replaced or sub-
stantially modified to conform to the requirements of this regulation pro-
vided that the user demonstrates to the Department's satisfaction
achievement of equivalent protection through other means.

(3) No person shall make, sell, lease, transfer, lend, or install X-ray or
fluoroscopic equipment or the supplies used in connection with such
equipment unless such supplies and equipment, when properly placed in
operation or properly used, will meet the requirements of this regulation.
This includes responsibility for the delivery of cones or collimators, fil-
ters, adequate timers and fluoroscopic shutters (where applicable).

(4) For X-ray equipment manufactured after July 31,1 974, the user
shall provide sufficient maintenance to keep the equipment in com-
pliance with all applicable radiation protection sections of the Code of
Federal Regulations, Title 21, Chapter 1, Subchapter J, Part 1020, Sec-
tions 1020.30, 1020.31, and 1020.32.

(5) Each installation shall be provided with such primary barriers and/
or secondary barriers as are necessary to ensure compliance with Sec-
tions 30265 and 30268. Special requirements are contained in Title 24,
California Code of Regulations, Sections 2-9102 through 2-9105.

(b) Use.

(1) The user shall assure that all X-ray equipment under his jurisdic-
tion is operated only by persons adequately instructed in safe operating
procedures and competent in safe use of the equipment.

(2) The user shall provide safety rules to each individual operating X-
ray equipment under his control, including any restrictions of the operat-
ing technique required for the safe operation of the particular X-ray ap-
paratus, and require that the operator demonstrate familiarity with these
rules.

(3) No user shall operate or permit the operation of X-ray equipment
unless the equipment and installation meet the applicable requirements
of these regulations and are appropriate for the procedures to be per-
formed.

(4) Deliberate exposure of an individual to the useful beam for training
or demonstration purposes shall not be permitted unless there is also a
medical or dental indication for the exposure and the exposure is pre-
scribed by a physician or dentist.

(c) Areas or rooms that contain permanently installed X-ray machines
as the only source of radiation shall be posted with a sign or signs

CAUTION
X-RAY

in lieu of other signs required by the United States, title 10, Code of Fed-
eral Regulations, part 20, section 20.1902 as incorporated by reference
in section 30253.

(d) High radiation areas caused by radiographic and fluoroscopic ma-
chines used solely in the healing arts and which are in compliance with
the access control and signal requirements of title 24, California Code of
Regulations, sections 9 1 02 through 9 1 05 shall be exempt from the access
control and signal requirements of the United States, title 10, Code of
Federal Regulations, part 20. section 20.1601 as incorporated by refer-
ence in section 30253.

NOTfc: Authority cited: Secfions 208 and 2581 1, Health and Safety Code. Refer-
ence: Secfions 25801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Amendment filed 3-5-71 ; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71. (Register 71, No. 10).

2. Renumbering and amendment filed 9-4-73 as an emergency; effective upon fil-
ing (Register 73, No. 36). Approved bv State Building Standards Commission
11-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No.
26).

5. New subsecfion (a)(5) and repealer of subsecfion (c) filed (3-18-87; operative
7-18-87 (Register 87, No. 28).

6. Amendment of article heading and new subsections (c) and (d) filed 3-3 94 as
an emergency; operafive 3-3-94 (Register 94, No. 9). A Certificate of Com-
pliance must be transmitted to OAL by 7-1-94 or emergency language will be
repealed by operation of law on the following day.

7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30306. Definitions.

(a) "Automatic exposure control" means a device which automatically
controls one or more technique factors in order to obtain at a preselected
location(s) a required quantity of radiation.

(b) "Cineradiography" means the making of a motion picture record
of the successive images appearing on a fluorescent screen.

(c) "Contact therapy" means irradiation of accessible lesions usually
employing a very short source-skin distance and potentials of 40-50 KV.

(d) "Dead-man switch" means a switch so constructed that a circuit-
closing contact can only be maintained by continuous pressure by the op-
erator.

(e) "Diagnostic-type tube housing" means an X-ray tube housing so
constructed that the leakage radiation measured at a distance of 1 meter
from the source cannot exceed 100 milliroentgens in 1 hour when the
tube is operated at its maximum continuous rate of current for the maxi-
mum rated tube potential.

(f) "Filter" means material placed in the useful beam to absorb prefer-
entially the less penetrating radiations.

(g) "Interlock" means a device for precluding access to an area of radi-
ation hazard either by preventing entry or by automatically removing the
hazard.

(h) "Leakage radiation" means all radiation coming from within the
tube housing except the useful beam.

(i) "Protective barrier" means a barrier of attenuating materials used
to reduce radiation exposure.

(j) "Primary protective barrier" means a barrier sufficient to attenuate
the useful beam to the required degree.

(k) "Scattered radiation" means radiation that, during passage through
matter, has been deviated in direction.

(/) "Secondary protective barrier" means a barrier sufficient to attenu-
ate stray radiation to the required degree.

Page 197

§ 30307

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(m) "Shutler" means a device, generally of lead, fixed to an X-ray tube
housing to intercept the useful beam.

(n) "Stray radiation" means radiation not serving any useful purpose.
It includes leakage and scattered radiation.

(0) "Therapeutic-type tube housing" means.

( 1 ) For X-ray therapy equipment not capable of operating at 300 kVp
or above, an X-ray tube housing so constaicted that the leakage radiation
at a distance of 1 meter from the source does not exceed 1 roentgen in an
hour when the tube is operated at its maximum rated continuous current
for the maximum rated tube potential.

(2) For X-ray therapy equipment capable of operating at 500 kVp or
above, an X-ray tube housing so constructed that the leakage radiation
at a distance of 1 meter from the source does not exceed either 1 roentgen
in an hour or 0. 1 percent of the useful beam dose rate at 1 meter from the
source, whichever is greater, when the machine is operated at its maxi-
mum rated continuous current for the maximum rated accelerating poten-
tial.

(3) In either case, small areas of reduced protection are acceptable pro-
vided the average reading over any 1 00 square centimeters area at 1 meter
distance from the source does not exceed the values given above.

(p) "Useful beam" means that part of the radiation which passes
through the window, aperture, cone, or other coUimating device of the
tube housing. (T17-30306-T24).

Note-. Authority cited: Sections 208 and 2581 1. Health and Safety Code. Refer-
ence: Sections 2.S801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Renumbering and amendment filed 9-4-73 as an emergency ; effective upon fil-
ing (Register 73, No. 36). Approved by State Building Standards Commission
11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Amendment of subsection (e) filed 6-18-87; operative 7-18-87 (Register 87,
No. 28).

§ 30307. Fluoroscopic Installations

(a) Equipment.

( 1 ) The tube housing shall be of diagnostic type.

(2) The target-to-panel or target-to-table top distance should not be
less than 18 inches and shall not be less than 12 inches.

(3) The total filtration permanently in the useful beam shall not be less
than 2.5 millimeters aluminum equivalent. This requirement may be as-
sumed to have been met if the half-value layer is not less than 2.5 milli-
meters aluminum at normal operating voltages.

(4) The equipment shall be so constructed that the entire cross-section
of the useful beam is attenuated by a primary barrier. This barrier is usual-
ly the viewing device, either a conventional fluoroscopic screen or an
image intensification mechanism.

(A) The lead equivalent of the barrier of conventional fluoroscopes
shall be at least 1.5 millimeters for equipment capable of operating up to
1 00 k Vp, at least 1 .8 millimeters for equipment whose maximum operat-
ing potential is greater than 100 kVp and less than 125 kVp, and at least
2.0 millimeters for equipment whose maximum operating potential is
125 kVp or greater. Special attention must be paid to the shielding of
image intensifiers so that neither the useful beam nor scattered radiation
from the intensifier can produce a radiation hazard to the operator or per-
sonnel. With the fluorescent screen 14 inches (35 cm) from the panel or
table top, the exposure rate 2 inches 5 cm) beyond the viewing surface
of the screen shall not exceed 30 mR/hr for each R per minute at the table
top with the screen in the useful beam without a patient and with the fluo-
roscope operating at the highest potential employed.

(B) Collimators shall be provided to restrict the size of the useful beam
to less than the area of the barrier. For conventional fluoroscopes this re-
quirement is met if, when the adjustable diaphragm is opened to its fullest
extent, an unilluminated margin is left at all edges of the fluorescent
screen with the screen centered in the beam at a distance of 35 cm (14 in-
ches) from the panel or table top.

For image intensified fluoroscopy, shutters shall be provided which
can be adjusted to restrict the X-ray field to the visible portion of the
image receptor during fluoroscopy. For systems employing rectangular

X-ray fields and circular image receptors, this requirement is met if the
collimated beam forms a square which circumscribes, and is tangent to,
the circular margin of the image receptor.

(C) The tube mounting and the carrier shall be so linked together that
the carrier always intercepts the entire useful beam. The X-ray exposure
shall automatically terminate when the carrier is removed from the useful
beam.

(D) Collimators and adjustable diaphragms or shutters to restrict the
size of the useful beam shall provide the same degree of protection as is
required of the tube housing.

(5) The exposure switch shall be of the dead-man type.

(6) Each fluoroscopic unit shall be equipped with a manual-reset cu-
mulative timing device, activated by the exposure switch, which will ei-
ther indicate elapsed exposure time by a signal audible to the fluorocopist
or turn off the apparatus when the total exposure exceeds a predeter-
mined limit not exceeding five minutes in one or a series of exposures.

(7) Useful beam exposure rate.

(A) All fluoroscopic equipment. For routine fluoroscopy, the expo.sure
rate measured at the point where the center of the useful beam enters a
typical patient shall be as low as is practicable and shall not exceed
5 roentgens per minute under the conditions specified herein. This limit
shall not apply during magnification procedures or the recording of fluo-
roscopic images where higher exposure rates are required. Compliance
with this paragraph shall be determined using the measuring specifica-
tions of Section 30307(a)(7)(D). plus the following procedures when the
automatic exposure rate control is used:

1 . The useful beam exposure rate shall be measured with a phantom
equivalent to 9 inches of water or 7 7/8 inches of lucite, intercepting the
entire useful beam.

2. If the X-ray source is below the table, the X-ray exposure rate shall
be measured with the nearest part of the imaging assembly located at 14
inches above the table top.

3. The field size at the point of exposure rate measurement shall be at
least 6 1/4 square inches in area in the plane perpendicular to the central
ray.

(B) Fluoroscopic equipment manufactured after August 1, 1974, and
equipped with automafic exposure rate controls. Fluoroscopic equip-
ment which is provided with automatic exposure rate control shall not be
operable at any combination of tube potential and current which will re-
sult in an exposure rate in excess of 10 roentgens per minute at the point
where the center of the useful beam enters the patient, except during re-
cording of fluoroscopicimages. or when an optional high level control is
provided. When so provided, the equipment shall not be operable at any
combination of tube potential and current which will result in an expo-
sure rate in excess of 5 roentgens per minute at the point where the center
of the useful beam enters the patient unless the high level control is acti-
vated. Special means of acfivation of high level controls shall be re-
quired. The high level control shall only be operable when continuous
manual activation is provided by the operator. A continuous signal audi-
ble to the fluoroscopist shall indicate that the high level control is being
employed.

(C) Fluoroscopic equipment manufactured after August 1 , 1974, with-
out automatic exposure rate controls. Fluoroscopic equipment which is
not provided with automatic exposure rate control shall not be operable
at any combination of tube potential and current which will result in an
exposure rate in excess of 5 roentgens per minute at the point where the
center of the useful beam enters the pafient, except during recording of
fluoroscopic images, or when an optional high level control is activated.
Special means of activation of high level controls shall be required. The
high level control shall only be operable when continuous manual activa-
tion is provided by the operator. A continuous signal audible to the fluo-
roscopist shall indicate that the high level control is being employed.

(D) Measuring useful beam exposure rate compliance.

1 . If the X-ray tube is below the table, the exposure rate shall be mea-
sured 1 centimeter above the tabletop or cradle.

2. If the X-ray tube is above the table, the exposure rate shall be mea-
sured at 30 centimeters above the tabletop with the end of the beam-li-
miting device or spacer positioned as closely as possible to the point of
measurement.

•

Page 198

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Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30308

3. In a C-arm type of fluoroscope. the exposure rate shall be measured
at 30 centimeters from the input surface of the fluoroscopic imaging as-
sembly.

(8) Mobile fluoroscopic equipment shall meet the requirements of this
section where applicable, except that:

(A) Inherent provisions shall be made so that the machine is not oper-
ated at a source-skin distance of less than 30 cm ( 1 2 inches).

(B) Image intensification shall always be provided. Conventional
fluoroscopic screens shall not be used.

(D) It shall be impossible to energize the useful beam of a mobile fluo-
roscope unless the entire useful beam is intercepted by the image recep-
tor.

(9) Devices which indicate the X-ray tube potential and current shall
be provided, and should be located in such a manner that the operator may
monitor the tube potential and current during fluoroscopy.

( 1 0) A shielding device of at least 0.25 millimeters lead equivalent
shall be provided for covering the bucky-slot during fluoroscopy.

(11) Whenever practicable, protective drapes, or hinged or sliding
panels, of at least 0.25 millimeters lead equivalent shall be provided be-
tween the patient and the fluoroscopist to intercept scattered radiation
which would otherwise reach the fluoroscopist and others near the ma-
chine. Such devices shall not substitute for wearing of a protective apron.

(b) Operating Procedures.

( 1 ) Protective aprons of at least 0.25 mm lead equivalent shall be worn
in the fluoroscopy room by each person, except the patient, whose body
is likely to be exposed to 5 mR/hr or more.

(2) On fluoroscopes with automatic exposure controls the operator
shall monitor the tube current and potential at least once each week to as-
certain that they are in their usual ranges for a given set of operating pa-
rameters. This requirement may be met by adjusting the controls to usual
settings for fluoroscoping an average patient, and using a phantom of any
suitable material with attenuation roughly equivalent to six to ten inches
of water. Whenever the monitored tube current or potential vary in a way
which could increase the patient X-ray exposure rate by more than 25%
over the latest exposure rate measurement required by Section
30307(b)(3), the cause(s) for the change shall be determined promptly
and the patient exposure rate shall be remeasured. On fluoroscopes with
manual exposure control only, the operator shall monitor the tube current
and potential at least once each day during use to ascertain that they are
within the normal ranges used by the facility. A written log shall be kept
of all monitored readings and shall include at least the tube current and
potential, the date, identification of the fluoroscope, and name of the per-
son who did the monitoring. Records of all monitored readings shall be
preserved at the facility for at least three years.

(3) Measurements of the table top or patient exposure rate shall be
made at least once each year for units with automatic exposure control,
and at least once each 3 years for units without automatic exposure con-
trol, and immediately following alteration or replacement of a major
component, such as the X-ray tube, the exposure controls, the imaging
assembly, and the power source.

(4) On cineradiography equipment, the exposure rates to which pa-
tients are normally subjected shall be determined at least once each year,
and immediately following alterations or replacement of a major compo-
nent, such as the X-ray tube, the exposure controls, the imaging assem-
bly, and the power source.

Note: Authority cited: Sections 102, 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.

History

1 . Renumbering and amendment filed 9^4-73 as an emergency; effective upon fil-
ing (Register 73, No. 36). Approved by State Building Standards Commission
11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73. No. 52).

3. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No.
26).

4. Amendment filed 6-18-87; operadve 7-18-87 (Register 87, No. 28).

§ 30308. Radiographic Installations (Other Than Dental
and Veterinary Medicine).

(a) Equipment.

( 1 ) The tube housing shall be of diagnostic type.

(2) Suitable devices (diaphragms, cones, adjustable collimators), ca-
pable of restricting the useful beam to the area of clinical interest shall
be provided to define the beam and shall provide the same degree of at-
tenuation as that required of the tube housing. Such devices shall be cali-
brated in terms of the size of the projected useful beam at specified sour-
ce-film distances. For chest photofluorographic equipment, the
collimator shall restrict the beam to dimensions no greater than those of
the fluorographic screen. The field size indication on adjustable collima-
tors shall be accurate to within 2 percent of the source-film distance. The
light field shall be aligned with the X-ray field with the same degree of
accuracy.

(3) For equipment manufactured prior to August 1, 1974, the alumi-
num equivalent of the total filtraUon in the useful beam shall be not less
than that shown in Table I :

Table 1

Minimum Total Filter
Operating kVp (Inherent plus added)

Below 50 kVp 0.5 mm aluminum

50-70 kVp ; 1 .5 mm aluminum

Above 70 kVp 2.5 mm aluminum

For equipment manufactured on or after August 1, 1974, the half-va-
lue layer (HVL) of the useful beam for a given X-ray tube potential shall
not be less than the appropriate value specified in Table 2.

Table 2

X-ray tube voltage (liilovolt peaki

Designed Measured Minimum HVL

Operating Range Minimum HVL (mm ofAl)

Below 50 30 0.3

40 0.4

49 0.5

50 to 70 50 1.2

60 1.3

70 1.5

Above 70 70 2.1

80 2.3

90 2.5

100 2.7

110 3.0

120 3.2

130 3.5

140 3.8

150 4.1

(4) A device shall be provided to terminate the exposure after a pre-set
time or exposure.

(5) A dead-man type of exposure switch shall be provided and so ar-
ranged that it cannot be convenienfly operated outside a shielded area,
except that exposure switches for "spot film" devices used in conjunction
with fluoroscopic tables are excepted from this shielding requirement.

(6) The control panel shall include a device (usually a milliammeter)
to give positive indication of the producfion of X-rays whenever the X-
ray tube is energized.

(7) The control panel shall include devices (labeled control settings
and/or meters) indicating the physical factors (such as kVp, mA, expo-
sure time, or whether timing is automafic) used for the exposure.

(8) Machines equipped with beryllium window X-ray tubes shall con-
tain keyed filter interlock switches in the tube housing and suitable indi-
cation on the control panel of the added filter in the useful beam if the total
filtradon permanenUy in the useful beam is less than 0.5 mm aluminum
equivalent. The total filtration permanently in the useful beam shall be
clearly indicated on the tube housing.

(9) The aluminum equivalent of the table top when a cassette tray is
used under the table top, or the aluminum equivalent of the front panel
of the vertical cassette holder, shall not be more than 1 mm at 1 00 kVp.

(b) Operating Procedures.

Page 199

§ 30309

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1) No individual occupationally exposed to radiation shall be per-
mitted to hold patients during exposures except during emergencies, nor
shall any individual be regularly used for this service. If the patient must
be held by an individual, that individual shall be protected with appropri-
ate shielding devices such as protective gloves and apron and he shall be
so positioned that no part of his body will be stmck by the useful beam.

(2) Only individuals required for the radiographic procedure shall be
in the radiographic room during exposure; and, except for the patient, all
such persons shall be equipped with appropriate protective devices.

(3) The radiographic field shall be restricted to the area of clinical in-
terest.

(4) Gonadal shielding of not less than 0.5 mm lead equivalent shall be
used for patients who have not passed the reproductive age during radio-
graphic procedures in which the gonads are in the direct beam, except for
cases in which this would interfere with the diagnostic procedure.

(5) The operator shall stand behind the barrier provided for his protec-
tion during radiographic exposures.

NOTE; Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 23801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Renumbering and amendment filed 9-^1—73 as an emergency; effective upon fil-
ing (Register 73, No. 36). Approved by State Building Standards Commission

11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§ 30309. Special Requirements for IVIobile Radiographic
Equipment.

(a) Equipment.

(1) All requirements of Section 30308(a) apply except 30308 (a)(5)
and 30308 (a)(9).

(2) The exposure control switch shall be of the dead-man type and
shall be so arranged that the operator can stand at least 6 feet from the pa-
tient and well away from the useful beam.

(3) Inherent provisions shall be made so that the equipment is not oper-
ated at source-skin distances of less than 12 inches.

(b) Operating Procedures.

(1) All provisions of Section 30308(b) apply except 30308(b)(5).

(2) The target-to-skin distance shall be not less than 12 inches.

(3) Personnel monitoring shall be required for all individuals operat-
ing mobile X-ray equipment.

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Amendment filed 3-5-7 1 ; effecfi ve thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71. (Register 71, No. 10).

2. Renumbering and amendment filed 9-4-73 as an emergency; effective upon fil-
ing (Register 73, No. 36). Approved by State Building Standards Commission
1 1-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment of subsection (b)(1) filed 6-18-87; operative 7-18-87 (Register
87, No. 28).

§ 30310. Special Requirements for Chest

Photofluorographic Installations.

(a) Equipment.

(1) All provisions of Section 30308 (a) apply.

(2) A collimator shall restrict the useful beam to the area of the photo-
fluorographic screen.

(3) The incident X-ray exposure where the central ray enters the pa-
tient shall not exceed 200 milliroentgens per radiograph for the average
patient, and should not exceed 100 milliroentgens per radiograph.

(b) Operating Procedures.

(1) All provisions of Section 30308(b) apply.
NOTE: Authority cited: Secdons 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 and 25815, Health and Safety Code.

History
1. Amendment filed 3-5-71 ; effective thirtieth day thereafter. Approved by State

Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Renumbering and amendment filed 9-4-73 as an emergency; effective upon fil-
ing (Register 73, No. 36). Approved by State Building Standards Commission
1 1-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§ 3031 1 . Dental Radiographic Installations.

(a) Equipment.

( 1 ) The tube housing shall be of diagnostic type.

(2) Diaphragms or cones shall be used for collimating the useful beam
and shall provide the same degree of protection as the housing.

(A) For intra-oral radiography the useful beam shall be restricted to
a diameter of not more than 7 cm (2.75 inches) at the surface of the skin.

(3) For intra-oral film exposures a cone or spacer frame shall provide
a target-to-skin distance of not less than 1 8 cm (7 inches) with apparatus
operating above 50 kVp or 10 cm (4 inches) with apparatus operating at
50 kVp or below.

(4) The total filtration permanently in the useful beam shall be equiva-
lent to at least 0.5 millimeters of aluminum for equipment operating be-
low 50 kVp, equivalent to at least 1 .5 inillimeters of aluminum for equip-
ment operating from 50 kVp through 70 kVp, and equivalent to at least
2.5 millimeters of aluminum for equipment operating above 70 kVp.

(5) A device shall be provided to terminate the exposure after a pre-set
time or exposure.

(6) The exposure control switch shall be of the dead-man type. If a re-
cycling timer is employed it shall not be possible to make a repeat expo-
sure without release of the exposure switch to reset the timer.

(7) Each installation shall be provided with a protective barrier for the
operator or shall be so arranged that the operator can stand at least 6 feet
from the patient and well away from the useful beam.

(8) Mechanical support of the tube head and cone shall maintain the
exposure position without drift or vibration.

(9) Panoramic installations. This part applies to those installations
which consist of a tube head with a collimator providing a narrow useful
beam and an extra oral film carrier which are interlocked in their motion
about the patient.

(A) All provisions of Section 303 1 1 (a) apply except 303 1 1 (a)(2)(A),
30311 (aj(3), 30311 (a)(10).

(10) Cephalometric installations.

(A) All provisions of Section 3031 1 (a) apply except 3031 1 (a)(2)(A),
30311 (a)(3), and 303 11 (a)(9).

(B) The radiographic field shall be restricted to the area of the image
receptor.

(11) The X-ray control panel shall include means for indicating X-ray
tube voltage (kVp), tube current (mA), and exposure duration. The tube
voltage and current shall be indicated by meters or by control settings. A
miUiammeter, a light or other device shall give clear and distinct visual
or audible indication to the operator when X-rays are being produced.

(b) Operating Procedures.

(1) No individual occupationally exposed to radiation shall be per-
mitted to hold patients or films during exposure, nor shall any individual
be regularly used for this service.

(2) During each exposure, the operator shall stand at least 6 feet from
the patient or behind a protective barrier.

(3) Only the patient shall be in the useful beam.

(4) Neither the tube housing nor the position indicating device (cone,
cylinder) shall be hand-held during exposure.

(5) Fluoroscopy shall not be used in dental examinations.

(6) Each patient undergoing dental radiography shall be draped with
a protective apron of not less than 0.25 millimeter lead-equivalent to
cover the gonadal area.

(7) For intra-oral and cephalometric radiography the X-ray beam and
the film shall be aligned very carefully with the area to be radiographed.

(8) Only persons required for the radiographic procedure shall be in

the radiographic room during exposures.

NOTE: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 and 25815, Health and Safety Code.

Page 200

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30312

History

1 . Renumbering and amendment filed 9^^-73 as an emergency: effective upon fil-
ing (Register 73, No. 36). Approved by State Buildins Standards Commission
11^30 73.

2. Certificate of Compliance filed 12-28-73 (Register 73. No. 52).

3. Hditorial correction (Register 74, No. 6).

4. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No.
26).

5. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§ 3031 2. Therapeutic X-Ray Installations.

(a) Equipment.

( 1 ) The lube housing shall be of therapeutic type.

(2) For equipment installed on or before August 1, 1979, permanent
diaphragms or cones used for collimating the useful beam shall afford the
same degree of protection as the housing. Adjustable or removable
beam-defining diaphragms or cones shall transmit not more than 5 per-
cent of the useful beam obtained at the maximum kilovoltage and with
maximum treatment filter.

(3) Forequipment installed after August 1, 1979, permanent beam-de-
fining devices or diaphragms shall afford the same degree of protection
as the housing. Adjustable or interchangeable beam-defining devices
shall transmit no more than 2 percent of the useful beam for the portion
of the useful beam which is to be attenuated by the beam limiting device.
Measurements shall be averaged over an area up to but not exceeding 100
square centimeters at the normal treatment distance.

(4) Filters shall be secured in place to prevent them from dropping out
during treatment. A filter indication system shall be used on all therapy
machines using interchangeable filters. It shall indicate, from the control
panel, or from the control station, the presence or absence of any filter
except compensating filters, and it shall be designed to permit easy iden-
tification of the filter in place. The filter slot shall be so constructed that
the radiation escaping through it does not exceed 1 roentgen per hour at
1 meter, or, if the patient is likely to be exposed to radiation escaping from
the slot, 30 roentgens per hour at 5 centimeters from the external opening.
Each interchangeable filter shall be marked with its thickness and materi-
al.

(5) The X-ray tube shall be so mounted that it cannot turn or slide with
respect to the aperture.

(6) Means shall be provided to immobilize the tube housing during sta-
tionary portal treatment.

(7) A suitable exposure control device such as an automatic timer, ex-
posure meter, or dose meter shall be provided to terminate the exposure
after a preset time interval or preset exposure or dose limit. A timer shall
be provided to terminate the exposure after a preset time regardless of
what other exposure limiting devices are present. Means shall be pro-
vided for the operator to terminate the exposure at any time.

(8) Equipment utilizing shutters to control the useful beam shall have
a shutter position indicator on the control.

(9) An easily discernible indicator which shows whether or not X-rays
are being produced shall be on the control panel.

(10) Mechanical and/or electrical stops shall be provided on X-ray
machines capable of operating at 1 50 kVp or above to insure that the use-
ful beam is oriented only toward primary barriers.

(11) When the relationship between the beam interceptor (when pres-
ent) and the useful beam is not permanently fixed, mechanical or electri-
cal stops shall be provided to insure that the beam is oriented only toward
primary barriers.

(b) Operafing Procedures.

(1) When a patient must be held in position for radiation therapy, me-
chanical supporting or restraining devices shall be used.

(2) No patient other than the one being treated shall be in the treatment
room during exposure.

(3) No person other than the patient shall be in the treatment room
when the tube is operated at potentials exceeding 150 kVp. At operating
potentials of 1 50 kVp or below, persons other than the patient and opera-
tor may be in the treatment room for good reason but only if they are ade-

quately protected and their radiation exposure is appropriately moni-
tored.

(4) A calibration of the output of each radiation therapy system shall
be performed before the system is first used for irradiation of a patient.
and thereafter at intervals not to exceed 24 months. Therapy equipment
shall not be used for any therapy treatments except at those combinations
of effective energy, field size, and treatment distance for which the equip-
ment has been calibrated. The calibration shall be performed by or under
the direct supervision of a person who has been determined by the De-
partment to have adequate training, experience and knowledge in radi-
ation therapy physics, and who shall be present at the facility during such
calibration. After any change which might significantly alter the output,
spatial distribufion. or other characteristics of the therapy beam, the pa-
rameters which might be affected shall be measured.

(A) For therapy systems operating ai potentials above 500 kVp, the de-
terminations included in the calibration shall be provided in sufficient de-
tail so that the absorbed dose in tissue in the useful beam may be calcu-
lated to within 5 percent. The cahbration shall include, but shall not be
limited to, the following determinations:

1 . Verification that the equipment is operating in compliance with the
design specifications concerning the light localizer, the side light and
back-pointer alignment with the isocenter when these specifications are
known and applicable, variation in the axis of rotation for the table,
gantry and jaw system, and beam flatness and symmetry at specified
depths.

2. The relative dose at various depths in a tissue equivalent phantom
for each effective energy and the ranges of field sizes and treatment dis-
tances used for radiadon therapy.

3. The congruence between the radiation field and the field indicated
by the localizing device.

4. The uniformity of the radiation field and its dependency upon the
direcUon of the useful beam.

5. The absolute dose per unit time and dose per monitor .setting.

(B) For therapy systems operating at potentials between 1 50 kVp and
500 kVp inclusive, the calibration shall include, but shall not be limited
to, the following determinations:

1. The exposure rates and/or dose rates for each combination of field
size, technique factors, filter, and treatment distance used.

2. The degree of congruence between the radiation field and the field
indicated by the localizing device if such device is present.

3. An evaluation of the uniformity of the radiation field symmetry for
the field sizes used, and any dependence upon tube housing assembly
orientation.

(5) All new installations and existing installations not previously sur-
veyed shall have a radiation protection survey performed by c^r under the
direction of a person determined by the Department to have adequate
knowledge and training to advise regarding radiation protection needs,
to measure ionizing radiation and to evaluate safety techniques. If the
survey shows that supplementary shielding is required a resurvey shall
be performed after its installation. In addition, a resurvey shall be made
after every change which might decrease radiation protection signifi-
cantly. The surveyor shall report his findings in writing to the user. The
report shall indicate whether or not the installation is in compliance with
all applicable radiation protection requirements of this section. The user
shall report the findings of the survey in writing to the Department within
15 days of his receipt of the survey report.

(6) The exposure rate or dose rate of the useful beam and the size and
shape of the useful beam shall be known with reasonable certainty at all
times during operadon of the radiation therapy apparatus for medical
purposes.

(7) Spot checks shall be performed at least once each week for therapy
systems operadng at potendals above 500 kVp. and at least once each
month for therapy systems operating at 500 kVp or below.

(A) The measurements taken during spot checks shall demonstrate the
degree of consistency of the operating characteristics which can affect

Page 201

§ 30313

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

the radiation output of the system or the radiation dehvered to a patient
during a therapy procedure.

(B) For systems in which the caHbrating person beHeves beam quality
can vary significantly, spot checks shall include beam quality checks.

(C) The spot check procedures shall be in writing and shall have been
developed or approved by the individual who made the most recent cali-
bration of the system pursuant to Section 30312(b)(4). The written spot
check procedures shall specify when measurements and determinations
indicate an inconsistency or potential change in radiation output. When
more than the minimum frequency of spot checking is necessary, the spot
check procedures shall specify the frequency at which spot checks are to
be performed.

(D) When spot check results are erratic or inconsistent with calibration
data, the person who designed the spot check procedures, or a person of
equivalent competence, shall be consulted immediately and the reason(s)
for the inconsistency corrected before the system is used for patient irra-
diation.

(8) Calibration of the therapy beam shall be performed with a measure-
ment instrument which has been calibrated within the preceding two
years directly, or through no more than one exchange, at the National In-
stitute of Standards and Technology, or facility determined acceptable by
the Department. In addition, indirect spot checks or intercomparisons of
measurement instruments with secondary standards shall be made at
least each six months.

(9) Reports of each radiation safety survey spot check and calibration
performed pursuant to this section shall be maintained at the facility for
at least three years. A copy of the treatment data developed from the latest
calibration shall be available for use by the operator at the treatment con-
trol station.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Renumbering and amendment filed 9-4-73 as an emergency ; effective upon fil-
ing (Register 73, No. 36). Approved by State Building Standards Commission
11-30-73.

2. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

3. Amendment of subsection (c)(5) filed 12-12-75: effective thirtieth day thereaf-
ter (Register 75, No. 50).

4. Amendment filed 6-24-80; effective thirtieth day thereafter (Register 80, No.
26).

5. Amendment filed 6-18-87; operafive 7-18-87 (Register 87, No. 28).

6. Change without regulatory effect amending subsection (b)(7)(C) and (b)(8)
filed 11-1-91 pursuant to section 100, title 1, California Code of Regulations
(Register 92, No. 5).

§ 30313. Special Requirements for X-Ray Therapy

Equipment Operated at Potentials of 50 kV and
Below.

(a) Equipment.

(1) All provisions of Section 30312(a) apply.

(2) A therapeutic-type protective tube housing shall be used. Contact
therapy machines shall meet the additional requirement that the leakage
radiation at 2 inches from the surface of the housing not exceed 0. 1 R/hr.

(3) Automatic timers shall be provided which will permit accurate pre-
setting and determination of exposures as short as one second.

(b) Operating Procedures.

(1) All provisions of Section 30312(b) apply except 30312(b)(1) and
30312(b)(7).

(2) In the therapeutic application of apparatus constructed with beryl-
lium or other low-filtration windows adequate shielding shall be re-
quired to protect against unnecessary exposure from the useful beam, and
special safeguards are essential to avoid accidental exposures to the use-
ful beam. There shall be on the control panel some easily discernible de-
vice which will give positive information as to whether or not the tube
is energized.

(3) Machines having an output of more than 1 ,000 roentgens per min-
ute at any accessible place shall not be left unattended without the power
being shut off at the primary disconnecting source.

(4) If the X-ray tube of a contact therapy machine is hand-held during
irradiation, the operator shall wear protective gloves and apron.
NOTH: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Amendment filed 3-5-7 1 ; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Renumbering and amendment filed 9^4-73 as an emergency; effective upon fil-
ing (Register 73. No. 36). Approved by State Building Standards Commission
11-30-73.

3. Certificate of Comphance filed 12-28-73 (Register 73, No. 52).

4. Amendment of subsections (a)(1), (b)(1) and (b)(4) filed 6-18-87; operative
7-18-87 (Register 87, No. 28).

5. Change without regulatory effect amending subsection (b)(3) filed 11-1-91
pursuant to secuon 1 00, title 1 , California Code of Regulations (Register 92, No.
5).

6. Amendment of section heading filed 3-3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certitlcate of Compliance must be transmitted
to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day.

7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30314. Veterinary Medicine Radiographic Installations.

(a) Equipment.

(1) The tube housing shall be of diagnostic type.

(2) Diaphragms or cones shall be provided for collimating the useful
beam to the area of clinical interest and shall provide the same degree of
protection as is required of the housing.

(3) The total filtration permanently in the useful beam shall not be less
than 1.5 millimeters aluminum-equivalent for equipment operating up
to 70 kvp and 2.0 millimeters aluminum-equivalent for machines oper-
ated in excess of 70 kvp.

(4) A device shall be provided to terminate the exposure after a pre-set
time or exposure.

(5) A dead-man type of exposure switch shall be provided, together
with an electrical cord of sufficient length so that the operator can stand
out of the useful beam and at least 6 feet from the animal during all X-ray
exposures.

(b) Operating Procedures.

( 1 ) The operator shall stand well away from the tube housing and the
animal during radiographic exposures. The operator shall not stand in the
useful beam. If film must be held, it shall be held by individuals not occu-
pationally exposed to radiation. Hand-held fluoroscopic screens shall
not be used. The tube housing shall not be held by the operator. No indi-
viduals other than the operator shall be in the X-ray room while expo-
sures are being made unless such person's assistance is required.

(2) In any application in which the operator is not located behind a pro-
tective barrier, clothing consisting of a protective apron having a lead-
equivalent of not less than 0.25 millimeter shall be worn by the operator
and any other individuals in the room during exposures.

(3) No individual shall be regularly employed to hold or support ani-
mals during radiation exposures. Operating personnel shall not perform
this service except very infrequently and then only in cases in which no
other method is available. Any individual holding or supporting an ani-
mal during radiation exposure shall wear protective gloves and apron
having a lead-equivalent of not less than 0.25 millimeter.

Note: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1 and 25815, Health and Safety Code.

History

1 . Amendment filed 3-5-7 1 ; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71. (Register 71, No. 10).

2. Renumbering filed 9-4-73 as an emergency; effective upon filing (Register 73,
No. 36). Approved by State Building Standards Commission 1 1-30-73.

3. Certificate of Compliance filed 12-28-73 (Register 73, No. 52).

4. Amendment filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

Page 202

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30315.10

Article 4.5. Requirements for the Use of
X-Ray in Mammography

§30315.10. Definitions.

(a) The definitions in section 30100 shall apply to this article.

(b) As used in this article:

( 1 ) "Action limit" means the minimum or maximum value of a quality
assurance measurement representing acceptable performance.

(2) "Activities" means the operation of a mammography system to
produce the mammogram, the initial interpretation of the mammogram,
and the maintenance of the viewing conditions for that interpretation.

(3) "Adverse event" means an undesirable experience associated with
mammography activities such as:

(A) Poor image quality;

(B) Failure to send mammography reports within 30 calendar days
from the date of the mammographic examination to the referring physi-
cian or to the patient; and

(4) "Air kerma" means the kerma. measured in Gray (Gy), in a given
mass of air.

(5) "Automatic exposure control" (AEC) means a device that automat-
ically controls one or more technique factors in order to obtain at pre-se-
iected locations a required quantity of radiation.

(6) "Average glandular dose" means the value in millirad (mrad) or
milligray (mGy) for a given breast or phantom thickness that estimates
the average absorbed dose to the glandular tissue extrapolated from free
air exposures and based on fixed filter thickness and target material.

(7) "Category I" means medical educational activities that have been
designated as Category I by the Accreditation Council for Continuing
Medical Education, the American Osteopathic Association, or a state
medical society.

(8) "Clinical image review" means the process whereby the mammo-
grams produced by a specific mammography system are evaluated for
image quality.

(9) "Consumer" means an individual who chooses to comment on or
complain in reference to a mammographic examination, including the
patient or representative of the patient, such as a family member or refer-
ring physician.

(10) "Continuing education unit" means one hour of training received
through either:

(A) Face-to-face interaction between instructor(s) and student(s), as
when the instructor provides a lecture, conducts demonstrations, or re-
views student performance; or

(B) The administration and correction of student examinations by an
instructor(s) with subsequent feedback to the student(s).

(11) "Direct supervision" means the oversight of operations that in-
clude the following:

(A) During joint interpretation of mammograms, the supervising in-
terpreting physician reviews, discusses, and confirms the diagnosis of the
physician being supervised and signs the resulting report before it is en-
tered into the patient's record.

(B) During performance of a mammographic examination, the super-
vising mammographic radiologic technologist is physically present to
observe, and correct, as needed, the performance of the individual who
is performing the mammographic examination.

(C) During performance of a survey, the supervising medical physicist
is physically present to observe, and correct, as needed, the performance
of the individual who is performing the survey.

(12) "Established operating level" means the value of a particular
quality assurance parameter that has been established as an acceptable
normal level by the facility's quality assurance program.

(13) "Facility" means a hospital, outpatient department, clinic, radiol-
ogy practice, an office of a physician, mobile setting, or other place or
building in which a person conducts:

(A) Mammography activities; and/or

(B) Interventional mammography or research mammography.

( 14) "Facility accreditation certificate" means a document issued by
the Department authorizing a facility to perform mammography.

(15) "FDA" means the United States Food and Drug Administration.

(16) "Image receptor" means any device that transforms incident X-
ray photons either into a visible image or into another form that can be
made into a visible image by further transformations.

(17) "Interpreting physician" means a licensed physician who inter-
prets mammograms and meets the requirements of section 30315.50.

(18) "Interim Facility Accreditation Certificate" means a document is-
sued by the Department pursuant to section 30315.24.

( 1 9) "Interventional mammography" means the creation of a mammo-
gram during invasive interventions for localization, biopsy procedures,
or therapeutic procedures.

(20) "Kerma" means the sum of the initial energies of all the charged
particles liberated by uncharged ionizing particles in a material of given
mass.

(21) "Lead interpreting physician" means the interpreting physician
designated either by the person who owns or leases the facility, or an au-
thorized agent of that person to ensure that the facility' s quality assurance
program meets all of the requirements of this article.

(22) "Mammogram" means an X-ray image of the human breast.

(23) "Mammographic examination" means the performance of mam-
mography on a human being.

(24) "Mammographic modality" means a technology for radiography
of the breast such as screen-film mammography, digital mammography
and xeromammography.

(25) "Mammography" means the procedure for creating a mammo-
gram.

(26) "Mammography medical outcomes audit" means a systematic
collection of mammography results and the comparison of those results
with outcome data.

(27) "Mammography system" means a system that includes all of the
following:

(A) A radiation machine used as a source of radiation to produce a
mammogram;

(B) An imaging receptor used for the formation of a latent image of a
mammogram or for converting X-ray photons to a digital signal;

(C) A processing device for changing a latent image of a mammogram
or a digital signal to a visual image that can be used for diagnostic or ther-
apeutic purposes; and

(D) A viewing device, such as a view box or computer monitor, used
to visually evaluate a mammogram.

(28) "Mammography system evaluation" means an evaluation of the
mammography system by a medical physicist to ensure the system is in
compliance with sections 30316 and 30316.20(e).

(29) "Medical physicist" means an individual trained in performing
mammography system evaluations, quality assurance testing evaluations
and surveys.

(30) "Mobile service provider" means a person who performs mam-
mography in a mobile setting.

(31) "Mobile setting" means a setting in which mammography is per-
formed with a radiation machine that is fixed or used exclusively in a mo-
bile vehicle or unit, or is transported to a different location for the purpose
of providing mammography, but does not include a radiation machine
moved from room to room within a facility.

(32) "Multi-reading" means two or more physicians interpreting the
same mammogram, at least one of whom meets the requirements of sec-
tion 30315.50.

(33) "Overall assessment of findings" moans the results of an inter-
preting physician's evaluation of mammograms produced during a mam-

Page 202.1

§ 30315.20

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

mographic examination and categorized using the assessment categories
specified in section 30317.40(a)(4).

(34) "Phantom" means a test object used to simulate radiographic
characteristics of compressed breast tissue and containing components
that radiographically model aspects of breast disease and cancer.

(35) "Phantom image" means a radiographic image of a phantom.

(36) "Physical science" means physics, chemistry, radiation science
(including medical physics and health physics), and engineering.

(37) "Positive mammogram" means a mammogram that has an overall
assessment of findings that are either "suspicious" or "highly suggestive
of malignancy."

(38) "Quality assurance technologist" means an individual who meets
the requirements of section 30315.51 and has experience performing or
assisting in the performance of quality assurance tests specified in sec-
tion 30316.20(a) through (d) and (f)

(39) "Quality assurance testing evaluation" means an evaluation of a
facility' s quality assurance testing by a medical physicist to ensure quali-
ty assurance testing is performed in accordance with section 30316.20
excluding subsection (e) of section 30316.20.

(40) "Research mammography" means the creation of a mammogram
with an investigational mammography device as part of a scientific study
conducted in accordance with FDA's investigational device exemption
regulations in part 812 of title 21, Code of Federal Regulations.

(41 ) "Serious adverse event" means an adverse event that may signifi-
cantly compromise clinical outcomes, or an adverse event for which ap-
propriate corrective action was not taken in a timely manner.

(42) "Serious complaint" means a report of a serious adverse event.

(43) "Source-to-image receptor distance" (SID) means the distance
from the X-ray source to the center of the input surface of the image re-
ceptor.

(44) "Standard breast" means a 4.2 cm thick compressed breast con-
sisting of 50 percent glandular and 50 percent adipose tissue.

(45) "Survey," in lieu of the definition found in title 10, Code of Feder-
al Regulations, section 20.1001 incorporated by reference in section
30253, means the on-site performance of a mammography system evalu-
ation and a quality assurance testing evaluation by a medical physicist.

(46) "Traceable to a national standard" means that the instrument used
to quantitatively measure radiation has been calibrated at:

(A) The National Institute of Standards and Technology (NIST); or

(B) A calibration laboratory that participates in a proficiency program
with NIST at least once every two years during which the calibration lab-
oratory achieves agreement within plus or minus 3.0 percent of the NIST
standard at mammography energy levels.

NOTE: Authority cited: Sections 100273 and 115060, Health and Safety Code.
Reference: Section 1 15060, Health and Safety Code.

History

1. New article 4.5 (sections 30315.10-30320.90) and section filed 2-10-2003 as
an emergency; operative 2-10-2003 (Register 2003, No. 7). A Certificate of
Compliance must be transmitted to OAL by 6-10-2003 or emergency language
will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
sections (b)(17) and (b)(33), transmitted to OAL 6-6-2003 and filed
7-18-2003 (Register 2003, No. 29).

§ 30315.20. Facility Accreditation Certificate and Interim
Facility Accreditation Certificate.

(a) Except for persons only performing interventional mammography
or research maminography, a person shall not perform mammography
activities unless performed in a facility that:

(1) Possesses a current and valid Facility Accreditation Certificate or
an Interim Facility Accreditation Certificate; and

(2) Meets the requirements of this subchapter.

(b) An Interim Facility Accreditation Certificate shall be valid for six
months beginning on the date of issuance.

beginning on the date of issuance.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Section 115060, Health and Safety Code.

History

1 . New section filed 2-10-2003 as an emergency; operafive 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-1 0-2003 or emergency language will be repealed by operation of law on the
following day.

2. Editorial correction adding inadvertently omitted History 1 (Register 2003,
No. 8).

3. Certificate of Compliance as to 2-1 0-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 3031 5.22. Eligibility for a Facility Accreditation
Certificate.

(a) To be eligible for a Facility Accreditation Certificate a facility
shall:

(1) Submit the application described in section 30315.33;

(2) Comply with section 30108;

(3) Pass a Department inspection verifying that:

(A) Physicians interpreting mammograms meet the requirements of
section 30315.50;

(B) Mammographic radiologic technologists meet the requirements of
section 30315.51;

(D) Mammography systems meet the requirements of section 303 16;

(E) The mammography quality assurance program is capable of meet-
ing the requirements of section 30317.10;

(F) By following the procedure specified in section 30316.20(b),
phantom images of a phantom that meets the requirements of section
30316.22 produced by all mammography systems, meet the criteria spe-
cified in section 30316.20(b)(1) through (3);

(G) By use of the facility's proposed technique factors for a standard
breast, the average glandular dose for each radiation machine used for
mammography does not exceed the value specified in section
30316.20(e)(I0);

(H) The quality assurance manual meets the requirements of section
30317.20;

(1) The mammography procedures manual meets the requirements of
section 30317.30;

(J) The facility is capable of ensuring mammograms and mammo-
graphic examination reports meet the requirements of sections 30316.50
and 30317.40;

(K) The facility is capable of conducting a mammography medical
outcomes audit that meets the requirements of section 30317.60;

(L) The facility has a consumer complaint procedure that meets the re-
quirements of section 30317.70; and

(M) The requirements of Group 3 of this regulation are met.

(4) After receipt of an interim facility accreditation certificate issued
pursuant to section 303 15.24, for each machine that will be used to per-
form mammography, pass a clinical image review conducted by the De-
partment pursuant to section 30315.35, or conducted by an entity ap-
proved by the FDA pursuant to 42 United States Code Section
263b(e)(l)(A); and

(5) After receipt of an interim facility accreditation certificate issued
pursuant to section 30315.24, possess a current and valid certificate is-
sued by FDA pursuant to title 2 1 , Code of Federal Regulations, section
900.11(b).

NOTE; Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Section 1 15060, Health and Safety Code.

History

1 . New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30315.23. Renewal of a Facility Accreditation Certificate.

(a) To renew a Facility Accreditation Certificate, a facility shall:
(1) Seven months prior to the expiration date of the facility accredita-
tion certificate submit the facility application described in section
30315.33;

Page 202.2

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30315.33

(2) For each radiation macliine tlial will be used for mammography,
cither:

(A) Pass a clinical image review conducted by the Department pur-
suant to section 303 1 5.35(c) prior to the expiration date of the current fa-
cility accreditation certificate; or

(B) Have the machine's accreditation renewed by an entity approved
by FDA pursuant to 42 United States Code Section 263b(e)(l)(A); and

(3) Possess a current and valid certificate issued by FDA pursuant to
title 21, Code of Federal Regulations, section 900.1 1(b).

NOTH; Authority cited: Sections 100275 and 115060. Health and Safety Code.
Reference: Section 1 15060, Health and Safety Code.

History

2. Certificate of Compliance as to 2-1 0-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30315.24. Interim Facility Accreditation Certificate.

An interim facility accreditation certificate shall not be issued until a
facility has complied with section 303 1 5.22(a)(l ) through (3) and has ob-
tained a provisional certificate issued by FDA pursuant to title 2 1 , Code
of Federal Regulations, section 900.1 1(b)(2).

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Section 1 15060, Health and Safety Code.

History

1 . New section filed 2-1 0-2003 as an emergency; operative 2-1 0-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sec-
tion, transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No.
29).

§ 30315.33. Complete Facility Application.

(a) An application submitted for compliance with sections 30315.22
or 30315.23 shall be considered complete if the application contains the
following:

( 1 ) The legal name of the applicant, the mailing address, and the tele-
phone number;

(2) Tlie name under which the applicant's facility does business and,
if doing business under a fictitious name, a copy of the applicant's ficti-
tious name permit;

(3) The name of the contact person for the facility;

(4) The facility location address and mailing address if different from
location address.

(5) The registration number issued by the Department pursuant to sec-
tion 30108 and the expiration date of registration;

(6) The applicant's federal employer identification number and
California taxpayer identification number;

(7) If the facility is accredited by an entity approved by the FDA pur-
suant to 42 United States Code Section 263b(e)(l)(A), the name of that
entity.

(8) If the applicant requests approval to perform mammography in a
mobile setting:

(A) The physical address of each location where mammography will
be performed;

(B) For each location where mammography will be performed, the
name and telephone number of the responsible person who is allowing
the service to be provided at the location;

(C) Whether the mammograms will be processed with an on-board
processor or at specific locations. If the facility will process mammo-
grams at specific locations, the physical address of each location where
mammograms v^'ill be processed;

(D) Whether the radiation machine is fixed or used, exclusively, in a
mobile vehicle or is transported to the use location and moved to where
mammographic examinations will be performed. If the radiation ma-
chine is moved to where mammographic examinations will be per-

formed, the designated room number within the physical building at each
location of use; and

(E) A description of the quality assurance tests that will be performed
each lime the radiation machine is relocated.

(9) Responses to the following questions:

(A) "Have you ever performed mammography authorized pursuant to
a certificate issued by FDA?" If the answer is yes, provide in your re-
sponse the names under which mammography was performed;

(B) "If you have been certified by FDA to perform mammography, has
that cerfificate ever been revoked or suspended, or has FDA ever denied
to renew that certificate?" If the answer is yes, provide in your response
the following:

1 . The identity of any specific radiation machine(s) that failed to pass
clinical image review;

2. The dates of failure;

3. The acfions taken to correct any clinical image review deficiencies
including physician or technologist training, radiation machine or pro-
cessor repair and acquisition of replacement equipment or image recep-
tors;

4. Whether the radiadon machine passed the clinical image review
subsequent to actions taken as identified in subsection (a)(9)(B)3 and
when;

5. If, within the three years prior to the date of application, any radi-
ation machine used for mammography idenfified in subsection (a)( 15)
failed clinical image review during a lime when accredited by an entity
approved by the FDA pursuant to 42 United Slates Code Section
263b(e)(l)(A), copies of the failure reports; and

6. If accreditation issued by an entity approved by the FDA pursuant
to 42 United States Code Section 263b(e)(l)(A), was suspended or re-
voked, a description of the circumstances that led to suspension or re-
vocation.

(C) "Is any interpreting physician you seek to allow to interpret mam-
mograms currently under a Department-directed plan of corrective ac-
tion for interpretation done at some other facility?" If the answer is yes,
provide in your response the following:

1 . The name and medical license number of the interpreting physician;
and

2. The facility's name and registration number where the interpreting
physician was required to complete a directed plan of corrective action.

( 1 0) The name of the individual designated as the lead interpreting
physician.

(11) The name, medical license number, certificate number and ex-
piration date as shown on the individuals certificate issued pursuant sec-
tions 30466(d) or 30467 of each physician who will interpret mammo-
grams produced by the facility;

(12) The name, certificate number and expiration date of certification
shown on the certificate issued pursuant to section 30455.1 for each
mammographic radiologic technologist who will perform mammo-
graphic examinations for the facility;

(13) The name of each medical physicist who will perform the tests
specified in secdon 30316.20(e) for the facility;

(14) The name of the quality assurance technologist;

(15) For each radiadon machine that will be used to perform mammo-
graphic examinadons;

(A) The machine's manufacturer, model number, and the facility's
radiadon machine identificadon number as specified in section
30317(g);

(B) Whether the machine will be used in a mobile setdng. If the ma-
chine will not be used in a mobile setting, the designated room number
within the facility where the machine is installed or fixed;

(C) Whether the machine is a screen-film, xeromammography or digi-
tal system. If the machine is a screen-film system, the name of the
manufacturer of the screen and film, and the type of screen and film used;
and

Page 202.3

§ 30315.34

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(D) If the machine requires a screen-film image receptor, a phantom
image of a phantom that meets the requirements of section 3031 6.22.

( 16) A copy of the report indicating the results of a mammography sys-
tem evaluation performed less than 6 months prior to the date of the ap-
plication by a medical physicist or in lieu thereof for renewal applica-
tions, a copy of the report indicating the results of a survey performed less
than 1 2 months prior to the date of the renewal application by a medical
physicist and if the mammography system evaluation report or the survey
report identifies deficiencies or recommendations for improvements in
facility operations:

(A) A list and description of corrective actions taken and the date
corrections were achieved;

(B) Copies of work invoices;

(C) Documentation that those corrective actions were taken and those
actions corrected the deficiencies or thai those recommendations were
followed.

(17) For each film processor that is used to process mammograms:

(A) The make and model number; and

(B) Whether the processor uses extended processing or standard pro-
cessing.

(18) If this is a renewal application, the number of the following proce-
dures performed in the previous year:

(A) Screening procedures;

(B) Diagnostic procedures;

(D) Biopsy procedures;

(E) Needle localization procedures; and

(F) Therapeutic procedures.

( 19) If this is a renewal application, the identification number and ex-
piration date shown on the FDA certificate issued to the applicant's facil-
ity;

(20) Whether the applicant participates or intends to participate in ei-
ther the Breast Cancer Early Detection Program or the Breast and Cervi-
cal Cancer Control Program of the Department or any of their successors;

(21 ) If the applicant is a Medi-Cal provider, the nine-digit Medi-Cal
number used to bill for mammographic examinations performed at the
facility's location;

(22) If the applicant is a Medicare provider, the nine-digit Medicare
number used to bill for mammographic examinations performed at the
facility's location;

(23) Name, title, signature and date of signature of the applicant and
lead interpreting physician.

NOTE; Authority cited: Sections 1 15060, 1310.S] and 131200, Health and Safety
Code. Reference; Section 11 5060, Health and Safety Code.

History

1 . New section filed 2-1 0-2003 as an emergency; operative 2-1 0-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

3. Amendment of subsection (a)(15)(A) and Note filed 7-11-2007; operative
8-10-2007 (Register 2007, No. 28).

§ 30315.34. Application Processing Times.

(a) Within 30 calendar days of receipt of an application for or renewal
of a facility accreditation certificate, the Department shall:

(1) Notify the applicant that the apphcation is complete; or

(2) Notify the applicant that the application is incomplete and identify
what is required for the Department to consider it complete.

(b) Unless the applicant responds to the notification in subsection
(a)(2) within 30 calendar days the application shall be deemed withdrawn
and the applicant may reapply by submitting a new application.

(c) Within six months of receipt of a complete application, the Depart-
ment shall issue or deny the facility accreditation certificate.

(d) The Department's time periods for processing an application for
or renewal of a facility accreditation certificate from receipt of the initial
application to the date the final decision is made, are as follows:

( 1 ) The median time is five and one-half months;

(2) The minimum time is four months;

(3) The maximum time is 12 months.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reierence: Section 15376, Government Code.

History

1 . New section filed 2-1 0-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-1 0-2003 order, includina amendment of sub-
section (b), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Reeister 2003,
No. 29).

§ 30315.35. Clinical Image Review.

(a) After receipt of an interim facility accreditation certificate issued
pursuant to section 30315.24, applicants for a facility accreditation cer-
tificate shall:

( 1 ) Select mammograms in accordance with the criteria specified in
title 21, Code of Federal Regulations, section 900.4(c)(4); and

(2) Within 73 calendar days of the date of issuance as shown on the
interim facility accreditation certificate, submit those mammograms for
clinical image review.

(b) If the mammograms fail the review, additional mammograms may
be submitted if the resubmission is made no less than 75 calendar days
prior to the expiration date of the interim facility accreditation certificate.

( 1 ) Select mammograms in accordance with the criteria specified in
title 21, Code of Federal Regulations, section 900.4(c)(4); and

(2) Submit those mammograms for clinical image review no less than
75 calendar days prior to the expiration date of the facility accreditation
certificate.

(d) Mammograms submitted pursuant to this section shall meet the
FDA-accepted attributes as specified in fitle 2 1 , Code of Federal Regula-
tions, section 900.4(c)(2).

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 1 15100 and 115115, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§30315.36. Mammography Review.

(a) Each facility possessing a facility accreditation certificate shall,
upon request, make mammograms and reports specified in section
303 1 7.40(a) available to the Department and allow those mammograms
and reports to be removed from the facility for the purpose of evaluating
mammogram image quality.

(b) For sample sizes of two mammographic examinations:

( 1 ) If one mammographic examination fails the review, the facility
shall submit a plan of corrective action, acceptable to the Department, ad-
dressing those areas that resulted in the failure and satisfactorily com-
plete that plan; or

(2) If both mammographic examinations fail the review, the facility
shall satisfactorily complete a plan of corrective action as directed by the
Department addressing those areas of the review that resulted in the fail-
ure. The facihty shall be subject to additional review using a larger sam-
ple.

(1) If 20 percent of the mammographic examinations fail the review,
the facility shall submit a plan of corrective action, acceptable to the De-
partment, addressing those areas that resulted in the failure and satisfac-
torily complete that plan;

(2) If 40 percent of the mammographic examinations fail the review,
the facihty shall satisfactorily complete a plan of corrective action as di-
rected by the Department addressing those areas of the review that re-
sulted in the failure; or

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§ 30315.60

(3) If 80 percent or more of the mammographic examinations fail the
review, the facility shall cease the performance of mammography and
submit to additional review and:

(A) If 70 percent or more of the mammographic examinations pass this
additional review, the facility may restart the performance of mammog-
raphy after satisfactorily completing a plan of corrective action as di-
rected by the Department and shall, within 75 calendar days of notifica-
tion that the mammograms passed the review, submit mammograms in
accordance with section 30315.35(a)(]); or

(B) If less than 70 percent of the mammographic examinations pass
this additional review, the facility shall not restart the performance of
mammography and shall notify every patient who had a mammogram at
the facility during the two-year period preceding the date of failure. The
notification shall be approved by the Department prior to mailing and in-
clude:

1 . The name of the patient;

2. The date the patient's mammogram was performed;

3. The statement, "The Department of Health Services of the State of
California has conducted a review of the mammograms produced by (the
name of the facility) and has determined that the mammograms do not
meet the standards set by the Department. Therefore, we strongly advise
you to consult with your physician as soon as possible regarding a repeat
mammographic examination."

(d) Mammograms reviewed pursuant to this section shall meet the
FDA-accepted attributes as specified in title 2 1 , Code of Federal Regula-
tions, section 900.4(c)(2).

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 115060, 115100 and 115115, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (c)(3)(B)3., transmitted to OAL 6-6-2003 and filed 7-18-2003 (Regis-
ter 2003, No. 29).

§ 30315.50. Interpreting Physician Requirements.

(a) An interpreting physician for a facility shall:

( 1 ) Possess a current and valid radiology supervisor and operator cer-
tificate issued pursuant to sections 30467 or 30466(d); and

(2) Meet the requirements specified in title 21, Code of Federal Regu-
lations, section 900.12(a)(1).

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Section 11 5060, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operafive 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operadon of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 3031 5.51 . Personnel Requirements for Individuals Who
Perform Mammography.

(a) Mammographic examinations shall not be performed unless the in-
dividual who performs the mammographic examination:

(1) Possesses a current and valid mammographic radiologic technolo-
gy certificate issued pursuant to section 30455.1; and

(2) Meets the requirements specified in title 2 1 , Code of Federal Regu-
lations, section 900.12(a)(2).

NOTE: Authority cited: Secfions 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060 and 115115, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30315.52. Medical Physicist Requirements.

(a) A medical physicist for a facility shall:

(1 ) Be authorized by the Department pursuant to .section 30315.60;

(2) Have a inasters degree or higher in a physical science from an ac-
credited institution, with no less than 20 semester hours or 30 quarter
hours of college undergraduate or graduate level physics;

(3) Complete 20 hours of documented specialized training in conduct-
ing surveys of inammography facilities; and

(4) Conduct a survey of at least one mainmography facility and a total
of at least ten mammography radiation machines under the direct super-
vision of a medical physicist who has already met the requirements of this
section, but in no case may more than one survey of a specific radiation
machine conducted within a period of 60 calendar days be counted to-
wards the total number of radiation machines surveyed. The period of
time spent in meeting the survey requirement may be counted toward
meeting the 20-hour training requirement in subsection (a)(3). After
April 28, 1999, experience conducting surveys shall be acquired under
the direct supervision of a medical physicist who meets the requirements
of subsections (a)(1) through (4) and (b); or

(5) In lieu of subsections (a)(2) through (4), qualify as a medical physi-
cist under Title 2 1 , Code of Federal Regulations, section 900. 1 2(a)(3), as
published in the December 21, 1993 Federal Register (58 Fed. Reg.
67571) and have retained that qualification by maintenance of the active
status of any licensure, approval, or certification required under those
regulations and prior to April 28, 1999:

(A) Received a bachelor's degree or higher in a physical science from
an accredited institution with no less than 1 0 semester hours or equivalent
of college undergraduate or graduate level physics;

(B) After meeting the requirements of subsection (a)(5)(A), com-
pleted forty hours of documented specialized training in conducting sur-
veys of mammography facilities; and

(C) After meeting the requirements of subsection (a)(5)(A), conducted
surveys of at least one mammography facility and a total of at least 20
mammography radiation machines but in no case may more than one sur-
vey of a specific radiation machine conducted within a period of 60 cal-
endar days be counted towards the total radiation machine survey re-
quirement. The period of time spent in meeting the survey requirement
may be counted toward meeting the 40-hour training requirement in sub-
section (a)(5)(B).

(b) A medical physicist for a facility shall meet the requirements speci-
fied in title 21, Code of Federal Regulations, section 900. 1 2(a)(3)(iii) and
(iv).

NOTE: Authority cited: Sections 100275, 1 15060 and 1 15100, Health and Safety
Code. Reference: Sections 1 15060, 1 15100 and 1 151 15, Health and Safety Code.

History

L New secdon filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-1 0-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (a)(5), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register
2003, No. 29).

§ 30315.60. Authorization and Renewal of Authorization to
Conduct Mammography Surveys, Revocation
and Suspension of Authorization and
Application Processing Times.

(a) To be eligible for authorization to conduct mammography surveys
an individual shall submit a complete application consisting of the fol-
lowing:

(1) Name, social security number (pursuant to the authority found in
sections 100275 and 115 100 of the Health and Safety Code and as re-
quired by section 1 7520 of the Family Code, providing the social security
number is mandatory. The social security number will be used for pur-
poses of identification), mailing address, daytime telephone number, and
FAX number;

(2) Documentation that the applicant meets the requirements of:
(A) Sections 30315.52(a)(2) through (4); or

Page 202.5

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(B) Section 30315.52(a)(5).

(3) Documentation that the applicant meets the requirements of sec-
tion 30315.52(b);

(4) Three sample survey reports, meeting the requirements of section
30316.60, indicating the name of the medical physicist providing direct
supervision and that the applicant performed all tests. Each report shall
include language and data that establishes that all tests were performed
to determine if the facility meets the requirements of this article and that,
if a test method is specified, the test method was followed; and

(5) The following information:

(A) Manufacturer, model and serial number of the phantom used to
produce phantom images;

(B) Whether the type of system resolution tool used to evaluate system
resolution is a bar pattern or. until October 28, 2002, a star pattern;

(D) Method used to evaluate compression;

(E) Type of instamients used to determine average glandular dose and
a copy of the most recent calibration report for that instrument indicating
that it complies with section 30316.61;

(F) Whether aluminum filters used to determine the radiation ma-
chine's half-value layer of the useful beam is type 1 100 or type 1 145;

(G) Manufacturer, model and serial number of the densitometer, sen-
sitometer and photometer used during surveys; and

(H) A list of equipment used to evaluate the mammography system for
artifacts and the radiation machine's AEC performance; or

(6) In lieu of subsections (a)(2) and (3), a copy of the letter issued to
the applicant by FDA stating that the applicant met the requirements of
title 21, Code of Federal Regulations, section 900.12(a)(3).

(b) Individuals approved by use of subsection (a)(2)(B) shall not pro-
vide direct supervision.

(c) Surveys of radiation machines used to perform interventional
mammography or research mammography shall not be used to comply
with this section.

(d) Authorization shall be valid for three years.

(e) To be eligible for renewal of authorization to conduct mammogra-
phy surveys an individual shall submit a complete application consisting
of the following:

( 1 ) Name, social security number (pursuant to the authority found in
sections 100275 and 1 15100 of the Health and Safety Code and as re-
quired by section 17520 of the Family Code, providing the social security
number is mandatory. The social security number will be used for pur-
poses of identification), mailing address, daytime telephone number, and
FAX number;

(2) The following information:

(A) If changes to the information submitted pursuant to subsection
(a)(5) have occurred, the updated information;

(B) A copy of the most recent calibration report for the instrument used
to determine average glandular dose.

(3) Documentation indicating that at least 8 hours of training in sur-
veying radiation machines were received for each new mammographic
modality; and

(4) Documentation that the applicant meets the requirements of sec-
tion 30315.52(b).

(f) Authorization to conduct mammography surveys may be revoked,
suspended, amended or restricted for any of the following:

(1) Failure to comply with section 30315.52(b);

(2) Knowingly conduct or perform mammography system evalua-
tions, quality assurance testing evaluations or surveys that cause or
would have caused, if not detected, a facility to be in violation of any pro-
vision of the Act, any regulation promulgated pursuant to the Act, any
provision of the Radiologic Technology Act, as defined in Health and
Safety Code section 27, any regulation promulgated pursuant to the Ra-
diologic Technology Act, or any order of the Department;

(3) Knowingly submits to the Department false, incorrect or fraudu-
lent information;

(4) Failure to inform a facility that a violation of this article has oc-
curred when the medical physicist knows of the violation; or

(5) Procuring authorization by fraud, or misrepresentation, or because
of mistake.

(g) Within 10 calendar days of receipt of an application for or renewal
of authorization, the Department shall:

(1) Notify the applicant that the application is complete; or

(2) Notify the applicant that the application is incomplete and identify
what is required for the Department to consider it complete.

(h) Unless the applicant responds to the notification in subsection
(g)(2) within 30 calendar days the application shall be deemed with-
drawn.

(i) Within 30 calendar days of receipt of a complete application, the
Department shall issue or deny the authorization.

(j) Any applicant deemed by the Department to have withdrawn an ap-
plication pursuant to subsection (e) may reapply by submitting a new ap-
plication.

(k) The Department's time periods for processing an application for
authorization from receipt of the initial application to the date the final
decision is made, are as follows:

(1 ) The median time is 30 calendar days;

(2) The minimum time is seven days;

(3) The maximum time is 90 calendar days.

NOTE: Authority cited: Sections 100275, 11 5060 and 115100, Health and Safety
Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code;
and Section 15376, Government Code.

History

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (a)(4), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register
2003, No. 29).

§ 30316. Mammography System Requirements.

(a) A radiation machine designed for general purpose radiography, or
special nonmammography procedures or that has been modified or
equipped with special attachments for mammography shall not be used
for mammography.

(b) Radiation machines used for mammography shall:

(1) Be specifically designed and manufactured for mammography and
meet the requirements of section 30305(a)(4).

(2) Provide a tube-image receptor assembly that is capable of being
fixed in any operating position where it is designed to operate and once
fixed in any such position, does not undergo unintended motion and does
not fail in the event of power interruption.

(3) If equipped with screen-film image receptors:

(A) Be able to be operated with image receptors of 1 8 x 24 centimeters
(cm) and 24 x 30 cm;

(B) Have moving grids matched to all image receptor sizes provided;
and

(4) If used to perform noninterventional problem solving procedures,
have a radiographic magnification capability with at least one magnifica-
tion value within the range of 1.4 to 2.0.

(5) When equipped with more than one focal spot, indicate, prior to ex-
posure, which focal spot has been selected.

(6) When equipped with more than one target material, indicate, prior
to exposure, the preselected target material.

(7) When equipped such that the target material and/ or focal spot are
selected by a system algorithm that is based on the exposure or on a test
exposure, display, after the exposure, the target material and/or focal spot
actually used during the exposure.

(8) Incorporate a compression device that:
(A) Effective October 28, 2002, provides:

Page 202.6

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Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30316.10

1. An initial power-driven compression activated by hands-free con-
trols operable from both sides of the patient; and

2. Fine adjustment compression controls operable from both sides of
the patient.

(B) Provides different sized compression paddles that match the sizes
of all full-field image receptors provided for the system. Compression
paddles for special purposes, including those smaller than the full size of
the image receptor (for "spot compression") may be provided but shall
be exempt from the requirements of subsection (b)(8)(C); and

(C) Except as provided in subsection (b)(8)(D), provides a compres-
sion paddle that is tlat and parallel to the image receptor holder assembly
and does not deflect from parallel by more than 1 .0 cm at any point on
the surface of the compression paddle when compression is applied. The
chest wall edge of the compression paddle shall be straight and parallel
to the edge of the image receptor. The chest wall edge shall not appear
on the image;

(D) If the compression paddle is intended by the manufacturer's de-
sign to not be flat and parallel to the image receptor holder assembly dur-
ing compression, the paddle shall meet the manufacturer's design speci-
fications and maintenance requirements; and

(E) If the chest wall edge is bent upward for patient comfort, the edge
shall not appear on the image.

(9) Provide manual selection of milliampere-seconds (mAs) or mil-
liamperes (mA) and time, and;

(10) Indicate kVp, mA and time and/or mAs before the exposure be-
gins, or when AEC is used, the technique factors that are set prior to the
exposure;

(11) When the AEC mode is used, indicate the actual technique factors
(kVp and mAs or mA and time) used, after completion of the exposure;

(12) If it is a screen-film system, provide an AEC mode that is oper-
able in all combinations of equipment configuration provided on that
unit, such as grid, nongrid, magnification, nonmagnification and various
target-filter combinations, and:

(A) Provides a positioning or selection of the detector that is flexible
in the placement of the detector under the target tissue;

(B) Clearly indicates the size and available positions of the detector at
the X-ray input surface of the compression paddle;

(D) Provides a means to vary the selected optical density from the nor-
mal or baseline setting.

(13) If equipped with a light beam that passes through the X-ray
beam-limiting device, the light provides an average illumination of 160
lux (15 foot candles) at the lesser of:

(A) 100 centimeters; or

(B) The maximum source-to-image-distance the machine can obtain.

( 1 ) There are at least four image receptors of 1 8 x 24 centimeters (cm)
and at least four image receptors of 24 x 30 cm available for use by the
person performing mammographic examinations;

(2) The X-ray film and intensifying-screens are designated by the film
manufacturer and the screen manufacturer as appropriate for mammog-
raphy and the X-ray film matches the screen's spectral output as speci-
fied by the screen manufacturer;

(3) Chemical solutions used for processing mammograms are capable
of developing the film so as to meet the minimum requirements specified
by the film manufacturer;

(4) Special lights for film illumination, or hot lights, that are capable
of producing light levels greater than that provided by the view box are
available; and

(5) Film masking devices that can limit the illuminated area to a region
equal to or smaller than the exposed portion of the film are available to
all physicians interpreting mammograms for the facility.

(d) Documentation demonstrating compliance with this section shall
be maintained in accordance with section 30319.20.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 1 15100 and 115115, Health and Safety Code.

History

1. New section filed 2-10-2003 as aji emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (b)(9), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Reeister
2003, No. 29).

§ 30316.10. Evaluations of New, Replaced or Repaired
Equipment.

(a) Whenever the following occur, the affected equipment shall meet
the requirements specified in sections 303 1 6 and 303 1 6.20 before the af-
fected equipment is used to produce or process mammograms:

(1) Installation of a new radiation machine or processor;

(2) Disassembly and reassembling of a radiation machine or processor
at the same or a new location; or

(3) Repair or replacement of any major component of the mammogra-
phy system.

(b) The evaluation to determine if equipment specified in subsections
(a)(1) through (3) are in compliance with subsection (a) shall be per-
formed by a medical physicist or an individual under the direct supervi-
sion of a medical physicist.

(1) Possess a current and valid facility accreditation certificate issued
pursuant to section 30315.22 or interim facility accreditation certificate
issued pursuant to section 30315.24;

(2) Submit the results of tests with measurements and calculated data
used to establish compliance with subsection (a), the information speci-
fied in section 30315.33(a)(1), (a)(4), (a)(7), (a)(15), (a)(17) and (a)(23)
and the calibration record required in section 30316.61(a); and

(3) Pass a clinical image review conducted by an entity approved by
FDA pursuant to 42 United States Code Section 263b(e)( 1 )(A) or by the
Department in which mammograms shall:

(A) Be selected in accordance with the criteria specified in title 21,
Code of Federal Regulations, section 900.4(c)(4);

(B) Be submitted within 75 calendar days of being notified by the De-
partment that subsections (c)(1) and (2) have been met; and

(d) To use a radiation machine that was disassembled and reassembled
for mammography, a facility shall:

(1) Possess a current and valid facility accreditation certificate issued
pursuant to section 30315.22 or interim facility accreditation certificate
issued pursuant to section 30315.24;

(2) Submit the results of tests with measurements and calculated data
used to establish compliance with subsection (a), the information speci-
fied in section 30315.33(a)(1), (a)(4), (a)(7), (a)(15), (a)(I7) and (a)(23)
and the calibration record required in section 30316.61(a); and

(3) Submit a mammography system evaluation performed by a medi-
cal physicist or an individual under the direct supervision of a medical
physicist.

(e) Documentation of the tests performed, the analysis of data ob-
tained, corrective actions and the effectiveness of those actions taken
pursuant to this section shall be maintained in accordance with section
30319.20.

NOTE: Authority cited: Secfions 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 115100 and 115115, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-1 0-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
sections (a), (c)(l)-(2) and (d)(l)-(2), transmitted to OAL 6-6-2003 and filed
7-18-2003 (Register 2003, No. 29).

Page 202.7

§ 30316.20

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 3031 6.20. Quality Assurance Testing.

(a) Each facility using screen-film systems for mammography shall
adjust and maintain each processor used to develop mammograms so that
the manufacturer's technical development specifications for the mam-
mography film in use are met. Each day mammograms are processed and
before processing mammograms the facility shall determine that the pro-
cessor used to develop mammograms, using the mammography film of
the type used clinically, meets the following:

( 1 ) Base plus fog-density is within plus 0.03 of the established operat-
ing level;

(2) Mid-density is within plus or minus 0. 15 of the established operat-
ing level; and

(3) Density difference is within plus or minus 0.15 of the established
operating level.

(b) Each facility using screen-film systems for mammography shall,
each week in which mammography is performed, produce an image of
a phantom that meets the requirements of section 303 16.22. The test shall
be performed prior to mammography on the day the test is performed. Be-
fore exposing the phantom an acrylic disc measuring one centimeter in
diameter and four millimeters thick shall be placed on the phantom in the
image area so it will not obscure details in the phantom and where it can-
not cast a shadow on any portion of the AEC detector. The phantom shall
then be exposed using the mammography film of the type used clinically
and the techniques used for clinical images of a standard breast. The re-
sulting phantom image shall meet the following:

( 1 ) The center of the image has an optical density (OD) of at least 1 .40
and once an established operating level is determined, the difference does
not change by more than plus or minus 0.20 OD when compared to the
established operating level;

(2) The difference between the OD measured inside the image of the
disc and the OD measured adjacent to the image of the disc is at least 0.40
and once an established operating level is determined, the difference does
not change by more than plus or minus 0.05 OD when compared to the
established operating level; and

(3) Obtains a score of at least 4.0 for fibers, 3.0 for specks and 3.0 for
masses using the phantom image scoring protocol in section 30316.30.

( 1 ) Test the residual fixer retained in the film to determine that it is no
more than 5 micrograms per square centimeter; and

(2) Perform a repeat analysis on mammograms repeated or rejected.
If the total repeat or reject rate changes from the previously determined
rate by more than 2.0% of the total films included in the analysis, the rea-
son(s) for the change shall be determined by the facility. Any corrective
actions shall be documented and the results of those corrective actions
shall be assessed. Test films, cleared films, or film processed as a result
of exposure of a film bin shall not be included in the count for repeat anal-
ysis but shall be counted to determine reject rate changes and may be dis-
posed of following completion of the analysis.

(d) Each facility conducting mammography shall, prior to initial use
and at intervals not to exceed six months:

(1) Determine that the optical density attributable to darkroom fog
does not exceed 0.05, by performing a test which uses mammography
film of the type used clinically in the facility in which the film is exposed
such that the film has a mid-density of no less than 1 .4 OD, and is ex-
posed to typical darkroom conditions for two minutes while such film,
with one-half of the film covered, is placed on the counter top, emulsion
side up. If the darkroom has a safelight used for mammography film, it
shall be on during this test;

(2) Conduct testing on all cassettes used for mammography in the fa-
cility for screen-film contact using 40 mesh copper screen during which
the entire area of the cassette that may be clinically exposed shall be
tested; and

(3) Determine that the X-ray system is able to compress the breast with
a force of at least 25 pounds and maintain this compression for at least
15 seconds, except that for systems with automatic compression, the
maximum force applied without manual assistance shall be greater than
25 pounds and shall not exceed 45 pounds.

(e) Each facility conducting mammography shall, annually, ensure
that a medical physicist verifies that:

( 1 ) Until October 28, 2002, the automatic exposure control (AEC) can
maintain film optical density within plus or minus 0.30 of the average of
the optical densities measured using homogeneous acrylic thicknesses of
2, 4. and 6 centimeters and the kilovoltage peak (kVp) is varied appropri-
ately for such thicknesses over the kVp range used clinically in the facil-
ity. Each image of the homogenous acrylic shall have an optical density
(OD) of at least 1.20. If the AEC cannot meet this requirement, a chart
shall be posted that specifies appropriate techniques (kVp and density
control settings) for different breast thicknesses and compositions so that
optical densities within plus or minus 0.30 of the average under photo-
timed conditions can be produced;

(2) After October 28, 2002, the AEC can maintain film optical density
within plus or minus 0. 1 5 of the average of the opfical densities measured
using homogeneous breast-tissue equivalent material thicknesses of 2,
4, and 6 centimeters (cm) and the kVp is varied appropriately for such
thicknesses over the kVp range used clinically in the facility. Each image
of the homogenous breast-tissue equivalent material shall have an OD
of at least 1.20;

(3) When the AEC mode is used and the OD is increased or decreased
from the normal or baseline setting, the net overall change in OD across
the range of clinically used density control settings shall exceed the OD
range established under subsection (e)(12) and if that net overall change
in OD is equal to or greater than the maximum difference in OD allowed
under subsection (e)(12), this change shall be distributed over a mini-
mum of two density control settings removed from the normal or baseline
setting;

(4) By using the protocol specified in subsection (b), the mammogra-
phy system, if a screen-film system, can produce a phantom image that
meets the following:

(A) The center of the image has an OD of at least 1 .40;

(B) The difference between the OD measured inside the image of the
disc and the OD measured adjacent to the image of the disc is at least 0.40;
and

(C) Obtains a score of 4.0 for fibers, 3.0 for specks and 3.0 for masses
using the phantom image scoring protocol in section 30316.30.

(D) The difference between the OD measured inside the image of the
disc and the OD measured adjacent to the image of the disc is at least 0.40
and the difference is not more than plus or minus 0.05 OD when
compared to the facility's established operating level.

(5) At the most commonly used clinical setfings of kVp, the coefficient
of variadon of reproducibility of the kVp is equal to or less than 0.02;

(6) The kVp is accurate to within plus or minus 5.0% of the indicated
or selected kVp at the following:

(A) The lowest clinical kVp that can be measured by a kVp test device;

(B) The most commonly used clinical kVp; and

(7) The focal spot condition meets one of the following:

(A) Until October 28, 2002, the measured focal spot length (dimension
parallel to the anode cathode axis) and width (dimension perpendicular
to the anode cathode axis) shall be within the tolerance limits specified
in Table I. If a star pattern is used to evaluate focal spot condition, the
star pattern shall, for evaluation of the large focal spot, be no larger than
1.5 degrees and, for evaluation of the small focal spot, be no larger than
1 .0 degree.

Page 202.8

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Radiation — Radiologic Technology — Nuclear Medicine Technology

§30316.20

Table I
Focal Spol Tolerance Limit

Nominal Focal Spot Size (mm)

0.10
O.LS
0.20
0.30
0.40
0.60

Maximum Measured Dimensions

Width (mm) Length (mm)

0.15 0.15

0.23 0.23

0.30 0.30

0.45 0.65

0,60 0.85

0.90 1.30

(B) The focal spot condition shall be evaluated by determining the
mammography system resolution in accordance with the following and
meet the specified criteria:

(1 ) Each mammography system used for mammography, in combina-
tion with the mammography screen-film combination used in the facil-
ity, shall provide a minimum resolution of 1 1 cycles/millimeter (mm)
(line-pairs/mm) when a high contrast resolution bar test pattern is ori-
ented with the bars perpendicular to the anode-cathode axis, and a mini-
mum resolution of 1 3 line-pairs/mm when the bars are parallel to that
axis;

(2) The bar pattern shall be placed 4.5 cm above the breast support sur-
face, centered with respect to the chest wall edge of the image receptor,
and with the edge of the pattern within 1 cm of the chest wall edge of the
image receptor;

(3) When more than one target material is provided, the measurement
in subsection (e)(7)(A) shall be made using the appropriate focal spot for
each target material;

(4) When more than one source-image-distance (SID) is provided, the
test shall be performed at the SID most commonly used clinically; and

(5) Test kVp shall be set at the value used clinically by the facility for
a standard breast and shall be performed in the AEC mode, if available.
If necessary, a suitable absorber may be placed in the beam to increase
exposure times. The screen-film cassette combination used by the facil-
ity shall be used to test for this requirement and shall be placed in the nor-
mal location used for cUnical procedures.

(8) The half-value layer (HVL) of the useful beam is not less than the
value specified in Table 2 of section 30308(a)(3) for the minimum HVL.
These values, extrapolated to the mammographic range, are shown as
follows, except that values not shown in Table 2 may be determined by
linear interpolation or extrapolation:

Table 2
X-ray Tube Voltage (kilovolt peak) and Minimum HVL

Designed Measured Operating Minimum HVL

Operating Range (kV) Voltage (kV) (mm of aluminum)

Below 50 20 0.20

25 0.25

30 0.30

(9) The coefficient of variation for both air kerma and milliampere-se-
conds (mAs) does not exceed 0.05;

(10) By performance of a test using the techniques the facility uses
clinically for a standard breast, the average glandular dose delivered by
screen-film systems during a single craniocaudal view of an FDA ac-
cepted phantom simulating a standard breast does not exceed 3.0 milH-
gray (mGy) (0.3 rad) per exposure;

(1 1) All systems meet the following:

(A) Possess beam-limiting devices that allow the entire chest wall
edge of the X-ray field to extend to the chest wall edge of the image re-
ceptor and provide means to assure that the X-ray field does not extend
beyond any edge of the image receptor by more than 2.0% of the SID;

(B) Provide that if a Ught field that passes through the X-ray beam li-
mitation device is used, it is aligned with the X-ray field so that the total
of any misalignment of the edges of the light field and the X-ray field
along either the length or the width of the visually defined field at the
plane of the breast support surface shall not exceed 2.0% of the SID; and

(C) The chest wall edge of the compression paddle does not extend be-
yond the chest wall edge of the image receptor by more than 1 .0% of the
SID when tested with the compression paddle placed above the breast

support surface at a distance equivalent to standard breast thickness. The
shadow of the verfical edge of the compression paddle shall not be visible
on the image.

(12) The uniformity of screen speed of all cassettes in the facility are
tested, and that the difference between the maximum and minimum opti-
cal densities do not exceed 0.30. The optical density of the test films shall
be no less than 1 .4;

(13) During the uniformity of screen speed test specified in subsection
(e)(12), system artifacts are evaluated with a high-grade, defect-free
sheet of homogeneous material large enough to cover the mammography
cassette and performed on all cassette sizes used in the facilit)' using a
grid appropriate for the cassette size being tested. The optical density of
the test films shall be no less than 1.4;

( 14) System artifacts are evaluated for all available focal spot sizes and
target/filter combinaUons used clinically;

(15) Unfil October 28, 2002, each machine produces, over 3.0 se-
conds, a minimum output of 4.5 mGy air kerma per second (513 milli-
roentgen (mR) per second) when operating at 28 kVp in the standard
mammography (molybdenum/molybdenum) mode at any SID where the
system is designed to operate and when measured by a detector with its
center located 4.5 cm above the breast support surface with the compres-
sion paddle in place between the source and the detector;

(16) After October 28, 2002, each machine produces, over 3.0 se-
conds, a minimum output of 7.0 mGy air kerma per second (800 milli-
roentgen (mR) per second) when operaUng at 28 kVp in the standard
mammography (molybdenum/molybdenum) mode at any SID where the
system is designed to operate and when measured by a detector with its
center located 4.5 cm above the breast support surface with the compres-
sion paddle in place between the source and the detector;

(17) If the system is equipped with a provision for automatic decom-
pression after compleUon of an exposure or interruption of power to the
system, it provides:

(A) An override capability to allow maintenance of compression;

(B) A continuous display of the override status; and

(18) The calibrauon of the densitometer and sensitometer used by the
facility meets the manufacturer's specifications; and

(19) For systems with image receptor modalities other than screen-
film, the quality assurance program meets the quality assurance program
recommended by the image receptor manufacturer, except that the maxi-
mum allowable dose shall not exceed the maximum allowable dose for
screen-film systems specified in subsection (e)(10).

(f) Each facility conducting mammography shall ensure that:

( 1 ) The darkroom or the area used to load or unload mammography
film is cleaned each day before any mammography is performed;

(2) Intensifying screens are cleaned each week using a screen cleaner
recommended by the screen manufacturer; and

(3) All view boxes used to score phantom images and interpret mam-
mograms are cleaned each week. If the view box used to interpret mam-
mograms is at a different location than where the mammograms are tak-
en, the facility shall ensure that documentation establishing the following
is available to personnel and Department inspectors:

(A) Physical location(s) where the mammograms produced by the fa-
cility are interpreted;

(B) For each location, the individual responsible for ensuring the view
boxes are cleaned at intervals not to exceed seven calendar days; and

(g) After complefion of the tests specified in subsections (a), (b), (d)
and (e)(4), (10) and (19), if any of the test results fail to meet the specified
criteria, the source of the problem shall be identified and corrective ac-
tions shall be taken before any further mammographic examinations are
performed or any films are processed using the component of the mam-
mography system that failed the test.

(h) Each facility conducting mammography shall, if any of the results
of the tests specified in subsections (c), (e)(] ) through (3), (5) through (9)

Page 202.9

§ 30316.22

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

and (11) through (18) and (f) fall outside the action limits, identify the
source of the problem and take corrective actions within 30 days of the
test date.

(i) All quality assurance data collected during tests conducted pur-
suant to this section shall be analyzed and if any problems are detected
by analysis of that data, the problems shall be corrected to ensure com-
pliance with this section.

(j) Documentation of the tests performed, the analysis of data ob-
tained, corrective actions and the effectiveness of those actions taken
pursuant to this section shall be maintained in accordance with section
30319.20.

NOTI-: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 1 15100 and 1 15] 15, Health and Safety Code

History

1 . New section filed 2-10-2003 as an emergency; operative 2-1 0-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-1 0-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
sections (bHb)(2), (c), (e)(2)-(3), (e)(6)(A), (e)( 13) and (f)(2)-(3), transmitted
to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).

§ 30316.22. Acceptable Phantoms.

(a) A phantom shall not be used unless it is approved by the FDA and
is:

( 1 ) Mammographic Accreditation Phantom Model 1 56 produced by
Radiation Measurement, Inc.;

(2) Mammographic Accreditation Phantom Model 18-220 produced
by Nuclear Associates; or

(3) Equivalent in thickness to a standard breast and;

(A) Contains six nylon fibers with the following diameters:

1. 1.56 millimeters (mm);

2. 1.12 mm;

3. 0.89 mm;

4. 0.75 mm;

5. 0.54 mm;

6. 0.40 mm;

(B) Contains five aluminum oxide speck groups, each containing six
specks and each speck in the group has the same diameter. The diameter
of the specks shall be:

1.0.54 mm;

2. 0.40 mm;

3. 0.32 mm;

4. 0.24 mm;

5. 0.16 mm; and

1. 2.00 mm;

2. 1.00 mm;

3. 0.75 mm;

4. 0.50 mm;

5. 0.25 mm.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 115100 and 1 15115, Health and Safety Code.

History

1 . New section filed 2-1 0-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (a), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003,
No. 29).

§ 30316.30. Phantom Image Scoring Protocol.

(a) This section shall apply only to screen-film mammography sys-
tems.

(b) Phantom images shall be scored in accordance with the following
protocol. Each of the following object groups shall be scored separately
and shall meet the criteria specified in section 303 1 6.20(b)(3) and (e)(4):

(1) Score the fibers as follows:

(A) Begin with the largest fiber and move down in size, adding one
point for each full fiber until a score of zero or one half is given, then stop.

(B) If the entire length of the fiber can be seen and its location and
orientation are correct, that fiber receives a score of one.

(C) If at least half, but not all, of the fiber can be seen and its location
and orientation are correct, that fiber receives a score of one half.

(D) If less than one half of a fiber can be seen or if the location or
orientation is incorrect, that fiber receives a score of zero.

(E) After determining the last fiber to be counted, look at the overall
background for artifacts. If there are background objects that are fiber-
like in appearance and are of equal or greater brightness than the last vis-
ible half or full fiber counted, subtract the last half or full fiber scored.

(2) Score the speck groups as follows:

(A) Begin with the largest speck group and move down in size adding
one point for each full speck group unfil a score of one half or zero is giv-
en, then stop.

(B) If at least four of the specks in any group are visualized, the speck
group is scored as one.

(D) If one speck or no specks from a group are visualized, the score
is zero.

(E) After determining the last speck group to receive a full or one-half
point, look at the overall background for artifacts. If there are speck-like
artifacts within the insert region of the phantom that are of equal or great-
er brightness than individual specks counted in the last visible half or full
speck group counted, subtract the artifact speck from the observed
specks, one by one. Repeat the scoring of the last visible speck group af-
ter these deducfions.

(3) Score the masses as follows:

(A) Begin with the largest mass and add one point for each full mass
observed unfil a score of one half or zero is assigned, then stop.

(B) Score one for each mass that appears as a minus density object in
the correct location that can be seen clearly enough to observe round, cir-
cumscribed borders.

(C) Score one-half if the mass is clearly present in the correct locafion,
but the borders are not visualized as circular.

(D) After determining the last full or half mass to be counted, look at
the overall background for arfifacts. If there are background objects that
are mass-like in appearance and are of equal or greater visibility than the
last visible mass, subtract the last full or half point assigned from the orig-
inal score.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 1 15100 and 1 151 15, Health and Safety Code.

History

1 . New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003. No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30316.40. Processing of Mammograms and Phantom
Images.

Each facility possessing a facility accreditafion certificate and con-
ducfing screen-film mammography shall process phantom images in the
processor(s) designated by the facility to process mammograms.
Note: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 115060, Health and Safety Code.

History

1 . New secfion filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30316.50. Mammographic Image Identification.

(a) The following information shall be placed on each mammogram
in a permanent, legible manner that does not obscure anatomic structures:

Page 202.10

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

8 30317.10

(1) Name of patient and an additional patient identifier;

(2) Date of examination;

(3 ) View and laterality, which shall be indicated on the image in a posi-
tion near the axilla using the abbreviations specified in subsections (b)
and (c);

(4) Facility name, city, state and zip code of the facility that performed
the mammogram;

(5) Technologist identification;

(6) Identification of the cassette/screen used in producing the mammo-
graphic image; and

(7) Radiation machine identification if there is more than one radiation
machine used for mammography at the facility.

(b) The following abbreviations shall be used to indicate laterality:

(1) Right; "R";

(2) Left; "L".

(1) Craniocaudal; "CC";

(2) Mediolateral oblique; "MLO";

(3) Mediolateral; "ML";

(4) Lateromedial; "LM";

(5) Lateromedial oblique; "LMO".

NOTE: Authority cited: Sections 100275 and 1 LS060, Health and Safety Code.
Reference: Sections 1 15060, 1 15100 and 1 151 15, HeaUh and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30316.60. Medical Physicist Survey Reports.

(a) Each facility conducting mammography shall undergo an annual
survey by a medical physicist or an individual under the direct supervi-
sion of a medical physicist, and shall obtain a survey report, dated and
signed by the medical physicist and, if an individual performed the sur-
vey under the direct supervision of a medical physicist, the individual be-
ing supervised, showing;

(1) The results with measurements and calculated data used for the
mammography system evaluation and the calibration record required in
section 30316.61(a);

(2) The results of the quality assurance testing evaluation, as well as
written documentation of any corrective actions taken and their results;
and

(3) Written recommendations for corrective actions according to all
results required to be in the report, if applicable.

(b) The survey report, specified in subsection (a), shall be obtained
within 30 calendar days of the date the medical physicist performed and
completed the survey. A facility shall require the medical physicist to
notify them within 72 hours of the date the tests were performed of any
deficiencies that involve any of the items listed in subsection (g) of sec-
tion 30316.20.

(c) The survey report shall identify each radiation machine by the fa-
cility's radiation machine identification number as specified in section
30317(g).

(d) The survey report, reviews, and calibration documentation re-
quired by this section shall be maintained in accordance with section
30319.20.

NOTE: Authority cited: Sections 1 15060, 131051 and 131200, Health and Safety
Code. Reference: Sections 1 15060 and 1 15100, Health and Safety Code.

History

1 . New section filed 2-1 0-2003 as an emergency; operative 2-1 0-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (a)(1), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register
2003, No. 29).

3. Amendment of subsection (c) and NoTi; filed 7-1 ] -2007; operative 8 10 2007
(Register2007, No. 28).

§ 30316.61 . Instruments Used by Medical Physicists.

(a) Instruments used by medical physicists to measure the air kerma
or air kerma rate from a radiation machine shall be calibrated at least once
every two years and each time the instrument is repaired. The instrument
calibration shall be traceable to a national standard and calibrated with
an accuracy of plus or minus 6.0% {959c confidence level) in the mam-
mography energy range. The calibration record shall be maintained in ac-
cordance with section 30319.20.

(b) Instrumentation used by the medical physicist to measure the illu-
mination as specified in section 303 1 6(b)( 1 3 ) shall be calibrated in units
of lux or foot candles and shall meet manufacturer specifications.
NOTE: Authority cited: Sections 100275 and 1 15060, Health and Safety Code.
Reference: Sections 1 15060 and 1 15100, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-1 0-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30317. General Facility Requirements.

(a) The facility shall designate a quality assurance technologist.

(b) Tests specified in section 30316.20(a) through (d) and (f) shall be
performed by the quality assurance (QA) technologist or by other person-
nel qualified to perform the tasks. When other personnel are utilized for
these tasks, the QA technologist shall ensure that the specified tests are
performed correctly. The QA technologist shall maintain documentation
of training received by the other personnel.

(c) The facility's lead interpreting physician shall verify that the provi-
sions of this section and sections 30316.20, 30316.40, 30316.50.
30316.60, 30317.10, 30317.20, 30317.30, 30317.40, 30317.60, and
30319.20 are met

(d) A facility shall ensure an interpreting physician is available by tele-
phone or in person for consultation when mammographic examinations
are performed.

(e) A facility shall ensure that mammographic examinations are per-
formed under the supervision, as defined in Health and Safety Code sec-
tion 1 14850(g), of an individual who meets the requirements of section
30315.50.

(f) Each facility shall provide and require that all operators of radiation
machines used for mammography use a chart or manual that specifies
technique factors to be utilized relative to the patient's body habitus.

(g) Each facility shall maintain an inventory of each mammography
X-ray machine. The inventory shall identify each machine by a unique
radiadon machine identification number. That number shall be perma-
nently affixed to the machine.

NOTE: Authority cited; Sections 115060, 131051 and 131200, Health and Safety
Code. Reference: Sections 1 15060, 1 1 5 100 and 1 15 1 15, Health and Safety Code,

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-1 0-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

3. New subsecUon (g) and amendment of Note filed 7-11-2007; operative
8-10-2007 (Register 2007, No. 28).

§ 3031 7.1 0. Mammography Quality Assurance Program.

(a) Each facility shall establish and maintain a mammography quality
assurance (QA) program to ensure the safety, reliability, clarity and accu-
racy of mammography services performed at the facility. A review of the
QA program shall be conducted and documented by the lead interpreting
physician at intervals not to exceed six months. The QA program shall,
at a minimum, include the following;

( 1 ) Establishment of operating levels meeting manufacturer specifica-
tions by which the criteria specified in secfion 30316.20(a) is compared.

Page 202.11

§ 30317.20

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) Documentation of accreditation by an entity approved by the FDA
pursuant to 42 United States Code Section 263b(e)(l)(A) and certifica-
tion by FDA;

(3) Documentation that each interpreting physician who interprets
mammograms for the facility meets the requirements of section
30315.50.

(4) Documentation that each mammographic radiologic technologist
who performs mammography meets the requirements of section
30315.51;

(5) Documentation that each medical physicist who performs the tests
specified in section 30316.20(e) meets the requirements of section
30315.52;

(6) The QA manual required by section 30317.20;

(7) The mammography procedures manual required by section
30317.30; and

(8) If the facility is a mobile service provider, a list identifying the
physical location where radiation machines are used.

NOTE; Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 115060, 1 15100 and 1151 15, Health and Safety Code.

History

1 . New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Comphance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30317.20. Quality Assurance Manual.

(a) Each facility that performs mammography shall establish and
maintain a written quality assurance (QA) manual. The lead interpreting
physician shall document a review of the QA manual at intervals not to
exceed six months. At a minimum, the QA manual shall contain:

( 1) A list of names identifying the following:

(A) The lead interpreting physician designated by the facility;

(B) The quality assurance technologist;

(D) The company providing processor and equipment services.

(2) The procedures to be used to ensure that the tests specified in sec-
tion 30316.20(a) through (d) and (f) are performed and the criteria have
been met;

(3) Tlie procedure for correcting each finding that fails to meet the re-
quirements of section 30316.20(a) through (0;

(4) Examples of the forms to be used for each test specified in section
30316.20 (a) through (d) and (f);

(5) Documentation that equipment used during QA tests specified in
section 30316.20 meet manufacturer specifications;

(6) The most recent survey report required to be obtained pursuant to
section 30316.60 and evidence that instruments used by the medical
physicist are calibrated pursuant to section 30316.61;

(7) Documentation of all QA tests required to be performed pursuant
to section 30316.20(a) through (d) and (f);

(8) Documentation of compliance with section 30316.20(g) and (h);

(9) Documentation of comphance with section 30316.10 covering the
previous two years;

(10) Documentation that each interpreting physician, mammographic
radiologic technologist and medical physicist has reviewed the manual
annually or, if any update has occurred, evidence that the manual has
been reviewed by the said individuals; and

( 1 1 ) Documentation of preventive and corrective maintenance, chem-
istry replacement and cleaning of each processor used to process mam-
mograms. The documentation shall contain the signature of the individu-
al who performed the maintenance.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 1 5060, 1 1 5 1 00 and 11 5 1 1 5, Health and Safety Code.

History
1 . New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by

6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-1 0-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003. No. 29).

§ 30317.30. Mammography Procedures Manual.

(a) Each facility shall establish a written mammography procedures
manual. The lead interpreting physician shall document a review of the
manual at intervals not to exceed six months. The mammography proce-
dures manual shall, at a minimum, contain the following:

(1) The procedure for corrective action when the images interpreting
physicians are asked to interpret are of poor quality and documentation
that the procedure is followed;

(2) A policy that requires each interpreting physician to participate in
the mammography medical outcomes audit as specified in section
30317.60;

(3) Examples of mammographic examination reports in lay language
for each assessment of findings category and the procedures used to en-
sure the patient, if the patient does not indicate a health care provider, is
referred to a health care provider if the patient's mammogram is inter-
preted by an interpreting physician as a positive mammogram;

(4) The procedure used to inquire whether or not the patient has pros-
thetic devices implanted in the breast prior to the mammographic ex-
amination and evidence that the procedure is followed. The procedure
shall specify that except where contraindicated, or unless modified by a
physician's directions, patients with such implants shall have mammo-
graphic views to maximize the visualization of breast tissue;

(5) The procedure to be used by each mammographic radiologic
technologist to ensure that prior to each mammographic examination the
mammography equipment is disinfected. The procedure shall comply
with title 29, Code of Federal Regulations section 1910.1030 as of July
1 , 2001 , title 8, California Code of Regulations section 5 1 93 and with the
manufacturer's recommended procedures for cleaning and disinfection
of the mammography equipment used in the facility;

(6) The procedures used to comply with section 30317.70 pertaining
to consumer complaints;

(7) The procedure used to ensure mammographic examination reports
are sent as required by section 30317.40; and

(8) Documentation that the mammography medical outcomes audit is
performed as specified in section 30317.60.

(b) Procedures and policies developed to comply with this section
shall be followed by the facility.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060. 1 15100 and 1151 15, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (a)(5). transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register
2003, No. 29).

§ 30317.40. Mammographic Examination Reports.

(a) Each facility shall ensure that a written report of the results of each
mammographic examination conducted at that facility is prepared and in-
cludes at least the following:

(1) Name of the patient and an additional patient identifier;

(2) Date of the examination;

(3) Name of the interpreting physician who interpreted the mammo-
gram;

(4) Overall assessment of findings, classified in one of the following
categories:

(A) "Negative:" Nothing to comment upon (if the interpreting physi-
cian is aware of clinical findings or symptoms, despite the negative as-
sessment, these shall be explained);

(B) "Benign:" Also a negative assessment;

•

Page 202.12

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30317.70

(D) "Suspicious:" Finding(s) without all the characteristic morpholo-
gy of breast cancer but indicating a definite probability of being malig-
nant;

(E) "Highly suggestive of malignancy:" Finding(s) has a high proba-
bility of being malignant;

(5) In cases where a final assessment category cannot be assigned due
to incomplete work-up, "Incomplete: Need additional imaging evalua-
tion" shall be assigned as an assessment and reasons why no assessment
can be made shall be stated by the interpreting physician; and

(6) Recommendations made to the patient's health care provider about
what additional actions, if any, should be taken. All clinical questions
raised by the referring physician shall be addressed in the report to the
extent possible, even if the assessment of findings is negative or benign.

(b) Each facility shall ensure that the report specified in subsection (a)
is summarized in lay terms and sent no later than 30 calendar days from
the date of the mammographic examinafion to the patient.

(c) Each faciHty shall ensure that the report specified in subsection (a)
is sent no later than 30 calendar days from the date of the mammographic
examination to the referring physician(s), or if the patient is self-re-
ferred, to the physician indicated by the patient or the physician to whom
the facility refers the patient.

(d) Each facility shall verify that:

( 1 ) Patients with an overall assessment of findings of "suspicious" or
"highly suggestive of malignancy" and patients needing repeat examina-
tions have received notification; and

(2) Physicians have received noUficafion of patients with an overall as-
sessment of findings of "suspicious" or "highly suggesfive of malignan-
cy" and needing repeat examinations.

(e) If an interpreting physician has given a mammogram an assessment
of findings as "suspicious" or "highly suggestive of malignancy," the fa-
cility shall attempt to communicate the results to the patient within five
working days and the health care provider or if the health care provider
is unavailable, to a responsible designee of the health care provider with-
in three working days.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Section 115060, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003. No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
sections (a)(6) and (e), transmitted to OAL 6-6-2003 and filed 7-18-2003
(Register 2003, No. 29).

§ 30317.50. Mammogram and Report Retention.

Unless otherwise required by law, each facility that performs mam-
mography shall:

(a) Unless transferred in accordance with subsection (b), maintain
mammograms and the reports specified in section 30317.40 for a mini-
mum of seven years and if no additional mammograms of the patient are
taken by the facility, mammograms and reports shall be maintained for
a minimum of ten years.

(b) Upon request or on behalf of the pafient, permanently or temporari-
ly transfer the original mammograms and copies of the patient's mam-
mographic examination reports to a medical institution, a physician or to
the patient directly. Any fee charged for this service shall not exceed the
documented cost of the service.

(c) If the facility will discontinue the performance of mammography,
notify the Department prior to discontinuing mammography of how all
records kept pursuant to subsection (a) will be maintained.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.

Reference: Sections 115060 and 123145, Health and Safety Code.

History

1 . New section filed 2-1 0-2003 as an emergency; operative 2-1 0-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6 2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30317.60. Mammography Medical Outcomes Audit.

(a) Each facility possessing a facility accreditation certificate shall col-
lect and review outcome data for all mammograms interpreted by the fa-
cility as a positive mammogram, including follow-up on the disposition
of all positive mammograms and correlation of pathology results with the
interpreting physician's mammographic examination report. Each facil-
ity shall analyze these outcome data for all interpreting physicians, both
individually and collectively. The lead interpreting physician or an inter-
preting physician designated by the lead interpreting physician shall per-
form the analysis.

(b) For any cases of an individual diagnosed with breast cancer who
was imaged at the facility and whose identity became known to the facil-
ity, the facility shall initiate follow-up on surgical and/or pathology re-
sults and conduct a review of any mammogram taken prior to the diagno-
sis of a malignancy. These cases shall be included in the analysis required
pursuant to subsection (a).

(c) Each facility possessing a facility accreditation certificate shall en-
sure that the analysis required by subsection (a) is initiated no later than
12 months after the date of issuance of the facility accreditation certifi-
cate. The analysis shall be completed within 1 2 months of the date the
analysis was initiated. Subsequent audit analyses shall be performed at
least once every 1 2 months thereafter.

(d) The facility's lead interpreting physician or an interpreting physi-
cian designated by the lead interpreting physician, shall:

(1) Record the dates of the audit period(s);

(2) Document the results;

(3) Review the medical outcomes audit data;

(4) Analyze the results of the audit;

(5) Provide the results of the review of a specific interpreting physician
to that interpreting physician and the overall results of the review for the
facility review; and

(6) Provide a written description of any follow-up actions and the na-
ture of the follow-up actions taken.

(e) Each facility shall maintain reports, outcome data, analyses and
documentation of actions taken specified in this section in accordance
with section 30319.20.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 1 15100 and 115115, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§30317.70. Consumer Complaints.

Each facility possessing a facility accreditation certificate shall:

(a) Establish a written procedure for collecting and resolving consum-
er complaints;

(b) Maintain a record of each serious complaint received by the facility
in accordance with section 30319.20;

(c) Provide to the consumer, upon request, a copy of the facility's pro-
cedure required in subsection (a) and instructions for filing serious com-
plaints to the entity approved by the FDA pursuant to 42 United States
Code Section 263b(e)(l)(A) that accredited the facility;

(d) Report unresolved serious complaints to the Department within 30
calendar days of receiving the complaint.

NOTE; Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Section 1 15060, Health and Safety Code.

History

1 . New section filed 2-10-2003 as an emergency: operative 2-10-2003 ( Rcgi.ster
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order, including amendment of sub-
section (b), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003,
No. 29).

Page 202.13

§ 30318.10

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 30318.10. Additional Requirements for Mobile Service
Providers.

(a) Prior to the performance of mammography by a mobile service pro-
vider at a location other than a location identified on the application sub-
mitted pursuant to section 30315.22 or 30315.23. the provider shall
notify the Department. The notification shall include:

(1) The name and address of the mobile service provider;

(2) The certificate number as shown on the facility accreditation certif-
icate of the mobile service provider:

(3) The physical location of the new location where mammography
will be performed;

(4) The name and telephone number of the individual who is allowing
the service to be provided at the new location;

(5) If the radiation machine is moved to where the mammographic ex-
aminations will be performed, the designated room number within the
physical building at the new location of use; and

(6) The physical location where mammograms produced at the new
location will be processed.

(b) After each relocation of the radiation machine and before the per-
formance of mammography on humans, the processor shall be tested to
ensure that the criteria specified in section 30316.20(a) are met, and the
radiation machine shall be tested to ensure that it meets the requirements
of section 30316.20(b)(1) through (3). If a processor is not available at
the location where mammography is performed, a phantom image shall
be produced by using the procedure specified in section 30316.20(b).
The selected kilo voltage-peak and milliampere-seconds (mAs) shall be
recorded and compared to the mAs value previously established as meet-
ing the phantom image criteria specified in section 30316.20(b). If the
two mAs values are within plus or minus 10 percent of each other, mam-
mography may be performed. If the values exceed the limits, mammog-
raphy shall not be performed and corrective actions shall be taken to
bring the two values within the limit.

( 1 ) The mammograms shall be transported in a container that protects
the film from exposure to light, heat, humidity, radiation, and conditions
that may damage the mammograms and processed within 48 hours from
the time the mammogram is taken;

(2) A log shall be maintained that includes the name of each patient and
unique identification number, date, and time of the first exam of each
batch, and date and time of batch processing in accordance with section
30319.20; and

(3) The container used to transport the mammograms shall be cleaned
at intervals not to exceed seven days or if mammography is performed
at greater intervals, before the mammograms are transported.

(d) Prior to processing mammograms, the provider shall ensure that
the test specified in section 303 16.20(a) has been met and that the phan-
tom image produced during the test specified in subsection (c) of this sec-
tion meets the phantom image criteria specified in section 30316.20(b)
and if the phantom image fails due to processing problems, the problems
shall be corrected prior to processing the mammograms. If the phantom
image fails due to a non-processor problem, the provider may process the
mammograms, but the lead interpreting physician shall evaluate each
mammogram to determine whether any patient must be recalled to have
their mammograms repeated. Prior to further clinical use, the mammog-
raphy system shall be evaluated and problems corrected to ensure that the
mammography system is in compliance with all requirements of this ar-
ticle.

(e) Documentation demonstrating compliance with this section shall
be maintained in accordance with section 30319.20.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.

Reference: Sections 1 15060, 115100 and 1 15115, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register
2003, No. 7). A Certificate of CompHance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Cenificate of Compliance as to 2-1 0-2003 order, including amendment of sub-
sections (b) and (c)(1), transmitted to OAL 6-6-2003 and filed 7-18-2003
(Register 2003, No. 29).

§ 3031 8.1 1 . Posting Requirements for Mobile Service
Providers.

(a) Each mobile service provider shall ensure the following are kept
with each radiation machine used to perform mammography in a mobile
setting:

(1) All items required to be posted pursuant to section 30255;

(2) The mammographic radiologic technologist's certificate issued
pursuant to section 30455.1 to the individual performing the mammo-
graphic examination and posted so the patient can view it during the ex-
amination;

(3) For facilities performing mammography, the lead interpreting phy-
sician's radiology supervisor and operator certificate issued pursuant to
section 30466(d) or 30467 and posted so the patient can view it during
the examination;

(4) The document required to be posted on the radiation machine pur-
suant to Health and Safety Code section 1 15115(b) so the patient can
view it during the examination;

(5) A copy of the certificate issued by FDA and posted so the patient
can view it during the examination;

(6) The quaUty assurance records for on-board processors as specified
in section 303 16.20(a) for at least the last 30 calendar days.

(7) Documentation that, for each location of use visited in the last 30
calendar days, section 30318.10(b) has been met; and

(8) The quality assurance manual as specified in secfion 30317.10.

(b) Each provider shall maintain a log that idenufies the date and
physical location where each radiation machine is used.

NOTE: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Sections 1 15060, 1 15100 and 115115, Health and Safety Code.

History

1. New section filed 2-10-2003 as an emergency; operaUve 2-10-2003 (Register
2003, No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

§ 30319. Notification Requirements.

(a) Within 30 calendar days of the occurrence of any of the following
events, each facility that performs mammography shall inform the De-
partment of the event:

(1) Change in the information submitted in response to section
30315.22(a)(1);

(2) Change in the identity of the entity approved by the FDA pursuant
to 42 United States Code Section 263b(e)(l)(A) that accredited the facil-
ity;

(3) Change in certification status with the FDA;

(4) Change in facility personnel and, if adding an interpreting physi-
cian, mammographic radiologic technologist, or medical physicist;

(5) Change in location of a radiafion machine within the facility;

(6) Change in facility name or owner;

(7) Disassembly and reassembly of any radiation machine or proces-
sing equipment;

(8) Change in the accreditation status;

(9) Change in the facility's contact person.

(b) Notifications made pursuant to this secfion shall be made in writing
and contain the name, signature and date of signature of the facility ad-
ministrator, owner or designee.

Note: Authority cited: Sections 100275 and 115060, Health and Safety Code.
Reference: Section 115060, Health and Safety Code.

History

2. Certificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

Page 202.14

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30320.90

§30319.20. Record Keeping Requirements.

(a) Each facility shall maintain and make available for inspection by
the Department the records specified in Table 1 until Department inspec-
tion or the time interval specified which ever is greater:

Specific Section
30315.50

30455.1

30315.52

30316.20(a)

30316.20(b)

30316.20(c)(1)

30316.20(c)(2)
30316.20(d)(1)

30316.20(d)(2)

30316.20(d)(3)
30316.20(f)

30316.60

30316.10
30317.60
30317.70
30318.10

Table 1 . Record Keeping Requirements
Type of Record
Personnel Qualifications for physicians

Personnel Qualifications for niainmographic
radiologic technologists

Personnel Qualifications for medical physicists

QA logs

Processor film strips

Phantom image score sheets
Phantom images

Fixer retention log sheet
Fixer retention test film

Repeat Analysis

Darkroom fog log sheets
Dai'kroom test films

Screen-film contact log sheets
Screen-film contact test films

Compression test log sheet

Darkroom cleaning logs
Intensifying screen cleaning logs
View box cleaning logs

Medical Physicist Survey Report, evaluations &
instrument calibration reports

Evaluations of new or repaired equipment

Medical Outcomes Audit analysis

Consumer complaints

All mobile service provider documents

Time Inten'uJ for Record Keeping

At least two years after the physician no longer
worked at the facility

At least two years after the technologist no longer
worked at the facility

At least two years after the medical physicist no
longer worked at the facility

3 years
1 year

3 years

3 years
1 year

3 years

3 years
3 years
3 years

3 years

3 years
3 years
3 years
3 years

(b) Each facility shall maintain records for inspection by the Depart-
ment showing calibrations, maintenance, and modifications performed
on each radiation machine for three years. These records shall include the
date of the calibration, maintenance, or modification performed, the
name of the individual making the record, and the manufacturer's model
and the facility's radiation machine identification number as specified in
section 30317(g).

(c) Each facility shall maintain records showing the receipt, transfer,
and disposal of radiation machines pursuant to section 30293. These re-
cords shall include the date of receipt, transfers, or disposal, the name and
signature of the individual making the record, and the manufacturer's
model and the facility's radiation machine identification number as spe-
cified in section 303 17(g). Records shall be maintained for inspection by
the Department until the facility ceases use and disposes of the radiation
machine.

NOTE: Authority cited: Sections 1 15060, 131051 and 131200, Health and Safety
Code. Reference: Section 1 15060, Health and Safety Code.

History

1 . New section filed 2-1 0-2003 as an emergency; operative 2-1 0-2003 (Register
2003. No. 7). A Certificate of Compliance must be transmitted to OAL by
6-10-2003 or emergency language will be repealed by operation of law on the
following day.

2. Cenificate of Compliance as to 2-10-2003 order transmitted to OAL 6-6-2003
and filed 7-18-2003 (Register 2003, No. 29).

3. Amendment of subsections (b)-(c) and amendment of Note filed 7-1 1-2007;
operative 8-10-2007 (Register 2007, No. 28).

§ 30320.90. Grounds for Suspension, Revocation,
Amendment or Restriction of a Facility
Accreditation Certificate.

(a) A facility accreditation certificate may be revoked, suspended,
amended or restricted for any of the following:

(1 ) Violation of any provision of the Act, any regulation promulgated
pursuant to the Act, any provision of the Radiologic Technology Act, as
defined in Health and Safety Code section 27, any regulation promul-
gated pursuant to the Radiologic Technology Act, or any order of the De-
partment;

(2) Failure to pay fees pursuant to sections 30145 or 30145. 1;

(3) Refusal to submit to clinical image review or mammography re-
view as directed by the Department;

(4) Failure of clinical images to pass clinical image review or mam-
mography review;

(5) Failure to take corrective action when directed by the Department;

(6) Failure to report changes pursuant to section 3031 9;

(7) Procuring a facility accreditation certificate by fraud, or misrepre-
sentation, or because of mistake;

(8) Failure to maintain mammograms and reports pursuant to section
30317.50;

(9) Failure to ensure the average glandular dose criteria specified in
section 303]6.20(e)(10) is not exceeded;

(10) Failure during a Department inspection to obtain the phantom
image score specified in section 30316.20(b)(3);

Page 202.15

§ 30320.90 BARCLAYS CALIFORNIA CODE OF REGULATIONS Title 17

(11) Failure to comply with policies or procedures required to be de- History

veloped pursuant to section ^03 1 7.30; and 1 • New section filed 2-1 0-2003 as an emergency; operative 2-10-2003 (Register

(12) Suspension or revocation of the facility's certificate issued by f ?LmJ^' ^ ^^'^^''''f «*" Compliance must be transmitted to OAL by

^ ^ •' 6-10-2003 or emergency laneuaae will be repealed by operation of law on the

FDA pursuant to title 2 1 , Code of Federal Regulations, section 900. 1 1 (a). following day.

NOTt-: Authority cited: Sections 100275 and 115060, Health and Safety Code. 2. Certificate ofCompliance as to 2-1 0-2003 order transmitted to OAL 6-6-2003

Reference: Sections 115060, 115100, 115115, 115145. 115165 and 115215, and filed 7-18-2003 (Register 2003. No. 29).
Health and Safety Code.

[The next page is 203.]

Page 202.16 Register 2007, No. 28; 7-13-2007

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30330

Article 5. Special Requirements for the Use
of Radioactive Material in the Healing Arts

§ 30321 . Accountability, Storage, and Transit.

(a) In each hospital and clinic possessing sealed sources, there shall be
a custodian of such sources. The custodian or his specified alternate shall
keep a permanent record of the issue and return of all such sources.

(b) When not in use, sources and applicators containing sealed sources
shall be kept in a protective enclosure of such material and wall thickness
as may be necessary to assure compliance with the United States, title 10,
Code of Federal Regulations, part 20, subparts C and D as incorporated
by reference in section 30253.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815, 25875 and 25876, Health and Safety
Code.

History

1. Repealer of article 8 (30320, 30321) and new article 8 (30321) filed 1 1-29-65;
effective thirtieth day thereafter (Register 65, No. 23). For former article 8 see
Register 62, No. 1.

2. Change without regulatory effect adding Note (Register 87, No. 11).

3. Amendment of article heading and subsection (b) filed 3-3-94 as an emergency;
operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be
transmitted to OAL by 7-1-94 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30321 .1 . Confirming Removal of Implants.

The custodian or his specified alternate shall assure that patients
treated with removable radioactive source implants remain hospitalized
until a source count and a radiation survey of the patient confirm that all
implants have been removed.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815, 25875 and 25876, Health and Safety
Code; and 10 CFR 35.15(b) (vi) and (vii) (39 FR 26143 and 43 FR 553467).

History
1. New section filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

§ 30322. Records and Reports of Misadministration.

(a) When a misadministration involves a therapy procedure, the U-
censee shall notify the Department. The licensee shall also notify the ref-
erring physician of the affected patient and the patient or the responsible
relative or guardian, unless the referring physician agrees to inform the
patient or believes, based on medical judgment, that telling the patient or
the patient's responsible relative or guardian would be harmful to one or
the other, respectively. These notifications shall be made within 24 hours
after the licensee discovers the misadministration. If the referring physi-
cian, patient, or the patient's responsible relative or guardian cannot be
reached within 24 hours, the licensee shall notify them as soon as practi-
cable. The licensee is not required to notify the patient or the patient's re-
sponsible relative or guardian without first consulting the referring phy-
sician; however, the licensee shall not delay medical care for the patient
because of this.

(b) Within 15 days after the initial therapy misadministradon report to
the Department, the licensee shall report, in writing, to the Department
and to the referring physician, and furnish a copy of the report to the pa-
tient or the patient's responsible relative or guardian if either was pre-
viously notified by the licensee, as required by Subsection 30322(a). The
written report shall include the licensee's name; the referring physician's
name; a brief description of the event; the effect on the patient; the action
taken to prevent recurrence; whether the licensee informed the patient or
the patient's responsible relative or guardian, and if not, why not. The re-
port shall not include the patient' s name or other information that could
lead to identification of the patient.

(c) When a misadministration involves a diagnostic procedure, the ra-
diation safety officer shall promptly investigate its cause, make a record
for agency review, and retain the record as directed by Subsection

30322(d). The licensee shall also notify the referring physician and the
Department, in writing on Department Form DHS 8453 (1 1/89) (Diag-
nostic Misadministration Report) within 15 days, if the misadministra-
tion involved use of radioactive material not intended for medical use,
administration of dosage five-fold different from the intended dosage,
or administration of radioactive material such that the patient is likely to
receive an organ dose greater than 2 Rem or a whole body dose of greater
than 500 millirem (mRem). Licensees shall use the best available dosim-
etry data, correcting only for amount of radioactivity administered, to de-
termine whether a report is required. Reports and records required pur-
suant to this section shall include reference to the source for dosimetry
data used to determine whether a report is required.

(d) Each licensee shall retain a record of each misadministration for 1 0
years. The record shall contain the names of all individuals involved in
the event, including the physician, allied health personnel, the patient and
the patient's referring physician, the patient's social security number or
identification number if one has been assigned, a brief description of the
event, the effect on the patient, and the action taken, if any, to prevent re-
currence.

(e) Aside from the notification requirement, nothing in Subsections
30322(a) through (d) shall affect any rights or duties of licensees and
physicians in relation to each other, patients, or responsible relatives or
guardians.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section field 9-5-89; operative 10-5-89 (Register 89, No. 36)

Article 6. Special Requirements for

Radiographic Operations in Industrial

Radiography

§ 30330. Definitions Specific to Industrial Radiography.

(a) The definitions in section 30100 apply to this article.

(b) As used in this article:

(1) "Annual refresher safety training" means training conducted or
provided by a licensee or registrant for its employees on radiation safety
aspects of industrial radiography including the topics specified in sec-
tions 30333(d) or 30336. l(q);

(2) "Associated equipment" means equipment that is used in conjunc-
tion with a radiographic exposure device to make radiographic exposures
that drives, guides, or comes in contact with the sealed source (e.g., guide
tube, control tube, control cable, removable source stop, "J" tube and col-
limator when it is used as an exposure head);

(3) "Cabinet X-ray system" means an X-ray system with the X-ray
tube installed in an enclosure independent of existing architectural struc-
tures except the floor on which it may be placed and intended to contain
at least that portion of a material being irradiated, provide radiation atten-
uation, and exclude personnel from its interior during generation of radi-
ation. An X-ray tube used within a shielded part of a building, or X-ray
equipment that may temporarily or occasionally incorporate portable
shielding, is not considered a cabinet X-ray system;

(4) "Collimator" means a radiation shield that is placed on the end of
the guide tube or directly onto a radiographic exposure device to restrict
the size of the radiation beam when the sealed source is cranked into posi-
tion to make a radiographic exposure;

(5) "Control cable" means the cable that is connected to the source as-
sembly and used to drive the source to and from the exposure location;

(6) "Control mechanism" means a device that enables the source as-
sembly to be moved to and from the radiographic exposure device;

(7) "Control tube" means a protective sheath for guiding the control
cable, which connects the control mechanism to the radiographic expo-
sure device;

(8) "Exposure head" means a device that locates the sealed source in
the selected working position;

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§ 30331

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(9) "Field radiography" means industrial radiography using a radi-
ation machine but excludes cabinet X-ray systems and shielded-room
radiography machines;

(10) "Field station" means a facility where licensed material may be
stored or used and from which equipment is dispatched;

(11) "Guide tube" means a flexible or rigid lube (i.e., "J" tube) for
guiding the source assembly and the attached control cable from the ra-
diographic exposure device to the exposure head;

(12) "Identification card" (ID) means either an ID card issued by:

(A) A licensee, pursuant to section 30333(b)(2), designating the indi-
vidual as a radioactive materials radiographer's assistant;

(B) A registrant, pursuant to section 30336.5, designating the individ-
ual as a radiation machine radiographer's assistant; or

(13) "Industrial radiography" means the examination of the physical
structure, but not the microscopic structure, or elemental or chemical
composition, of materials, other than human beings or animals, utilizing
radiation;

(14) "Permanent radiographic installation" means a shielded installa-
tion or structure designed or intended for industrial radiography and in
which industrial radiography is performed;

(15) "Practical examination" means a demonstration through practical
application of the safety rules and principles in industrial radiography in-
cluding use of all appropriate equipment and procedures;

(16) "Radiation Safety Officer" means an individual with the respon-
sibility for the overall radiation safety program on behalf of the:

(A) Licensee and who meets the requirements of section 30333.07; or

(B) Registrant and who meets the requirements of section 30336.7;

(17) "Radiographer" means any individual who performs radiograph-
ic operations or who, while in attendance at the site where radiographic
operations are being performed, personally supervises such operations
and who is responsible to the user for assuring compliance with the re-
quirements of this regulation, license or registration conditions and is
certified pursuant to sections 30335.2 or 30335.4 or is in compliance with
section 30335.3;

(18) "Radiographer certification" means written approval indicating
that an individual has satisfactorily met the requirements to be a radiogra-
pher;

(19) "Radiographer trainer" means a radiographer who meets the re-
quirements of sections 30333.05 or 30336.6;

(20) "Radiographer's assistant" means any individual who has met the
requirements of sections 30333(b) or 30336.5(a)(1) and who must be un-
der personal supervision as required by sections 30333(c) or 30336. 1 (o);

(21) "Radiographic exposure device" means any device containing a
sealed source used to make a radiograph;

(22) "Radiographic operations" means all activities associated with
the presence of radiation machines or radioactive sources for the perfor-
mance of industrial radiography (except when being transported by a
common or contract transport), and includes surveys to confirm the ade-
quacy of boundaries, setting up equipment and any activity inside a re-
stricted area;

(23) "Radiographic personnel" means any radiographer, radiographer
trainer, or radiographer's assistant;

(24) "Shielded position" means the location within the radiographic
exposure device or source changer where the sealed source is secured and
restricted from movement;

(25) "Shielded-room radiography" means industrial radiography us-
ing a radiation machine such that irradiation of the material occurs in an
enclosed room designed to allow admittance of individuals and the room
meets the requirements of subsections (d), (e) and (h) of section 30336;

(26) "Source assembly" means an assembly that consists of the sealed
source and a connector that attaches the source to the control cable;

(27) "Source changer" means a device designed and used for replace-
ment of sealed sources in radiographic exposure devices, including those
also used for transporting and storage of sealed sources;

(28) "Storage area" means any location, facility, or vehicle which is
used to store, to transport, or to secure a radiographic exposure device,
a storage container, or a sealed source when it is not in use and which is
locked or has a physical barrier to prevent accidental exposure, tamper-
ing with, or unauthorized removal of the device, container, or source;

(29) "Storage container" means a container in which sealed sources
are secured and stored;

(30) "S-tube" means a tube through which the radioactive source trav-
els when inside a radiographic exposure device;

(31) "Temporary jobsite" means a location where radiographic opera-
tions are conducted and where licensed material may be stored other than
those location(s) of use authorized on the license.

NOTE: Authority cited: Sections 1 14975, 115000, 131050, 131051 and 131200,
Heahh and Safety Code. Reference: Sections 114965, 114970, 115230 and
1 15235, Health and Safety Code.

History

1. Repealer of article 9 and new article 9 (sections 30330 through 30336) filed
1 1-29-65; effective thirtieth day thereafter (Register 65, No. 23). For former
article 9, see Register 62, No. 1 .

2. Change without regulatory effect adding Notf<: (Register 87, No. 1 1).

3. Amendment of article heading filed 3-3-94 as an emergency; operative 3-3-94
(Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL
by 7-1-94 or emergency language will be repealed by operation of law on the
following day.

4. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

5. Amendment of article heading and repealer and new section heading, section
and Note filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30331 . Eligibility for and Renewal of Approval as a
Radiation Safety Training Provider and
Provider Requirements.

(a) To be eligible for or renewal of approval as a radiation safety train-
ing provider an applicant shall submit a complete application consisting
of:

(1) The legal name, the mailing address and the telephone number of
the applicant;

(2) The applicant's federal employer identification number and
California taxpayer identification number, or if the applicant is an indi-
vidual, the applicant's social security number (pursuant to the authority
found in sections 131200 and 1 15000(b) of the Health and Safety Code
and as required by section 1 7520 of the Family Code, providing the social
security number is mandatory. The social security number will be used
for purposes of identification);

(3) Proof that the applicant's curriculum covers the subjects specified
in section 30335.10 and includes, at a minimum:

(A) A description of course content covering those subjects;

(B) The number of hours spent on each subject; and

(4) The names of all instructors including each individual's training
and experience in industrial radiography. There shall be at least one
instructor who meets the requirements specified in sections 30333.05
and 30336.6 or at least two instructors such that one meets the require-
ments specified in section 30333.05 and the other meets the requirements
of section 30336.6;

(5) A copy of a sample written examination and the correct answers
to the test questions used for determining an individual's understanding
of and competency in the subjects specified in section 30335. 1 0. The ex-
amination shall be at least 50 questions in length. Successful completion
shall be correctly answering at least 80 percent of the questions in a
closed-book testing session; and

(6) The application fee specified in section 30336.8.

(b) Approval as a radiation safety training provider shall be valid for
five years except that, for providers who possess a specific license issued
pursuant to section 30195.3, the approval shall be valid for the period of
time up to and including the expiration date as stated on the specific li-
cense unless that period of time is less than five years.

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Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30332.1

•

(1) Issue a certificate of training to each individual who satisfactorily
completes radiation safety training. The certificate shall contain, at a
minimum, the:

(A) Legal Name of the individual;

(B) Name and provider number as shown on the provider's approval;

(D) Statement "I (printed name of trainer or radiation safety officer)
certify that the individual named on this certificate has satisfactorily
completed the radiation safety training curriculum specified in Title 17,
California Code of Regulations, section 30335.10;" and

(E) Original signature and date of signature of the provider's trainer
or radiation safety officer;

(2) Maintain records of attendance for five years from the individual's
completion of the radiation safety training;

(3) Notify the Department 30 calendar days prior to any change in the
information submitted pursuant to subsections (a)(1) through (a)(4);

(4) Meet and continually maintain all standards set forth in the applica-
tion and this section; and

(5) Be subject to Department audit.

NOTE: Authority cited: Sections 114975, ] 15000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965 and 114970, Health and
Safety Code.

History

1. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

2. Renumbering of former subsections (a)(5) and (a)(6) to subsections (a)(6) and
(a)(7), and the new subsection (a)(5) filed 7-12-89; operative 8-1 1-89 (Regis-
ter 89, No. 28).

3. Repealer and new section heading, section and Note filed 4-1 1-2008; opera-
tive 5-11-2008 (Register 2008, No. 15).

§ 30332. Performance Requirements for Radiographic
Exposure Devices, Storage Containers, and
Source Changers.

(a) All radiographic exposure devices and associated equipment used
after January 10, 1996 shall comply with the following:

(1) Except as provided in subsection (b), each radiographic exposure
device, source assembly or sealed source and all associated equipment
shall meet the requirements specified in American Nafional Standard
N432-1 980 "Radiological Safety for the Design and Construction of Ap-
paratus for Gamma Radiography," published as NBS Handbook 136, is-
sued January 1981 (ANSI N432)*;

(2) Each radiographic exposure device shall have attached to it a dura-
ble, legible, clearly visible label bearing the:

(A) Chemical symbol and mass number of the radionuclide in the de-
vice;

(B) Activity and date on which this activity was last measured;

(D) Manufacturer of the sealed source; and

(E) Licensee's name, address and telephone number;

(3) Radiographic exposure devices intended for use as Type B trans-
port containers shall meet the appficable requirements of secfion 30373;

(4) Modificafion of radiographic exposure devices, source changers,
source assemblies and associated equipment is prohibited, unless the de-
sign of any replacement component, including source holder, source as-
sembly, controls or guide tubes would not compromise the safety design
features of the system;

(5) For radiographic exposure devices and associated equipment that
allow the source to be moved out of the device for routine operation:

(A) The coupling between the source assembly and the control cable
shall be designed in such a manner that the source assembly will not be-
come disconnected if cranked outside the guide tube. The coupling shall
be such that it cannot be unintentionally disconnected under normal and
reasonably foreseeable abnormal conditions;

(B) The device shall automatically secure the source assembly when
it is cranked back into the fully shielded position within the device. This
securing system may only be released by means of a deliberate operation
on the exposure device;

(C) The outlet fittings, lock box, and control cable fittings on each ra-
diographic exposure device shall be equipped with safety plugs or covers
which shall be installed during storage and transportation to protect the
source assembly from water, mud, sand or other foreign matter;

(D) Each sealed source or source assembly shall have attached to it or
engraved in it, a durable, legible, visible label with the words "Danger —
Radioactive." The label shall not interfere with the safe operation of the
exposure device or associated equipment;

(E) The guide tube shall have passed the crushing tests for the control
tube as specified in ANSI N432 and a kinking resistance test that cio.sely
approximates the kinking forces likely to be encountered during use;

(F) Guide tubes shall be used when moving the source out of the de-
vice.

(G) An exposure head or similar device designed to prevent the source
assembly from passing out of the end of the guide tube shall be attached
to the outermost end of the guide tube during radiographic operations;

(H) The guide tube exposure head connection shall be able to with-
stand the tensile test for control units specified in ANSI N432; and

(I) Source changers shall provide a system for assuring that the source
will not be accidentally withdrawn from the changer when connecting or
disconnecting the control cable to or from a source assembly.

(b) Equipment used in radiographic operations need not comply with
section 8.9.2(c) of the Endurance Test in ANSI N432, if the prototype
equipment has been tested using a torque value representative of the
torque that an individual using the industrial radiography equipment can
realistically exert on the lever or crankshaft of the control mechanism.

(c) Storage containers and source changers shall not exceed a radiation
exposure rate of 200 millirems per hour (mrem/hr) at any exterior surface
and 10 mrem/hr at one meter from any exterior surface with the sealed
source in the shielded position.

^Copies of American National Standard N432-1980 "Radiological Safety for the
Design and Construction of Apparatus for Gamma Radiography" (published as
NBS Handbook 1 36, issued January 1981) may be purchased from the Superinten-
dent of Documents, U.S. Government Printing Office. Washington, D.C. 20402
and from the American National Standards Institute, Inc., Global Engineering
Documents, 1819 L Street, NW, Suite 600, Washington DC 20036 or at
"http://global.ihs.com" using the title as the search parameter.
NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 1 15060,
1 15230 and 1 15235, Health and Safety Code.

History

1. Renumbering and amendment of former section 30332(a) to section 30332(a)
and (b), renumbering and amendment of former section 30332(b) to section
30332.1, renumbering and amendment of former section 30332(c) to section

30332.3, renumbering and amendment of former section 30332(d) to section

30332.4, renumbering and amendment of former section 30332(e) to section

30332.5, renumbering and amendment of former section 30332(0 to section

30332.6, and renumbering and amendment of former section 30332(g) to sec-
tion 30332.7 filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28). For prior history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section heading and Note and new subsections (c)-(c)(5)(I)
filed 9-16-92; operative 10-16-92 (Register 92, No. 38).

3. Amendment of section, Note and footnote filed 4-11-2008; operative
5-1 1-2008 (Register 2008, No. 15).

§ 30332.1 . Security of Radiographic Exposure Devices,
Storage Containers and Source Changers.

(a) Each radiographic exposure device shall be provided with a lock
or outer locked container designed to prevent unauthorized or accidental
exposure and shall be kept locked, and if a keyed-lock, with the key re-
moved, at all times except during authorized use or when under the direct
surveillance of a radiographer or radiographer's assistant. In addition,
during radiographic operations a sealed source assembly shall be secured
in the shielded position each time the source is returned to that position.

(b) Each storage container and source changer shall be provided with
a lock and kept locked, and if a keyed-lock, with the key removed, when
containing a sealed source except when the container is under the direct
surveillance of a radiographer or radiographer's assistant.

(c) Locked radiographic exposure devices, storage containers and
source changers shall be physically secured to prevent tampering or un-
authorized removal.

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§ 30332.2

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Title 17

NOTE; Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 114970. 115000, 115060,
1 15230 and 1 15235, Health and Safety Code.

History

1. Renumbering and amendment of former Section 30332(b) to Section 30332.1
filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior
history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and Noth filed 4-1 1-2008: operative 5-1 1-2008 (Reg-
ister 2008, No. 15).

§ 30332.2. Security of Permanent Radiographic
Installations.

(a) Each entrance that is used for personnel access to the high radiation
area, defined in title 10, Code of Federal Regulations, Part 20 (10 CFR
20), section 20. 1003 incorporated by reference in section 30253. in a per-
manent radiographic installation shall have either:

( 1 ) A control device that, upon entry into the area, causes the level of
radiation to be reduced below that level at which an individual might re-
ceive a deep-dose equivalent, defined in 1 0 CFR 20. section 20. 1003 in-
corporated by reference in section 30253, of 0.1 rem in one hour at 30
centimeters from the radiation source or from any surface that the radi-
ation penetrates; or

(2) Both conspicuously visible and audible warning signals to warn of
the presence of radiation. The visible signal shall be continuously actu-
ated by radiation whenever a source is exposed. Tlie audible signal shall
be actuated when an attempt is tnade to enter the installation while the
source is exposed.

(b) If access is controlled pursuant to subsection (a)(1), the entrance
control device shall be tested monthly. If access is controlled pursuant to
subsection (a)(2), the system shall be tested with a radiation source each
day before the installation is used for radiographic operations and shall
include a check of both the visible and audible warning signals. In either
case, if an entrance control device or warning signal is operating improp-
erly, it shall be immediately labeled as defective and repaired within 30
calendar days. The installation may continue to be used during this
30-day period provided the licensee complies with section 30334 and
each individual wears an alarming ratemeter in addition to other dosime-
ters required by section 30333.2(a).

(c) Documentation demonstrating compliance with this section shall
be maintained for three years and kept available for inspection.
NOTE; Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060,
1 15230 and 1 15235, Health and Safety Code.

History

1. New section filed 7-7-86; effective thirtieth day thereafter (Register 86, No.

28).

2. Repealer and new section and Note filed 4-11-2008; operative 5-11-2008
(Register 2008, No. 15).

§ 30332.3. Radiation Survey Instruments.

(a) Each user shall maintain a sufficient number of calibrated and oper-
able radiation survey instruments to make radiation surveys as required
by this regulation. Each instrument shall be capable of measuring a range
of two millirems per hour through one rem per hour.

(b) Each radiation survey instrument shall be calibrated:

(1) At intervals not to exceed six months and after each instrument
servicing;

(2) For linear scale instruments, at two points located approximately
one-third and two-thirds of full-scale on each scale; for logarithmic
scale instruments, at mid-range of each decade, and at two points of at
least one decade; and for digital instruments at three points between two
and 1000 millirems per hour; and

(3) So that an accuracy within plus or minus 20 percent of the calibra-
tion source can be demonstrated at each point checked.

(c) Records of the results of instrument calibrations shall be main-
tained for three years and kept available for inspection.

NOTE; Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970, 1 15000, 1 15060,
115230 and 115235, Health and Safety Code.

History

1. Renumbering and amendment of former Section 30332(c) to Section 30332.3
filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior
history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and Noti; filed 4-1 1-2008; operative 5-1 1-2008 (Reg-
ister 2008, No. 15).

§ 30332.4. Leak Testing, Repair, Tagging, Opening,
Modification, and Replacement of Sealed
Sources and Depleted Uranium Shielding.

(a) Replacement of any sealed source in a radiographic exposure de-
vice, and leak testing, repair, tagging, opening or any other modification
of any sealed source shall be performed only by persons specifically au-
thorized by the Department to do so pursuant to Group 2 of this subchapt-
er.

(b) Leak testing of sealed sources and radiographic exposure devices
using depleted uranium (DU) shielding and an S-tube configuration shall
be performed in accordance with section 30275 except that testing of ra-
diographic exposure devices shall be tested for DU contamination at in-
tervals not to exceed 12 inonths. If the test reveals the presence of 0.005
microcuries or more of removable DU contamination, the radiographic
exposure device shall be removed from service and an evaluation of the
S-tube shall be made. If the evaluation reveals that the S-tube is worn
through, the radiographic exposure device shall not be used. Radiograph-
ic exposure devices with DU shielding need not be tested while in storage
and not in use except that before using or transferring such a device, the
device shall be tested for DU contamination if the interval of storage or
non-use exceeded 12 months.

Note; Authority cited: Secdons 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 1 15060,
1 15230 and 1 15235, Health and Safety Code.

History

1. Renumbering and amendment of former Section 30332(d) to Secfion 30332.4
filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior
history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of secfion heading, secfion and NOTE filed 4-11-2008; operative
5-1 1-2008 (Register 2008, No. 15).

§ 30332.5. Quarterly Inventory of Sealed Sources.

(a) Each user shall conduct a quarterly physical inventory to account
for all sealed sources under his control.

(b) Records of the inventories shall be maintained for three years, kept
available for inspection and include the:

(1) Quantities and kinds of radioactive material;

(2) Location of sealed sources;

(3) Date of the inventory; and

(4) Name of the individual conducting the inventory.

NOTE; Authority cited: Secfions 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Secfions 114965, 114970, 115000, 115060,
1 15230 and 1 15235, Health and Safety Code.

History

1. Renumbering and amendment of former Section 30332(e) to Section 30332.5
filed 7-7-86; effecfive thirtieth day thereafter (Register 86, No. 28). For prior
history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and Note-, filed 4-1 1-2008; operaUve 5-1 1-2008 (Reg-
ister 2008, No. 15).

§ 30332.6. Utilization Logs.

(a) Each user shall maintain current logs, which shall be maintained
for three years and kept available for inspection at the address specified
in his license, containing the following information for each sealed
source:

(1) A description (or make, model, and serial number) of the radio-
graphic exposure device or transport or storage container in which the
sealed source is located;

(2) The identity and signature of the radiographer to whom assigned;
and

(3) Locations where used and dates of use including the dates removed

and returned to storage.

NOTE; Authority cited: Secfions 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060,
115230 and 115235, Health and Safety Code.

•

Page 206

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30333

History

1. Rcnumhcring and amendment of former Section 30332(f) to Section 30332.6
filed 7-7-86': effective thirtietii day thereafter (Register 86, No. 28). For prior
histor>', see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section and NoTt-: filed 4-1 1-2008; operative 5-1 1-2008 (Reg-
ister 2008. No. 15).

§ 30332.7. Inspection and Maintenance of Radiographic

Exposure Devices, Storage Containers, Source
Changers and Survey Instruments.

(a) Each user shall perform visual and operability checks on survey
instruments, radiographic exposure devices, transport and storage con-
tainers, associated equipment and source changers before use on each
day the equipment is to be used to ensure that the equipment is in good
working condition, that the sources are adequately shielded, and that re-
quired labeling is present. Survey instrument operability shall be per-
formed using a radiation source. If equipment problems are found, the
equipment shall be removed from service until repaired.

(b) Each user shall establish and implement written procedures for:

(1) Inspection and routine maintenance of radiographic exposure de-
vices, source changers, associated equipment, transport and storage con-
tainers, and survey instruments at intervals not to exceed three months
or before the first use thereafter to ensure components important to safety
are functioning. Replacement components shall meet design specifica-
tions. If equipment problems are found, the equipment shall be removed
from service until repaired; and

(2) Inspection and maintenance necessary to assure that Type B pack-
ages are shipped and maintained in accordance with section 30373.

(c) Records of equipment problems and of any maintenance per-
formed pursuant to this section shall be maintained for three years after
the record is made. The record shall include the date of check or inspec-
tion, name of inspector, equipment involved, any problems found, and
what repair and/or maintenance, if any, was done.

(d) Documentation demonstrating compliance with this section shall
be maintained for three years and kept available for inspection.
NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 115000, 115060, 115230
and 1 15235, Health and Safety Code.

History

1. Renumbering and amendment of former Section 30332(g) to Section 30332.7
filed 7-7-86; effective thirtieth day thereafter (Register 86, No. 28). For prior
history, see Registers 72, No. 42 and 67, No. 46.

2. Amendment of section heading and repealer and new section and Note filed
4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30332.8. Reporting Requirements.

(a) In addition to the reporting requirements specified in section 30295
and under other sections of this subchapter, each licensee shall provide
a written report to the Department within 30 days of the occurrence of any
of the following incidents involving radiographic exposure devices and
associated equipment:

( 1 ) Unintentional disconnection of the source assembly from the con-
trol cable;

(2) Inability to retract the source assembly to its fully shielded position
and secure it in this position; or

(3) Failure of any component (critical to safe operation of the device)
to properly perform its intended function.

(b) The licensee shall include the following information in each report
submitted under subsection (a):

( 1 ) A description of the equipment problem;

(2) Cause of each incident, if known;

(3) Manufacturer and model number of equipment involved in the in-
cident;

(4) Place, time and date of the incident;

(5) Actions taken to establish normal operations;

(6) Corrective actions taken or planned to prevent recurrence; and

(7) Qualifications of personnel involved in the incident.

(c) Any licensee conducting radiographic operations or storing radio-
active material at any location not listed on the license for a period in ex-
cess of 180 days in a calendar year shall notify the Department prior to
exceeding the 1 80 days.

NOTE: Authority cited: Sections 114975, 1 15000, 1310.50. 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970, 1 15105. 115110.
and 1 15235, Health and Safety Code.

History

1. New section filed 9-9-97; operative 10-9-97 (Register 97. No. 37). For prior
history, see Register 94, No. 28.

2. Amendment of section and NoTt- filed 4-1 1 -2008: operative 5-1 1-2008 ( Reg-
ister 2008, No. 15).

§ 30333. Training and Supervision for Radiographers and
Radiographer's Assistants Using Sealed
Sources.

(a) Prior to allowing an individual to perform as a radiographer, a user
shall ensure the individual is a certified radioactive materials radiogra-
pher and has;

( 1 ) Received copies of, instruction in, and demonstrated understand-
ing of, applicable provisions of Group 3 of this subchapter, the conditions
of the user' s radioactive material license and operating and emergency
procedures by successful completion of a written or oral examination
covering this material. Instruction in this material shall be at least eight
hours long. The examination shall be at least 50 questions in length. Suc-
cessful completion shall be correctly answering at least 80 percent of the
questions in a closed-book testing session;

(2) Demonstrated competence to use the radiographic exposure de-
vices, sealed sources, related handling tools, and radiation survey instru-
ments employed by the user by successful completion of a practical ex-
amination covering this material. Instmction in this material shall be at
least four hours long; and

(3) Received the instruction and training specified in subsections
(a)( 1 ) and (a)(2) from a radioactive materials radiographer trainer or radi-
ation safety officer.

(b) Prior to allowing an individual to perform as a radioactive materi-
als radiographer's assistant, a user shall:

(1) Ensure the individual has:

(A) Received copies of, instruction in, and demonstrated understand-
ing of, applicable provisions of Group 3 of this subchapter, the conditions
of the user's radioactive material hcense and operating and emergency
procedures by successful completion of a written examination covering
this material. Instruction in this material shall be at least eight hours long.
The examination shall be at least 50 quesdons in length. Successful
completion shall be correctly answering at least 80 percent of the ques-
tions in a closed-book testing session;

(B) Demonstrated competence to use the radiographic exposure de-
vices, sealed sources, related handling tools, and radiation survey instru-
ments employed by the user by successful completion of a practical ex-
amination covering this material. Instruction in this material shall be at
least four hours long; and

(C) Received the instruction and training specified in subsections
(b)( 1 )(A) and (b)( 1 )(B) from a radioactive materials radiographer trainer
or the user's radiation safety officer.

(2) Once the individual has met the requirements of subsecfion (b)( 1 ),
issue to the individual a durable identification card, resistant to water,
containing:

(A) The statement "I certify that (the printed name of the individual)
has met the requirements to be a radiographer's assistant.";

(B) The name and license number, as shov/n on the specific license,
of the user issuing the card; and

(c) Whenever a radiographer's assistant uses radiographic exposure
devices, sealed sources or related source handling tools, or conducts radi-
ation surveys required by section 30334 to determine that the sealed
source has returned to the shielded posifion after an exposure, the radio-

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

grapher's assistant shall be under the personal supervision of a radiogra-
pher trainer. The personal supervision shall include:

( 1 ) The radiographer trainer's physical presence at the site where the
sealed sources are being used;

(2) The ability of the radiographer trainer to give immediate assistance
if required; and

(3) The radiographer trainer's watching the assistant's performance of
the operations referred to in this section.

(d) Each user shall provide annual refresher safety training to all radio-
graphic personnel at intervals not to exceed 1 2 months. The radiation
safety officer (RSO) or an individual designated by the RSO shall con-
duct this training and, at a minimum, address or provide:

(1) Results of internal and Department inspections;

(2) New procedures or equipment;

(3) New or revised regulations about industrial radiography using
sealed sources;

(4) Accidents or errors that have been observed and steps to prevent
their recurrence; and

(5) Opportunities for individuals to ask safety questions.

(e) Except in those operations where a single individual serves as one
of the radiographers required by section 30334(b) and the radiation safe-
ty officer (RSO) and performs all radiographic operations, the RSO or the
RSO's designee shall conduct an internal inspection program to assure
that radiographers and radiographer's assistants comply with this regula-
tion and license conditions and the licensee's operating and emergency
procedures. The inspection program shall include or provide:

( 1 ) Observation of the performance of each radiographer and radiogra-
pher's assistants during an actual radiographic operation at intervals not
to exceed six months; and

(2) That, if a radiographer or a radiographer's assistant has not partici-
pated in a radiographic operation for more than six months since the last
inspection, that individual's performance shall be observed and recorded
the next time the individual participates in a radiographic operation.

(f) Documentation demonstrating compliance with this section shall
be maintained for three years and kept available for inspection.
NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 114970, 1 15000, 1 15060,
1 15230 and 1 15235, Health and Safety Code.

History

1. Renumbering and amendment of former Section 30333(a) to Section
30333(aHc), renumbering and amendment of former Section 30333(b) to Sec-
tion 30333.1, and renumbering and amendment of former Section 30333(c) to
Section 30333.2 tiled 7-7-86; effective thirtieth day thereafter (Register 86,
No. 28). For prior history, see Register 72, No. 42.

2. Amendment of section heading, section and Note filed 4-1 1-2008; operative
5-11-2008 (Register 2008, No. 15).

§ 30333.05. Radioactive Materials Radiographer Trainer
Requirements.

(a) A user shall not allow any individual to act as a radioactive materi-
als radiographer trainer unless the:

(1) Individual is a radioactive materials radiographer who:

(A) Is certified pursuant to section 30335.2 or is in compliance with
section 30335.3;

(B) Has complied with the requirements of section 30333(a)(1) and
(2); and

(C) Has at least 2,000 hours of experience as a radiographer using
sealed sources, performing radiographic operations, radiation surveys
and radiation safety related activities. The experience may not include
film development and interpretation, darkroom activities, travel, safety
meetings, classroom training, and any work activity not related to the per-
formance of industrial radiography; and

(2) User has received, pursuant to subsection (b), an amended license
identifying the individual as a radiographer trainer.

(b) A user may apply for amendment of the specific license to identify
a radiographer trainer by submitting:

(1) The name and Hcense number as shown on the applicant's specific
license; and

(2) For each individual who will perform as a radiographer trainer:

(A) The name and number as shown on the individual's radiographer
certificate issued by the Department or a copy of both sides of the certifi-
cation identification card issued by one of the entities listed in section
30335.3(b); and

(B) Documentation that the individual has complied with subsections
(a)(1)(B) and (a)(1)(C). The documentation shall include the beginning
and ending dates of the experience, the name of licensee under whom the
experience was obtained and, for each radiographic exposure device
used, the model and manufacturer's name.

NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115060 and
1 15235. Health and Safety Code.

History

1 . New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30333.07. Radioactive Material Radiation Safety Officer
Requirements.

(a) For an individual to be a radiation safety officer (RSO) for a specif-
ic licensee, the individual shall:

(1) Meet the requirements of section 30333.05(a)(1). Possession of a
provisional radiographer certificate issued pursuant to section 30335.4
is not acceptable for complying with this section. No more than 900 hours
of experience as a radiographer using radiation machines may be counted
toward meeting the 2,000 hours specified in section 30333.05(a)(1)(C);
and

(2) Have completed 4,000 hours of experience using radioactive mate-
rials and experience in radiation protection activities such as developing
or implementing procedures relating to the protection of workers and the
public from radiation including the development or implementation of
procedures for radiation surveys, leak testing of radioactive sources, as-
sessment of dosimetry for radiation work, determination of necessary
radiation shielding, review of survey, leak testing, and personnel dose
measurements, training of personnel, use and maintenance of sealed
sources and devices, monitoring of radiation emergency events, sealed
source and device security, disposal of radioactive material, audits of ra-
diographic operations, survey meter maintenance and calibration, and
transportation of radioactive material.

(b) The RSO shall ensure that radiation safety activities are being per-
formed in accordance with approved procedures, conditions of the li-
censee's license, and the requirements of this regulation in the daily op-
eration of the hcensee's radiation safety program. Designation of an RSO
does not relieve the specific licensee of any of its responsibility for com-
plying with the Act and this regulation.

NOTE: Authority cited: Secdons 1 14975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Secdons 114965, 114970, 115060 and
1 15235, Health and Safety Code.

History

1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30333.1. Operating and Emergency Procedures.

(a) Each user shall establish, implement, maintain and keep current
written operating and emergency procedures which shall include de-
tailed instructions in at least the following matters:

(1) The handling and use of radiographic exposure devices and the
manner of employment to control and limit radiation exposures to indi-
viduals;

(2) Methods and occasions for conducting radiation surveys;

(3) Methods and occasions for controlling access to radiography areas;

(4) Methods and occasions for locking and securing radiographic ex-
posure devices, transport and storage containers and sealed sources;

(5) Personnel monitoring and the use of personnel monitoring devices;

(6) Steps that must be taken immediately by radiographic personnel in
the event a pocket dosimeter is found to be off scale or an alarm ratemeter
alarms unexpectedly;

(7) Transporting sealed sources to field locations, including packing
of radiographic exposure devices and storage containers in the vehicle,
placarding of vehicles when needed and control of the sealed sources
during transportation;

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Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30334

(8) Procedures in the event of an accident, including sealed source
handling, minimizing radiation exposure to individuals, and notifying
proper persons;

(9) Maintenance of records;

(10) The inspection, maintenance, and operability checks of radio-
graphic exposure devices, survey instruments, transport and storage con-
tainers and source changers; and

(11) Source recovery procedures if licensee will perform source re-
covery.

NOTIi: Aulhority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970, 1 15000, 1 15060,
1 15230 and 1 15235, Health and Safely Code.

History

1. Renumbering and amendment of former Section 30333(b) to Section 30333.2
tiled 7-7-86: effective thirtieth day thereafter (Register 86, No. 28). For prior
history, see Register 72, No. 42.

2. Amendment of section and Noth filed 4-1 1-2008; operative 5-1 1-2008 (Reg-
ister 2008, No. 15).

§ 30333.2. Personnel Monitoring Control.

(a) Radiographic operations using sealed sources shall not be per-
formed unless, at all times during radiographic operations, all radio-
graphic personnel wear, on the trunk of the body, a direct reading pocket
dosimeter, an operating alarm ratemeter, and a personnel dosimeter that
requires processing to determine the radiation dose except that at perma-
nent radiographic installations, the wearing of an alarming ratemeter is
not required. Each personnel dosimeter shall be assigned to and worn by
only one individual.

(b) Film badges shall be replaced at periods not to exceed one month
and other personnel dosimeters that require processing to determine the
radiation dose shall be replaced at periods not to exceed three months. Af-
ter replacement, personnel dosimeters shall be sent for processing by the
users" dosimetry processor meeting the requirements of section
20.1501(c) of title 10, Code of Federal Regulations incorporated by ref-
erence in section 30253 as soon as possible but no later than recom-
mended by the dosimetry processor.

(c) Pocket dosimeters shall have a range from zero to 200 millirems
and be recharged at the start of each shift. Electronic personal dosimeters
may only be used in place of ion-chamber pocket dosimeters.

(d) Pocket or electronic personal dosimeters shall be read and expo-
sures recorded at the beginning and end of each shift. A record of these
exposures shall be retained for three years after the record is made and
indicate, for each dosimeter used, the manufacturers name, model and se-
rial number and name of individual to whom assigned.

(e) Pocket and electronic personal dosimeters shall be checked at peri-
ods not to exceed one year for correct response to radiation and shall read
within plus or minus 20 percent of the true radiation exposure.

(0 If an individual's pocket dosimeter is found to be discharged be-
yond its range or if the individual's electronic personal dosimeter reads
greater than 200 millirems and the pos.sibility of radiation exposure can-
not be ruled out as the cause, the individual's personnel dosimeter shall
be sent for processing within 24 hours. The individual may not resume
work associated with any source of radiation until the individual's radi-
ation exposure has been determined. TTie user's radiation safety officer
or his designee shall make this determination and the results shall be kept
available for inspection and maintained until the Department terminates
the license.

(g) Reports received from the dosimetry processor shall be retained for
inspection until the Department terminates each license that authorizes
the activity that is subject to the recordkeeping requirement.

(h) Each alarming ratemeter shall:

(1) Be checked to ensure that the alarm functions properly (sounds)
prior to use at the start of each shift;

(2) Be set to give an alarm signal at a preset dose rate of 500 millirems
per hour;

(3) Require special means to change the preset alarm function;

(4) Be calibrated at periods not to exceed one year for correct response
to radiation; and

(5) Alarm within plus or minus 20 percent of the true radiation dose
rate.

(i) Alarming ratemeter calibration records shall be maintained for
three years.

(j) If a personnel dosimeter that requires processing to determine the
radiation dose is lost or damaged during radiographic operations, the
worker shall cease work immediately until a replacement personnel do-
simeter is provided and the exposure is calculated for the time period
from issuance to loss or damage of the personnel dosimeter. The radi-
ation safety officer shall perform the calculation. The results with mea-
surements, calculated data, and assumptions made to obtain the calcu-
lated exposure and the time period for which the personnel dosimeter was
lost or damaged shall be retained for inspection until the Department ter-
minates the license.

Note: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Heahh and Safety Code. Reference: Sections 114965, 114970, 115060 and
1 15235, Health and Safety Code.

History

1. Repealer and new section filed 7-18-94 as an emergency; operative 7-18-94
(Register 94, No. 29). A Certificate of Compliance must be transmitted to OAL
by 1 1-15-94 or emergency language will be repealed by operation of law on
the following day. For prior history, see Register 86, No. 28.

2. Editorial correcfion of subsection (a) (Register 94, No. 51).

3. Certificate of Compliance as to 7-18-94 order including amendment of Noth
transmitted to OAL 1 1-7-94 and filed 12-21-94 (Register 94, No. 51).

4. Amendment of section and Note filed 4-1 1-2008; operative 5-1 1-2008 (Reg-
ister 2008, No. 15).

§ 30333.3. Location of Documents and Records.

(a) In addition to the requirements of section 30293, each licensee
shall maintain copies of records required by tliis regulation at the location
identified in the specific license.

(b) Each licensee shall also maintain copies of the following docu-
ments and records sufficient to demonstrate compliance at each applica-
ble field station and each temporary jobsite:

(1) The license authorizing the use of licensed material;

(2) A copy this regulation, as defined in section 30100;

(3) Utilization records for each radiographic exposure device dis-
patched from that location as required by section 30332.6.

(4) Records of equipment problems identified in daily checks of equip-
ment as required by section 30332.7;

(5) Records of alarm system and entrance control checks required by
section 30332.2, if applicable;

(6) Records of direct reading dosimeters such as pocket dosimeter and/
or electronic personal dosimeters readings as required by section
30333.2;

(7) Operating and emergency procedures required by section 30333. 1 ;

(8) Evidence of the latest calibration of the radiation survey instru-
ments in use at the site, as required by section 30332.3;

(9) Evidence of the latest calibrations of alarm ratemeters and oper-
ability checks of pocket dosimeters and/or electronic personal dosime-
ters as required by section 30333.2;

(10) Latest survey records required by section 30334(h);

(11) Shipping papers for the transportation of radioactive materials re-
quired by section 30373; and

(12) When operating under reciprocity pursuant to section 30225, a
copy of the Department's Notice of Reciprocal Recognition.

NOTE; Authority cited: Sections 114975. 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Secfions 114965, 114970, 115060 and
1 15235, Health and Safety Code.

History
1. New section filed 4-11-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30334. Precautionary Procedures in Radiographic
Operations Using Sealed Sources.

(a) Radiographic operations shall not be performed unless performed
by radiographic personnel.

(b) Industrial radiography, at a location other than at a permanent ra-
diographic installation, shall not be performed, unless there are at least
two radiographic personnel one of whom is a radiographer. If one of the

Page 208.1

§ 30335

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

personnel is a radiographer's assistant, the other shall be a radiographer
trainer indicated as such on the specific license.

( 1 ) Each radiographer has in their possession a current and valid certi-
fication identification (ID) card issued to them by the Department or the
radiographer is in compliance with section 30335.3(a); and

(2) Each radiographer's assistant has in their possession the ID card
issued to them by the licensee pursuant to section 30333(b)(2).

(d) During each radiographic operation, radiographic personnel shall
maintain visual surveillance of the operation to protect against unautho-
rized entry into a high radiation area, except at permanent radiographic
installations where all entry ways are locked and the requirements of sec-
tion 30332.2 are met.

(e) Areas in which industrial radiography is being performed shall be
conspicuously posted as required by section 20.1902 of title 10, Code of
Federal Regulations, part 20 (10 CFR 20) incorporated by reference in
section 30253. Section 20. 1903 of 10 CFR 20 shall not apply to industrial
radiography.

(f) Radiographic operations shall not be performed unless calibrated
and operable radiation survey instruments meeting the requirements of
section 30332.3 are available and used.

(g) A radiation survey shall be made after each radiographic exposure
and before exchanging films, repositioning the exposure head, or dis-
mantling equipment to determine that the sealed source has been returned
to its shielded position. The entire circumferences of the radiographic ex-
posure device shall be surveyed. If the radiographic exposure device has
a source guide tube, the survey shall include the guide tube.

(h) A radiation survey shall be made to determine that each sealed
source is in its shielded condition prior to locking a radiographic expo-
sure device, storage container or source changer as required by section
30332.1. Records of all such surveys shall indicate the manufacturer's
name, model and serial number of the alarming ratemeter worn by and
survey instrument used by the surveyor and the exposure value obtained.
These records shall be maintained for three years and kept available for
inspection.

NOTE: Authority cited: Sections 114975, 115000, 131050. 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060,
1 15230 and 1 15235, Health and Safety Code.

History

1. Amendment of subsection (b) filed 10-12-72; effective thirtieth day thereafter
(Register 72, No. 42).

2. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No.

28).

3. Change without regulatory effect of subsection (c) (Register 87, No. 4).

4. Amendment of subsections (c)-(e), relettering of former subsection (f) to sub-
section (g) and new subsection (f) filed 7-12-89; operative 8-1 1-89 (Register
89, No. 28).

5. Change without regulatory effect amending subsection (f) filed 11-1-91 pur-
suant to section 100, title 1, California Code of Regulations (Register 92, No.
5).

6. Amendment of subsections (a)(1) and (b) filed 3-3-94 as an emergency; opera-
tive 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be trans-
mitted to OAL by 7-1-94 or emergency language will be repealed by operation
of law on the following day.

7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

8. Amendment of section heading, section and Note filed 4-1 1-2008; operative
5-11-2008 (Register 2008, No. 15).

§ 30335. Minimum Subjects to Be Covered in Training
Radiographers. [Repealed]

NOTE; Authority cited: Sections 208 and 2581 1 , Health and Safety Code. Refer-
ence: Sections 25801, 25802, 2581 1, 25815 and 25876, Health and Safety Code.

History

1. Amendment of subsection (c) filed 1 1-16-67; effecfive thirtieth day thereafter
(Register 67, No. 46).

2. New subsecfions (b)(3)(D), (d) and (e) filed 7-7-86; effecfive thirtieth day
thereafter (Register 86, No. 28)

3. Repealer filed 4-1 1-2008; operafive 5-1 1-2008 (Register 2008, No. 15).

§ 30335.1. Radiographer Certification Categories.

(a) The categories for radiographer certificates are:

( 1 ) Radioactive materials;

(2) Radiation machines; and

(3) Combination (Radioactive materials and radiation machines).

(b) A radiographer certificate in the:

( 1 ) Category of radioactive materials authorizes the individual to per-
form radiographic operations using sealed sources under a specific li-
censee;

(2) Category of radiation machines authorizes the individual to per-
form radiographic operations using radiation machines under a regis-
trant; and

(3) Combination category authorizes the individual to perform radio-
graphic operations using sealed sources and radiation machines under a
licensee and registrant as applicable.

NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970 115000, 115060
1 15230 and 1 15235, Health and Safety Code.

History
1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30335.2. Eligibility for and Renewal of a Radiographer
Certificate.

(a) Except as provided in sections 30335.3 or 30335.4, to be eligible
for or renewal of a radiographer certificate an individual shall:

(1) Submit the application described in section 30335.5; and

(2) Pass a Department examination. If any applicant fails the test three
times, the individual shall no longer be eligible unless they obtain addi-
tional radiation safety training and experience as directed by the Depart-
ment. If any applicant fails the test on the fourth try, the individual shall
not be eligible to take the exam for one year after which they may reapply
pursuant to this section if the radiation safety training and experience re-
quirements have been met in the year immediately preceding the date of
re-application.

(b) The radiographer certificate shall be valid for five years.

(c) To renew an expired radiographer certificate, an applicant shall
comply with subsection (a) and shall be considered as an initial applicant.
NOTE: Authority cited: Secfions 114975, 11500O 131050 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060,
1 15230 and 1 15235, Health and Safety Code.

History
1. New secfion filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30335.3. Reciprocal Recognition.

(a) Individuals certified by one of the entities listed in subsection (b)
for the specified category need not possess a Department issued radiogra-
pher certificate provided:

(1) The individual's certification is current and valid;

(2) No escalated enforcement action is pending with the U.S. Nuclear
Regulatory Commission, the certifying entity or any other state; and

(3) The certification identification card issued by the certifying entity
is in the possession of the individual during radiographic operations
within the jurisdiction of the Department in which the individual partici-
pates.

(b) The following certifying entities are recognized for compliance
with subsection (a) in the:

(1 ) Category of radioactive materials by the:

(A) State of Alabama, Georgia, Illinois, Iowa, Louisiana, Maine,
North Dakota, Oklahoma, South Carolina, or Texas; or

(B) American Society of Nondestructive Testing, Inc. in Industrial Ra-
diography Radiation Safety Personnel Certification;

(2) Category of radiation machines by the;

(A) State of Alabama, Illinois, Iowa, Louisiana, Maine, North Dakota,
or Texas; or

(B) American Society of Nondestructive Testing, Inc. in Industrial Ra-
diography Radiation Safety Personnel Certification; or

(3) Combination category (radioactive materials and radiation ma-
chines) by the:

•

Page 208.2

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Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30335.5

(A) State of Alabama, Illinois, Iowa, Louisiana, Maine. North Dakota,
or Texas; or

(B) American Society of Nondestructive Testing, Inc. in Industrial Ra-
diography Radiation Safety Personnel Certification.

(c) Reciprocal recognition granted pursuant to this section may be re-
voked, suspended, amended or restricted for any of the following:

( 1 ) Failure to maintain the certification upon which the reciprocal rec-
ognition was granted;

(2) Violation of any provision of the Act, any regulation promulgated
pursuant to the Act, or any order of the Department;

(3) Incompetence or gross negligence in performing radiographic op-
erations; or

(4) Exposing any individual to radiation with the intent to harm that
individual.

NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970, 1 15000, 1 15060,
1 15230 and 1 15235, Health and Safety Code.

History
1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30335.4. Provisional Radiographer Certificates.

(a) Until December 3 1 , 2009, an application for a provisional radiogra-
pher certificate shall be considered complete if the applicant submits the
information for the certificate category as specified below. After Decem-
ber 31, 2009, applications for provisional radiographer certificates will
not be accepted. To obtain a provisional radiographer certificate in the:

( 1 ) Radioactive materials category, submit the informafion specified
in section 30335.5(b)(1) and (2), the application fee specified in section
30336.8 and:

(A) If specified on a specific license as a radiographer, the name and
license number as shown on the specific license; or

(B) Except as provided in subsecfion (b), if designated as a radiogra-
pher by a licensee, the name and license number of the licensee as shown
on the specific license, and a letter from the licensee signed by the licens-
ee's radiation safety officer verifying that the applicant has met the re-
quirements of secdon 30335.10, has participated in (number of hours)
hours of radiographic operafions using radioactive materials and has
demonstrated the capabihty of working independently as a radiographer.
The number of hours of participation shall be at least 200 but shall not
include the number of hours spent in safety meetings, classroom training,
travel, darkroom activities, film development and interpretation, and any
work acfivity not related to the performance of industrial radiography. If
the training specified in section 30335. 10 and the required hours were ob-
tained under multiple licensees, the applicant shall submit enough docu-
ments to support complefion of all required training;

(2) Radiation machine category, submit the information specified in
section 30335.5(b)(1) and (2), the applicaUon fee specified in section
30336.8 and, except as provided in subsecfion (b):

(A) Documentafion that the requirements of section 30335.10 have
been met. Documentation shall indicate where the training occurred, to-
tal number of hours spent on the subjects listed in section 30335. 10, and
include a copy of the training certificate if one was issued. If a training
certificate was not issued, the applicant shall so state; and

(B) Documentation of at least 1 20 hours of participation in radiograph-
ic operations using radiation machines. The hours of participation shall
not include safety meetings, classroom training, travel, darkroom activi-
ties, film development and inteipretation, and any work activity not re-
lated to the performance of industrial radiography. Documentation shall
indicate the name and registration number of the registrant under whom
the operations were performed, the dates and total number of hours of
participation. If participation occurred under multiple registrants, the ap-
plicant shall submit enough documents to support completion of the 120
hours; or

(3) Combination category, submit the information specified in section
30335.5(b)( 1 ) and (2), the information specified in subsections (a)( 1 ) and
(a)(2)(B) of this section and the application fee specified in section
30336.8. Individuals applying for the combination category must com-

plete both the 200 hours of participation using radioactive material and
120 hours using radiation machines for a total of 320 hours.

(b) In lieu of the requirement in subsections (a)(1)(B) or (a)(2), train-
ing obtained through providers approved by one of the entities listed in
section 30335.3(b) for the specified certificate category shall be accepted
if the applicant completed that training. Documentation of completion
shall be submitted.

(c) Certificates issued pursuant to this section shall be valid for two
years and shall not be renewable. Applications for a renewable radiogra-
pher certificate shall be submitted pursuant to section 30335.2 and be
considered as initial applications.

NOTi;: Authority cited: Sections 114975. 115000. 131050. 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 1 14970, 1 15000, 1 15060,
1 15230 and 1 15235, Health and Safety Code.

History

1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30335.5. Complete Radiographer Certificate Application.

(a) For applicants possessing a current provisional radiographer certif-
icate in a specified category issued pursuant to section 30335.4, an ap-
plication submitted for compliance with section 30335.2 shall be consid-
ered complete if the application contains the applicant's legal name,
mailing address, telephone number, the certificate number as shown on
their provisional certificate and the examination fee as specified in sec-
tion 30336.8.

(b) For applicants who do not possess a current provisional radiogra-
pher certificate, an application submitted for compliance with section
30335.2 shall be considered complete if the application contains:

(1 ) The legal name, maihng address, and telephone number of the ap-
plicant;

(2) The applicant's social security number (pursuant to the authority
found in sections 131200 and 115000(b) of the Health and Safety Code
and as required by section 1 7520 of the Family Code, providing the social
security number is mandatory. The social security number will be used
for purposes of identification);

(3) Except as provided in subsection (c), for a radiographer certificate
in the radioactive materials category:

(A) A copy of the applicant's certificate of training issued by a radi-
ation safety training provider approved pursuant to .section 30331 or if
renewing the radiographer certificate, the certificate number as shown on
the certificate; and

(B) Except for renewal applicants, documentation of at least 200 hours
of participation in radiographic operations using radioactive material.
The hours of participation shall not include the time spent on completing
the requirements specified in section 30333(b)(1), safety meetings,
classroom training, travel, darkroom activities, film development and in-
terpretation, and any work activity not related to the performance of in-
dustrial radiography. Documentation shall be a letter from the licensee
under whom the operations were performed verifying that the applicant
has demonstrated the capabihty of independently working as a radiogra-
pher. The letter shall indicate the licensee's name and license number as
shown on the specific license, the dates and total number of hours of par-
ticipation and be signed by the Hcensee's radiation safety officer. If par-
ticipation occurred under multiple Hcensees, the applicant shall submit
enough documents to support completion of the 200 hours;

(4) Except as provided in subsection (c), for a radiographer certificate
in the radiation machine category:

(A) A copy of the apphcant's certificate of training issued by a radi-
ation safety training provider approved pursuant to section 30331 or if
renewing the radiographer certificate, the certificate number as shown on
the certificate; and

(B) Except for renewal applicants, documentation of at least 1 20 hours
of participation in radiographic operations using radiation machines. The
hours of participation shall not include the time spent on completing the
requirements specified in section 30336.5(a)( 1 ), safety meetings, class-
room training, travel, darkroom activities, film development and inter-
pretation, and any work activity not related to the performance of indus-

Page 208.3

§ 30335.6

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

trial radiography. Documentation shall indicate the name and
registration number of the registrant under whom the operations were
performed, the dates and total number of hours of participation. If partici-
pation occurred under multiple registrants, the applicant shall submit
enough documents to support completion of the 120 hours;

(5) Except as provided in subsection (c), for a radiographer certificate
in the combination category, all items specified in subsections (b)(3) and
(b)(4)(B). Individuals applying for the combination category must com-
plete both the 200 hours of participation using radioactive material and
120 hours using radiation machines for a total of 320 hours; and

(6) An application fee and an examination fee as specified in section
30336.8.

(c) In lieu of the requirement in subsections (b)(3), (b)(4) or (b)(5) to
obtain training from providers approved pursuant to section 30331 and
experience under a licensee or registrant, training obtained through pro-
viders approved by one of the entities listed in section 30335.3(b) for the
specified certificate category shall be accepted if the applicant has com-
pleted that training. Documentation of completion shall be submitted.
NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970, 1 15000, 1 15060,
1 15230 and 1 15235, Health and Safety Code.

History

1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30335.6. Notification of Change of Name or Address.

Each individual certified pursuant to this Article shall report to the De-
partment in writing any change of name or mailing address within 30 cal-
endar days of the change.

NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060,
1 15230 and 1 15235, Health and Safety Code.

History
1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30335.10. Radiation Safety Training Curriculum.

An applicant for approval as a radiation safety training provider shall
ensure each student completes at least 40 hours of training in:

(a) Fundamentals of Radiation Safety that addresses:

( 1 ) Characteristics of radiation;

(2) Units of radiation dose and quantity of radioactivity;

(3) Significance of radiation dose to include hazards of excessive ex-
posure to radiation, biological effects of radiation dose, radiation protec-
tion standards and case histories of industrial radiography accidents;

(4) Levels of radiation from radiation machines and radiographic ex-
posure devices; and

(5) Methods of controlling radiation dose: working time, working dis-
tance, shielding.

(b) Radiation instrumentation that addresses:

(1 ) Use of radiation survey instruments: operation, calibration, and li-
mitations;

(2) Radiation survey techniques; and

(3) Characteristics and use of personnel monitoring equipment: film
badges, pocket dosimeters and chambers, thermoluminescent dosime-
ters, alarming ratemeters, and optically stimulated luminescent dosime-
ters.

(1) Operation and control of radiographic exposure devices, remote
handling equipment, storage and transport containers, source changers,
storage, control and disposal of radioactive material;

(2) Operation and control of radiation machines; and

(3) Inspection and maintenance of equipment.

(d) Federal and State radiation control regulations pertaining to indus-
trial radiography.

(e) Generic written operating and emergency procedures addressing

the procedures specified in section 30333.1.

NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970, 1 15000, 115060,
1 15230 and 11 5235, Health and Safety Code.

History

1 . New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30336. Requirements for Shielded-Room Radiography.

(a) A user conducting shielded-room radiography shall designate an
individual as the radiation safety officer. This individual shall meet the
criteria specified in section 30336.7.

(b) A user shall not allow any individual to perform shielded-room ra-
diography unless the individual:

(1) Has completed the training specified in section 30335.10 from a
provider approved pursuant to section 30331;

(2) Has received copies of, instruction in, and demonstrated under-
standing of, the user's operating and emergency procedures by obtaining
a passing grade of at least 80 percent on a written examination covering
this material. The written examination shall be at least 50 questions in
length. Instruction in this material shall be at least eight hours long; and

(3) Has demonstrated competence to use the radiation machines and
survey instruments employed by the user and in the kinds of radiographic
operations that will be performed by obtaining a passing grade of at least
80 percent on a practical examination covering this material. The practi-
cal examination shall be at least 25 questions in length. Instruction in this
material shall be at least four hours long.

(c) A user shall supply personnel dosimeters that require processing
to determine the radiation dose to and require the use by every individual
who operates, who makes "setups," or who performs maintenance on a
shielded-room radiography unit. Each personnel dosimeter shall be as-
signed to and worn by only one individual and processed in accordance
with section 30333.2(b). Reports received from the dosimetry processor
shall be available for inspection and maintained until the Department ter-
minates the user's registration. If a personnel dosimeter is lost or dam-
aged during radiographic operations, the worker shall immediately cease
work using radiation sources until a replacement personnel dosimeter is
provided and the exposure is calculated for the time period from issuance
to loss or damage of the persomiel dosimeter. The radiation safety officer
shall perform the calculation. The results with measurements, calculated
data, and assumptions made to obtain the calculated exposure and the
time period for which the personnel dosimeter was lost or damaged shall
be retained for inspection until the Department terminates the user's reg-
istration.

(d) All openings through which an individual could gain access to the
room shall be interlocked so that the radiation machine will not operate
unless all openings are securely closed. The required controls shall be de-
signed such that an individual is not prevented from leaving the room.

(e) The room shall not be occupied during radiation exposures.

(f) A device shall be installed within the room that will, upon actuation,
terminate production of radiation. It shall not be possible to reset, over-
ride, or bypass the device from outside the room.

(g) Radiation machines used in shielded-room radiography shall meet
the requirements specified in American National Standard N537-1976
"Radiological Safety Standard for the Design of Radiographic and Fluo-
roscopic Industrial X-ray Equipment" published as NBS Handbook 123,
issued August 1977*, which is incorporated by reference.

(h) The interior of the room shall be shielded so that every location on
the exterior does not exceed the dose limits for an unrestricted area as spe-
cified in 10 CFR 20, subpart D incorporated by reference in section
30253.

(i) Documentation demonstrating compliance with this section shall
be maintained for three years and kept available for inspection.

*Copies of American National Standard N537-1976 "Radiological Safety Stan-
dard for the Design of Radiographic and Fluoroscopic Industrial X-ray Equip-
ment" (published as NBS Handbook 123, issued August 1977) may be purchased
from the American National Standards Institute, Inc., Global Engineering Docu-
ments, 1819 L Street, NW, Suite 600, Washington DC 20036 or at "http://glo-
bal.ihs.com" document number "NBS HDBK 123."

NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970 and 1 15060, Health
and Safety Code.

Page 208.4

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30336.1

History

1 . Amendment of subsection (c)(4) filed 5-1 3-69; effective thirtieth day thereafter
(Register69, No. 20).

2. Amendment of subsection (c)(5) filed 10-12-72; effective thirtieth day thereaf-
ter (Register 72, No. 42).

.3. Change without regulatory effect adding Note-; (Register 87, No. 1 1).

4. Amendment of subsections (a), (b) and (c)(5) filed 3-3-94 as an emergency; op-
erative 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be trans-
mitted to OAL by 7-1-94 or emergency language will be repealed by operation
of law on the following day.

5. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

6. Repealer and new section heading, section and Ncm-; and filed 4-1 1-2008; op-
erative 5-1 1-2008 (Register 2008, No. 15).

§ 30336.1. Requirements for Field Radiography.

(a) A user conducting field radiography shall designate an individual
as the radiation safety officer. This individual shall meet the criteria spe-
cified in section 30336.7.

(b) Except as provided in subsection (e), field radiography shall not be
performed unless:

(1) Performed by radiographic personnel; and

(2) There are at least two radiographic personnel one of whom is a radi-
ation machine radiographer. If one of the personnel is a radiation ma-
chine radiographer's assistant, the other shall be a radiation machine ra-
diographer trainer; and

(3) During each radiographic operation, radiographic personnel main-
tain visual surveillance of the operation to protect against unauthorized
entry into a high radiation area.

(c) Except as provided in subsection (e), a user shall not allow any indi-
vidual to act as a radiation machine radiographer unless the individual:

(1) Is a certified radiation machine radiographer or is in compliance
with section 30335.3; and

(2) Has met the requirements of section 30336.5(a)(1).

(d) Except as provided in subsection (e), a user shall not allow any in-
dividual to act as a radiation machine radiographer's assistant unless the
individual meets the requirements of section 30336.5(a)(1) and is under
personal supervision of a radiation machine radiographer trainer or the
radiation safety officer as required pursuant to subsection (o).

(e) The requirements of subsections (b), (c), (d), (n) and (o) do not ap-
ply if:

( 1 ) Field radiography is performed with a radiation machine that is not
capable of exceeding an operating potential of 150 kVp;

(2) The operator of the radiation machine has received at least eight
hours of instruction in, and demonstrated, by successful completion of
a written examination, an understanding of the following subjects. The
examination shall be at least 50 questions in length. Successful comple-
tion shall be correctly answering at least 80 percent of the questions in
a closed-book testing session:

(A) Characteristics of X-radiation;

(B) Units of radiation dose;

(D) Radiation levels from radiation machines;

(E) Methods of controlling radiation exposure: time, distance, and
shielding;

(F) Use of radiation survey instruments: operation, calibration, and li-
mitations;

(G) Radiation survey techniques;

(H) Characteristics and use of personnel monitoring equipment; and
(I) Use of radiation machines in radiography; and

(3) The operator has demonstrated competence to safely use the radi-
ation machine in the kinds of radiographic operations that will be per-
formed. Demonstration shall be by successful completion of a practical
examination covering this material. Instruction in this material shall be
at least four hours long.

(f) Each user shall implement, keep current, and maintain written oper-
ating procedures for the kinds of radiation machines and the kinds of ra-

diographic procedures employed. These procedures shall include de-
tailed instructions in at least the following:

( 1 ) Means to be employed to control and limit exposure to individuals;

(2) Methods and occasions for conducting radiation surveys and for
controlling access to radiography areas; and

(3) The use of radiation survey instruments and personnel monitoring
devices.

(g) Radiographic operations shall not be performed unless, for each
radiation machine energized, at least one radiation survey instrument,
which meets the requirements of section 30332.3, capable of measuring
radiation of the energies and at the dose rates to be encountered is avail-
able and used. Each registrant shall perform visual and operability checks
on all survey instruments before use on each day the radiographic equip-
ment is to be used to ensure that the radiographic equipment is in good
working condition. Survey instrument operability shall be performed us-
ing a radiation source. If equipment problems are found, the equipment
shall be removed from service until repaired.

(h) Areas in which field radiography is being performed shall be con-
spicuously posted as required by title 10 Code of Federal Regulation
(CFR) Part 20, subpart J incorporated by reference in section 30253. The
limits of a high radiation area need not be separately defined and posted
if the surrounding radiation area is posted and controlled as a high radi-
ation area.

(i) The boundaries of the controlled area for each "setup" shall be de-
termined by a radiation survey during the first radiographic exposure to
confirm that subsection (e) has been met and that unrestricted areas do
not have radiation levels in excess of the limits specified in 1 0 CFR 20,
subpart D incorporated by reference in section 30253. A radiation survey
shall be made after each radiographic exposure to determine that the radi-
ation machine is "off." Survey results and records of boundary locations
shall be maintained for three years and kept available for inspection.

(j) Protecfion against unauthorized entry into a high radiation area
shall be controlled in accordance with section 20.1601(a) through (d) of
10 CFR 20 incorporated by reference in section 30253.

(k) Each user shall maintain current utilization logs, which shall be
maintained for three years and kept available for inspection, containing
the following information for each radiation machine:

(1 ) The identity of the machine;

(2) The location, date, and the identity of the individual operator for
each use; and

(3) The voltage, current, and exposure time for each use.
(/) All requirements of secfion 30333.2 apply.

(m) Radiation machines used in field radiography shall meet the re-
quirements specified in American National Standard N537-1976 "Ra-
diological Safety Standard for the Design of Radiographic and Fluoro-
scopic Industrial X-ray Equipment" published as NBS Handbook 123,
issued August 1977*, which is incorporated by reference.

(n) Unless exempted pursuant to subsection (e), field radiography
shall not be performed unless, during radiographic operations:

(1) Each radiographer has in their possession the identification (ID)
card issued to them by the Department and the ID card is current and valid
or the radiographer is in compliance with secfion 30335.3(a); and

(2) Each radiographer's assistant has in their possession the ID card
issued to them by the registrant pursuant to secfion 30336.5(a)(2).

(0) Unless exempted pursuant to subsecfion (e), whenever a radiation
machine radiographer's assistant (RA) uses radiafion machines or con-
ducts radiafion surveys to determine that the radiafion machine is "off,"
the RA shall be under the personal supervision of a radiafion machine ra-
diographer trainer or the radiafion safety officer. The personal supervi-
sion shall include:

(1) The radiographer trainer's physical presence at the site where the
radiafion machine is being used;

(2) The ability of the radiographer trainer to give immediate assistance
if required; and

(3) The radiographer trainer's watching the RA's performance of the
operafions referred to in this secfion.

Page 208.5

§ 30336.5

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(p) If a user possesses a radiation machine such that an individual
could, in a single exposure to the primary beam with the machine set at
maximum exposure factors, receive an exposure exceeding 10 percent of
the occupational dose limits specified in title 10, Code of Federal Regula-
tions, Part 20, subpart C incorporated by reference in section 30253, the
user shall establish and maintain an internal inspection program to ensure
radiographers and radiographer's assistants comply with this regulation
and registration conditions and the registrant's operating and emergency
procedures. The inspection program shall include or provide:

( 1 ) Observation of the performance of each radiographer and radiogra-
pher's assistant during an actual radiographic operation at intervals not
to exceed six months;

(2) That, if a radiographer or a radiographer' s assistant has not partici-
pated in a radiographic operation for more than six months since the last
inspection, that individual's performance shall be observed and recorded
the next time the individual participates in a radiographic operation; and

(3) Retention of inspection records on the performance of radiogra-
phers or radiographer's assistants for three years.

(q) Each user shall provide annual refresher safety training to each ra-
diographer and radiographer's assistant at intervals not to exceed 12
months. This training shall, at a minimum, address or provide:

( 1 ) If an inspection program is required pursuant to subsecdon (p), re-
sults of internal inspections;

(2) Results of Department inspections;

(3) New procedures or equipment;

(4) New or revised regulations about industrial radiography using
radiation machines;

(5) Accidents or errors that have been observed and steps to prevent
recurrence; and

(6) Opportunities for individuals to ask safety questions.

(r) Unless otherwise stated in this section, documentation demonstrat-
ing compliance with this section shall be maintained for three years and
available for inspection.

*Copies of American National Standard N537-1976 "Radiological Safety Stan-
dard for the Design of Radiographic and Fluoroscopic Industrial X-ray Equip-
ment" (published as NBS Handbook 123, issued August 1977) may be purchased
from the American National Standards Institute, Inc., Global Engineerins Docu-
ments, 1819 L Street, NW, Suite 600, Washington DC 20036 or at "http://glo-
bal.ihs.com" document number "NBS HDBK 123."

NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 1 14965, 1 14970 and 1 15060, Health
and Safety Code.

History
1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30336.5. Requirements for Radiation Machine
Radiographer's Assistants.

(a) Prior to allowing an individual to perform as a radiation machine
radiographer's assistant, a user shall:

(1) Ensure the individual has:

(A) Received copies of, instrucUon in, and demonstrated understand-
ing of, the user's operating and emergency procedures by obtaining a
passing grade of at least 80 percent on a written examination covering
this material. The written examinadon shall be at least 50 quesdons in
length. Instruction in this material shall be at least eight hours long; and

(B) Demonstrated competence to use the radiation machines and sur-
vey instruments employed by the user and in the kinds of radiographic
operadons that will be performed by obtaining a passing grade of at least
80 percent on a pracdcal examinadon covering this material. The practi-
cal examination shall be at least 25 questions in length. Instruction in this
material shall be at lest four hours long; and

(C) Received the instruction and training specified in subsections
(a)(1)(A) and (a)(1)(B) from a radiation machine radiographer trainer or
the registrant's radiation safety officer.

(2) Once the individual has met the requirements of subsection (a)(1),
issue to the individual a durable identification (ID) card, resistant to wa-
ter, containing the:

(A) Statement "1 certify that (the name of the individual) has met the
requirements to be a radiation machine radiographer's assistant.";

(B) Name and registration number of the registrant issuing the ID card;
and

(C) Printed name, signature and date of signature of the registrant's
radiation safety officer or radiation machine radiographer trainer.

(b) A user may apply to be an approved provider of radiation safety
training in accordance with section 30331.

NOTE: Authority cited: Sections 114975, 115000, 115060, 131050, 131051 and
131200, Health and Safety Code. Reference: Sections 114965, 114970 and
11 5060, Health and Safety Code.

History
1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30336.6. Radiation iVIachine Radiographer Trainer
Requirements.

(a) A user shall not allow any individual to act as a radiation machine
radiographer trainer unless the individual:

(1) Is a certified radiation machine radiographer or is in compliance
with section 30335.3;

(2) Has complied with the requirements of section 30336.5(a)(1); and

(3) Has at least 2,000 hours of experience using radiation machines,
performing radiographic operations, radiation surveys and radiation
safety related activities. The experience shall not include film develop-
ment and interpretation, darkroom activities, travel, safety meetings,
classroom training, performance of cabinet radiography, and/or any
work activity not related to the performance of industrial radiography.
Documentation shall specify:

(A) The user's name, registration number and name of the user's radi-
ation safety officer;

(B) The beginning and ending dates of the experience; and

(b) Documentation demonstrating compliance with this section shall
be maintained and available for inspection.

NOTE: Authority cited: Sections 114975, 115000, 115060, 131050, 131051 and
131200, Health and Safety Code. Reference: Sections 114965, 114970 and
1 15060, Health and Safety Code.

History
I. New section filed 4-11-2008; operative 5-11-2008 (Register 2008, No. 15).

§ 30336.7. Radiation IVIachine Radiation Safety Officer
Requirements.

(a) Except as specified in subsection (c), for an individual to be a radi-
ation safety officer (RSO) for a registrant, the individual shall:

(1) Meet the requirements of section 30336.6(a). Possession of a pro-
visional radiographer certificate issued pursuant to section 30335.4 is not
acceptable for complying with this section. No more than 900 hours of
experience as a radiographer using radioactive material may be counted
toward meeting the 2,000 hours specified in section 30336.6(a)(3); and

(2) Have completed 4,000 hours of experience using radiation ma-
chines and experience in radiation protection activities such as develop-
ing or implementing procedures relating to the protection of workers and
the public from radiation including the development or implementation
of procedures for radiation surveys, assessment of dosimetry for radi-
ation work, determination of necessary radiation shielding, review of
survey and personnel dose measurements, training of personnel, use and
maintenance of radiation machines, monitoring of radiation emergency
events, radiation machine security, audits of radiographic operations,
and survey meter maintenance and calibration.

(b) The RSO shall ensure that radiation safety activities are being per-
formed in accordance with the requirements of this regulation in the daily
operation of the registrant's radiation safety program. Designation of an
RSO does not relieve the registrant of any of its responsibility for com-
plying with the Act and this regulation.

Page 208.6

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30337

NOTK: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000 and
1 15060, Health and Safety Code.

History

1. New section filed 4-1 1-2008; operative 5-1 1-2008 (Register 2008, No. 15).

§ 30336.8. industrial Radiography Certification and
Provider Fees.

(a) The application fee for any category of radiograplier certificate
shall be $75.00.

(b) The examination fee for any category of radiographer certificate
shall be $75.00. Each individual repeating a failed examination shall pay
a fee of $75.00.

(d) The fee for replacement of a Department identification card shall
be $10.00.

(e) Fees required by this section shall be nonrefundable.

NOTE: Authority cited; Sections 114975, 115000, 115065, 115080, 131050,
131051 and 131200, Health and Safety Code. Reference; Sections 114965,
1 14970, 1 15060, 1 15065 and 1 15080, Health and Safety Code.

History
1. New section filed 4-1 1-2008; operative 5-11-2008 (Register 2008, No. 15).

§ 30337. Requirements for Use of Cabinet X-ray Systems.

(a) As used in this section:

( 1 ) "Access panel" means any barrier or panel which is designed to be
removed or opened for maintenance or service purposes, requires tools
to open, and permits access to the interior of the cabinet;

(2) "Aperture" means any opening in the outside surface of the cabi-
net, other than a port, which remains open during generation of X-rays;

(3) "Door" means any barrier which is designed to be movable or
opened for routine operation purposes, does not generally require tools
to open, and permits access to the interior of the cabinet;

(4) "External surface" means the outside surface of the radiation ma-
chine, including the high-voltage generator, doors, access panels,
latches, control knobs, and other permanently mounted hardware and in-
cluding the plane across any aperture or port;

(5) "Ground fault" means an accidental electrical grounding of an
electrical conductor;

(6) "Port" means any opening in the outside surface of the radiation
machine which is designed to remain open, during generation of X-rays,
for the purpose of conveying material to be irradiated into and out of the
cabinet, or for partial insertion for irradiation of an object whose dimen-
sions do not permit complete insertion into the cabinet;

(7) "Primary beam" means the radiation emitted directly from the tar-
get and passing through the window of the X-ray tube;

(8) "Safety interlock" means a device, which is intended to prevent the
generation of radiation when access by any part of the human body to the
interior of the detection system through a door or access panel is possible;

(9) X-ray system means an assemblage of components for the con-
trolled generation of X-rays;

(10) "X-ray tube" means any electron tube, which is designed for the
conversion of electrical energy into X-ray energy.

(b) Cabinet X-ray systems shall meet and be continually maintained
to ensure the following are met:

(1) Radiation emitted from the system shall not, under any condition
of use, exceed an exposure of 0.5 milliroentgen in one hour at any point
five centimeters (cm) outside the external surface, or any door or port.
The exposure shall be determined by measurements averaged over a
cross-sectional area of ten square cm with no linear dimension greater
than five cm with doors and access panels fully closed as well as fixed
at any position, which will allow the generation of X-rays;

(2) The insertion of any part of the human body through any port into
the primary beam shall not be possible. The insertion of any part of the
human body through any aperture shall not be possible;

(3) The system shall have a lock-and-key control, which will ensure
that X-ray generation is not possible with the key removed. When the

system is not in use, the key shall be removed and controlled to prohibit
unauthorized use of the system;

(4) The system shall have a control or controls to initiate and terminate
the generation of X-rays other than by functioning of a safety interlock
or the main power control;

(5) The system shall have two independent means (indicators), which
indicate when and only when X-rays are being generated. At least one
of the indicators shall be illuminated when X-rays are being generated.
One, but not both, of the required indicators may be a milliammeter la-
beled to indicate X-ray tube current. All other indicators shall be legibly
labeled "X-RAY ON." If the X-ray generation period is less than one-
half second, the indicators shall be activated for one-half second and
shall be discernible from any point at which initiation of X-ray genera-
tion is possible. Failure of a single component of the system shall not
cause failure of both indicators to perform their intended function. The
system shall have additional means other than milliamineters as needed
to insure that at least one indicator is visible from each door, access panel,
and port. If the X-ray generation period is less than one-half second, the
indicators shall be activated for one-half second and be legibly labeled
"X-RAY ON";

(6) In systems used to inspect objects such as, but not limited to, bag-
gage, boxes, backpacks, purses, and mail, the system shall be designed
such that:

(A) During an exposure or preset succession of exposures of one-half
second or greater duration, the operator can terminate the exposure or
preset succession of exposures at any time and is in a position that permits
surveillance of the ports and doors during X-ray generation; and

(B) During an exposure or preset succession of exposures of less than
one-half second duration, completion of the exposure in progress may
continue but shall enable the operator to prevent additional exposures;

(7) There shall be permanently affixed or inscribed:

(A) At the location of any controls which can be used to initiate X-ray
generation, a clearly legible and visible label bearing the statement:
"Caution: X-Rays Produced When Energized;" and

(B) Adjacent to each port a clearly legible and visible label bearing the
statement: "Caution: Do Not Insert Any Part of the Body When System
is Energized — X-ray Hazard;"

(8) Each door shall have a minimum of two safety interlocks. One, but
not both of the required interlocks shall be such that door opening results
in physical disconnection of the energy supply circuit to the high-voltage
generator, and such disconnection shall not be dependent upon any mov-
ing part other than the door;

(9) Each access panel shall have at least one safety interiock;

(10) Following interruption of X-ray generation by the functioning of
any safety interlock, use of a control provided in accordance with subsec-
tion (b)(4) shall be necessary for resumption of X-ray generation;

(11) Failure of any single component of the system shall not cause fail-
ure of more than one required safety interlock; and

( 12) A ground fault shall not result in the generation of X-rays.

( 1 ) Received copies of, instruction in, and demonstrated understand-
ing of, the user's operating and emergency procedures by obtaining a
passing grade of at least 80 percent on a written examination covering
this material. The written examination shall be at least 50 questions in
length; and

(2) Demonstrated competence to use the radiation machines by obtain-
ing a passing grade of at least 80 percent on a practical examination cov-
ering this material. The practical examination shall be at least 25 ques-
tions in length. An individual operating such a system need not obtain
radiographer certification.

(d) Interiocks shall be annually tested to ensure they function as de-
signed.

(e) The user shall conduct an annual evaluation of the cabinet X-ray
system to ensure compliance with title 10, Code of Federal Regulations,
Part 20, subpart D incorporated by reference in section 30253.

Page 208.7

§ 30338

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(f) Individuals shall not be exposed to the primary beam.

(g) Documentation demonstrating compliance with this section shall
be maintained for three years and kept available for inspection.
NOTE: Authority cited: Sections 114975, 115000, 131050. 131051 and 131200,
Health and Safety Code. Reference: Sections 1 1 4965, 1 14970 and 1 15060, Health
and Safety Code.

History

1. New section filed 10-29-73 as an emersency; effective upon filing (Register
73, No. 44).

2. Certificate of Compliance filed 2-22-74 (Register 74, No. 8).

3. Change without regulatory effect adding Noth (Register 87, No. 11).

4. Amendment of section heading, section and NoTi; and filed 4-1 1-2008; opera-
tive 5-1 1-2008 (Register 2008, No. 15).

§ 30338. Grounds for Suspension, Revocation,

Amendment, or Restriction of Radiographer
Certificates and Radiation Safety Training
Provider Approvals.

Radiographer certificates and any approval as a radiation safety train-
ing provider issued under this article may be revoked, suspended,
amended or restricted for any of the following:

(a) Violation of any provision of the Act, any regulation promulgated
pursuant to the Act, or any order of the Department.

(b) Failure to pay fees pursuant to section 30336.8.

(d) Failure to take corrective action when directed by the Department.

(e) Failure to maintain the standard under which the training provider
was approved pursuant to section 30331.

(f) Incompetence or gross negligence in performing radiographic op-
erations.

(g) Procuring any certificate or approval by fraud, or misrepresenta-
tion, or because of mistake.

(h) Exposing any individual to radiation deliberately.

(i) Failure to comply with policies or procedures required to be devel-
oped pursuant to sections 30333.1 or 30336.1(e).

()) Failure to provide complete and accurate information to the Depart-
ment when required.

(k) Failure to pass a Department audit or inspection.
NOTE: Authority cited: Sections 114975, 115000, 131050, 131051 and 131200,
Health and Safety Code. Reference: Sections 114965, 114970, 115000, 115060,
1 15230 and 1 15235, Health and Safety Code.

History
1. New secfion filed 4-1 1-2008; operadve 5-1 1-2008 (Register 2008, No. 15).

Article 7. Radiation Safety Requirements
for Well Logging Operations

§30345.1. Scope.

The regulations in this Article shall apply to all licensees or registrants
who use sources of radiation for well logging operations including oil,
gas, mineral-logging, radioactive markers, or subsurface tracer studies.
NOTE: Authority cited: Sections 208 and 2581 1 , Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section filed 11-4-91; operadve 12-4-91 (Register 92, No. 5). For prior
history of former article 10, see Register 85, No. 48.

2. Amendment of article heading filed 3-3-94 as an emergency; operative 3-3-94
(Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL
by 7-1-94 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30345.2. Definitions.

(a) The definitions in section 30100 apply to this article.

(b) As used in this article:

(1) "Energy compensation source" means a small sealed source (not
exceeding an activity of 100 microcuries), used within a logging tool, or
other tool components, to provide a reference standard to maintain the
tool's calibration when in use;

(2) "Field station" means a facility where licensed radioactive material
or radiation machines may be stored or used and from which equipment
is dispatched to temporary jobsites;

(3) "Fresh Water Aquifer" means a geologic formation that is capable
of yielding fresh water to a well or spring;

(4) "Injection tool" means a device used for controlled subsurface in-
jection of radioactive tracer material;

(5) "Irretrievable well logging source" means any sealed source con-
taining radioactive material that is pulled off or not connected to the wire-
line that suspends the source in the well and for which all reasonable ef-
fort at recovery has been expended;

(6) "Logging assistant" means any individual who, under the personal
supervision of a logging supervisor, handles radiation sources that are not
in logging tools or shipping containers or who performs surveys required
by section 30348.4;

(7) "Logging supervisor" means any individual who uses radiation
sources or provides personal supervision in the use of radiation sources
at a temporary jobsite and who is responsible to the user for assuring com-
pliance with the requirements of this regulation and the conditions of the
license;

(8) "Logging tool" means a device used subsurface to perform well
logging;

(9) "Personal supervision" means guidance and instruction by a log-
ging supervisor who is physically present at a temporary jobsite, who is
in personal contact with logging assistants, and who can give immediate
assistance;

(10) "Radioacdve marker" means radioactive material used for depth
determination or direction orientation. The term includes radioactive col-
lar markers and radioactive iron nails;

(11) "Safety review" means a periodic review provided by the user for
its employees on radiation safety as it relates to well logging. The review
may include, as appropriate, the results of internal inspections, new pro-
cedures or equipment, accidents or errors that have been observed, and
safety questions by employees;

( 1 2) "Source holder" means a housing or assembly into which a sealed
source is placed to facilitate the handling and use of the source in well
logging;

(13) "Subsurface tracer study" means the release of unsealed radioac-
tive material or a substance labeled with radioactive material in a single
well for the purpose of tracing the movement or position of the material
or substance in the well or adjacent formation;

(14) "Surface casing for protecting fresh water aquifers" means a pipe
or tube used as a lining in a well to isolate fresh water aquifers from the
well;

(15) "Temporary jobsite" means a place where licensed radioacdve
materials or radiadon machines are present for the purpose of performing
well logging or subsurface tracer studies;

(16) "Tridum neutron generator target source" means a tridum source
used within a neutron generator tube to produce neutrons for use in well
logging applications;

(17) "Uranium sinker bar" means a weight containing depleted ura-
nium used to pull a logging tool towards the bottom of a well;

(18) "Well" means a drilled hole in which well logging may be per-
formed and includes drilled holes for the purpose of oil, gas, mineral,
groundwater, or geological exploration;

(19) "Well logging" means all operadons involving the lowering and
raising of measuring devices or tools which contain radiadon sources or

[The next page is 209.]

Page 208.8

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§30346.1

are used to detect radiation sources in wells for the purpose of obtaining
information about the well or adjacent formations which may be used in
oil, gas, mineral, groundwater, or geological exploration;

(20) "Wireline" means a cable containing one or more electrical con-
ductors, which is used to lower and raise logging tools in the well-bore.
NOTK: Authority cited: Sections 100275, 1 14975, 1 15000 and 1 15060, Health and
Safety Code. Reference: Sections 1 14965, 114970, 114985, 115060, 11 5230 and
1 15235, Health and Safety Code.

History

1. New section filed 1 1^-91; operative 12-4-91 (Register 92. No. 5).

2. Amendment of section and NoTi-; filed 4-10-2006; operative 5-10-2006 (Reg-
ister 2006, No. 15).

§ 30345.3. Specific License for Well Logging.

(a) The applicant for Hcensure or registration as described in Section
30194 shall meet the requirements specified in that section and any spe-
cial requirements contained in this section.

(b) The applicant shall develop a program for training logging supervi-
sors and logging assistants and submit to the Department a description
of this program which specifies:

(1) Initial training;

(2) On the job training;

(3) Annual safety reviews provided by the licensee;

(4) Means the applicant will use to demonstrate the logging supervi-
sor's knowledge and understanding of and ability to comply with the reg-
ulations and licensing requirements and the applicant's operating and
emergency procedures; and

(5) Means the applicant will use to demonstrate the logging assistant's
knowledge and understanding of and ability to comply with the regula-
tions and licensing requirements and the apphcant's operating and emer-
gency procedures.

(c) The applicant shall submit to the Department written operating and
emergency procedures as described in Section 30348.2 or an outline or
summary of the procedures that include the important radiation safety as-
pects of the procedures.

(d) The applicant shall establish and submit to the Department its pro-
gram for annual inspections of the job performance of each logging su-
pervisor to ensure that the Department regulations, license requirements,
and the applicant's operating and emergency procedures are followed.
Inspection records must be retained for three years after each annual in-
ternal inspection.

(e) The applicant shall submit a description of its overall organization-
al structure as it applies to the radiation safety responsibihties in well log-
ging, including specified delegations of authority and responsibility.

(f) If an applicant wants to perform leak testing of sealed sources, the
applicant shall identify the manufacturers and the model numbers of the
leak test kits to be used. If the applicant wants to analyze its own wipe
samples, the applicant shall establish procedures to be followed and sub-
mit a description of these procedures to the Department. The description
shall include:

( 1 ) Instruments to be used;

(2) Methods of performing the analysis; and

(3) Pertinent experience of the person who will analyze the wipe sam-
ples.

NOTE: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History
1. New section filed 1 1-4-91; operative 12^-91 (Register 92, No. 5).

§ 30346. Agreement with Well Owner or Operator.

(a) No licensee shall perform well logging services operations with a
sealed source unless, prior to commencement of the operation, the licens-
ee has a written agreement with the well operator, well-owner, drilling
contractor, or land owner describing who shall be responsible for meet-
ing the following requirements:

( 1 ) In the event a sealed source is lodged downhole, a reasonable effort
shall be made to recover it.

(2) A person shall not attempt to recover a sealed source in a manner
which, in the licensee's opinion, could result in its rupture.

(3) Radiation monitoring required in Section 30348.5(a) shall be per-
formed.

(4) If the environment, any equipment, or personnel are contaminated
with licensed radioactive material, they shall be decontaminated before
release from the site or release for unrestricted use.

(5) If the sealed source is classified as irretrievable after reasonable ef-
forts at recovery have been expended, the following requirements shall
be implemented within 30 days:

(A) Each irretrievable well logging source shall be immobilized and
sealed in place with a cement plug.

(B) A mechanical device to prevent inadvertent intrusion on the source
shall be set at some point in the well above the cement plug, unless the
cement plug and source are not accessible to any subsequent drilling op-
erations.

(C) A permanent identification plaque, constructed of long lasting ma-
terial such as stainless steel, brass, bronze, or monel, shall be mounted
at the surface of the well, unless the mounting of the plaque is not practi-
cal. The size of the plaque shall be at least 7 inches square and 1/8 inch
thick. The plaque shall contain the word "Caution", the radiation symbol
(color requirements as described in Section 30278(a) do not have to be
met), the date the source was abandoned, the name of the well owner or
well operator as appropriate, the well name and well identification num-
ber(s) or other designations, an identification of the sealed source(s) by
radionuclide and quantity, the depth of the source and the depth to the top
of the plug and an appropriate warning such as "Do not reenter this well".

(b) The licensee shall retain a copy of the written agreement for three
years after the completion of the well logging operation.

(c) A licensee may apply, pursuant to Section 30104, for approval on
a case-by-case basis of proposed procedures to abandon an irretrievable
well logging source in a manner not otherwise authorized in paragraph
(a)(5) above.

(d) A written agreement between the licensee and the well owner or
operator is not required if the licensee and the well owner or operator are
part of the same corporate structure or otherwise similarly affiliated.
However, the licensee shall still otherwise meet the requirements in Sec-
tions (a)(1) through (a)(5).

NOTE: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section filed 1 1-4-91; operative 12-4-91 (Register 92, No. 5). For prior
history, see Register 87, No. 28.

§ 30346.1 . Labels, Security and Transportation.

(a) The license shall not use a radiation source or source holder or log-
ging tool that contains radioactive material unless the smallest compo-
nent that is transported as a separate piece of equipment with the radioac-
tive material inside bears a durable, legible, and clearly visible marking
or label. The marking or label shall contain the radiation symbol speci-
fied in the United States, Utle 10, Code of Federal Regulafions, part 20,
subpart J as incorporated by reference in section 30253 and the wording
"Danger (or Caution) Radioactive Material".

(b) The licensee shall not use a container to store radioactive material
unless the container has securely attached to it a durable, legible, and
clearly visible label. The label must contain the radiation symbol speci-
fied in the United States, Utle 10, Code of Federal Regulafions, part 20,
subpart J as incorporated by reference in section 30253 and the wording
"CAUTION (or DANGER) RADIOACTIVE MATERIAL. NOTIFY
CIVIL AUTHORITIES (OR NAME OF COMPANY)".

(c) The licensee shall not transport radioactive material unless the ma-
terial is packaged, labeled, marked, and accompanied with appropriate
shipping papers in accordance with regulafions set forth in 10 CFR Part
71 (53 FR 21550, Pub. 6/8/88).

(d) The licensee shall store each source containing radioactive materi-
al in a storage container or transportafion package. The container or pack-

Page 209

§ 30346.2

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

age must be locked and physically secured to prevent tampering or re-
moval of radiation sources from storage by unauthorized personnel. The
licensee shall store radiation sources in a manner which will minimize
danger from explosion or fire.

(e) The licensee shall lock and physically secure the transport package
containing radiation sources in the transporting vehicle to prevent acci-
dental loss, tampering, or unauthorized removal of the radioactive mate-
rial from the vehicle.

NOTtv. Authority cited: Sections 208 and 2581 1. Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section filed 1 1-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of subsections (a) and (b) filed 3-3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted
to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30346.2. Radiation Detection Instruments.

(a) The licensee or registrant shall keep a calibrated and operable radi-
ation survey instrument capable of detecting beta and gamma radiation
at each field station and temporary jobsite to make the radiation surveys
required by this section and by Section 30275. To satisfy this require-
ment, the radiation survey instrument must be capable of measuring 0. 1
mR per hour through at least 50 mR per hour. Survey instruments ac-
quired before the effective date of these regulations shall be capable of
measuring 0. 1 mR per hour through at least 20 mR per hour.

(b) The licensee or registrant shall have available additional calibrated
and operable radiation survey instalments with the sensitivity to detect
the low radiation and contamination levels that could be encountered if
a sealed source ruptured. The licensee may own the instrument or may
have a procedure to obtain them quickly from a second party.

(c) The licensee or registrant shall have each radiation survey instru-
ment required under subsection (a) above calibrated:

(1) At intervals not to exceed six months and after instrument servic-
ing;

(2) At two points located approximately 1/3 and 2/3 of full scale on
each scale for linear scale instruments, at mid range of each decade and
at two points on each decade for logarithmic scale instalments, and at ap-
propriate points for digital instruments; and

(3) So that an accuracy within plus or minus 20 percent of the calibra-
tion standards can be demonstrated on each scale.

(d) The licensee or registrant shall retain calibration records for at least
three years after the date of calibration for inspection by the Department.
NOTE: Authority cited: Sections 208 and 2581 1 , Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New secfion filed 1 1-4-91; operative 12^-91 (Register 92, No. 5).

§ 30346.3. Leak Testing of Sealed Sources.

Each licensee who uses a sealed source shall have the source tested for
leakage as described in section 30275, except that energy compensation
sources (ECS) that are not exempt from testing pursuant to section
30275(c) shall be tested at intervals not to exceed three years. In the ab-
sence of a certificate from a transferor that a test has been made within
the three years before the transfer, the ECS may not be used until tested.
NOTE: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and
Safety Code.

History

1. New section filed 11-4-91; operafive 12-4-91 (Register 92, No. 5).

2. Amendment of section and Note filed 3-1-2007; operative 3-31-2007 (Regis-
ter 2007, No. 9).

§ 30346.4. Physical Inventory.

Each licensee shall conduct a semi-annual physical inventory to ac-
count for all licensed radioactive material received and possessed under
the license. The licensee shall retain records of the inventory for three
years from the date of the inventory for inspection by the Department.

The inventory shall indicate the quantity and kind of radioactive material,
the location of the radioactive material, the date of the inventory, and the
naine of the individual conducting the inventory. Physical inventory re-
cords may be combined with leak test records.

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1 . New section filed 1 1-4-91 ; operative 12^1-91 (Register 92, No. 5).

§ 30346.5. Records of Material Use.

(a) Each licensee or registrant user shall maintain records for each use
of radiation sources showing:

( 1 ) The make, model number, and a serial number or a description of
each radiation source used;

(2) In the case of unsealed radioactive material used for subsurface
tracer studies, the radionuclide and quantity of activity used in a particu-
lar well and the disposition of any unused tracer materials;

(3) The identity of the logging supervisor who is responsible for the
radiation sources and the identity of logging assistants present; and

(4) The location and date of use of the radiation source.

(b) The licensee or registrant shall make the records required by sub-
section (a) of this section available for inspection by the Department. The
records shall be kept for three years from the date of the recorded event.
NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History
1. New section filed 11-4-91; operative 12^1-91 (Register 92, No. 5).

§ 30346.6. Design and Performance Criteria for Sealed
Sources.

(a) A licensee shall not use a sealed source in well logging unless the
sealed source:

(1) Is doubly encapsulated;

(2) Contains licensed radioactive material whose chemical and physi-
cal forms are as insoluble and nondispersible as practical; and

(3) Meets one of the following:

(A) For a sealed source manufactured on or before July 14, 1989,
meets the requirements of USASI N5. 10-1 968, "Classification of Sealed
Radioactive Sources"* which is incorporated by reference; or

(B) For a sealed source manufactured after July 14, 1989, meets the
oil-well logging requirements of ANSI/HPS N43.6-1997, "Sealed Ra-
dioactive Sources — Classification"* which is incorporated by reference;
or

(C) For a sealed source manufactured after July 14, 1989, if the sealed
source's prototype has been tested and found to maintain its integrity af-
ter each of the following tests:

1 . The test source shall be held at - 40 deg. C. for 20 minutes, 600 deg.
C. for one hour, and then be subject to a thermal shock test with a temper-
ature drop from 600 deg. C. to 20 deg. C. within 15 seconds;

2. A 5 kg. steel hammer, 2.5 cm. in diameter, shall be dropped from
a height of 1 meter onto the test source;

3. The test source shall be subject to a vibration from 25 Hz to 500 Hz
at 5 g amplitude for 30 minutes;

4. A one gram hammer and pin, 0.3 cm pin diameter, shall be dropped
from a height of 1 m onto the test source; and

5. The test source shall be subjected to an external pressure of 24,600
pounds per square inch absolute (1.695 X 10^ pascals).

(b) The requirements in subsection (a) do not apply to sealed sources
that contain radioactive material in gaseous form or to energy compensa-
tion sources (ECS). ECSs shall be registered pursuant to section
30192.1(b).

*Copies of USASI N5. 10-1968, "Classification of Sealed Radioactive Sources"
may be obtained from the Department. Copies of American National Standard
N43.6-1997," Sealed Radioacfive Sources — Classification" may be purchased
from the American National Standards Institute, Inc., Global Engineering Docu-
ments, 1819 L Street, NW, Suite 600, Washington DC 20036 or at "http://glo-
bal.ihs.com" using "ANSI N43.6" as the document number; or the Health Physics
Society at http://hps.org/documents/hpsstandardsorder.pdf

Page 210

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S 30348.1

NOTH: Authority cited: Sections 100275, 1 14975, 1 15000 and 1 15060, Health and
Safety Code. Reference: Sections 1 14965, 1 14970, 1 15060, 1 15230 and 1 15235,
Health and Safety Code.

History

1. New section filed 1 1-4-91: operative 12-4-91 (Register 92, No. 5).

2. Amendment of section and NoTi-: filed 4-10-2006; operative 5-10-2006 (Reg-
ister 2006, No. 15).

§ 30346.7. Inspection, Maintenance and Opening of a
Source Holder.

(a) Each licensee shall visually check source holders, logging tools,
and source handling tools, for defects before each use to ensure that the
equipment is in good working condition and that required labeling is
present. If defects are found, the equipment must be removed from ser-
vice until repaired, and a record must be made listing the date of check,
name of inspector, equipment involved, defects found, and repairs made.
These record shall be retained for three years after the defect is found.

(b) Each licensee shall have a program of semi-annual visual inspec-
tion and routine maintenance of source holders, logging tools, injection
tools, source handling tools, storage containers, transport containers, and
uranium sinker bars to ensure that the required labeling is legible and that
no physical damage is visible. If defects are found, the equipment must
be removed from service until repaired, and a record must be made listing
date, equipment involved, inspection and maintenance operations per-
formed, any defects found, and any actions taken to correct the defects.
These records must be retained for three years after the defect is found.

(c) Removal of a sealed source from a source holder or logging tool,
and maintenance on sealed sources or holders in which sealed sources are
contained shall not be performed by the licensee unless a written proce-
dure developed pursuant to Section 30348.2 has been approved by the
Department.

(d) If a sealed source is stuck in the source holder, the licensee shall
not perform any operation, such as drilling, cutting, or chiseling on the
source holder unless the licensee is specifically approved by the Depart-
ment.

(e) The opening, repair, or modification of any sealed source is prohib-
ited unless performed by persons specifically approved to do so by the
Department.

NOTE: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History
1. New section filed 1 1-4-91; operative 12^-91 (Register 92, No. 5).

§ 30346.8. Subsurface Tracer Studies.

(a) The licensee shall require all personnel handling radioactive tracer
material to use protective gloves and, if required by the license, other pro-
tective clothing and equipment. The licensee shall take precautions to
avoid ingestion or inhalation of radioactive tracer material and to avoid
contamination of field stations and temporary jobsites.

(b) The licensee shall not knowingly inject radioactive material into
fresh water aquifers unless specifically authorized to do so by the Depart-
ment.

Note; Authority cited: Sections 208 and 258 11 , Health and Safety Code. Refer-
ence: Sections 25608, 25801, 25802, 25815, 25875 and 25876, Health and Safety
Code.

History
1. New section filed 1 1-4-91; operative 12-4-91 (Register 92, No. 5).

§ 30346.9. Radioactive Markers.

The licensee shall use radioactive markers in wells only if the individ-
ual markers contain quantities of radioactive material not exceeding the
quantities specified in Section 30235 Schedule A. The use of markers is
subject to the requirements of Section 30346.4 only.
NOTK: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History
1. New section filed 11-4-91; operative 12^-91 (Register 92, No. 5).

§ 30346.10. Uranium Sinker Bars.

The licensee shall use a uranium sinker bar in well logging, only if it
is legibly impressed with the words "Caution — Radioactive-Depleted
Uranium" and "Notify Civil Authorities (or Company Name) If l-'ound."
NOTE: Authority cited: Sections 208 and 2581 1 , Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safely Code.

History

1. New section filed 11-4-91; operative 12^4-91 (Register 92, No. 5).

§ 30346.1 1 . Use of Energy Compensation Sources.

A licensee may use an energy comipensation source (ECS), which is
contained in a logging tool, or other tool components, provided the ECS
contains quantities of licensed materials not exceeding 100 microcuries.
For well logging applications with a surface casing for protecting fresh
water aquifers, use of the ECS is only subject to the requirements of sec-
tions 30346.3, 30346.4 and 30346.5. For well logging applications with-
out a surface casing for protecting fresh water aquifers, use of the ECS
is only subject to the requirements of sections 30346, 30346.3, 30346.4.
30346.5 and 30350.3 and the procedure required to be developed and im-
plemented pursuant to section 30348. 2(a)( 1 ).

NOTE: Authority cited: Sections 100275, 11 4975, 1 15000 and 1 15060, Health and
Safety Code. Reference: Sections 1 14965, 1 14970, 1 15060, 1 15230 and 1 15235,
Health and Safety Code.

History
1. New section filed 4-10-2006; operative 5-10-2006 (Register 2006, No. 15).

§ 30346.12. Use of Tritium Neutron Generator Target
Sources.

(a) Use of a tritium neutron generator target source shall be subject to
the requirements of this article except:

(1) Sections 30346, 30346.6, and 30350.3 shall not apply when the:

(A) Activity of the source is no more than 30 curies; and

(B) Source is used in a well with a surface casing for protecting fresh
water acquifers; or

(2) Section 30346.6 shall not apply when the:

(A) Activity of the source is greater than 30 curies; or

(B) Source is used in a well without a surface casing to protect fresh
water acquifers.

NOTE: Authority cited: Sections 100275, 1 14975, 1 15000 and 1 15060, Health and
Safety Code. Reference: Sections 1 14965, 1 14970, 1 15060, 1 15230 and 1 15235,
Health and Safety Code.

History
1. New section filed 4-10-2006; operaUve 5-10-2006 (Register 2006, No. 15).

§30348.1. Training Requirements.

(a) The licensee or registrant shall not permit an individual to act as a
logging supervisor until that person:

( 1 ) Has completed training in the subjects outlined in subsection (e)
of this section;

(2) Has received copies of, and instruction in:

(A) Regulations contained in Subchapter 4, Title 17, California Code
of Regulations;

(B) The Department license or registration under which the logging
supervisor will perform well logging; and

(3) Has completed on-the-job training and demonstrated competence
in the use of radiation sources, remote handling tools, and radiation sur-
vey instruments by a field evaluation; and

(4) Has demonstrated understanding of the requirements in paragraphs
(a)(1) and (2) of this section by successfully completing a written test.

(b) The licensee or registrant shall not permit an individual to act as a
logging assistant until that person:

(1) Has received instruction in applicable requirements of the United
States, title iO, Code of Federal Regulations, part 20, subparts C, D, F,
G, I, J, K, L, and M as incorporated by reference in section 30253;

(2) Has received copies of, and instruction in, the licensee's or regis-
trant's operating and emergency procedures required by Section
30365.2;

Page 211

§ 30348.2

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(3) Has demonstrated understanding of the materials listed in para-
graphs (b)( 1 ) and (2) of this section by successfully completing a written
or oral test; and

(4) Has received instruction in the use of radiation sources, remote
handling tools, and radiation survey instruments, as appropriate for the
logging assistant's intended Job responsibilities.

(c) The licensee or registrant shall provide safety reviews for logging
supervisors and logging assistants at least once during each calendar
year.

(d) The licensee or registrant shall maintain a record on each logging
supervisor's and logging assistant's training and annual safety review.
The training records must include copies of written tests and dates of oral
tests. The training records must be retained for three years following the
date of termination of employment. Records of annual safety reviews
must list the topics discussed and be retained for three years.

(e) The licensee or registrant shall include the following subjects in the
training required in paragraph (a)(1) of this section:

( 1 ) Fundamentals of radiation safety including:

(A) Characteristics of radiation;

(B) Units of radiation dose and quantity of radioactivity;

(D) Levels of radiation from licensed material;

(E) Methods of controlling radiation dose (time, distance, and shield-
ing); and

(F) Radiation safety practices, including prevention of contamination,
and methods of decontamination.

(2) Radiation detection instruments including:

(A) Use, operation, calibration, and limitations of radiation survey in-
stalments;

(B) Survey techniques; and

(3) Equipment to be used including:

(A) Operation of equipment, including source handling equipment
and remote handling tools;

(B) Storage, control, and disposal of licensed material; and

(4) The requirement of pertinent regulations, and

(5) Case histories of accidents in well logging.

NOTE: Authority cited: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801. 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1 . New section filed 1 1^4-91 ; operative 12-4-91 (Register 92, No. 5).

2. Amendment of subsection (b)(1) filed 3-3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted
to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30348.2. Operating and Emergency Procedures.

(a) Each licensee shall develop and follow written operating and emer-
gency procedures that cover:

(1) The handling and use of radiation sources, including protection of
fresh water aquifers, if appropriate;

(2) The use of remote handling tools for handling sealed sources and
radioactive tracer material except low-activity calibration sources;

(3) Methods and occasions for conducting radiation surveys, includ-
ing surveys for detecting contamination, as required by Section 30348.4
(c)-(e);

(4) Minimizing personnel exposure including exposures from inhala-
tion and ingestion of radioactive tracer materials;

(5) Methods and occasions for locking and securing stored radioactive
materials;

(6) Personnel monitoring and the use of personnel monitoring equip-
ment;

(7) Transportation of radioactive materials to field stations or tempo-
rary jobsites, packaging of licensed materials for transport in vehicles,
placarding of vehicles when needed, and physically securing radioactive

materials in transport vehicles during transportation to prevent acciden-
tal loss, tampering, or unauthorized removal;

(8) Picking up, receiving, and opening packages containing radioac-
tive materials, in accordance with the United States, title 10, Code of Fed-
eral Regulations, part 20, section 20.1906 as incorporated by reference
in section 30253;

(9) For the use of tracers, decontamination of the environment, equip-
ment, and personnel;

( 1 0) Maintenance of records generated by logging personnel at tempo-
rary fieldsites;

(11) Inspection and maintenance of sealed sources, source holders,
logging tools, injection tools, source handling tools, storage containers,
transport containers, and uranium sinker bars as required by Section
30346.10;

( 1 2) Actions to be taken if a sealed source is lodged in a well;

(13) Notifying proper persons in the event of an accident; and

(14) Actions to be taken if a sealed source is ruptured including actions
to prevent the spread of contamination and minimize inhalation and in-
gestion of radioactive materials and actions to obtain suitable radiation
survey instalments as required by Section 30346.2(b).

NOTE: Authority cited: Sections 208 and 258 11, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Amendment of subsection (a)(8) filed 3-3-94 as an emergency; operative
3-3-94 (Register 94, No. 9). A Certificate of Compliance must be transmitted
to OAL by 7-1-94 or emergency language will be repealed by operation of law
on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30348.3. Personnel Monitoring.

(a) The user shall not permit an individual to act as a logging supervi-
sor or logging assistant unless that person wears, at all times during the
handling of radiation sources, a personnel dosimeter that requires proces-
sing to determine the radiation dose. Each personnel dosimeter shall be
assigned to and worn by only one individual. Film badges shall be re-
placed at least monthly and other personnel dosimeters replaced at least
quarterly. After replacement, personnel dosimeters shall be sent for pro-
cessing by the users' dosimetry processor meeting the requirements of
section 20.1501(c) of title 10, Code of Federal Regulations incorporated
by reference in section 30253 as soon as possible but no later than recom-
mended by the dosimetry processor.

(b) The licensee shall provide bioassay services to individuals using
radioactive materials in subsurface tracer studies if required by the li-
cense.

(c) Reports received from the dosimetry processor shall be retained for
inspection until the Department terminates each license or registration
that authorizes the activity that is subject to the recordkeeping require-
ment.

NOTE: Authority cited: Secfions 100275, 1 14975. 1 15000 and 1 1 5060, Health and
Safety Code. Reference: Sections 1 14965, 114970, 115060, 115110, 115230 and
1 15235, Health and Safety Code.

History

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

2. Repealer of subsection (c) filed 3-3-94 as an emergency; operative 3-3-94
(Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL
by 7-1-94 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

4. Amendment of subsecdon (a), new subsection (c) and amendment of Note filed
4-10-2006; operative 5-10-2006 (Register 2006, No. 15).

§ 30348.4. Radiation Surveys.

(a) The licensee shall make radiation surveys including, but not lim-
ited to, the surveys required under subsections (b) through (e) of this sec-
tion, of each area where radioactive materials are used and stored.

(b) Before transporting radioactive materials, the licensee shall make
a radiation survey of the position occupied by each individual in the ve-
hicle and of the exterior of each vehicle used to transport radioactive ma-
terials.

Page 212

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Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30350.3

(c) If the sealed source assembly is removed from the logging tool be-
fore departure from the temporary jobsite, the licensee shall confirm thai
the logging tool is free of contamination by energizing the logging tool
detector or by using a survey meter.

(d) If the licensee has reason to believe that, as a result of any operation
involving a sealed source, the encapsulation of the sealed source could
be damaged by the operation, the licensee shall conduct a radiation sur-
vey, including a contamination survey, during and after the operation.

(e) The licensee shall make a radiation survey at the temporary jobsite
before and after each subsurface tracer study to confirm the absence of
contamination.

(0 The results of surveys required under subsections (a) through (e)
of this section must be recorded and must include the date of the survey,
the name of the individual making the survey, the identification of the
survey instrument used, and the location of the survey. The licensee shall
retain records of surveys for inspection by the Department for three years
after they are made.

NOTE: Authority ciled: Sections 208 and 25811, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section filed 1 1-4-91; operative 12-4-91 (Register 92, No. 5).

§ 30348.5. Radioactive Contamination Control.

(a) If the licensee detects evidence that a sealed source has ruptured or
radioactive materials have caused contamination, the licensee shall initi-
ate immediately the emergency procedures required by Section 30348.2.

(b) If contamination results from the use of radioactive material in well
logging, the licensee shall decontaminate all work areas, equipment, and
unrestricted areas.

(c) During efforts to recover a sealed source lodged in a well, the h-
censee shall continuously monitor, with an appropriate radiation detec-
tion instrument or a logging tool with a radiation detector, the circulating
fluids from the well, if any, to check for contamination resulting from
damage to the sealed source.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876. Health and Safety Code.

History

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5).

§ 30350. Security.

(a) A logging supervisor shall be physically present at a temporary job-
site whenever radioactive materials or particle accelerators are being
handled or are not stored and locked in a vehicle or storage place. The
logging supervisor may leave the jobsite in order to obtain assistance if
a source becomes lodged in a well.

(b) During well logging, except when radiation sources are below
ground or in shipping or storage containers, the logging supervisor or
other individual designated by the logging supervisor shall maintain di-
rect surveillance of the operation to prevent unauthorized entry into a
"controlled area", as defined in title 10, Code of Federal Regulations,
section 20.1003, as incorporated by reference by section 30253.
Note: Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970, 115060, 115230 and 115235, Health and
Safety Code.

History

1. New section filed 11-4-91; operative 12-4-91 (Register 92, No. 5). For prior
history, see Register 87, No. 28.

2. Repealer of article 1 1 heading filed 3-3-94 as an emergency; operative 3-3-94
(Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL
by 7-1-94 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28)

4. Amendment of subsection (b) and Note filed 10-15-2001; operarive
1 1-14-2001 (Register 2001, No. 42).

§ 30350.1 . Documents and Records Required at Field
Stations.

(a) Each licensee or registrant shall maintain the following documents
and records at the field station:

( 1 ) A copy of the California Code of Regulations, Title 1 7; Subchapter
4;

(2) The license or registration authorizing the use of radioactive mate-
rial or particle accelerators;

(3) Operating and emergency procedures required by Section
30348.2.

(4) The record of radiation survey instrument calibrations required by
Section 30346.2.

(5) The record of leak test results required by Section 30346.3.

(6) Physical inventory records required by Section 30346.4.

(7) Utilization records required by Section 30346.5.

(8) Records of inspection and rriaintenance required by Section
30346.7.

(9) Training records required by Section 30348.1; and

(10) Survey records required by Section 30348.4.

NOTE: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Secfions 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History
1. New section filed 11-4-91; operafive 12-4-91 (Register 92, No. 5).

§ 30350.2. Documents and Records Required at
Temporary Jobsites.

(a) Each licensee or registrant conducting operations at a temporary
jobsite shall maintain the following documents and records at the tempo-
rary jobsite until the well logging operation is completed:

(1) Operating and emergency procedures required by Section
30348.2.

(2) Evidence of latest calibration of the radiation survey instruments
in use at the site required by Section 30346.2.

(3) Latest survey records required by Section 30348.4(a)(2), (3), and
(5).

(4) The shipping papers for the transportation of radioactive materials
required by Group 4, Article 1 of this chapter; and

(5) When operating under reciprocity pursuant to Section 30225 of this
chapter, a copy of the U.S. Nuclear Regulatory Commission or Agree-
ment State license authorizing use of radioactive materials.

Note: Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. New section filed 1 1-4-91; operative 12-4-91 (Register 92, No. 5).

§ 30350.3. Notification of Incidents and Lost Sources;
Abandonment Procedures for Irretrievable
Sources.

(a) The licensee shall immediately notify the Department by telephone
and subsequently, within 30 days, by confirmation letter if the licensee
knows or has reason to believe that a sealed source has been ruptured. The
letter must designate the well or other location, describe the magnitude
and extent of the escape of radioactive materials, assess the consequences
of the rupture, and explain efforts planned or being taken to mitigate these
consequences.

(b) If a sealed source becomes lodged in a well, and when it becomes
apparent that efforts to recover the sealed source will not be successful,
the licensee shall:

( 1 ) Notify the Department by telephone of the circumstances that re-
sulted in the inability to retrieve the source and:

(A) Obtain approval to implement abandonment procedures; or

(B) Report that abandonment was implemented before receiving De-
partment approval because the licensee believed there was an immediate
threat to public health and safety;

(2) Advise the well owner or operator, as appropriate, of the abandon-
ment procedures under section 30346(a)(5); and

(3) Either ensure that abandonment procedures are implemented with-
in 30 days after the sealed source has been classified as irretrievable or
request an extension of time if unable to complete the abandonment pro-
cedures.

(c) The licensee shall, within 30 days after a sealed source has been
classified as irretrievable, make a report in writing to the Department.

Page 213

§ 30353

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

The licensee shall send a copy of the report to each appropriate State or
Federal agency thai issued permits or otherwise approved of the drilling
operation. The report shall contain the following information:

( 1 ) Dale of occurrence;

(2) A description of the irretrievable well logging source involved in-
cluding the radionuclide and its quantity, chemical, and physical form;

(3) Surface location and identification of the well;

(4) Results of efforts to immobilize and seal the source in place;

(5) A brief description of the attempted recovery effort;

(6) Depth of the source;

(7) Depth of the top of the cement plug;

(8) Depth of the well;

(9) If the licensee implemented abandonment procedures prior to De-
partment approval pursuant to subsection (b)(1)(B), the reasons why the
licensee believed there was an immediate threat to public health and safe-
ly including any documents on which those reasons are based;

(10) Any other information, such as a warning statement, contained on
the permanent identification plaque; and

(11) State and Federal agencies receiving a copy of this report.
NOTE; Authority cited: Sections 100275 and 115000, Health and Safety Code.
Reference: Sections 114965, 114970, 11.5060, 115230 and 115235, Health and
Safety Code.

History

1. New section filed 1 1-4-91; operative 12-4-91 (Register 92, No. 5).

2. Repealer of subsection (b) and subsection redesignation filed 3-3-94 as an
emergency; operative 3-3-94 (Register 94, No. 9). A Certificate of Compliance
must be transmitted to OAL by 7-1-94 or emergency language will be repealed
by operation of law on the following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

4. Amendment of subsection (b)(1), new subsections (b)(l)(A)-(B), amendment
of subsection (b)(2), new subsection (b)(9), subsection renumbering and
amendment of Note filed 3-1-2007; operative 3-31-2007 (Register 2007, No.
9).

§ 30353. Particle Accelerators For Weil Logging.

(a) Registrants who use particle accelerators for well logging purposes
shall comply with Group 1.5, and Articles 1, 3, 4, and 13 of Group 3.

(b) No registrant shall permit above ground testing of particle acceler-
ators designed for use in well logging which results in the production of
radiation except in areas or facilities controlled or shielded so that the re-
quirements of the United States, title 10, Code of Federal Regulations,
part 20, subpart C and D as incorporated by reference in section 30253
are met.

NOTE; Authority cited: Secdons 208 and 2581 1, Health and Safety Code. Refer-
ence: Secfions 25801, 25802, and 25815, Health and Safety Code.

History

1. New secfion filed 1 1-4-91; operative 12^-91 (Register 92, No. 5).

2. Amendment of subsection (b) filed 3-3-94 as an emergency; operative 3-3-94
(Register 94, No. 9). A Certificate of Compliance must be transmitted to OAL
by 7-1-94 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30355. Appendix A. Concentrations in Air and Water
Above Natural Background.

NOTE; Authority cited: Sections 102, 208 and 25811, Health and Safety Code.
Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety
Code.

History

1 . Amendment filed 1 1-29-65; effective thirtieth day thereafter (Register 65, No.
23). For former section see Register 62, No. 1, and 63, No. 26.

2. Repealer and new section filed 11-16-67; effective thirtieth day thereafter
(Register 67, No. 46).

3. Amendment filed 7-22-71; effective thirtieth day thereafter (Register 71, No.
30).

4. Amendment filed 6-19-73; effective thirtieth day thereafter (Register 73, No.
25).

5. Amendment filed 7-7-86; effective thirtieth day thereafter (Register 86, No.
28).

6. Repealer of article 12 heading and section filed 3-3-94 as an emergency; opera-
tive 3-3-94 (Register 94, No. 9). A Certificate of Compliance must be trans-

mitted to OAL by 7-1-94 or emergency language will be repealed by operation
of law on the following day.
7. Certificate of Compliance as to 3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30356. Appendix B.

History

1. Amendment filed 6-19-73; effecfive thirtieth day thereafter (Register 73, No.
25). For prior history, see Register 71, No. 46.

3. Certificate of Compliance as to .3-3-94 order transmitted to OAL 6-7-94 and
filed 7-14-94 (Register 94, No. 28).

§ 30357. Form RH 2364— Notice to Employees.

History
1 . Repealer filed 8-23-76; effective thirtieth day thereafter (Register 76, No. 35).
For prior history, see Register 73, No. 25.

§ 30358. Form RH 2365— Current Occupational External
Radiation Exposure.

NOTE; Authority cited: Sections 208 and 2581 1, Health and Safety Code. Refer-
ence: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.

History

1. Amendment filed 5-13-69; effective thirtieth day thereafter (Register 69,
No. 20).

2. Repealer filed 6-18-87; operative 7-18-87 (Register 87, No. 28).

Group 4.

Transportation of Radioactive
Material

Article 1 . Requirements for Transportation
of Radioactive Material

§ 30373. Transportation Regulations.

(a) No person shall transport any radioactive material outside the con-
fines of that person's facility or other authorized location of use, or offer
any radioactive material to a carrier for transportation, unless that person
complies with applicable requirements of the regulations, appropriate to
the mode of transport, of the United States Federal Government in 1 0
CFR, Part 71 (as effective November 30, 1988) insofar as such regula-
tions relate to the packaging of radioactive material, marking and label-
ing of the packages, loading and storage of packages, placarding of the
transportation vehicle, monitoring requirements and accident reporting.

(b) Persons are exempt from this regulation to the extent that they
transport any radioactive material or offer any radioactive material to a
carrier for transportation where such transportation is subject to the ex-
clusive jurisdiction of the United States Federal Government.

(c) Physicians are exempt from the requirements of this section to the
extent that they transport radioactive material for use in the practice of
medicine.

NOTE: (1) Authority cited: Sections 208, 25611, 25651 and 25811, Health and
Safety Code. Reference: Secfions 25606 and 2561 1, Health and Safety Code.
Note: (2) Copies of Title 1 0, Code of Federal Regulations — Energy, are for sale
by the Superintendent of Documents, U.S. Government Printing Office, Washing-
ton, D.C. 20402.

History

1 . Repealer of group 4 and new group 4 (secfions 30365-30380) filed 1 1-29-65;
effective thirtieth day thereafter (Register 65, No. 23). For prior history, see
Register 62, No. 1.

2. Repealer of article 1 (sections 30365, 30366 and 30368); repealer of article 2
(secfion 30370); renumbering and amendment of former article 3 (secfion
30373) to article 1 (section 30373); repealer of article 4 (secfion 30378) and re-
pealer of article 5 (secfion 30380) filed 6-6-85; effecfive thirtieth day thereafter
(Register 85, No. 23). For prior history, see Registers 76, No. 4; 73, No. 25; 69,
No. 20; and 67, No. 46.

3. Change without regulatory effect of Note (Register 88, No. 6).

4. Amendment of subsecfion (a) filed 9-16-92; operafive 10-16-92 (Register 92,
No. 38).

Page 214

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30395

Group 5. Participation by Local Health
Departments

§ 30385. Authority.

History
1 . Repealer of Artiele 1 (Sections 30385 and 30386) filed 1-10-86; effective thir-
tieth day thereafter (Register 86, No. 2).

§ 30390. General Definitions.

History

1. Amendment filed 1-22-76; effective thirtieth day thereafter (Resister 76.

No. 4).

2. Repealer of Article 2 (Section 30390) filed 1-10-86; effective thirtieth day
thereafter (Register 86, No. 2).

Article 1 . Local Health Departments

§ 30393. Participation In Control Program.

Participation in tlie State radiation control program shall be pursuant
to an approved contract between the Department and the local health de-
partment. A local health department desiring to participate in the State
radiation control program within its area of jurisdiction shall apply to the
Department.

NOTE: Authority cited: Sections 208, 25651 and 2581 1, Health and Safety Code.
Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code.

History
1 . Renumbering of former Article 3 to Article 1 and amendment of Section 30393

filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

§ 30394. Application for Participation.

Application shall be made in writing, and shall set forth:

(a) The names and qualifications of personnel to be assigned to the ra-
diation control program;

(b) The nuinbers and types of radiation survey instruments available;

(c) The administrative relationship between the radiation control pro-
gram and other programs of the local health department; and

(d) A showing that the radiation control program proposed by the local
health department is compatible with standards imposed upon the State
by the U.S. Nuclear Regulatory Commission pursuant to the agreement
contained in the Health and Safety Code, Section 25876, and the general
poHcy statement "Guidelines for NRC Review of Agreement State Radi-
ation Control Programs" (46 FR 59341).

NOTE: Authority cited: Sections 208, 25651 and 2581 1. Health and Safety Code.
Reference: SecUons 25801, 25810, 25875 and 25876, Health and Safety Code.

History

1. Amendment filed 1-10-86; effective thirtieth day thereafter (Register 86,
No. 2).

2. Change without regulatory effect of subsecdon (d) (Register 88, No. 6).

§ 30395. Contract Authorizing Participation.

(a) An application will be approved if the Department determines with
the concurrence of the Department of Industrial Relations that the show-
ings required by Section 30394 are complete.

(b) Any authorization pursuant to this article shall be in the form of a
contract setting forth, as a minimum:

(1) Duties and responsibilities of the local health department;

(2) Conditions of financial reimbursement to the local health depart-
ment; and

(3) Terms and conditions for termination of the contract.

NOTE: Authority cited: Secfions 208, 25651 and 2581 1, Health and Safety Code.
Reference: Sections 25801, 25810, 25875 and 25876, Health and Safety Code.

[The next page is 233.]

Page 215

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30402

History

1 . Repealer ol" former Section 30395, and renumbering and amendment of former
Section 30396 to Section 30395 filed 1-10-86; effective thirtieth day thereafter
(Register 86. No. 2).

§ 30397, Terms of Participation.

History

1. Amendment filed 1-22-76; effective thirtieth day thereafter (Register 76.

No. 4).

2. Repealer filed 1-10-86; effective thirtieth day thereafter (Register 86, No. 2).

Subchapter 4.5. Radiologic Technology

Group 1. Administration

Article 1. Definitions

§ 30400. Fluoroscopy.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25668, Health and Safety Code.

History

1. New Subchapter 4.5 (Sections 30400-30438) filed 12-3-70; effective thirtieth
day thereafter (Register 70, No. 49).

2. Repealer of Group 1 (Articles 1-6, Sections 30400-30407 and Articles 8-10,
Sections 30409-30411); repealer of Group 2 (Articles 1-4, Sections
30412-30419); repealer of Group 3 (Articles 1-9, Sections 30420-30437.1);
repealer of Group 5 (Articles 1-6, Sections 30439-3045 1 , not consecutive); re-
pealer of Group 6 (Articles 1-6, Secfions 30460-30468, not consecutive) and
new Group 1 (Articles 1-5, Sections 30400-30405); new Group 2 (Articles 1-7,
Sections 30420-30436, not consecutive); new Group 3 (Articles 1 and 2, Sec-
tions 30440-30447); new Group 4 (Article 1, Secfions 30450-30452); and new
Group 5 (Article 1, Sections 30460-30468) filed 8-21-85; effective thirtieth
day thereafter (Register 85, No. 34). For prior history, see Registers 78, No. 10;
76, No. 49; 76, No. 4; 72, No. 32; 72, No. 26; 71, No. 41; 71, No. 25; 71, No.
17 and 71, No. 16.

3. Renumbering of former section 30400 to new section 30400.40 filed
10-29-2001; operative 1 1-28-2001 (Register 2001, No. 44).

§ 30400.5. Approved Continuing Education Credit.

"Approved continuing education credit" means one hour of instruc-
tion received in subjects related to the application of X-ray to the human
body and accepted for purposes of credentialing, assigning professional
status or certification by the:

(a) American Registry of Radiologic Technologists;

(b) Medical Board of California;

(d) California Board of Chiropractic Examiners;

(e) Board of Podiatric Medicine; or

(f) Board of Dental Examiners.

Note: Authority cited: Secfions 100275 and 1 14870(a), Health and Safety Code.
Reference: Secfions 106995, 1 14840, 1 14845, 1 14870(b), (c) and (e). Health and
Safety Code.

History

1 . New section filed 1 0-29-2001 ; operative 1 1-28-2001 (Register 2001 , No. 44).

§ 30400.40. Fluoroscopy.

"Fluoroscopy" means a radiological examination utilizing fluores-
cence for the observation of the transient image.

NOTE: Authority cited: Secfions 100275 and 1 14870(a), Health and Safety Code.
Reference: Secfions 106965, 107110, 114870(b), (c) and (e), Health and Safety
Code.

History
1. Renumbering of former section 30400 to new section 30400.40, including

amendment of Note, filed 10-29-2001; operafive 1 1-28-2001 (Register 2001,

No. 44).

§ 30400.60. Mammographlc Examination.

"Mammographic examination" means the performance of mammog-
raphy on a human being.

NOTE: Authority cited: Secfions 100275 and 1 14870(a), Health and Safety Code.
Reference: Sections 106995, 1 14845, 1 14870(b) and (c). Health and Safety Code.

History

1 . New section filed 10-29-2001 ; operafive 1 1-28-2001 (Register 2001 , No. 44).

§ 30400.85. Radiography.

"Radiography" means the recording of static images on any suitable
medium by passing X-rays through portions of the human body, and in-
cludes one or more of the following:

(a) Positioning the patient.

(b) Selecting exposure factors.

(c) Exposing the patient and the recording medium to X-rays.
NOTE; Authority cited: Secfions 100275 and 1 14870(a). Health and Safctv Code.
Reference: Sections 106965, 106975, 107045, 107110, 114850. 11487()(b). (c)
and (e). Health and Safety Code.

History
1. Renumbering of former section 30401 to new section 30400.85. including
amendment of Note, filed 10-29-2001; operative 1 1-28-2001 (Register 2001.
No. 44).

§ 30400.95. X-ray Bone Densitometry.

"X-ray bone densitometry" means a radiologic examination of all or
part of the skeleton utilizing X-rays from an X-ray source which is me-
chanically ganged to a detector for scanning all or part of the skeleton un-
der computer control.

Note: Authority cited: Secfions 100275 and 1 14870(a). Health and Safety Code.
Reference: Secfions 106965, 107045 and 114870(c), Health and Safety Code.

History

1. Renumbering of former secfion 30401.6 to new secfion 30400.95, including
amendment of Note, filed 10-29-2001; operafive 11-28-2001 (Register 2001,

No. 44).

§30401. Radiography.

Note: Authority cited: Secfion 25668(a), Health and Safety Code. Reference:
Secfion 25668, Health and Safety Code.

History
1. Renumbering of former section 30401 to new section 30400.85 filed
10-29-2001; operafive 11-28-2001 (Register 2001, No. 44).

§ 30401 .6. X-ray Bone Densitometry.

Note: Authority cited: Secfion 114870(a), Health and Safety Code. Reference:
Secfion 114870(c), Health and Safety Code.

History

1. New section filed 9-15-97 as an emergency; operafive 9-15-97 (Register 97,
No. 38). A Certificate of Compliance must be transmitted to OAL by 1-13-98
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 9-15-97 order, including amendment of secfion
heading and section, transmitted to OAL 1-8-98 and filed 2-24-98 (Register
98, No. 9).

3. Renumbering of former secfion 30401.6 to new section 30400.95 filed
10-29-2001; operafive 11-28-2001 (Register 2001, No. 44).

Article 2. Special Permits

§ 30402. Special Permits.

(a) To obtain a special permit an applicant shall have on file with the
Department a complete application.

(b) The Department considers an application for a special permit com-
plete if all of the following conditions have been met:

( 1 ) Application is made on forms furnished by the Department.

(2) Fee is paid pursuant to Section 30408.

(3) The application is accompanied by:

(A) A statement from a licendate of the healing arts who holds a certifi-
cate or permit issued pursuant to Sections 30466 or 30467 aUesting that
efforts to employ a Certified Radiologic Technologist were unsucces-
sful.

(B) A copy of a notice of employment opportunity for a radiologic
technologist in a local newspaper or periodical for the position for which
the special permit is being sought.

(4) The Department ascertains, by reviewing X-ray machine registra-
tion records, that no other medical X-ray facility capable of providing the
same radiologic health care that would be delivered at the applicant's fa-
cility is available in the locality where the special permit is being sought.

Page 233

§ 30403

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25670, Health and Safety Code.

Article 3. Requirements for Continuing

Education Performance, and Renewal of

Certificates and Permits

§ 30403. Requirements for Continuing Education and

Performance of Mammographic Examinations.

(a) Each individual certified or permitted pursuant to sections 30440,
30444, and/or 3045 1 shall, in the two years immediately preceding the
expiration date of the certificate or permit, earn 24 approved continuing
education credits, except that each individual who is certified pursuant
to sections 30440(a) and 30455. 1 shall meet the requirements of subsec-
tion (c).

(b) Each individual certified or permitted pursuant to sections 30466
and 30467 shall, in the two years immediately preceding the expiration
date of the certificate or permit, earn 10 approved continuing education
credits.

(c) Each individual certified pursuant to sections 30440(a) and
30455. 1 shall, in the two years immediately preceding the expiration date
of the certificate or permit:

(1) Earn 24 approved continuing education credits, 10 of which shall
be in mammography; and

(2) Perform at least 200 mammographic examinations.

(d) The two-year period referred to in subsections (a), (b) and (c) and
in section 30403.5 shall begin on the expiration date of the certificate or
permit:

(1) In the year 2001 for individuals with a certificate or permit that
ends in an odd number; and

(2) In the year 2002 for individuals with a certificate or permit that
ends in an even number.

NOTE: Authority cited: Sections 100275 and 1 14870(a) Health and Safety Code.
Reference: Sections 106965, 106995, 107015, 107070, 1071 10, 114840, 114845,
1 14870(b), (c) and (e). Health and Safety Code.

History

1 . Amendment of article 3 heading and repealer and new section heading, section

and Note filed 10-29-2001; operative 1 1-28-2001 (Register 2001, No. 44).

§ 30403.5. Renewal Procedures.

Each individual seeking renewal of a certificate or permit issued pur-
suant to this subchapter shall:

(a) At least 30 calendar days prior to the expiration date on the certifi-
cate or permit, submit to the Department a complete application for re-
newal consisting of the applicant's name, mailing address, telephone
number, and certificate or permit type and number.

(b) Every two years, submit to the Department the following informa-
tion for each approved continuing education credit as required by section
30403 subsections (a), (b) and (c)(1):

( 1 ) The identity of the group listed in section 30400.5 that has accepted
the instruction;

(2) The provider of the instruction;

(3) The title, if any, of the instruction;

(4) The date(s) of the instruction; and

(5) The location of the instruction;

(c) Submit to the Department an attestation every two years of having
completed mammographic examinations as required pursuant to section
30403 subsection (c)(2); and

(d) Pay the fee as required by section 30408.

NOTE: Authority cited: Sections 100275 and 1 14870(a) Health and Safety Code.
Reference: Sections 106965, 106995, 107015, 107070, 107110, 114840, 114845,
1 14870(b), (c) and (e). Health and Safety Code.

History
1. New section filed 10-29-2001; operative 1 1-28-2001 (Register 2001, No. 44).

§ 30403.8. Recordkeeping Requirement.

Each individual certified or permitted pursuant to this subchapter shall
maintain the document(s) that evidence the individual having earned ap-
proved continuing education credits and/or completing mammographic
examinations for five years following the dates the credits were earned
and/or the mammographic examinations were completed. Such docu-
ment(s) shall be made available to the Department upon request.
Note: Authority cited: Sections 100275 and 1 14870(a) Health and Safety Code.
Reference: Sections 106965. 106995, 107015, 107035, 107070, 1071 10, 1 14840.
1 14845, 1 14870(b), (c) and (e). Health and Safety Code.

History
1 . New section filed 10-29-2001 ; operative 1 1-28-2001 (Register2001,No.44).

Article 4.

Display of Certificates and
Permits

§ 30404. Display.

(a) Any radiologic technologist who holds a certificate pursuant to
Section 30440 or a fluoroscopy permit pursuant to Section 30451 shall
prominently display such certificate or permit, or a copy thereof, at each
place where the technologist performs activities which require a radio-
logic technologist certificate or permit.

(b) Any limited permittee who holds a permit pursuant to Section
30444 shall prominently display such permit, or a copy thereof, at each
place where the limited permittee performs functions which require a
limited permit.

(c) Any licentiate who holds a certificate or permit pursuant to Sec-
tions 30466 or 30467 shall prominently display such certificate or permit,
or a copy thereof, at each place of practice where the licentiate performs
activities which require a licentiate certificate or permit.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Sections 25671 and 25699, Health and Safety Code.

Article 5. Deadlines

§ 30405. Deadlines.

(a) For purposes of this subchapter:

(1) Submission of an application or information, documents, or fees
supporting an application shall be deemed to occur on the date the appli-
cation, information, documents, or fees are received by the Department.

(2) An application is considered complete when all documents, infor-
mation, or fees required to be submitted on or with the application have
been received by the Department, and the applicant has passed required
examinations.

(3) Written notification by the Department to applicants shall be
deemed to occur on the date the notifications are postmarked.

(b) The Department shall notify the applicant, within 30 calendar days
of submission of an apphcation for any certificate or permit issued under
this subchapter, of one of the following:

( 1) That the application is complete and the Department's decision re-
garding the application.

(2) That the application is not accepted for filing and what specific in-
formation, documentation or fee the applicant shall submit within 30 cal-
endar days in order for the Department to consider the application accept-
able.

(3) That the application is acceptable and what examinations the appli-
cant shall pass within 1 80 calendar days in order to complete the applica-
tion.

( 1 ) Within 30 calendar days of notification pursuant to subsection (b),
respond to the Department's request to submit specific information, doc-
umentation or fee, or

(2) Within 1 80 calendar days of notification pursuant to subsection
(b), pass Department-approved examinations.

Page 234

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30410

(d) Any applicant deemed by the Department to have withdrawn an
application pursuant to paragraph (c) may reapply by submitting a new
application.

(c) The Department's time periods for processing an application, from
the date the initial application is received by the Department to the date
the application is complete and the final decision is made regarding any
certificate or permit issued under this subchapter arc as follows:

( 1 ) The median time for processing an application is 90 calendar days.

(2) The minimum time for processing an application is one day.

(3) The maximum time for processing an application is 240 calendar

days.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 1 5376, Government Code.

Article 6. Change of Name and Address

§ 30406. Change of Name and Address.

Each individual certified or permitted pursuant to this subchapter shall
report to the Department any change of name or mailing address within
30 calendar days of the change.

NOTE: Authority cited: Sections 100275 and 1 14870(a) Health and Safety Code.
Reference: Sections 106965, 107015, 1071 10, 1 14870(b), (c) and (e). Health and
Safety Code.

History
1. New article 6 (section 30406) and section filed 10-29-2001; operative

1 1-28-2001 (Register 2001, No. 44).

Article 7. Fees

§ 30408. Fees.

(a) For any certificate or permit issued pursuant to this subchapter in
accordance with the Radiologic Technology Act (Health and Safety
Code section 27(f)), the application fee shall be $85.00 for licentiates and
$75.00 for technologists and limited permittees. If required to pass an ex-
amination to obtain the certificate or permit, the examination fee shall be
$75.00 for each examination administered by the Department or as speci-
fied by the entities or organizations designated by the Department to ad-
minister Department-approved examinations.

(b) The fee for repeating an examination failed within the previous 12
months shall be $75.00 per examination.

(c) Each individual applying to renew a certificate or permit shall pay
an annual renewal fee of $35.00. The renewal fee shall be collected bien-
nially and such fee shall be twice the annual renewal fee.

(d) The fee for a duplicate certificate or permit shall be $1.09.

(e) The penalty fee for renewal of any expired certificate or permit
shall be $5.44 and shall be in addition to the fee for renewal.

(f) Failure to pay the annual fee for renewal on or before the expiration
date of the certificate or permit shall automatically suspend the certificate
or permit. If the annual renewal fee is not paid within six months follow-
ing such date, the certificate or permit shall be revoked. A certificate or
permit revoked for nonpayment of the renewal fee may be reinstated
within five years from the time of revocation upon payment of the penalty
fee specified in subsection (e) plus twice the annual renewal fee specified
in subsecfion (c). If the application for reinstatement is not made within
five years from the date of suspension of the certificate or permit, the cer-
fificate or permit shall be canceled and shall not be subject to reinstate-
ment.

(g) Each person applying to be an approved school of radiologic tech-
nology shall pay an application fee of $1,175.00 with the applicaUon for
approval.

(h) Each approved school of radiologic technology shall, on or before
the anniversary of the effective date of approval, pay a fee of $190.00
and, for each physical location where clinical education is given, a fee of
$110.00

(i) Each person approved as a limited permit X-ray technician school
pursuant to secfions 30424, 30425, 30427, or 30427.2 that requests ap-

proval to provide training in a new limited permit category as specified
in sections 30442 and 30443 shall pay an application fee of $430.00 with
the application for approval.

(j) Any school failing to pay the annual fees by the anniversary of the
effective date of the approval shall immediately cease operations requir-
ing Department approval until such time as the annual fees and a late fee
of 25 percent of the annual fees has been paid.

(k) Fees required by this section shall be nonrefundable.
Note: Authority cited: Sections 100275, 1 14870 and 1 15000, Health and Safety
Code. Reference: Sections 107080, 107085. 107090, 107095 and I071()(). Health
and Safety Code.

History

1. Amendment filed 3-7-78; effective thirtieth day thereafter (Register 78,
No. 10).

2. Amendment of subsections (a)-(f), and adoption of subsections (g), (h), and
Note filed 1 1-1-93 as an emergency: operative 1 1-1-93 (Register 93, No. 45).
A Certificate of Compliance must be transmitted to OAL by 3-1-94 or emer-
gency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 1 1-1-93 order transmitted to OAL 2-24-94;
disapproved by OAL 4-7-94 (Register 94, No. 27).

4. Amendment of subsections (a)-(f) and new subsections (g)-(h) and Noti-: re-
filed 7-6-94 as an emergency; operative 7-6-94 (Register 94, No. 27). A Cer-
tificate of Compliance must be transmitted to OAL by 1 1-3-94 or emergency
language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 7-6-94 order transmitted to OAL 6-30-94 and
filed 7-20-94 (Register 94, No. 29).

6. Amendment of secdon and Notb filed 6-22-2005 as an emergency; operative
6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be trans-
iTiitted to OAL by 10-20-2005 or emergency language will be repealed by op-
eration of law on the following day.

7. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

Article 8. Authorization to X-Ray
Technicians to Perform Digital Radiography

§ 30410. Authorization to X-Ray Technicians to Perform
Digital Radiography.

(a) Any individual holding a current and valid limited permit in the fol-
lowing categories, as defined in section 30443, may perform digital radi-
ography within their respecfive scopes of pracfice if the individual has
completed 20 hours or more of the instrucfion specified in sccfion
30410.2:

(1 ) Chest radiography.

(2) Extremities radiography.

(3) Gastrointestinal radiography.

(4) Genitourinary radiography.

(5) Leg-podiatric radiography.

(6) Skull radiography.

(7) Torso-skeletal radiography.

(b) To be eligible for authorization pursuant to subsection (a), the indi-
vidual shall submit the following to the department:

(1) Name and permit number as specified on the individual's limited
permit issued by the Department; and

(2) Documentation that the individual has completed the instrucfion
in digital radiologic technology specified in section 30410.2 from a:

(A) Diagnostic radiologic technology school approved by the Depart-
ment as meefing the requirements of section 3042 1 ;

(B) Limited permit X-ray technician school approved by the Depart-
ment as meefing the requirements of section 30424; or

(C) Provider whose continuing education activity pertaining to the
subject areas specified in section 30410.2 is designated as "Category A"
credit by an organization approved by the American Registry of Radio-
logic Technologists as a Recognized Continuing Education Evaluation
Mechanism.

(c) Completion of the instruction specified in section 30410.2 shall be
considered 20 approved continuing education credits for purposes of
complying with section 30403 only if the credit is identified in accor-
dance with section 30403.5(b).

Page 235

§ 30410.2

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Note: Authority cited: Sections 114870, 131050, 131051 and 13 1200, Health and
Safety Code. Reference: Sections 106995, 1 14840, 1 14845 and 114870, Health
and Safety Code.

History
1. New article 8 (sections 30410-30140.2) and section filed 2-14-2008; operative
3-15-2008 (Register 2008, No. 7).

§ 30410.2. Instruction in Digital Radiologic Technology.

(a) Instruction in digital radiologic technology shall be no less than 20
hours in length and shall include all of the following:

(1) Basic principles of digital radiography addressing digital image
characteristics, types of digital receptors in cassette-less systems and
cassette-based systems, comparison of detector properties and evalua-
tive criteria, and dynamic range versus latitude;

(2) Image acquisition addressing raw data acquisition, and image ex-
traction and exposure indicators in cassette-less and cassette-based sys-
tems;

(3) Image acquisition errors addressing exposure field recognition,
histogram analysis error, low intensity radiation response, scatter control
such as coning and use of optimal exposures, and grid use including
Moire effect;

(4) Software (default) image processing addressing automatic rescal-
ing, final image processing, effects of excessive processing, and recogni-
tion of image processing errors that affect linage clarity;

(5) Fundamental principles of exposure addressing optimal receptor
exposure, receptor response and detective quantum efficiency, selection
of exposure factors, exposure myths associated with digital imaging sys-
tems, controlling patient exposure, monitoring patient exposure;

(6) Image evaluation addressing evidence of appropriate exposure
level and exposure recognition failure or histogram analysis error, con-
trast, recorded detail, and artifacts;

(7) Quality assurance and maintenance issues addressing initial accep-
tance testing, cassette-based system reader preventive maintenance,
plate maintenance, uniformity of default processing codes, and reject
analysis; and

(8) Image display issues to include types of viewing monitors as
compared to film/screen, picture archiving and communication systems,
teleradiology, and operator responsibilities such as image annotation and
manipulation, and patient confidentiality.

NOTE: Authority cited: Sections 1 14870, 131050, 131051 and 131200, Health and
Safety Code. Reference: Sections 106995, 114840, 114845 and 114870, Health
and Safety Code.

History
1. New section filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

Group 2. Training of Students of
Radiologic Technology

Article 1 . General

§ 30420. Application Procedure.

Applicants seeking approval of a school or a course of study in radio-
logic technology shall submit to the Department all of the following:

(a) An application on forms furnished by the Department.

(b) Documents which explain the nature and extent of education and
training to be offered.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Sections 25668(d) and 25686, Health and Safety Code.

History
1. New Group 2 (Articles 1-7, Sections 30420-30436, not consecutive) filed
8-21-85; effective thirtieth day thereafter (Register 85, No. 34). For prior histo-
ry, see Registers 78, No. 10; 72, No. 32; 72, No. 26; 71, No. 25; 71, No. 17 and
71, No. 16.

Article 2. Radiologic Technology Schools

§ 30421 . Diagnostic Radiologic Technology Schools.

(a) In order to be approved by the Department as a diagnostic radiolog-
ic technology school, a training facility shall include in its curriculum all
requirements of subsections (b) through (g), inclusive, of this section.

(b) The course of study shall meet at least the following:

(1 ) 520 hours of formal classroom instaiction.

(2) 50 hours of general radiographic laboratory.

(3) 75 hours of positioning laboratory.

(4) 25 hours of radiation protection laboratory.

(5) 1850 hours of supervised clinical education.

Subject Hours of Instruction

(1) Radiation protection pertaining to radiography 50

(2) Introduction to radiologic technology 5

(3) Professional ethics 5

(4) Anatomy and physiology 50

(5) Medical terminology 15

(6) Physics and electricity 40

(7) Principles of radiographic exposure 30

(8) Film/image receptor processing (theory and equipment) 10

(9) Survey of diseases 10

(10) Nursing procedures 15

(11) Pediatric radiography 10

(12) Procedures involving contrast media 80

(13) Departmental administrative and office procedures 5

(14) Equipment and accessory care 5

(15) Radiographic positioning 70

(16) Film critique 80

(17) Senior student seminar 20

(18) Digital radiologic technology as specified in

section 30410.2 20

(d) In the general radiographic laboratory each student shall perform
experiments, using phantoms, to illustrate at least the following:

(1) X-ray output (effects of kilovoltage, miUiamperage, filtration, dis-
tance, and heel effect).

(2) Radiographic contrast — subject and film (kilovoltage, filtration,
scatter radiation, film type and speed, exposure, processing).

(3) Control of scatter radiation (collimation, field size accuracy, X-
ray/light-field congruence, grids, air gap technique)

(4) Intensifying screens (type and speed, screen-film contact, cassette
types).

(5) Image sharpness (penumbra, inverse square law, source and sub-
ject-film distance, size of the focal spot, motion, magnification and dis-
tortion).

(6) Quality control experiments.

(e) In the positioning laboratory each student shall:

(1) Position simulated patients for routine X-ray procedures to illus-
trate different patient care situations.

(2) Perform on phantoms X-ray procedures to illustrate the selection
of exposure factors, proper positioning, film and other image receptor
processing/developing techniques.

(f) In the radiation protection laboratory each student shall perform ex-
periments to illustrate at least all of the following:

(1 ) Methods of reducing dose per exposure to patient (limiting expo-
sure field, use of filters, optimum kilovoltage techniques, film-intensify-
ing screen combinations, gonadal shielding, source-film distance).

(2) Reduction of dose to personnel (shielding, such as X-ray tube
housing and primary protective barriers, protection against secondary or
scatter radiation).

(3) Safe practice for protection of personnel (monitoring, use of pro-
tective shielding and distance in portable work, use of protective cloth-
ing).

(g) In the supervised clinical education each student shall perform or
assist in the performance of not less than the following number of radio-
graphic procedures:

Page 236

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30423

Procedures Number

( 1 ) Chest 200

(2) Bony skeleton 400

(3) Gastrointestinal and genitourinary 200

(4) Vascular and contrast studies 50

(5) Special studies and X-ray imaging modalities 50

(6) Bedside and surgical 50

(h) Each training facility approved as a diagnostic radiologic technolo-
gy school shall meet and maintain all standards set forth in this section.
Failure of an applicant to meet any of these standards shall be grounds
for denial of approval. Failure of an approved diagnostic radiologic tech-
nology school to maintain any of these standards shall be grounds for sus-
pension or revocation of approval.

NOTF: Authority cited: Sections 114870, 131050, 131051 and 131200, Health and
Safety Code. Reference: Sections 107045 and 1 14870(d), Health and Safety Code.

History

1. Amendment of subsection (b)(]), new subsection (c)(I8) and amendment of
NoTii filed 2-14-2008; operative 3-15-2008 (Register 2008, No. 7).

§ 30422. Therapeutic Radiologic Technology Schools.

(a) In order to be approved by the Department as a therapeutic radio-
logic technology school, a training facility shall include in its curriculum
all requirements of subsections (b) through (g), inclusive, of this section.

(b) The course of study shall meet at least all of the following:

(1) 455 hours of formal classroom instruction.

(2) 15 hours of general radiographic laboratory.

(3) 60 hours of physics and radiation protection laboratory.

(4) 75 hours of radiotherapy laboratory.

(5) 1500 hours of supervised clinical education.

Subject Hours of Instruction

(1) Radiation protection pertaining to

radiation therapy 50

(2) Introduction and orientation 5

(3) Professional ethics 5

(4) Anatomy and physiology 50

(5) Medical terminology 10

(6) Physics of radiation therapy 85

(7) Mathematics 15

(8) Pathology 25

(9) Nursing procedures 25

( 1 0) Radiobiology and chemotherapy 25

(11) Principles of radiation therapy 25

(12) Technical radiation therapy and treatment planning 55

(13) Intercavitary and interstitial therapy 25

(14) Principles of radiography 35

(15) Senior student seminar 20

(d) In the general radiographic laboratory each student shall perform
experiments, using phantoms, to illustrate at least the following:

( 1 ) X-ray output (effects of kilovoltage, milliamperage, filtration, dis-
tance).

(2) Radiographic contrast (kilovoltage, filtration, scatter, film type,
exposure, processing).

(3) Control of scatter (coUimation, grids).

(4) Intensifying screens (type, screen-film contact, cassette).

(5) Sharpness (penumbra, inverse square law, source and phantom-
film distance, size of the focal spot, motion, magnification and distor-
tion).

(e) In the physics and radiation protection laboratory each student shall
perform experiments that will illustrate at least all of the following:

(1) Method of reducing dose to the patient (shutters, cones, collima-
tors, filters, optimum exposure techniques, optimum film and screen use,
gonadal shielding, source-film distance).

(2) Reduction of dose to personnel (shielding of the X-ray tube and
treatment room, protection against secondary radiation, monitoring, pro-
tective clothing).

(3) Quality control procedures:

(A) Identification of parts of basic therapy equipment.

(B) Functions of various types of therapy equipment.

(D) Use of computer in treatment planning.

(E) Calibration of therapy equipment and use of ionization chambers.

(F) Care and safe operation of equipment (testing for safety, inter-
locks, shutters, communication and viewing systems, erratic operation of
machinery, daily inspection and routine maintenance, emergency proce-
dures).

(G) Handling of radioactive materials (use of radiation measuring de-
vices, area surveys, wipe and leak tests, storage and disposal, einergency
decontamination).

(f) In the radiotherapy procedures laboratory each student shall:

(1) Manipulate treatment and simulator units.

(2) Operate darkroom equipment and accessories, including automatic
processor.

(3) On simulated patients and phantoms, position and select exposure
factors for routine localization procedures such as chest, abdomen, head
and neck, and pelvis.

(4) Position simulated patients and phantoms for treatment of chest,
pelvis and abdomen.

(g) During the supervised clinical education each student shall per-
form or assist in performing radiation therapy procedures involving the
following:

(1) Head and neck.

(2) Central nervous system.

(3) Respiratory system.

(4) Digestive system.

(5) Reproductive system.

(6) Urinary system.

(7) Endocrine system.

(8) Circulatory system.

(9) Reticulo-endothelial system.

(10) Skin.

(11) Soft tissue.

(12) Pediatric.

(13) Metastases.

(h) Each training facility approved as a therapeutic radiologic technol-
ogy school shall meet and maintain all standards set forth in this section.
Failure of an applicant to meet any of these standards shall be grounds
for denial of approval. Failure of an approved therapeutic radiologic
technology school to maintain any of these standards shall be grounds for
suspension or revocation of approval.

NOTE: Authority cited: Section 25668(a). Health and Safety Code. Reference:
Sections 25668(d) and 25686, Health and Safety Code.

Article 3. Radiologic Technologist
Fluoroscopy Permit Schools

§ 30423. Radiologic Technologist Fluoroscopy Permit
Schools.

(a) In order to be approved by the Department as a radiologic technolo-
gist fluoroscopy permit school, a school shall offer a course of study that
includes in its curriculum all requirements of subsections (b) and (c) of
this section.

(b) The classroom instruction shall include at least the following:

Subject Hours of Instruction

(1) Fluoroscopy regulations and radiation safety 10

(2) Fluoroscopy equipment 5

(3) X-ray image intensifiers 4

(4) Television, including closed circuit equipment 4

(5) Image recording and image recording equipment 6

(6) Special fluoroscopy equipment 5

(7) Mobile image intensified units 2

(8) Anatomy and physiology of the eye 2

(9) Three-dimensional and radiological anatomy 2

(c) At least 15 hours of laboratory in which each student shall conduct
experiments on phantoms to illustrate at least the following:

(1) Methods of reducing dose to patients during fluoroscopy proce-
dures.

Page 237

§ 30424

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) Methods of reducing exposure to self and personnel.

(3) Image recording during the exposure of phantom.

(4) Quality control of fluoroscopy equipment.

(d) Each training facility approved as a radiologic technology fluoros-
copy permit school shall meet and maintain all standards set forth in this
section. Failure of an applicant to meet any of these standards shall be
grounds for denial of approval. Failure of an approved radiologic tech-
nology fluoroscopy permit school to maintain any of these standards
shall be grounds for suspension or revocation of approval.
NOTE: Authority cited: Section 23668(a), Health and Safety Code. Reference:
Sections 25668(d) and 25686, Health and Safety Code.

Article 4.

Limited Permit X-Ray Technician
Schools

§ 30424. Limited Permit X-Ray Technician Schools
Teaching the Chest, Extremities,
Gastrointestinal, Genitourinary, Leg-Podiatric,
Skull, or Torso-Skeletal Categories.

(a) An applicant for approval as a Limited Permit X-ray Technician
School teaching chest, extremities, gastrointestinal, genitourinary, leg-
podialric, skull, or torso-skeletal categories shall require that each stu-
dent who graduates from the school complete, for each limited permit
category, the following course of study, within 24 months of beginning
the course of study, and the supervised clinical education within one con-
secutive period of 1 2 months during that 24 month period:

(1) One hundred forty (140) hours of formal classroom education for
each limited permit category, which shall include the following:

Subject Hours of Instruction

(A) Radiation protection and safety 50

(B) Radiological physics 15

(D) Equipment operation and care 10

(E) Darkioom and film processing 10

(F) Medical terminology 5

(G) Medical ethics 1

(H) Nursing procedures 4

(1) Film critique 5

(J) Anatomy and physiology 5

(K) Digital radiologic technology as specified in

section 30410.2 20

(2) For each category, the following hours of specialized classroom in-
struction in anatomy and physiology, and positioning:

Category Hours of Instruction

(A) Chest 10

(B) Extremities 20

(D) Genitourinary 10

(E) Leg-podiatric 10

(F) Skull 30

(G) Torso-skeletal 30

(3) Fifteen (15) hours of radiation protection laboratory during which
each student shall conduct experiments that demonstrate:

(A) Methods of reducing dose per exposure to patient.

(B) Methods of reducing dose to personnel.

(4) Ten (10) hours of general radiographic laboratory during which
each student shall conduct experiments that demonstrate:

(A) Effects of kilovoltage, milliamperage, filtration, distance, and heel
effect on radiographic contrast and detail.

(B) Control of scatter.

(5) Supervised clinical education for each category during which each
student shall perform or assist in the performance of the following num-
ber of radiographic procedures:

Catei>or\' Number of Procedures

(A) Chest .\..' iOO

(B) Extremities 100

(D) Genitourinary 100

(E) Leg-podiatric 50

(F) Skull 100

(G) Torso-skeletal 200

NOTE: Authority cited: Sections 1 14870(a). 131050, 131051 and 131200, Health
and Safety Code. Reference: Sections 106975, 107045, 1 14850, 1 14870(c) and (d)
and 1 14880, Health and Safety Code.

History

1. Editorial correction of subsection (b)(2)(E) (Register 2000. No. 1).

2. Amendment of section headins, section and NOTC filed 1 0-29-2001 ; operative
1 1-28-2001 (Register 2001, No. 44).

3. Amendment of subsections (a)(1) and (a)(1)(A). new subsection (a)(l)(K) and
amendment of Notk filed 2-14-2008; operative 3-15-2008 (Register 2008,
No. 7).

§ 30425. Limited Permit X-Ray Technician Schools

Teaching the Dental Laboratory Category.

(a) An applicant for approval as a limited permit X-ray technician
school teaching the Dental Laboratory category shall require that each
student who graduates from the school complete the following course of
study within 24 months of beginning the course of study, and the super-
vised clinical education within one consecutive period of 12 months dur-
ing that 24 month period:

(1) One hundred and twenty (120) hours of formal classroom educa-
tion, extending over a period of no less than six months, which shall in-
clude the following:

Subject Hours of Instruction

(A) Radiation protection and safety 30

(B) Radiological physics 15

(D) Equipment operation and care 10

(E) Darkroom, dental and medical film processing 10

(F) Professional ethics and hygienic procedures 4

(G) Cephalometrics 16

(H) Terminology 5

(1) Film critique 5

(J) Computers and image formation 10

(2) Forty-five (45) hours of specialized instruction in:

Subject Hours of Instruction

(A) Intra-oral anatomy and physiology, and positioning 20

(B) Extra-oral anatomy and physiology, and positioning .... 20

dental bone age determination 5

(3) Twenty-five (25) hours of laboratory during which each student
shall perform experiments using phantoms that demonstrate:

(A) Methods of reducing dose per exposure to the patient and operator.

(B) Effects of kilovoltage, milliamperage, filtration and distance on
radiographic contrast and detail.

(4) Supervised clinical education during which each student shall per-
form or assist in the performance of the following number of radiograph-
ic procedures:

Procedures Minimum Number

(A) Peri-apical survey (consisting of at least 14 films) 100

(B) Bitewing survey (consisting of at least four films) 50

(D) Cephalometrics 100

(E) Mandible, lateral view 50

(F) Panographic 50

(G) Temporo-mandibular joints 20

(H) Dental bone age studies 20

NOTE: Authority cited: Sections 100275 and 1 14870(a), Health and Safety Code.
Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880,
Health and Safety Code.

History
1 . Amendment of section heading, section and Note filed 1 0-29-2001 ; operative
11-28-2001 (Register 2001, No. 44).

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Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30436

•

§ 30426. Photofluorographic Chest X-Ray Technician
Courses of Study.

NoTH: Authority cited: Section 114870(a), Health and Safety Code. Reference:
Sections 1 14870(c), 1 14870(d) and 107045, Health and Safety Code.

History

1. Repealer of section and amendment of NoTH filed 11-24-98: operative
12-24-98 (Register 98. No. 48).

§ 30427. Limited Permit X-Ray Technician Schools

Teaching the Dermatology X-Ray Therapy
Category.

An applicant for approval as a litnited permit X-ray technician school
teaching the dermatology X-ray therapy categoiy shall require that each
student who graduates from tlie school complete the following course of
study within 12 months of beginning the course of study:

(a) Thirty hours (30) of formal classroom education, which shall in-
clude the following:

Subject Hours of Instruction

( 1 ) Radiation protection and safety 5

(2) Biological effects of radiation 5

(3) Radiological physics and equipment 10

(4) Structure and function of the skin 2

(5) Application of X-rays to dermatology 8

(b) Supervised clinical education during which each student shall as-
sist or perform procedures on at least the following malignancies: Basal
cell carcinoma, squamous carcinoma, and mycosis fungoides.

Note: Authority cited: Sections 100275 and 1 14870(a). Health and Safety Code.
Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880,
Health and Safety Code.

History
1 . Amendment of section heading, section and Note filed 1 0-29-2001 ; operative
11-28-2001 (Register 2001, No. 44).

§ 30427.2. Limited Permit X-Ray Technician Schools
Teaching the X-Ray Bone Densitometry
Category.

An applicant for approval as a limited permit X-ray technician school
teaching the X-ray bone densitometry category shall require that each
student who graduates from the school complete the following course of
study within 12 months of beginning the course of study:

(a) Eighteen (18) hours of formal classroom education consisting of
the following:

Subject Hours of Instruction

(1) Radiation physics, biology, and protection 3

(2) Bone biology, bone disease and therapy, and

densitometry parameters 3

(3) X-ray bone densitometry equipment 4

(4) Computers and image formation 3

(5) Anatomy and positioning 4

(6) Ethics and patient handling 1

(b) Four (4) hours of laboratory training during which each student
shall perform experiments using phantoms and evaluate images.

(c) Supervised clinical education during which each student shall per-
form the following number of radiographic procedures:

Procedure Number

( 1 ) Posterior/ Anterior spine 5

(2) Hip 5

(3) Extremity 10

NOTE: Authority cited: Sections 100275 and 1 14870(a), Health and Safety Code.
Reference: Sections 106975, 107045, 114850, 114870(c) and (d) and 114880,
Health and Safety Code.

History

1. New section fded 9-15-97 as an emergency; operative 9-15-97 (Register 97,
No. 38). A Certificate of Compliance must be transmitted to OAL by 1-13-98
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 9-15-97 order, including amendment of section
heading and section, transmitted to OAL 1-8-98 and filed 2-24-98 (Register
98, No. 9).

3. Amendment of section headins, section and Noth filed 10-29-2001 ; operative
1 1-28-2001 (Register 2001, No. 44).

Article 5.

On-the-Job Training for X-Ray
Technicians

§ 30428. Approval of On-the-Job Training.

(a) In order to be approved by the Department as an on-the-job train-
ing program, the supervisor and operator and the prospective student of
radiologic technology shall subinit to the Department an application for
each limited permit category on forms furnished by the Department.

(b) The application for approval shall include a training schedule for
each limited permit category applied for.

(c) The standards for approval of on-the-job training programs shall
be those standards required of approved schools for limited permits as
outlined in Sections 30424 and 30425 or for limited permit courses of
study as outlined in Section 30427.

(d) Limited permit categories for on-the-job training programs shall
be restricted to the categories listed in Section 30442.

(e) Each approved on-the-job training program shall meet and main-
tain all applicable standards set forth in this section and in Sections
30424, 30425 and 30427. Failure of an applicant to meet the applicable
standards shall be grounds for denial of approval. Failure of an approved
on-the-job training program to maintain any of the applicable standards
shall be grounds for suspension or revocation of approval.

NOTE: Authority cited: Section 1 14870(a), Health and Safety Code. Reference:
Section 1 14875. Health and Safety Code.

History
1. Amendment of subsections (c) and (e) and Note filed 11-24-98; operative
12-24-98 (Register 98, No. 48).

Article 6. Notification

§ 30435. Notification Requirements.

Within 30 days after any of the following, an official of an approved
school, course of study, or on-the-job training program shall, on forms
furnished by the Department, inform the Department of:

(a) Change in facility location or telephone number.

(b) Change in course offerings.

(d) Change of affiliation agreements.

(e) Names and addresses of students who have been dismissed, sus-
pended or who have voluntarily withdrawn from the clinical education.

(f) Names and addresses of students who have graduated.

Note: Authority cited: Section 25668(a). Health and Safety Code. Reference:
Section 25668, Health and Safety Code.

Article 7. Disciplinary Action

§ 30436. Standards for Suspension or Revocation of
Approval.

(a) Approval of any school or on-the-job training program, which has
been granted pursuant to section 30420 or 30428, may be revoked, sus-
pended, limited or conditioned for any of the following reasons:

(1) Violation of any provision of the Radiologic Technology Act, as
defined in Health and Safety Code section 27, or any regulation promul-
gated pursuant thereto; or

(2) If, at any time, fewer than 159c of the Department-approved ex-
aminations referenced in sections 30440, 30444, 3045 1 and 30455. 1 and
administered in the previous five years to graduates of the school have
received a passing score.

NOTE: Authority cited: Sections 100275 and 1 14870(a), Health and Safetv Code.
Reference: Sections 107045, 114840, 114870(b)-(d), 114875 and 1 14880, Health
and Safety Code.

History
1. Repealer and new section heading, section and NoTt-: filed 10-29-2001 ; opera-
tive 1 1-28-2001 (Register 2001, No. 44).

Page 239

§ 30437

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 8. Additional School Requirements
and Recordkeeping

§ 30437. Additional School Requirements and
Recordkeeping.

(a) A school approved pursuant to section 30420 shall:

( 1 ) Issue to each student who graduates or who successfully completes
a required course of study, a certificate or diploma, which includes:

(A) The student's name;

(B) The name or the category listed in section 30442 or course of study
completed by the student;

(D) The number of the certificate issued by the Department to the
school; and

(E) The signature of the school's chief executive officer, dean or de-
partment administrator.

(2) Within 30 days of discontinuance of the school:

(A) Notify the Department of how all records kept pursuant to subsec-
tion (b) will be preserved and surrender the school approval certificate
to the Department; or

(B) Notify the Department, transmit all records required to be kept pur-
suant to subsection (b) to the Department and surrender the school ap-
proval certificate to the Department.

(3) Within 30 days of discontinuance of instruction in any limited per-
mit category notify the Department.

(b) Each school approved pursuant to section 30420 and each on-the-
job training program approved pursuant to 30428 shall retain for at least
five years:

(1) Records of attendance;

(2) Proof of participation in clinical education;

(3) Proof of performance of laboratory procedures;

(4) Certificates or diplomas issued; and

(5) Program transcripts.

NOTE: Authority cited: Sections 100275 and 1 14870(a), Health and Safety Code.
Reference: Sections 107000, 107045, 114850, 114870(c) and (d) and 114880,
Health and Safety Code.

History
1. New article 8 (section 30437) and section filed 10-29-2001; operative
1 1-28-2001 (Register 2001, No. 44).

Group 3. Certificates for Radiologic

Technologists and Permits for Limited

Permit X-Ray Technicians

Article 1. Certification of Technologists

§ 30440. Issuance of Certificates.

To obtain a radiologic technology certificate an appHcant shall have
on file with the Department an application as described in Section 30441 ,
and in addition:

(a) For the diagnostic radiologic technology certificate, shall pass De-
partment-approved examinations in:

(1) Diagnostic radiation protection and safety, and

(2) Diagnostic radiologic technology.

(b) For the therapeutic radiologic technology certificate, shall pass De-
partment-approved examinations in:

(1) Therapeutic radiation protection and safety, and

(2) Therapeutic radiologic technology.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Sections 25668(b) and 25677, Health and Safety Code.

History
1. New Group 3 (Articles 1 and 2, Sections 3044(K30447) filed 8-21-85; effective

thirtieth day thereafter (Register 85, No. 34). For prior history, see Registers 78,

No. 10; 72, No. 32; 72, No. 26; and 71, No. 16.

§ 30441 . Acceptable Applications.

The Department considers an application for a radiologic technologist
certificate acceptable if all of the following conditions have been met:

(a) Application is made on forms furnished by the Department.

(b) Fee is paid pursuant to Section 30408.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25675, Health and Safety Code.

History

1. Change without regulatory effect amending suhsection (a) filed 1 1-1-91 pur-
suant to section 100, title 1, California Code of Regulations (Register 92, No.

5).

Article 2.

Permits for Limited Permit X-Ray
Technicians

§ 30442. Categories.

The categories for limited permits are:

(a) Chest radiography.

(b) Dental laboratory radiography.

(d) Extremities radiography.

(e) Gastrointestinal radiography.

(f) Genitourinary radiography.

(g) Leg-podiatric radiography,
(h) Skull radiography.

(i) Torso-skeletal radiography.

(j) X-ray bone densitometry.
NOTE: Authority cited: Section 114870(a), Health and Safety Code. Reference:
Section 1 14870(c), Health and Safety Code.

History

1. New subsection (k) and amendment of Note filed 9-15-97 as an emergency;
operative 9-15-97 (Register 97, No. 38). A Certificate of CompUance must be
transmitted to OAL by 1-13-98 or emergency language will be repealed by op-
eration of law on the following day.

2. Certificate of Compliance as to 9-1 5-97 order, including amendment of subsec-
tion (k), transmitted to OAL 1-8-98 and filed 2-24-98 (Register 98, No. 9).

3. Repealer of subsection (h) and subsection relettering filed 1 1-24-98; operadve
12-24-98 (Register 98, No. 48).

§ 30443. Scopes.

The scope of each limited permit is as follows:

(a) Chest radiography permit: radiography of the heart and lungs.

(b) Dental laboratory radiography permit: radiography of the intra-
oral cavity, skull, and hand and wrist, for dental purposes.

(c) Dermatology X-ray therapy permit: application of X-ray to human
beings for the treatment of diseases and tumors of the skin.

(d) Extremities radiography permit: radiography of the upper extremi-
ties, including shoulder girdle, and lower extremities, excluding pelvis.

(e) Gastrointestinal radiography permit: radiography of the esopha-
gus, stomach, small and large intestine, and biliary tract.

(f) Genitourinary radiography permit: radiography of the kidneys, ure-
ters, urinary bladder, urethra, and internal and external genitalia.

(g) Leg-podiatric radiography permit: radiography of the knee, tibia
and fibula, and ankle and foot.

(h) Skull radiography permit: radiography of the bone and soft tissues
of the skull and upper neck.

(i) Torso-skeletal radiography permit: radiography of the shoulder
girdle, rib cage and sternum, vertebral column, pelvis and hip joints.

(j) X-ray bone densitometry permit: radiography of the total skeleton
or part thereof, using X-ray bone densitometry.

NOTE: Authority cited: Section 114870(a), Health and Safety Code. Reference:
Section 1 14870(c), Health and Safety Code.

History

2. Certificate of Compliance as to 9-1 5-97 order, including amendment of subsec-
tion (k), transmitted to OAL 1-8-98 and filed 2-24-98 (Register 98, No. 9).

Page 240

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30451

3. Repealer of subseetion (h) and subsection reletterine filed 1 1-24-98; operative
1 2-24-98 ( Register 98, No, 48).

§ 30444. Issuance of Limited Permits.

To obtain any of the limited permits described in Section 30442 an
applicant shall fulfill all of the following conditions:

(a) Have on file with the Department an application, as described in
Section 30445, for each permit applied for, and

(b) Pass Department approved examinations in:

(1) Radiation protection and safety, for each permit category applied
for, and

(2) Radiologic technology, for each permit category applied for.
NoTE; Authority cited: Section 25668(a), Health and Safety Code. Reference:
Sections 25668(c) and 25675, Health and Safety Code.

§ 30445. Acceptable Applications.

The Department considers an application for a limited permit accept-
able if all of the following conditions have been met:

(a) The following is submitted to the Department:

( 1 ) The legal name, mailing address, and telephone number of the ap-
plicant;

(2) The applicant's social security number (pursuant to the authority
found in sections 1 3 1 050, 1 3 1 05 1 , 1 3 1 200 and 1 1 4870 of the Health and
Safety Code and as required by section 17520 of the Family Code, pro-
viding the social security number is mandatory. The social security num-
ber will be used for purposes of identification); and

(3) Identification of the permit category for which the individual is ap-
plying.

(b) Fee is paid pursuant to Section 30408.

(1) A limited permit X-ray technician school graduation diploma or
certificate in the limited permit category applied for.

(2) A statement, signed by the supervisor and operator who provided
the training, attesting that the applicant has completed Department-ap-
proved on-the-job training in the limited permit category applied for.

(3) A resume showing that education, training, and clinical experience
is equivalent to the limited permit X-ray technician school curriculum in
the limited permit category applied for.

(d) For authorization to perform procedures involving digital
radiography upon issuance of the limited permit pursuant to section
30444, documentation is submitted showing completion of instruction in
digital radiologic technology specified in section 30410.2 from any enti-
ty specified in section 30410(b)(2).

Note: Authority cited: Sections 114870, 131050, 131051 and 13 1200, Health and
Safety Code. Reference: Section 106995, Health and Safety Code.

History
1. Repealer and new subsection (a), new subsections (a)(l)-(3), amendment of

subsection (c)( 1 ), new subsection (d) and amendment of Note filed 2-14-2008;

operative 3-15-2008 (Register 2008, No. 7).

§ 30445.1. Acceptable Applications: X-ray Bone
Densitometry.

All persons authorized by the Department to perform X-ray bone den-
sitometry as of September 1 , 1 997, who make application for limited per-
mit in the category of X-ray bone densitometry on or before September
1, 1998, shall be deemed to have met the requirements of sections
30444(b) and 30445(c) for the purpose of making application for a lim-
ited permit in the category of X-ray bone densitometry.
Note: Authority cited: Section 114870(a), Health and Safety Code. Reference:
Section 1 14870(c). Health and Safety Code.

History

1. New section filed 9-1.5-97 as an emergency; operative 9-15-97 (Register 97,
No. 38). A Certificate of Compliance must be transmitted to OAL by 1-13-98
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 9-1 5-97 order, including amendment of section
heading and section, transmitted to OAL 1-8-98 and filed 2-24-98 (Register
98, No. 9).

§30446. Title.

No person other than an individual to whom the Department has issued

a limited permit described in section 30442 shall use the title "X-ray

Technician" or "XT."

Note: Authority cited: Sections 100275 and 1 14870(a), Health and Safety Code.
Reference: Section 106990, Health and Safety Code.

History
1. Repealer and new section and amendment of NoTi; filed 6-26-97; operative
7-26-97 (Register 97, No. 26).

§ 30447. Restrictions.

(a) Limited permits issued pursuant to section 30444 exclude authori-
zation to:

(1 ) Operate fluoroscopy equipment during exposure of a patient to X--
rays.

(2) Operate portable or mobile X-ray equipment.

(3) Perform procedures involving computerized tomography.

(4) Perform mammography procedures.

(5) Perform vascular procedures.

(6) Perform procedures involving scanned projection radiography
(digital radiography or digital tomography), or digital fluorography.

(b) Exclusions listed in subsecfions (a)(2) and (a)(6) shall not apply to
individuals who possess a current and valid limited permit in X-ray Bone
Densitometry, issued pursuant to section 30444.

(c) The exclusions listed in subsection (a)(6) shall not apply to individ-
uals who possess a current and valid limited permit in Dental Laboratory
Radiography, issued pursuant to section 30444.

(d) The exclusion listed in subsection (a)(6) shall not apply to individ-
uals who have been issued:

(1) Authorization to perform digital radiography pursuant to section
30410.

(2) A limited permit pursuant to section 30444 indicating the individu-
al has met the requirements of section 30410.

Note: Authority cited: Sections 1 14870(a), 131050, 131051 and 131200, Health
and Safety Code. Reference: Sections 106965, 106975, 114845, 114850,
1 14870(c), 1 14875 and 1 14880, Health and Safety Code.

History

1. Amendment of secfion and Note filed 10-29-2001; operative 11-28-2001
(Register2001,No. 44).

2. New subsections (d)-(d)(2) and amendment of Note filed 2-14-2008; opera-
tive 3-15-2008 (Register 2008, No. 7).

Group 4. Use of Fluoroscopy Equipment
by Radiologic Technologists

Article 1. Radiologic Technologist
Fluoroscopy Permits

§ 30450. Permit Requirement.

A radiologic technologist fluoroscopy permit issued by the Depart-
ment shall be required of any technologist who exposes a patient to X-
rays in a fluoroscopy mode, or who does one or more of the following
during fluoroscopy of a patient:

(a) Positions the patient.

(b) Positions the fluoroscopy equipment.

Note: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Sections 25668(c) and 25675, Health and Safety Code.

History

1. New Group 4 (Article 1, Sections 30450-30452) filed 8-21-85; effective thir-
tieth day thereafter (Register 85, No. 34). For prior history, see Register 78. No.
10.

§ 30451 . Issuance of Technologist Fluoroscopy Permits.

To obtain a radiologic technologist fluoroscopy permit an applicant
shall fulfill all of the following:

(a) File with the Department an application as described in Section
30452, and

(b) Pass Department-approved examinations in:

Page 240.1

§ 30452

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

( 1 ) Fluoroscopy radiation protection and safety, and

(2) Use of fluoroscopy and ancillary equipment.

NOTE: Authority cited: Section 25668(a). Health and Safety Code. Reference:
Sections 25668(c) and 25675, Health and Safety Code.

§ 30452. Acceptable Applications.

The Department considers an application for a radiologic technologist
fluoroscopy permit acceptable if all of the following conditions have
been met:

(a) Application is made on forms furnished by the Department.

(b) Fee is paid pursuant to Section 30408.

( 1 ) A copy of technologist fluoroscopy school graduation diploma or
certificate.

(2) A resume showing that education, training and experience is equiv-
alent to that of the radiologic technologist fluoroscopy school curriculum
as specified in Section 30423.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25675, Health and Safety Code.

Group 4.5. Use of Mammography
Equipment by Radiologic Technologists

Amendment of subsection (b) and repealer of subsection (c) fded 7-29-98; op-
erative 8-28-98 (Register 98, No. 31 ).

Group 5. Certification of Licentiates

Article 1

Mammographic Technology
Certificates

§ 30455.1. Issuance of a Mammographic Radiologic
Technology Certificate.

(a) To obtain a Mammographic Radiologic Technology Certificate
an applicant shall hold a valid and current Diagnostic Radiologic Tech-
nology Certificate issued pursuant to Section 30440(a) and shall comply
with all of the following:

( 1 ) File with the Department a complete apphcation on the Department
form entitled "Application for a Certificate in Radiologic Technology",
Form DHS 8200 (6/96);

(2) Submit a fee pursuant to Section 30408;

(3) Submit evidence of having been awarded a mammographic radio-
logic technology school graduation diploma or certificate; and

(4) Pass a Department examination in mammography technology, in-
cluding radiation protection and mammography quality assurance.

(b) The following may be substituted for the requirement in subsection
(a)(3) with respect to applications filed prior to July 1, 2000:

( 1 ) Advanced certification in mammography issued to the appUcant by
the American Registry of Radiologic Technologists; or

(2) Evidence of having completed 40 hours of continuing education in

mammography courses.

NOTE: Authority cited: Sections 100275 and 114870, Health and Safety Code.
Reference: Sections 1 14840, 1 14845 and 1 14870, Health and Safety Code.

History

1. New group 4.5, article 1, and section filed 1 1-1-93 as an emergency; operative
1 1-1-93 (Register93, No. 45). ACertificate of Compliance must be transmitted
to OAL by 3-1-94 or emergency language will be repealed by operation of law
on the following day.

2. Certificate of Compliance as to 1 1-1-93 order transmitted to OAL 2-24-94;
disapproved by OAL 4-7-94 (Register 94, No. 27).

3. New group 4.5, article 1 and section refiled with amendments 7-6-94 as an
emergency; operative 7-6-94 (Register 94, No. 27). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-3-94 or emergency language will be
repealed by operation of law on the following day.

4. Certificate of Compliance as to 7-6-94 order transmitted to OAL 6-30-94 and
filed 7-20-94 (Register 94, No. 29).

5. Amendment of subsections (a)(1), (a)(2), (b) and (b)(2), repealer of subsection
(b)(3) and amendment of subsection (c) and Notk filed 7-26-96 as an emergen-
cy; operafive 7-26-96 (Register 96, No. 30). A Certificate of Compliance must
be transmitted to OAL by 1 1-25-96 or emergency language will be repealed by
operation of law on the following day.

6. Editorial correction of subsection (b) (Register 96, No. 49).

7. Certificate of Compliance as to 7-26-96 order transmitted to OAL 1 1-1-96 and
filed 12-2-96 (Register 96, No. 49).

Article 1.

Licentiate Certificates and
Permits

§ 30460. Licentiate Certificate.

The certificate category for licentiates of the healing arts is: Radiology

supervisor and operator.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:

Section 25668(e), Health and Safety Code.

History

1. New Group 5 (Article 1, Sections 30460-30468) filed 8-21-85; effective thir-
tieth day thereafter (Register 85, No. 34). For prior history, see Registers 78, No.
10;72, No. 26and71,No. 41.

§ 30461 . Licentiate Permits.

The permit categories for licentiates of the healing arts are:

(a) Fluoroscopy supervisor and operator.

(b) Radiography supervisor and operator.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25668(e), Health and Safety Code.

§ 30462. Radiology Certificate.

A radiology supervisor and operator certificate issued by the Depart-
ment shall be required of any licentiate of the healing arts who practices
as a radiologist.

NOTE: Authority cited: Secdon 25668(a), Health and Safety Code. Reference:
Section 25668(e), Health and Safety Code.

§ 30463. Fluoroscopy Permits.

A fluoroscopy supervisor and operator permit issued by the Depart-
ment shall be required of any licentiate of the healing arts who does one
or more of the following:

(a) Actuates or energizes fluoroscopy equipment.

(b) Directly controls radiation exposure to the patient during fluoros-
copy procedures.

fluoroscopy permits pursuant to Section 3045 1 .

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25668(e), Health and Safety Code.

§ 30464. Radiography Permits.

A radiography supervisor and operator permit issued by the Depart-
ment shall be required of any licentiate of the healing arts who does one
or more of the following:

(a) Actuates or energizes radiography X-ray equipment.

(b) Supervises one or more persons who hold radiologic technologist
certificates pursuant to Section 30440(a).

to Section 30444.

NOTE: Authority cited: SecUon 25668(a), Health and Safety Code. Reference:
Section 25668(e), Health and Safety Code.

§ 30465. Dermatology Permits.

A dermatology supervisor and operator permit issued by the Depart-
ment shall be required of any licentiate of the healing arts who practices
dermatology and who uses X-ray therapy equipment for the treatment of
diseases and tumors of the skin.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25668(e), Health and Safety Code.

§ 30466. Issuance of Licentiate Certificates or Permits.

To obtain a licentiate certificate or any licentiate permit an applicant
shall have on file with the Department an application as described in Sec-
tion 30468, and in addition:

(a) For obtaining a fluoroscopy supervisor and operator permit, shall
pass a Department approved examination in fluoroscopy radiation pro-

Page 240.2

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30477

tection and safety, and use and supervision of use of fluoroscopy and an-
cillary equipment.

(b) For obtaining a radiography supervisor and operator permit, shall
pass a Department approved examination in radiography radiation pro-
tection and safety, and use and supervision of use of radiography and an-
cillary equipment.

(c) For obtaining a dermatology supervisor and operator permit, shall
pass a Department approved examination in dermatology radiation pro-
tection and safety, and application and supervision of application of X-
rays for treating diseases and tumors of the skin.

(d) For obtaining a radiology supervisor and operator certificate, shall
pass examinations specified in subsections (a) and (b) of this section, un-
less qualified for a certificate pursuant to Section 30467.

NOTE: Authority cited: Section 23668(a), Health and Safety Code. Reference:
Section 25668(e), Health and Safety Code.

§ 30467. Certification of Qualified Licentiates.

An applicant who is certified by the American Board of Radiology or
the American Osteopathic Board of Radiology, upon submission of an
application, fee and documentary evidence of board certification, shall
be issued a radiology supervisor and operator certificate.
NOTE: Authority cited: Section 23668(a), Health and Safety Code. Reference:
Section 25699.1, Health and Safety Code.

§ 30468. Acceptable Applications.

The Department considers an application for a licentiate certificate or
permit acceptable if:

(a) Application is made on forms furnished by the Department.

(b) Fee is paid pursuant to Section 30408, and

(1) Physician and surgeon.

(2) Osteopathic physician and surgeon.

(3) Podiatrist.

(4) Chiropractor.

NOTE: Authority cited: Section 25668(a), Health and Safety Code. Reference:
Section 25668(e), Health and Safety Code.

§ 30471 . Transfer for Disposal, Manifests and Record
Keeping.

The regulations governing the transfer of radioactive materials and
manifests in Title 10, Code of Federal Regulations, Parts 20.2006,
61.12(n), 61.80(f) and (/), as published in the March 27, 1995 Federal
Register (60 Fed. Reg. 15649) are hereby incorporated by reference.

Note: Authority cited: Sections 100275, 11 5010, 1 15230 and 1 15235, Health and
Safety Code. Reference: Section 1 15010, Health and Safety Code.

History
1. Amendment of section headintr. section and Nori: filed 6-17-99; operative
7-17-99 (Register 99, No. 25).^

Group 7.

Requirements for Land Disposal
of Radioactive Waste

Article 2. General

§ 30473. Definitions.

(a) "Debt" means the obligations of the licensee or the named owner
thereof which are fixed as to amount and which give the obligee rights
as to assets of the licensee or any portion thereof which are superior to
the rights of the licensee.

(b) "Equity" means the total book value of tangible and intangible as-
sets which exceeds the amount of debt.

(c) "Letter of Acceptance" means a confirmation by the applicant that
it agrees to be the license designee and commits itself to perform in accor-
dance with statements, representations and procedures contained in its
application.

(d) "Reasonable cost" means a cost which is reasonable if, in its nature
or amount, does not exceed that which would be incurred by a prudent
person under the circumstances prevailing at the time the decision was
made to incur the cost.

Note: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Ref-
erence: Section 25812(b), Health and Safety Code.

Article 3. Proprietary Documents

§ 30475. Proprietary Documents.

All documents submitted pursuant to the instructions in this group
which are proprietary, private or confidential shall be so identified by the
applying license designee or licensee as appropriate.
Note: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Ref-
erence: Section 25812(b), Health and Safety Code.

Article 1. Applicable Federal Regulations Article 4. Selection of License Designee

§ 30470. Low-Level Radioactive Waste Disposal.

The regulations governing low-level radioactive waste in the U.S.
Government Code of Federal Regulations (CFR), Title 10, Code of Fed-
eral Regulations Part 61 , as published in the Federal Register on June 22,
1993 (58 Fed. Reg. 33886) are hereby adopted by reference with the fol-
lowing excepfions:

(a) The Department of Health Services shall be substituted in all cases
where Commission, Office of Nuclear Material Safety and Safeguards or
U.S. Nuclear Regulatory Commission are cited and the Department of
Industrial Relations shall be substituted in all cases where the U.S. De-
partment of Labor is cited.

(b) The following secfions are deleted: 61.4, 61.5, 61.8, 61.23(i),
61.230).

NOTE: Authority cited: Sections 100275, 1 15010, 115230 and 115235, Health and
Safety Code. Reference: Section 1 15010, Health and Safety Code.

History

1. New Group 7 (Articles 1-8, Sections 30470-30499, not consecutive) filed
4-5-84 as an emergency; effective upon filing (Register 84, No. 14). No Certifi-
cate of Compliance required to be filed with OAL pursuant to Health and Safety
Code Section 25812.

2. Editorial correction of HISTORY NOTE No. 1 and reprinting of Group 7 (Ar-
ticles 1-8. Sections 30470-30499, not consecutive) which was inadvertently
deleted in Register 85, No. 34. The text of Group 7 as filed with the Secretary
of State on 4-5-84 remains in effect uninterrupted (Register 85, No. 45).

3. Amendment of first paragraph and Note filed 3-16-99; operative 4-15-99
(Register 99, No. 12).

§ 30477. Application for Selection as License Designee.

(a) Application for designation shall be made to the Department and
shall be accompanied by a filing fee of ten thousand dollars.

(b) The application for designation shall contain all of the following:

(1) The information described in Titie 10, Code of Federal Regula-
tions. Part 61.1 1 and 61.12, as pubUshed in the December 28, 1982 Fed-
eral Register (Vol. 27, No. 248), except 61.11(c)(1), (2) and (3) and
61.12(a), (h) and (i).

(2) A description of any limitation in the site design which would re-
strict the receipt for disposal of low-level waste due to radiation levels,
waste form, waste class or waste packaging.

(3) A description of the natural and demographic characteristics which
will be emphasized in selection of the disposal site, including geologic,
hydrologic, meteorologic, climatologiic and biotic features of the dispos-
al site and vicinity.

(4) A plan for community involvement in the site selection and devel-
opment process, including brief descriptions of the applicant's experi-
ence with waste disposal or other developments requiring community in-
volvement.

(5) The financial information called for in Title 10, Code of Federal
Regulations, Parts 61. 15, 61. 61, 61. 62, 61. 63, as published in the Decem-
ber 28, 1982 Federal Register (Vol. 27, No. 248); a description of the
sources of financing, the terms of financing; the filing of a financial pro
forma; and revenue documentation.

Page 240.2(a)

§ 30479

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(6) An estimate in 1984 dollars of the charges to be levied on waste
received for disposal. The estimate shall assume the following:

(A) A preoperational period of five years, commencing in August
1984.

(B) An operating period of 20 years.

(D) Administrative controls extending for 1 00 years following the op-
erating period.

(E) A site capacity of 250,000 cubic meters.

(F) A waste mix as described for Region 4 in Table D.9 "Untreated"
Waste Volumes Projected to be Generated to the Year 2000 per Region
(m-^). U.S. Nuclear Regulatory Commission. Draft Environmental Im-
pact Statement on 10 CFR Part 61 NUREG-0782. Volume 3, September
1981.

NOTE: Authority cited: Sections 208, 258 1 2.5(c) and 258 1 2.5(e), Health and Safe-
ty Code. Reference: Sections 25812.5(c) and (e). Health and Safety Code.

§ 30479. Standards for Selecting the License Designee.

(a) The applicants shall be ranked in accordance with the degree to
which their application demonstrates their ability to:

(1) Meet the financial standards and qualifications by reason of train-
ing, experience and character to carry out the disposal operations;

(2) Provide the best concept for site development and operation as re-
quired by Title 10, Code of Federal Regulations, Part 61.23, as published
in the December 28, 1982 Federal Register (Vol. 27. No. 248) except that
information which would pertain only to a specific site;

(3) Present an effective program to deal with concerns of the public re-
garding establishment of a low-level radioactive waste disposal site; and

(4) Establish, based on estimates, a reasonable schedule of charges for

disposal of low-level radioactive waste.

NOTE: Authority cited: Sections 208 and 25812.5(c), Health and Safety Code.
Reference: Section 25812.5(c), Health and Safety Code.

§ 30481 . Acceptance by License Designee.

(a) The applicant ranked highest pursuant to Section 30479 shall, with-
in five days of nodfication of its ranking, either:

(1) File a letter of acceptance, post a performance bond of one miUion
dollars in favor of the Department and pay the annual license fee; or

(2) File a letter withdrawing their appUcation.

(b) In the event that the highest ranked applicant withdraws its applica-

Uon, the next highest ranked applicant shall follow the processes set forth

in Section 30481(a).

NOTE: Authority cited: Sections 208 and 25812.5(c), Health and Safety Code.
Reference: Section 25812.5(c), Health and Safety Code.

Article 5. Forfeiture of Performance Bond

§ 30483. Standards for Forfeiture of the Performance
Bond.

(a) The performance bond posted pursuant to Section 30481 shall be
forfeited upon:

(1) Declaration of insolvency or voluntary reorganization under the
bankruptcy laws, or

(2) Failure to maintain the promised schedule and such failure is not
the result of an act of God or Departmentally caused delay and the license
designee cannot provide assurance that this delay will be remedied with-
out jeopardizing the overall project schedule.

(3) Failure to comply with requirements of this group, or

(4) Failure to pay the performance bond premium 30 days prior to its
expirafion.

(b) Upon the issuance of the operating license the licensee shall be re-
lieved of its obHgation to maintain the performance bond.

NOTE: Authority cited: Sections 208 and 258 1 2.5(f), Health and Safety Code. Ref-
erence: Section 25812.5(f), Health and Safety Code.

Article 6. Fees

§ 30485. License Fee.

The license designee or the licensee shall pay an annual license fee of
two-hundred fifty thousand dollars.

NOTE: Authority cited: Sections 208 and 25812(d), Health and Safety Code. Ref-
erence: Section 25812(d), Health and Safety Code.

Article 7. Financial Assurances

§ 30487. Additional Licensee Requirements and Financial
Assurances.

(a) The licensee shall retain a certified public accounting firm ap-
proved by the Department for the purpose of making reports and audits
of the operation of the low-level radioactive waste disposal site.

(b) An unqualified audit statement shall be prepared annually with re-
spect to all matters which bear upon the license designee's or the licens-
ee' s ability to operate pursuant to the Letter of Acceptance or license. The
unqualified annual audited statement shall be submitted to the Depart-
ment no later than three months after the end of the license designee' s or
licensee" s fiscal year in each year following the filing of the Letter of Ac-
ceptance, or issuance of the license.

(c) No security interest in the site shall be executed by the licensee
without the consent of the Department which would give a creditor any
right to stop the operation of the site.

NOTE: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Ref-
erence: Section 25812(b), Health and Safety Code.

§ 30489. Funding for Disposal Site Closure and
Stabilization.

(a) Funding for the approved plan for closure and stabilization shall be
obtained from a closure surcharge often percent of the disposal charges
levied by the licensee on disposers of low-level radioactive waste.

(b) The surcharge shall be deposited, within thirty days following col-
lection, with a trustee approved by the Department, in a fund which shall
be known as the Low-Level Radioactive Waste Disposal Site Closure
Trust Fund. All balances in the fund shall be invested by the trustee in
accordance with the investment standards set forth in Government Code,
Section 16408.2.

(c) The amount of the financial assurance mechanism, Title 10, Code
of Federal Regulations, Part 61.62, as published in the December 28,
1982 Federal Register (Vol. 27, No. 248), shall change as necessary to
take into account both the increased costs of closure and the available bal-
ance in the Low-Level Radioactive Waste Disposal Site Closure Trust
Fund. Changes in costs caused by inflation shall be calculated using an
inflation factor derived from the annual Implicit Price Deflator for Gross
National Product as published by the U.S. Department of Commerce in
its Survey of Current Business. The inflation factor is calculated by di-
viding the latest published annual Deflator by the Deflator for the pre-
vious year.

(d) Payment for site closure and stabilization shall be made from the
Low-Level Radioactive Waste Disposal Site Closure Trust Fund. Upon
filing a petition to close, a licensee or any other person authorized to per-
form closure shall request payment for closure expenditures by submit-
ting itemized bills to the trustee. The trustee is authorized to pay those
bills which the trustee finds to be in accord with the approved plan and
shall make reports of the expenditures to the Department quarterly in the
first 12 months of closure and annually thereafter.

NOTE: Authority cited: Sections 208 and 25812(b), Health and Safety Code. Ref-
erence: Section 25812(b), Health and Safety Code.

§ 30491 . Liability Insurance.

The hcensee shall carry nuclear liability insurance of no less than ten
milUon dollars for both sudden and accidental or slow and gradual con-
tamination to people or property off site.

Page 240.2(b)

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 3(>5()1

•

NOTH: Authoritv cited: Sections 208 and 25812(b), Health and Safety Code. Ref-
erence: Section 258 12(b), Health and Safety Code.

Article 8. Rate Review and Approval
Process

§ 30493. Establishment and Approval of Rates.

(a) The licensee shall establish a schedule of rates for waste disposal
subject to approval by the Department.

(b) The rates for disposing of waste shall remain in effect for no less
than two years from the effective date of the rates and shall be subject to
review by the Department biennially.

to the Department by the licensee or a waste generator.

NOTIi: Authority cited: Sections 208 and 25812.7, Health and Safety Code. Refer-
ence: Section 25812.7, Health and Safety Code.

§ 30495. Calculation of the Rate Schedule.

(a) The rate schedule shall be determined by dividing the total rate
base, as calculated pursuant to Section 30495(c), by the sum of the esti-
mated or actual amounts of all classes of waste received.

(b) Twenty-two months following establishment of the rate schedule,
the Hcensee shall furnish the Department with the actual monthly dispos-
al volumes by class compared with those assumed for that year.

( 1 ) Amortization on a straight-line basis, over a 20 year operating peri-
od, of costs incurred prior to the start of site operations. Costs shall in-
clude:

(A) Site acquisition costs, including but not limited to acquiring the
land for the low-level radioactive disposal site and deeding the land to
the State;

(B) Licensing costs, including but not limited to the costs associated
with initial site selection, and the development of any plans, reports, de-
signs, manuals and schedules necessitated by this group;

(C) Site development costs, including but not limited to grading, de-
velopment of roads, installation of fencing and lighting, or installation of
a system of wells and air monitors;

(D) Administrative costs, incurred during the time between approval
of the Letter of Acceptance and licensure that have not been included in
prior items.

(2) Depreciation on a twenty year straight-line basis of all buildings
and equipment used in the operation of the disposal site and not including
those costs specified in Section 30495(c)(1).

(3) Site operating costs consisting of those necessary and reasonable
costs incurred during the daily operations of the disposal site.

(A) Costs applicable to services, facilities, equipment or supplies fur-
nished to the licensee by organizations related to the licensee by common
ownership or control are includable as site operating costs for the purpose
of rate determination at the actual cost to the related organization.

(B) Fines or penalties are not includable as site operating costs in the
rate base.

(4) The actual interest costs for any necessary short-term or long-term
debt provided that the borrowed funds were devoted to the disposal site.

(5) A return factor specified by the licensee.
NOTH: Authority cited: Sections 208 and 25812.7. Health and Safety Code. Refer^
ence: Section 25812.7, Health and Safety Code.

§ 30497. Rate Review Documentation.

(a) For the purpose of verifying the rate base upon which rates have
been proposed or established, including any rate base changes aflecling
the calculating of proposed rates, the licensee shall supply the following
reports:

(1) Semiannual reports of all costs specified in Section 3()495(c) in-
curred prior to the issuance of the license.

(2) An annual financial report which includes data used or propt)sed
to be used by the licensee in the calculation of the rate base and/or rales
for disposal of waste. This report shall be due v/ithin three (3 ) months of
the licensee's fiscal year.

(3) The books and records supporting the reports referred to in tiiis sec-
tion shall be maintained in a form capable of and subject to review and
audit by the Department.

(4) All contracts made by the licensee which require payments by the
licensee of five percent or more of the latest annual reported gross reve-
nue shall require that an independent audit report be made available to
the Department.

NOTE: Authority cited: Sections 208 and 25812.7, Health and Safety Code. Refer-
ence: Section 25812.7, Heahh and Safety Code.

§ 30499. Adjustment of Rate Schedule.

If the actual volumes differ by five percent or more from the estimated
total for the twenty-two month period, the rates shall be adjusted on the
biennial review date to reflect the over- or under-estimation.
NOTE: Authority cited: Sections 208 and 25812.7, Health and Safety Code. Refer-
ence: Section 25812.7, Health and Safety Code.

Subchapter 4.6. Nuclear Medicine
Technology

Article 1. Definitions

§ 30500. Certified Technologist, Nuclear Medicine.

"Certified technologist, nuclear medicine" means a person who holds
a current certificate issued pursuant to Section 30532.
NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Government Code.

HlSTOl^Y
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For history

of former Section 30500, See Register 84, No. 43.

§ 30501 . Direct Supervision.

"Direct supervision" means that the supervisor is physically present
in the same room with the certified technologist, nuclear medicine, spe-
cial permit holder or student of nuclear medicine technology at the time
the nuclear medicine technology procedure is being performed.
NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History
1 . Renumbering of former Section 30501 to Section 30690 and new Section 3050 1

filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

[The next page is 240.3.]

Page 240.2(c)

•

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30520

•

§ 30502. General Supervision.

(a) "General Supervision" means that the supervisor is responsible for,
and has eontrol of, all of the following:

( 1 ) Quality, technical and medical aspects of all nuclear medicine
technology procedures.

(2) Radiation health and safety of patients, ancillary personnel and
other persons.

(3) Ascertaining that certified technologists, nuclear medicine, main-
tain their competency by participation in management-sponsored or for-
mal continuing education or training offered by professional organiza-
tions or societies, or by institutions of higher learning.

NOTI-: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History

1 . New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior his-
tory, see Register 84, No. 43.

2. Amendment of subsection (a)(3) filed 8-3-94; operative 9-2-94 (Register 94,
No. 31).

§ 30503. In Vitro Test.

"In vitro test" means a nuclear medicine technology procedure in
which the radioactive material is not administered to a human being.
NOTH: Authority cited: Section 208, Health and Safety Code. Reference: Sections
2.S625 and 25626, Health and Safety Code.

History

1. New section filed 6-6-88: operative 7-6-88 (Register 88, No. 24).

§ 30504. In Vivo Test.

"In vivo test" means a nuclear medicine technology procedure in
which the radioactive material is administered to a human being.
NOTH: Authority cited: Section 208. Health and Safety Code. Reference: Sections
25625 and 25626, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30505. Licensed Clinical Bioanalyst.

"Licensed clinical bioanalyst" means a person who holds a current li-
cense issued pursuant to Section 1 260 of the California Business and Pro-
fessions Code to practice clinical laboratory bioanalysis.
NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code; and Section 1260, Business and Professions Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30506. Nuclear Medicine Physician.

"Nuclear medicine physician" means a physician and surgeon who is
authorized by a specific radioactive material license issued pursuant to
Section 30195 of this title to use radioactive material for diagnosis and
treatment of disease in human beings.

NOTH; Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History

1 . New section filed 6-6-88; operative 7-6-88 (Register 88. No. 24).

§ 30507. Nuclear Medicine Technology Procedures.

(a) "Nuclear medicine technology procedure" means procedures uti-
lizing radioactive material for the diagnosis and treatment of disease in
human beings, and include, but are not limited to, one or more of the fol-
lowing:

( 1 ) Administration of radioactive material to human beings for diag-
nostic purposes.

(2) Withdrawal of blood samples for an in vitro test.

(3) Oral administration of radioactive material to human beings for
therapeutic purposes.

NoTl-: Authority cited: Section 208, Health and Safety Code. Reference: Sections
25625 and 25626, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30508. Special Permit.

"Special permit" means a permit issued pursuant to Section 30.541.
NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safcty Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30509. Student of Nuclear Medicine Technology.

"Student of nuclear medicine technology" means a person who has
started and is in good standing in a course of inslmction which, if success-
fully completed, would permit the person to receive a certificate in nu-
clear medicine technology issued pursuant to Section 30532.
NOTE; Authority cited: Section 208. Health and Safely Code. Reference: Section
25626, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§30510. Supervisor.

"Supervisor" means a nuclear medicine physician, or. when perform-
ing in vitro tests, a physician and surgeon or a licensed clinical bioana-
lyst.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
25625 and 25626, Health and Safety Code.

History

1 . New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior his-
tory, see Register 68, No. 20.

Article 2.

Certification of Nuclear Medicine
Technologists

§ 30520. Competency Criteria.

(a) To meet the competency criteria for basic education in nuclear
medicine technology, an applicant shall have successfully completed
college level instruction in at least the following:

(1) Human anatomy and physiology.

(2) Physics.

(3) Mathematics

(4) Medical terminology.

(5) Oral and written communications.

(6) General chemistry.

(7) Medical ethics.

(8) Methods of patient care.

(9) Radiation safety and protection.

(10) Nuclear medicine physics.

(11) Radiation physics.

(12) Nuclear instrumentation.

(13) Statistics.

(14) Radionuclide chemistry.

(15) Radiopharmacology.

(16) Department organization and 1 unction.

( 1 7) Radiation biology.

(18) Nuclear medicine in vivo and in vitro tests.

(19) Radionuclide therapy.

(20) Computer applications.

(b) To meet the competency criteria for laboratory instruction in nu-
clear medicine technology, an applicant shall have successfully com-
pleted college level instruction and training in at least the following:

(1) Collimators — sensitivity versus resolution.

(2) Survey instruments — composition, function, calibration and use.

(3) Gamma ray spectrometry — composition, function and use.

(4) Nuclear generators and dose calibration.

(5) Preparation of radioactive material for nuclear medicine technolo-
gy procedures.

(6) Radioactive material waste handling techniques.

(c) To meet the competency criteria for clinical experience in nuclear
medicine technology, an applicant shall have successfully performed at
least all of the following:

(1) Fifty in vitro tests.

Page 240.3

§ 30521

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) Participation in ten oral administrations of radioactive material to
human beings for therapeutic purposes.

(3) Ten of each of the following nuclear medicine technology proce-
dures.

(A) Brain imaging and cisternography.

(B) Bone imaging.

(D) Cardiac imaging.

(E) Pulmonary imaging.

(F) Gastrointestinal imaging.

(G) Genitourinary imaging.
(H) Great vessel imaging.

(I) Tumor and abscess imaging.

(4) Ten of each of the following in vivo tests:

(A) Thyroid uptake.

(B) Blood volume.

(5) Ten administrations of radioactive material to human beings for the
purpose of performing nuclear medicine technology procedures after
having received instruction in all of the following:

(A) Pertinent anatomy and physiology of all possible venipuncture
sites.

(B) Choice of instruments, intravenous solutions, and equipment.

(D) Techniques of intravenous line establishment.

(E) Hazards and complications of venipuncture.

(F) Post-puncture care.

(G) Composition and purpose of antianaphylaxis tray.

(H) First aid and instruction in basic cardiopulmonary resuscitation.
(I) Care of specimen.

(6) Ten withdrawals of blood samples for in vitro tests.

NoTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626. Health and Safety Code.

History
1 . New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior his-
tory, see Register 68, No. 20.

§30521. Supervision Requirements.

(a) Certified technologists, nuclear medicine, special permit holders,
and students of nuclear medicine technology shall be under:

(1) General supervision when performing nuclear medicine technolo-
gy procedures.

(2) Direct supervision when performing oral administration of radio-
active material to human beings for therapeutic purposes.

NoTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

Article 3. Administration

§ 30530. Acceptable Applications.

(a) The Department considers an application for a certificate in nuclear
medicine technology acceptable if all of the following conditions have
been met:

(1) Application is made on a Nuclear Medicine Technology Certifi-
cate Application form DHS 8435 (7/87) furnished by the Department.

(2) Fee is paid pursuant to Section 30535.

(3) Documentation provided with the application estabUshes that the
applicant's basic education, laboratory instruction and clinical experi-
ence meet at least the competency criteria set forth in Section 30520.
NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History
1 . New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior his-
tory, see Register 68, No. 23.

§ 30531 . Application Process and Deadlines.

(a) Submission of an application, documents, information, or fees sup-
porting the application for any certificate or special permit issued under
this subchapter shall be deemed to occur on the date the application, doc-
uments, information, or fees are received by the Department.

(1 ) An application is considered complete when all documents, infor-
mation, or fees required to be submitted on or with the application have
been received by the Department, and the applicant has passed any re-
quired examination.

(2) Written notification by the Department to applicants shall be
deemed to occur on the date the notification is postmarked.

(b) The Department shall notify the applicant, within 30 calendar days
of submission of the application for any certificate or special permit is-
sued under this subchapter, of one of the following:

( 1 ) That the application is complete and the Department's decision re-
garding the application.

(2) That the application is not accepted for filing and what specific
documents, information, or fees the applicant shall submit within 30 cal-
endar days in order for the Department to consider the application accept-
able.

(3) That the application is acceptable and what examination the appli-
cant shall pass in order to complete the application.

(c) The Department shall notify the applicant, within 60 calendar days
of the date of any examination required by subsection (b)(3) of the results
of the examination.

(d) The Department shall deem an application for a certificate or spe-
cial permit issued under this subchapter to have been withdrawn by the
applicant who fails to:

(1) Within 30 calendar days of notification, pursuant to subsection (b),
respond to the Department's request to submit specific documentation,
information, or fees; or

(2) Within 1 80 calendar days of nodfication pursuant to subsection
(b), pass any required examination.

(e) Any applicant deemed by the Department to have withdrawn an
application pursuant to subsection (d) may reapply by submitting a new
application.

(f) The Department's time periods for processing an applicafion, from
the date the initial application is received by the Department to the date
the application is complete and the final decision is made regarding a cer-
tificate or special permit issued under this subchapter are as follows:

( 1 ) The median time for processing an application is 90 calendar days.

(2) The minimum time for processing an application is one day.

(3) The maximum time for processing an application is 240 calendar
days.

NOTE; Authority cited: Section 208. Health and Safety Code. Reference: Section
15376, Government Code; and Section 25626, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30532. Issuance of Certificates.

(a) To obtain a certificate in nuclear medicine technology an applicant
shall have on file with the Department an acceptable application as de-
scribed in Section 30530, and

( 1 ) Pass an examinafion in nuclear medicine technology administered
by the Department, or

(2) Submit documentary evidence of having passed an examination
equivalent to that administered by the Department and offered by one of
the following:

(A) Nuclear Medicine Technology Cerfification Board.

(B) American Registry of Radiologic Technologists.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30533. Scopes of Certificates.

(a) Certificates shall be issued for one or more of the following:

Page 240.4

Title 17

Radiation — Radiologic Technology — Nuclear Medicine Technology

§ 30542

( 1 ) Diagnostic in vivo and in vitro tests involving measurement of up-
take, dilution, or excretion, including venipuncture, but not involving
imaging.

(2) Diagnostic nuclear medicine technology procedures involving
imaging, including venipuncture.

(3) Use of generators and reagent kits for preparation of radioactive
material.

(4) Internal radioactive material therapy.

NOTI-: Authority cilcd: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

2. Amendment of subsections (a)(l)-(2) and repealer of subsection (a)(5) filed
8-.V94; operative 9-2-94 (Register 94, No. 31).

§30534. Title.

No person other than individuals to whom the Department has issued
a certificate in nuclear medicine technology shall use the title "Certified
Technologist, Nuclear Medicine" or "CTNM."

NoTE; Authority cited: Section 208, Health and Safety Code. Reference: Sections
25626, 25629 and 25631, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30535. Fees.

(a) Each individual applying for a certificate in nuclear medicine tech-
nology shall pay an application fee of $153.00.

(b) Each individual applying for a special permit in nuclear medicine
technology shall pay an application fee of $183.00.

(d) The fee for replacement of a certificate in nuclear medicine tech-
nology shall be $12.00.

(e) Each individual applying for renewal of a certificate in nuclear
medicine technology shall pay a renewal application fee of $175.00.

(f) Any individual who fails to pay the renewal application fee by the
expiration date of the certificate shall immediately cease performance of
duties requiring a certificate in nuclear medicine technology until such
time as the fee and a late fee of 25 percent of the annual renewal applica-
tion fee has been paid.

(g) Fees required by this section shall be nonrefundable.

NOTH: Authority cited: Sections 100275 and 107160, Health and Safety Code.
Reference: Section 107160, Health and Safety Code.

History

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

2. Amendment of section and Noth filed 6-22-2005 as an emergency; operative
6-22-2005 (Register 2005, No. 25). A Certificate of Compliance must be trans-
mitted to OAL by 10-20-2005 or emergency language will be repealed by op-
eration of law on the following day.

3. Certificate of Compliance as to 6-22-2005 order transmitted to OAL
9-20-2005 and filed 10-18-2005 (Register 2005, No. 42).

§ 30536. Renewal Procedures.

(a) Certificates issued pursuant to Section 30532 shall expire five
years from the date of issuance.

(b) Applications for renewal of each certificate shall be:

(1) Made on a Nuclear Medicine Technology Certificate Renewal
form DHS 8437 (4/88) furnished by the Department.

(2) Accompanied by fee paid pursuant to Section 30535.

(3) Filed with the Department at least 60 days prior to the expiration
date of each certificate.

(c) The Department considers an application for renewal of a certifi-
cate in nuclear medicine technology complete if the following conditions
have been met.

( 1 ) Documentation submitted with the application establishes that the
applicant has participated in management-sponsored or formal continu-
ing education or training offered by one or more of the following:

(A) Professional organizations or societies.

(B) Institutions of higher learning.

(2) The applicant's education and training includes at least five clock
hours since the last certificate renewal or initial application in each of the
scopes specified in Section 30533 for which the certificate was issued.
NOTI.: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30537. Notification Requirements.

(a) Every person who holds a current certificate issued pursuant to
Section 30532 shall report to the Department any change of name or
mailing address within 30 days of the change.

NOTH: Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

Article 4. Exemptions and Enforcement

§ 30540. Students of Nuclear Medicine Technology.

The provisions of Section 30532 shall not apply to .students of nuclear
medicine technology when such students are performing nuclear medi-
cine technology procedures under supervision as outlined in Section
30521 and are under direct guidance of an instructor who holds a current
certificate issued pursuant to Section 30532.

Note: Authority cited: Section 208, Health and Safety Code. Reference: Sections
25626 and 25631, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24). For prior his-
tory, see Register 84, No. 43.

§30541. Special Permits.

(a) To obtain a special permit in nuclear medicine technology, an
applicant shall have on file with the Department a complete special per-
mit application.

(b) The Department considers an application for a special permit com-
plete if all the following conditions have been met:

(1) Application is made on a Nuclear Medicine Technology Special
Permit Application form DHS 8436 (7/87) furnished by the Department.

(2) Fee is paid pursuant to Section 30535.

(3) The application is accompanied by a statement from the employer,
verified by the Department, that the people in the locality in which the
special permit is sought would be denied nuclear medicine technology
services because of unavailability of certified technologists, nuclear
medicine.

(d) Special permits shall not be transferable to another facility.

(e) Minimum qualifications for an applicant for a special permit shall
be any of the following:

( 1 ) Bachelor's degree in physical or biological sciences or equivalent,
issued by an institution of higher learning.

(2) Sixty semester units in physical or biological sciences or equiva-
lent, obtained in an institution of higher learning.

(3) Proof of state or national registration or certification in radiologic
technology, medical technology, nursing, or respiratory technology.
Note; Authority cited: Section 208, Health and Safety Code. Reference: Section
25626, Health and Safety Code.

History

1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30542. Display.

Any nuclear medicine technologist who holds a current certificate is-
sued pursuant to Section 30532 shall prominently display such certificate
or photocopy thereof at each facility vi/here the technologist is perform-
ing nuclear medicine technology procedures.

Note-. Authority cited: Section 208, Health and Safety Code. Reference: Sections
25626 and 25631, Health and Safety Code.

History
1. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

Page 240.5

§ 30543

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 30543. Inspection.

The owner, occupant, or person in charge of any private or public facil-
ity specified as a condition of a license, certificate, or special permit is-
sued pursuant to this Subchapter shall permit any officer, employee, or
designated agent of the Department to enter such property at all reason-
able times for the purpose of inspecting those areas of the property where
authorized nuclear medicine technology procedures are performed and
determining whether or not there is compliance with or a violation of pro-
visions specified in Sections 23625 to 2563 1 , inclusive, of the Health and
Safety Code, or of this subchapter.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
25631, Health and Safety Code.

History
I. New section filed 6-6-88; operative 7-6-88 (Register 88, No. 24).

§ 30550. Fuel Tank Emissions.

History
1. New section filed 11-9-64; effective thirtieth day thereafter (Reeister 64,

No. 22).

2. Repealer filed 5-24-68; effective thirtieth day thereafter (Register 68, No. 20).

§ 30560. Carburetor Hot Soak Emissions.

History

1 . New section filed 1 1-9-64; effective thirtieth day thereafter (Register 64, No.

22).

2. Repealer filed 5-24-68; effective thirtieth day thereafter (Register 68, No. 20).

§ 30570. Exhaust Odor and Irritation.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Section
1 1349.7, Government Code.

History

1. New section filed 7-1-66; effective thirtieth day thereafter (Register 66,
No. 20).

2. Repealer filed 1 0-24-84; effective thirtieth day thereafter (Register 84, No. 43).

•

[The next page is 241 .]

Page 240.6

Title 17

State Department of Health Services

§ 30690

Subchapter 5. Air Sanitation'

For regulations of Air Resource Board see Title 13, Chapter 3.

Article 1 . Standards for Ambient Air Quality

§ 30690. Table of Standards and Explanatory Footnotes.

(a) Table of Standards

POLLUTANT

Phntoclieniiciil
Pnliutuiits

Hydriji'iirboiis

Uvidunt

Ozone

Photochemical
Aerosols

Nilrogeij Dioxide

(Carbon MrtiioxiHo

Kthylone
Hydrogen Sulfide

Piirtioylut'^ MdUcr
■Siiiftir Dinxiflp

Sulfuric Acid
C;arcino|i;ens
Hydrogen Fluoride
I^iid

"ADVKRSK" LKA'KI,
Lnvfl III wliifli llii-ri-
will he sensory trrilu-
Imii, (liiiniiKP to vpjfclu-
lion, rt'duftion in
visibility or similar ef-
I'ects.

"Oxidant
Index"
0,15 ppm for 1 hour b\'
the potiis.<iium iodidf^
method (eye irritation,
ditmiigft to vfifiptiitinii
and visibility rcdiic-
tiiiii)

0.25 ppm for 1 hour
(coloration of th^ .it-
mosphere during diiy
lijiht hour,\)
Not iip|ilii'iil)tp

0,5 ppm for 1 honr or
0,1 pjjm for k hours
(diiiniigo to vcgctil-
lion)

0.1 ppm for 1 hour
(sensory irritation)
SulTicicnt to reduce vis-
ibility to less than 3
mile.'i when relative hu-
midity i,1 le,ss than 7ft
[jtTfpnt

1 ppm for 1 hour or 0.3
ppm fur H liuuTN (dlUIl-

uge lo vegetiition )
Footnote ft
Not applicable
Footnote 1 1
Not iipplioaiilri

(b) Footnotes.

( 1 ) Hydrocarbons are a group of substances most of which, normally, are toxic
only at concentrations in the order of several hundred parts per million. Howev-
er, a number of hydrocarbons can react photochemically at very low concentra-
tions to produce irritating and toxic substances. Because of the large number of
hydrocarbons involved, the complexity of the photochemical reactions and the
reactivity of other compounds such as nitrogen dioxide and ozone, it is not yet
possible to establish "serious" and "emergency" levels for hydrocarbons. From
the public health standpoint, the concentration of those hydrocarbons which
react photochemically should be maintained at or below the level associated
with the oxidant index defined in the "adverse" standard.

(2) Ozone, at 1 ppm for eight hours daily for about a year, has produced bronchioli-
tis and fibrositis in rodents. Extropolation of these data to man is difficult. Func-
tional impairment data have been reported; at 1 .25 ppm some effect is observed
on residual volume and diffusing capacity. The variabiUty of the tests was not
reported. Additional data would be needed before a standard is set.

(3) A value of 2.0 ppm of ozone for one hour may produce serious interference
with function in health persons and the assumption is made that this might cause
acute illness in sensitive persons.

(4) Nitrogen dioxide, at concentrations above 2.5 ppm. causes acute damage to
sensitive plants. One ppm for eight hours will produce significant growth reduc-
tion, expressed as fresh and dry weight, with no visible lesions of damage. High
levels ( 1 50-220 ppm) in short exposures produce fibrotic changes in the lungs
of man that may end fatally.

(5) Given certain assumptions concerning ventilatory rates, acute sickness might
result from a carbon monoxide level of 240 ppm for one hour in sensitive groups
because of inactivation often percent of the body's hemoglobin. In any event

"SKHIOtl.S" LKVEL
Ix-vfl tit which there
will be alteration of
bodily function or
which is likely lo lead to
f hronic dispaso.

I<"ootnoii^ 1
Not applicable

Footnotf 2

Not fipp1llMllll(>

3 ppin for 1 hour (bron
chuL'onslneliuii)

3tl ppm for 8 hours or
120 ppm for 1 hour (in-
terference - with oxy-
gen transport by blood)

Not

ilii'iililc

I'ootnoie 6
Nut applicable

5 ppm for 1 hour (bron-
ehoeonslrielion)

Fooinoio ft
Footnote in
I'ootnotc 12
KoDtnntr 13

"EMEnCENCY"
UCVl'lL
Level at which it is likn
ly that aeiitrt .Mpknt'ss or
Hmilh in sensitive
jtroupsi of persons «'ill
occur.

Foiitnale 1
Niil iippliciihlc

KfHltllllll' .3

No\ iippliciible

FiHitiiati" 4
Footnote 5

Not upplicablc

Fnotnntp 7
Not applicable

10 ppm for 1 hour ( se-
vere distress in human
mlyectf)

FiMjtiiolf M
Nut applicuhll'
Not applicable
FoolJWtc 13

it is clear that when a population exposure limit has been set for carbon monox-
ide, because of exposure from other sources, cormnunity air pollution standards
should be based on some fraction of this limit.

(6) Hydrogen sulfide is not known to produce chronic disease in humans but there
may be durable sequelae from acute exposures. The disagreeable odor may in-
terfere with appefite in sensitive groups of persons at about 5 ppm. At high con-
centrations loss of the sense of smell occurs. This has been reported at 1 00 ppm
for exposure lasting two to fifteen minutes. Conjunctivitis and mild respiratory
tract irritation have been reported at levels of 50-100 ppm for one hour.

(7) Acute sickness and death with neurotoxicity may occur at concentrations of
several hundred ppm. It is very unlikely these levels will occur in community
air pollution.

(8) A sulfuric acid mist level of I mg/M-^ with an average particle size of 1 micron
will produce a respiratory response in man. It is not possible to generalize from
this fro all air pollution conditions, because under natural conditions, particle
size will vary. Only with large droplets would sensory irritation be produced
without other physiological effects.

(9) A level of 5 mg/M^ of sulfuric acid mist for a few minutes produces coughing
and irritation in normal individuals. Presumably, it could cause acute illness in
sensitive groups of persons in a period of one hour.

(10) Carcinogens include a few organic compounds such as some polycyclic hy-
drocarbons and some metals such as arsenic and chromium. Studies on effects
of such substances are currentiy under way, but there are not sufficient data, at
present, to set standards. In the meantime, it is recommended that concentra-
tions of carcinogens in air should be kept as low as possible.

(11) Hydrogen fluoride and other airborne fluorides settle upon and some are ab-
sorbed into vegetation. When forage crops containing 30-50 ppm of fluoride

Page 241

§ 30700

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

measured on a cli"y weight basis are regularly eonsuined over a long period the
teeth and hones of eattle may show changes, depending on age, nutritional fac-
tors and the form of fluoride ingested. Such changes may or may not have any
economic effect. Fluorides at these levels do not necessarily cause injury to the
forage plants themselves. However, injury may be produced in certain species
of vegetation upon long term exposure to low levels of atmospheric fluorides.

(12) The initating properties of hydrogen fluoride in experimental huinan expo-
sure have been manifested by desquamation of the skin, at concentrations of 2-5
ppm, mucous membrane irritation also occurs from hydrogen fluorides but
quantitative data are not adequate to support a standard.

( 13) It is clear that lead levels should be set on the basis of average values for long
periods. While data are abundant concerning human response to eight-hours-
a-day, five- days-a-week exposures, data are insufficient for the effects of the
continuous exposure inherent in community air pollution. While laboratory stu-
dies will be pursued with vigor, it becomes very important that local agencies
collect data on existing lead levels. Since lead exposures are from multiple
sources, community air pollution standards should be based on a portion of the
total limit for population exposure.

History

1. Amendment filed 3-26-62; effective thirtieth day thereafter (Register 62, No.
6).

2. Amendment filed 1 1-23-65; effective thirtieth day thereafter (Register 65, No.

23).

3. Renumbering of former Section 30501 to Section 30690 and new Section 30501
filed 6-6-88; operafive 7-6-88 (Register 88, No. 24).

Subchapter 6. Organized Camps

Article 1 . General

§ 30700. Definitions.

(a) "Aquatics Supervisor" means a person who provides supervision
to the aquatic facility, staff and program of the camp meeting the require-
ments of Section 30741(d)(1).

(b) "Camp" means an organized camp as defined in Health and Safety
Code, section 18897 and does not include facilities, programs and ar-
rangements listed in Health and Safety Code, section 1596.792.

(c) "Counselor" means a person who is directly involved with camp
program activities and camper supervision meeting the requirements of
Section 30751(b) and (c).

(d) "Director" means a person who is responsible for day-to-day deci-
sion making and supervision of the camp program and staff meeting the
requirements of Section 30751(a).

(e) "Health Screening" means an examination to identify observable
evidence of illness, injury, or communicable disease; to review and up-
date each person's health history; and to identify current medical treat-
ment (including medication), allergies or dietetic restrictions.

(f) "Health Supervisor" means a person who is either a physician, reg-
istered nurse, licensed vocational nurse who is licensed pursuant to Divi-
sion 2 of the Business and Professions Code or a person who is trained
in accordance with section 1596.866 of the Health and Safety Code.

(g) "Site Operator" means an individual, partnership, joint venture, or
organization that owns, leases, or rents an organized camp site.
NOTE: Authority cited: Sections 18897.2, 131050 and 131200. Health and Safety
Code. Reference: Sections 1 8897.2, 1 3 1 05 1 and 1 3 1 052, Health and Safety Code.

History

1 . Repealer of Subchapter 6 and new Subchapter 6 (Secfions 30700-30703,
30710-30715, 30720-30723, 30730-30736, 30740, 30741, 30750 and 30751)
filed 4-2-68; effective thirtieth day thereafter. Approved by State Building
Standards Commission (Register 68, No. 14). See Register62, No. 2, for former
secfions.

2. New subsection (e) filed 1 1-28-80; effective thirtieth day thereafter (Register
80, No. 48).

3. Editorial correcfion of NOTE filed 7-12-84 (Register 84, No. 28).

4. Repealer and new section and amendment of Note filed 3-10-2008; operafive
4-9-2008 (Register 2008, No. 11).

§ 30701 . Limitation of Scope.

The minimum standards pertaining to physical facilities set forth in
this subchapter shall not apply to camping activities carried out:

(a) In locations away from the main living and housing areas of the
camp and where primitive living conditions, that is, conditions lacking
service facilities such as water, sewage, bathing, food, or housing, are an
inherent part of the planned activity; or

(b) Where government regulated campgrounds, beaches, or parks are
utilized that have the equivalent physical facilities as those required by
this subchapter.

NOTE: Authority cited: Secfions 18897.2. 131050 and 131200. Health and Safety
Code. Reference: Sections 18897.2. 131051 and 1 31052, Health and Safety Code.

History

1. Editorial renumbering of foriner Section T 17-30701 to Section 30701 and new
NoTi-: filed 1 1-5-84 (Register 84, No. 45).

2. Amendment of section and Ncm-. filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 11).

§ 30702. General Camp Safety Requirements.

The camp and established trails, shall be in an area properly drained
and free or protected from natural or man-made hazards, such as mine
pits, quarries, and high-speed roads, or large numbers of insects and ven-
omous snakes. Poison oak shall be controlled. Excessive dust that may
be injurious to health and safety in the main living and housing areas of
the camp shall be prevented by suitable means.

NOTE: Authority cited: Secfions 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Secfions 18897.2, 131051 and 131052, Health and Safety Code.

History

1 . Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No.
18).

2. Amendment of secfion heading, section and Note filed 3-10-2008; operative
4-9-2008 (Register 2008, No. 11).

§ 30703. Notice of Intention to Operate.

(a) At least 30 days prior to the operation of any camp in any calendar
year, written notice shall be sent by the site operator to the local health
officer of the city, county, or city and county in which the camp is located,
setting forth the name, location and mailing address of the person or
agency that owns the camp, the name and address of the person or agency
proposing to operate the camp and the proposed dates of occupancy dur-
ing that calendar year. Camps which operate year-round shall provide
only an initial notice of operation.

(b) Written notice shall be sent to the local health officer at least 30
days prior to:

(1) Construction of any new camp,

(2) Any major expansion of physical facihties or

(3) Any changes to items of information required in (a) above.

(c) The local health officer shall acknowledge receipt in writing, with-
in seven days, of said notices and shall, at the same time, send a copy to
the State Fire Marshal.

NOTE: Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Sections 18897.2. 131051 and 131052, Health and Safety Code.

History

1 . Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No.
18).

2. Amendment of secfion and Note filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 11).

§ 30704. Requirements for Camps.

On an annual basis and at change of ownership the site operator shall
submit to the local health officer:

(a) A written verification that the camp is accredited by the American
Camp Association, (formerly the American Camping Association)

or:

(b)( 1 ) A written description of operating procedures that describes the
program of organized and supervised activities of the camp in the follow-
ing areas:

(A) Supervisor qualifications and training

(B) Staff skill verification criteria and process

(D) Staff-to-participant supervision ratios

(E) Equipment needed

(F) Safety procedures

(G) Emergency procedures specific to location

Page 242

Title 17

State Department of Health Services

§ 30720

•

(H) Environmental hazards

(1) Access and equipment control

(J) Equipment and maintenance repair

(2) An accepted reference for these operating procedures are the fol-
lowing chapters of the Accreditation Standards for Camp Programs and
Services (2007 Edition) published by the American Camp Association,
Martinsville. Indiana, identified as:

(A) PD — Program — Design and Activities

(B) PA — • Program — Aquatics

(D) PH — Program — Horseback Riding

(E) PT — Program — Trip and Travel

(c) A written statement by the Director that the Director has reviewed
the criminal history record check and voluntary disclosure statement as
described in section 3075 1 for all individuals for which it is required by
section 30751(a), and documentation of the criminal history record
check of the Director.

NOTH; Authority cited: Sections 18897.2. 131050 and 131200. Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History
1. New section filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 1 1).

Article 2. Utilities

§30710. Water Supply.

(a) A dependable supply of potable water adequate to furnish 50 gal-
lons of water per person per day shall be available. Where pit or chemical
toilets are used, this figure may be reduced to 30 gallons per person per
day.

(b) The water supply system shall conform to the following:

( 1 ) Water wells shall be constructed in accordance with the require-
ments of California Bulletin 74-81, Well Water Standards, Chapter II
and Appendices A, B, C (December 1 98 1 ) and California Bulletin 74-90
(June 1991 ), Well Water Standards published by the Department of Wa-
ter Resources, State of California Resources Agency.

(2) Springs shall meet the following requirements:

(A) Use of a spring as a potable water source shall not be permitted if
it is located on the side of or at the foot of a hill where cesspools, privies,
sewers, or other sources of contamination would be located above the
spring and in the path of the groundwater flow toward the spring. In no
case shall a spring be used if it is located closer than 200 feet to an up-
stream potential source of contamination.

(B) Springs used as a potable water source shall be developed with a
tight box or enclosure including a watertight cover with no openings that
will permit entrance of surface waters, windblown dusts or small ani-
mals.

(3) No stream sources for potable water shall be used without treat-
ment.

(4) Water supply, quality, monitoring, storage, and distribution shall
comply with the requirements of the California Safe Drinking Water Act,
Health and Safety Code, Section 1 16270, et seq.

Note: Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86,
No. 18).

2. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 11).

§ 3071 1 . Drinking Water.

Drinking water shall be provided and be centrally located in the camp.

Noi H: Authority cited: Sections 18897.2, 13 1050 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History
1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Recistcr 86.
No. 18).

3. Amendment of section heading, section and NoTH filed 3-10 2008; operative
4-9-2008 (Register 2008, No.^1 1 ).

§30712. Handwashing Facilities.

Handwashing facilities shall be provided adjacent to all flush toilets.
Single service soap dispensers shall be provided at handwashing facili-
ties, except for those handwashing facilities located in camper housing
facilities.

NotH: Authority cited: Sections 18897.2. 131050 and 131200. Health and Safety
Code. Reference: Sections 18897.2, 131051 and 1 31052, Health and Safety Code.

History
1 . New section filed 3-10-2008; operative 4-9-2008 (Register 2008. No. 1 1 ). For
prior history, see Register 86. No. 18.

§30713. Showers.

When campers are present for three or more consecutive days and
nights, showers shall be provided.

NoTfi: Authority cited: Sections 18897.2. 1310.S0 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History
1 . New section filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 1 1 ). For
prior history, see Register 86, No. 18.

§30714. Toilets.

Toilets shall be provided at the ratio required in Table 4-4, Part 5, Title
24, California Code of Regulations. Pit or chemical toilets may only be
used in remote areas where a plumbing system for water distribution is
unavailable. Pit or chemical toilets shall be located so as not to endanger
water supplies and shall be so constructed as to exclude flies and vermin.
NOTE; Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Sections 18897.2. 131051 and 1310.S2, Health and Safety Code.

History

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No.
18).

2. Amendment of section and Noth filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 11).

§ 3071 5. Plumbing. [Repealed]

NOTE: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Refer-
ence: Section 18897.2, Health and Safety Code.

History

1 . Amendment filed 3-5-7 1 ; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Register 71, No. 10).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No.
18).

3. Amendment filed 2-26-91; operative 3-28-91 (Register 91, No. 13).

4. Repealer filed .VlO-2008; operative 4-9-2008 (Register 2008, No. 1 1 ).

Article 3. Housing

§ 30720. Building Structures.

(a) Plans and specifications for every building or structure shall be ap-
proved by the local health officer prior to start of any construction.

(b) Nothing in this section shall prohibit the State Department of Pub-
lic Health or local health officer from contracting with the Office of the
State Architect of the Department of General Services or any private or
other governmental agency for the review of design and performance of
inspection of construction of camp buildings and structures, in accor-
dance with the provisions of this section.

NOTE: Authority cited: Sections 18897.2, 131050 and 131200. Health and Safctv
Code. Reference: Sections 18897.2, 131051 and 131052. Health and Safely Code.

History

1 . Amendment filed 3-5-71; effective thirtieth day thereafter. Approved h\ State
Building Standards Commission 2-26-71 (Regi.ster 71. No. 10).

2. Amendment filed 1 1-28-80; effective thirtieth day thereafter (RcL'istcr 80. No.
48).

3. Amendment filed 4-28-86; effective thirtieth day thereafter (Rctiister 86, No.
18).

4. Amendment of subsection (b) and deletion of reference citation filed 2 26-9 1 :
operative 3-28-91 (Register 9 \, No. 13).

5. Amendment of section and Note filed 3-10-2008; operative 4-9 2()()8 ( Regis
ter2008,No. 11).

Page 243

§ 30721

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 30721. Sleeping Accommodations.

Head-to-head sleeping accommodations sliall be prohibited. A mini-
mum space of 1 8 inches, or a physical barrier, shall be provided between
bed units including sleeping bags.

NOTH; Authority cited: Sections 18897.2, 13 1050 and 1 3 1 200, Health and Safety
Code. Reference: Sections 1 8897.2, 1 3 1 05 1 and 1 3 1 052, Health and Safety Code.

History

1 . New subsection (c) filed 1 1-28-80; effective thirtieth day thereafter (Register
80, No. 48).

2. Amendment filed 4-28-86; effective thirtieth dav thereafter (Register 86,

No. 18).

3. Amendment of section and NoTi-. filed 3-1 0-2008; operative 4-9-2008 (Reais-
ter2008. No. 11).

§ 30722. Repair, Safety, Maintenance and Sanitation.

(a) Every building, structure, tent, tent structure, cabin, and premises
shall be kept in good repair, and shall be maintained in a safe and sanitary
condition, clean and free from accumulations of paper, rubbish, or stand-
ing water, satisfactory to the local health officer.

(b) All appliances, equipment, devices, facilities, electrical, mechani-
cal, plumbing, refrigerating and ventilating systems shall be kept in good
repair, and shall be maintained in a safe and sanitary condition satisfacto-
ry to the local health officer.

(c) When provided, mattresses, mattress covers, blankets, sheets, pil-
lows, and/or sleeping bags shall be maintained sanitary and in good con-
dition. Blankets, sheets, pillows, and/or sleeping bags shall be laundered
and/or sanitized prior to issuance to a camper. Mattresses shall be cov-
ered with waterproof material or washable covers so as to be easily
cleaned and sanitized.

NOTl-:: Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1 . Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No.
18).

2. Amendment of subsecfions (a) and (b) and Note filed 3-10-2008; operative
4-9-2008 (Register 2008, No. 11).

§ 30723. Overhead Electrical Line Construction.

All overhead electrical lines installed in camp shall be in accordance
with the Public Utilities Commission, General Order No. 95 (January
2006), Rules for Overhead Electrical Line Construction.
NOTE: Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86, No.

18).

2. Amendment filed 2-26-91; operative 3-28-91 (Register 91, No. 13).

3. Amendment of section heading, section and Noth filed 3-10-2008; operative
4-9-2008 (Register 2008, No. 11).

§ 30724. Mechanical Installation. [Repealed]

NOTE: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Refer-
ence: Section 18897.2, Health and Safety Code.

History

1. New section filed 4-28-86; effective thirtieth day thereafter (Register 86, No.

18).

2. Amendment filed 2-26-91; operafive 3-28-91 (Register 91, No. 13).

3. Repealer filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

Article 4.

Food Service Facilities and
Operations

§ 30730. Food Service Facilities.

Food service facilities shall comply with the requirements of the Cali-
fornia Retail Food Code, Health and Safety Code, Section 1 1 3700, et seq.
NOTE: Authority cited: Secfions 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History
1 . Repealer of former Section Tl 7-30730 and new Section 30730 filed 4-28-86;

effective thirtieth day thereafter (Register 86, No. 18). For prior history, see

2. Amendment of section and Noti-: filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 1 1 ).

§ 30731. Light, Ventilation and Sanitary Facilities.

NOTE: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Refer-
ence: Section 18897.2. Health and Safety Code.

History
1 . Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86. No. 18).

§ 30732. Cleaning and Sanitizing of Multiuse Utensils.

NOTIi; Authority cited: Sections 208 and 1 8897.2, Health and Safety Code. Refer-
ence: Section 18897.2, Health and Safety Code.

History
1 . Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

§ 30733. Storage of Food, Utensils and Equipment.

NOTE: Authority cited: Sections 208 and 1 8897.2, Health and Safety Code. Refer-
ence: Section 18897.2, Health and Safety Code.

History
1 . Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 18).

§ 30734. Health Requisites for Food Service Personnel.

NOTE: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Refer-
ence: Secfion 18897.2, Health and Safety Code.

History
1 . Repealer filed 4-28-86; effective thirtieth day thereafter (Register 86, No. 1 8).

Article 4.1. Food Service Facilities and

Operations at Intermittent Short-Term

Organized Camps [Repealed]

§ 30734.1. Food Service Facilities and Operations at

Intermittent Short-Term Organized Camps.
[Repealed]

NOTE: Authority cited: Sections 208 and 18897.2, Health and Safety Code. Refer-
ence: Section 18897.2, Health and Safety Code.

History

1 . New Article 4. 1 (Section 30734. 1 ) filed 1 1-28-80; effective thirtieth day there-
after (Register 80, No. 48).

2. Amendment filed 4-28-86; effecfive thirtieth day thereafter (Register 86, No.
18).

3. Repealer of article 4.1 (secfion 30734.1) and section filed 3-10-2008; operative
4-9-2008 (Register 2008, No. 1 1 ).

Article 5. Solid Waste

§ 30735. Garbage and Refuse.

All garbage and refuse shall be deposited and stored in flytight con-
tainers, removed and disposed of at a frequency and in a manner satisfac-
tory to the local health officer.

NOTE: Authority cited: Sections 1 8897 .2, 1 3 1 050 and 1 3 1 200, Health and Safety
Code. Reference: Secfions 18897.2. 131051 and 131052, Health and Safety Code.

History

1. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86,
No. 18).

2. Amendment of section and Note filed 3-10-2008; operafive 4-9-2008 (Regis-
ter 2008, No. 11).

Article 6. Vector Control

§ 30736. Vectors and Pests.

Every camp shall have a plan and equipment for coping with excessive
numbers of flies, mosquitoes and other insects and with rodents. At times
or places where special risk of transmission of disease to humans from
insects, rodents or other animals exists, the camp shall institute special
measures to protect the campers, under the guidance of the local health
officer.

NOTE: Authority cited: Secfions 18897.2, 131050 and 131200, HeaUh and Safety
Code. Reference: Sections 18897.2. 131051 and 131052, Health and Safety Code.

History

1. New Note filed 7-12-84 (Register 84, No. 28).

2. Amendment of secfion and Note filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 11).

Page 244

Title 17

State Department of Health Services

§ 30750

Article 7. Swimming and Bathing

Article 8. Supervision

•

§ 30740. Swimming Facilities.

All swimming pools, pools, wading pools and special purpose pools
which are located in or provided for any camp shall be designed,
constructed, maintained, and operated in accordance with the provisions
of Article 5, Chapter 5. Part 10. Division 104, of the Health and Safety
Code. Sections 1 16035-1 16068. and with the applicable provisions of
Chapter 20. Division 4, Title 22. and Chapter 3 1 . Part 2. Title 24. Sections
3101B-3137B.2, and Figures 31B-1-31B-5 of the California Code of
Regulations.

NOTE: Authority cited: Sections 18897.2, 13 1050 and 131 200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1. Amendment filed 3-5-71; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Regi.ster 71, No. 10).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Recister 86,
No. 18).

3. Amendment of section and NoTi- filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 1 1 ).

§ 30741 . Lake, Stream, River or Ocean Swimming.

(a) A plan for the use of any lake, stream, river or the ocean by any
camp for swimming or boating shall be:

( 1 ) Developed and maintained by the Director,

(2) Submitted to the local health officer prior to use. and

(3) Implemented in accordance with any special conditions that may
be specified in writing by the local health officer to protect health and
safety.

(b) Any camp which uses places such as lakes, streams, rivers or the
ocean for swimming shall be equipped with at least one lifeboat or equiv-
alent water safety device that is suited to the size, location and use of the
water facility, population of the camp, and dangers inherent to the water
facility as determined by the Director of the camp and that shall:

( 1 ) Be used for no other purpose than for saving lives or for other emer-
gencies,

(2) Be kept in good repair and readily accessible to the areas of poten-
tial use, and

(3) Comply with Harbors and Navigation Code Section 652.

(c) No camp shall maintain or use a lake, stream or river unless careful
soundings of depth of water and location of eddies and pools and determi-
nations of the presence and nature of dangerous currents, sunken logs,
rocks and obstructions in the lake, stream or river have been made and:

( 1 ) Legible signs indicating in plain letters, the depth of water, the lo-
cation of pools or eddies, and the presence and direction of currents of
water shall be posted at any lake, stream or river used by a camp for camp-
er swimming, and

(2) The signs shall be visible from the swimming or bathing area dur-
ing the season when bathing and swimming are permitted.

(d) Lifeguard services equivalent to those defined in Section 1 16028,
Health and Safety Code, shall be provided at any location used for swim-
ming by campers.

(1) There shall be a designated aquatics supervisor who is at least 18
years of age and who shall possess an American Red Cross Lifeguard
Certificate, YMCA Swim Lifesaving Certificate or its equivalent cerfifi-
cate.

(2) Lifeguard service shall be provided at a ratio of 1 lifeguard for each
25 campers in the water.

NOTH: Authority cited: Sections 18897.2, 131050 and 1 3 1 200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1 . Amendment filed 3-5-7 1 ; effective thirtieth day thereafter. Approved by State
Building Standards Commission 2-26-71 (Register 71, No. 1(3).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86,
No. 18).

3. Amendment of section heading, secfion and Notk filed 3-10-2008; operative
4-9-2008 (Register 2008, No. 11).

§ 30750. Health Supervision.

(a) Every camper and each staff member entering camp shall furnish
a health history of his or her health status that is completed and signed
by the individual camper or staff memiber, or by the parent or guardian
if the camper or staff member is under the age of 1 8. This history shall
be kept on-site as long as the camper or staff member is at camp and shall
include the following:

( 1 ) A description of any health condifion requiring medication, treat-
ment, special restriction or consideration while at camp,

(2) A record of immunizations including date of the last tetanus shot,

(3) A record of any allergies.

(b) A signed statement by a parent or guardian to seek emergency med-
ical treatment shall be provided for each staff member or camper, except
those minors accompanied in camp by a parent or guardian. The local
health officer, when necessary for the protection of the health of campers
and staff members, may require special inoculations and testing for each
camper and staff member entering camp.

(c) There shall be a full-fime adult Health Supervisor charged with
health supervision at the camp when campers are present

(d) Health screening shall he conducted under the supervision of the
Health Supervisor by qualified staff that meet the requirements of section
30700(f) for:

(1) All staff prior to the arrival of campers; and

(2) All campers under the age of 1 8 who are unaccompanied by a par-
ent or guardian within 24 hours of arrival at camp.

(e) If a physician is not on site when campers are present, arrangements
shall be made for a physician to be available on an on-call basis. An infir-
mary (tentage or other shelter), with provision for isolating patients, shall
be provided. Advance arrangements shall be made for the immediate re-
moval of seriously sick or injured campers or staff members to a point of
adequate medical care, on recommendation of a physician. This subsec-
tion shall not apply to intermittent short-term organized camps operating
less then 72 hours except when required by the local health officer for the
protection of the health of campers and adult supervisors.

(f) A medical logbook shall be maintained by the Health Supervisor
which includes at least the following informafion for each accident, inju-
ry or illness:

( 1 ) Name of the person treated;

(2) Dosage and intervals of any medication dispensed;

(3) First aid or medical treatment rendered;

(4) Name of the person administering the first aid or medical treat-
ment;

(5) Date and time of treatment; and

(6) Date parent/guardian notified of accident, illness or injury.

(g) The Health Supervisors or the site operator shall report all occur-
rences of foodborne illness, suspected foodbome illness, or any other re-
portable disease as required by California Code of Regulations Title 1 7.
section 2500(b) promptly to the local health officer for the camp location.

(h) All medicadon brought to a camp by campers that needs to be dis-
pensed by the Health Supervisor or qualified staff that meet the require-
ments of section 30700(f) shall be:

(1 ) In the original container and labeled in accordance with California
Health and Safety Code, Division 104., Part 5, Chapter 6, Article 3. com-
mencing with section 1 1330, or

(2) In containers accompanied by specific written dispensing instruc-
tions from a parent, legal guardian, or physician licensed pursuant to Di-
vision 2 of the Business and Professions Code, and

(3) Stored in a locked container when unattended by the Health Super-
visor.

(i) A written health care plan developed and maintained by the Health
Supervisor shall be used at the camp. The health plan shall include:

( 1 ) The responsibilities and authority of the Health Supervisor and oth-
er qualified health staff meeting the requirements of section 307()0( f) that
provide health care including first aid,

(2) The procedures for camp health care and sanitation.

Page 245

§ 30751

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(3) A record keeping process,

(4) A plan for provisions and maintenance of supplies and equipment,
and

(5) The relationships and agreements with local medical personnel,
hospitals, and providers of emergency care and other emergency care
providers.

(6) A plan to prevent and control the spread of pandemic flu or other
communicable diseases among campers.

Note: Authority cited: Sections 18897.2, 1310.^0 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1. Amendment filed 11-29-80; effective thirtieth day thereafter (Register 80,
No. 48).

2. Amendment filed 4-28-86; effective thirtieth day thereafter (Register 86.
No. 18).

3. Amendment of section and NOTI- filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008. No. II).

§ 30751 . General and Safety Supervision.

(a) When campers are present, every camp shall have a Director at the
camp in charge who is at least 25 years of age and has at least two seasons
of administrative or supervisory experience in camp activities. The Di-
rector shall provide staff for the care, protection, and supervision of the
campers. The Director and all camp counselors shall not have direct un-
supervised contact with campers without first obtaining a satisfactory
criminal history record check from the California Department of Justice,
Bureau of Criminal Identification, or U.S. Department of Justice Nation-
al Sex Offender Public Registry, and a voluntary disclosure statement
that contains the same information as standard HR^ Staff Screening of
the Accreditation Standards for Camp Programs and Services, American
Camp Association (2007 Edition).

(b) When campers are present, there shall be at least one counselor
who is a high school graduate or who is at least 1 8 years of age, for each
10 campers under 16 years of age.

(c) The Health Supervisor shall verify that all counselors have been
trained in the principles of first aid and cardiopulmonary resuscitation.

(d) Subsections (b) and (c) shall not apply to intermittent organized
short-term camps.

NOTE: Authority cited: Sections 18897.2, 131050 and 131200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1. Amendment and new subsection (d) filed 11-28-80; effective thirtieth day
thereafter (Register 80, No. 48).

2. Relettering of former subsection (d) to (e) and new subsection (d) filed 4-28-86;
effective thirtieth day thereafter (Register 86, No. 18).

3. Amendment of section and Note filed 3-10-2008; operative 4-9-2008 (Regis-
ter 2008, No. 1 1 ).

§ 30752. Firearms.

All firearms and ammunition, when not in use for authorized camp ac-
tivities, shall be stored in a cabinet designated for this use and locked. The
key shall be in the possession of the Director or qualified designee meet-
ing the requirements of section 30751(a).

NOTE: Authority cited: Sections 18897.2, 131050 and 131200. Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1. New section filed 4-28-86; effective thirtieth day thereafter (Register 86,
No. 18).

2. Amendment of section heading, repealer and new section and amendment of
Note filed 3-10-2008; operative 4-9-2008 (Register 2008, No. 11).

§ 30753. Emergency Plan.

(a) Each camp shall retain on site a written site specific plan, approved
by the Director, outlining procedures which deal with the following
emergency situations:

(1) Natural disasters.

(2) Lost campers.

(3) Fires.

(4) Transportation emergencies.

(5) Severe illnesses and injuries.

(6) Strangers in camp.

(7) Aquatic emergencies as appropriate for the site.

(8) Other emergency situations as appropriate for the site.

(b) The site specific plan shall include procedures for:

( 1 ) Evacuation of the camp site,

(2) Control of vehicular traffic through the camp, and

(3) Communication from persons at the site of an emergency to the
emergency medical facilities, the nearest fire station, and both adminis-
trative and health staff of the camp.

NOTE: Authority cited: Sections 18897.2, 131050 and 1 31200, Health and Safety
Code. Reference: Sections 18897.2, 131051 and 131052, Health and Safety Code.

History

1. New section filed 4-28-86; effective thirtieth day thereafter (Register 86,
No. 18).

2. Amendment of section heading, section and Note filed 3-10-2008; operative
4-9-2008 (Register 2008, No.^1 1 ).

Subchapter 7. Wiping Rags

Article 1. Definitions

NOTE: Authority cited: Secfions 208, 3900, 3901, 15020 and 25800-25870,
Health and Safety Code; Section 1224. Business and Professions Code. Reference:
Sections 3900, 3901 , 15000-15023 and 2581 1, Health and Safety Code; Secfions
475, 480, 481, 482 and 1242.5, Business and Professions Code.

History

1. New Subchapter 7, Articles 1 and 2 (Sections 30800 and 30801) filed 12-12-75;
effective thirtieth day thereafter (Register 75, No. 50).

2. Amendment filed 7-2-80; effective thirtieth day thereafter (Register 80, No.

27).

3. Repealer of Article 1 (Secfion 30800) filed 10-24-84; effective thirtieth day
thereafter (Register 84, No. 43).

Article 2.

Minimum Standards for
Sanitizing

§30801. standards.

The wiping rags or materials to be processed and used as wiping rags
shall be washed using an effecdve soap or detergent and thoroughly
rinsed to remove soap or detergent and soil. Wiping rags shall be exposed
to water at a minimum temperature of 71°C (160°F) for at least 24 min-
utes during the washing process.

NOTE: Authority cited: Secfions 208 and 3901, Health and Safety Code. Refer-
ence: Section 3901, Health and Safety Code.

History
1 . Amendment filed 1 0-24-84; effective thirtieth day thereafter (Register 84, No.

43).

Subchapter 8.

Drinking Utensils and Ice
Buckets

Article 1. Definitions

§ 30850. Single Service.

"Single service" means a utensil, container, implement, wrapper, or
other article designed for use only once and then discarded in the prepara-
tion, storage, display, service, consumption, or sale of food or beverage.
NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

History

1. New Subchapter 8 (Sections 30850-30858) filed 12-21-78; effecfive thirtieth
day thereafter (Register 78, No. 51 ).

Page 246

Title 17

State Department of Health Services

§ 30858

§30851. Multiuse.

"MultiusL'" means a utensil, container, implement, wrapper, or other
article designed for use more than once in the preparation, storage, dis-
play, service, consumption, or sale of food or beverage.
NOTIi: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

Article 2. Washing, Sanitizing, and

Handling of Drinking Utensils and Ice

Buckets in Hotels, Motels, and Other Public

Places

§ 30852. Utensils and Containers, Conditions of Use and
Storage.

(a) Multiuse and single service drinking utensils and ice buckets shall
be protected from dirt, vermin, droplet infection, overhead leakage, and
other potential contamination during handling, storage, and distribution.

(b) Multiuse drinking utensils or ice buckets may be used in guest
rooms under the following conditions:

( 1 ) They are thoroughly washed and sanitized after each use.

(2) The drinking utensils, prior to distribution, are placed in protective
bags with the open end of the utensil placed in the closed end of the bag
to prevent handling of the lip contact surface.

(3) No utensil shall be labeled or otherwise indicate to have been
cleaned and sanitized unless it has been cleaned and sanitized in accor-
dance with Section 30853 and/or 30855.

(c) Single service drinking utensils or ice buckets may be used in guest
rooms under the conditions that the drinking utensils are dispensed by
one of the following methods:

( 1 ) From a dispenser which keeps the lip contact surface enclosed.

(2) Individually wrapped.

NOTt;: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

History
1 . Amendment filed 2-28-85; effective upon filing pursuant to Government Code
Section 1 1346.2(d) (Register 85, No. 9).

§ 30853. Hand Dishwashing and Sanitizing.

(a) Multiuse drinking utensils or ice buckets shall be washed and sani-
tized in a three-compartment metal sink equipped with hot and cold run-
ning water and integral metal drain boards.

(b) The drinking utensils and ice buckets shall be processed in the fol-
lowing sequence:

( 1 ) Washed with hot water 40.5-^9" Celsius ( 105-1 20°?) and deter-
gent in the first sink compartment until thoroughly cleaned.

(2) Rinsed in hot water 40.5-49° Celsius (105-120OF) in the second
compartment.

(3) Immersed in the third compartment containing a bactericidal solu-
tion in such concentration and for such time as specified in Section
30854.

(c) A facility with a two-compartment metal sink with metal drain-
boards on the effective date of these regulations may continue to use such
sink utilizing procedures listed in ( 1 ) and (3) of Subsection 30853(b) until
replacement is necessary because of deterioration or modernization of
premises.

NOTK: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

§ 30854. Sanitizing Solutions for Hand Dishwashing.

(a) Multiuse utensils and ice buckets shall be sanitized by immersion
in one of the following bactericidal solutions for a minimum of 30 sec-
onds in the last sink compartment.

(1 ) 100 parts per million (ppm) of available chlorine from either hy-
pochlorite or organic chlorine approved by the Department.

(2) 200 ppm of a quaternary ammonium compound approved by the
Department.

(3) 25 ppm of available iodine.

(4) 25 ppm of iodophor.

(5) 25 ppm of bromine-chlorine compounds.

NOTK: Authority cited: Section 208. Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

§ 30855. Machine Washing and Sanitizing.

(a) All dishwashing machines shall be designed, installed, and oper-
ated to thoroughly clean and provide an effective bactericidal rinse.

(b) Commercial type of dishwashing machines when used in food es-
tablishments regulated by the California Restaurant Act, shall meet all
the requirements of that chapter (Chapter 1 1, Division 22, of the Health
and Safety Code, commencing with Section 28520). These include, hut
are not limited to, the following:

(1) Hot water sanitizing dishwashing machines.

(2) Chemical sanitizing dishwashing machines approved by the De-
partment.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

§ 30856. Sanitizing Requirements for Dishwashing
Machines.

(a) The hot water sanitizing commercial dishwashing machine shall be
connected to a hot water system that is installed and maintained to contin-
uously provide water at least 82.2" Celsius ( 1 8()"F) at the final rinse man-
ifold of the machine during the required bactericidal rinse cycle.

(b) The domestic type hot v,'ater sanitizing dishwashing machine shall
produce a minimum water temperature of 74° Celsius ( 165"F) during the
wash and rinse cycles.

( 1 ) A sanitizing solution of at least 50 ppm hypochlorite.

(2) A sanitizing solution of at least 12.5 ppm iodophor.

(3) Any other bactericidal solution approved by the Department.

(d) Any other method approved by the Department.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

§ 30857. Maintenance and Construction Requirements.

(a) All drinking utensils, ice buckets, shelves, sinks, dishwashing ma-
chines, and other related equipment shall be:

( 1 ) Constructed of non-toxic materials,

(2) Constructed, installed, and maintained as to be readily cleanable,
and

(3) Kept clean and in good repair.

NOTE: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

§ 30858. Inspection Authority.

(a) The Director, agents, or Registered Sanitarians appointed by the
Director, and local health officers. Registered Sanitarians, and duly au-

[The next page is 247.

Page 246.1

•

Title 17

State Department of Health Services

§ 33004

thorized agents thereof may at reasonable times enter and inspect any ho-
tels, motels, or other public places governed by these regulations.
NOTH: Authority cited: Section 208, Health and Safety Code. Reference: Sections
3700 and 3701, Health and Safety Code.

Chapter 6.

Lead Poisoning Prevention
Programs

Article 1. Definitions

§33001. Applicant.

"Applicant" means a business entity either applying for an exemption
pursuant to section 105310(d) of the Health and Safety Code and Section
33040 of this chapter, or applying for a reassessment of the fees pursuant
to section 33050 of this chapter. "Applicant" includes any other business
entity who was historically associated with the business entity making
the application.

NOTK: Authority cited: Section 10531 0, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New chapter 6, article 3 (sections 33001-33030, not consecutive) filed 2-1-93
as an emergency; operative 2-1-93 (Register 93, No. 6). A Certificate of Com-
pliance must be transmitted to OAL 6-1-93 or emergency language will be re-
pealed by law on the following day. For prior history, see Register 78, No. 24.

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and
filed 7-12-93 (Register 93, No. 29).

3. Amendment of subsection (c)(2) and new subsecUon (c)(4) filed 5-15-95; op-
erative 6-1 4-95. Exempt from OAL review pursuant to Health and Safety Code
section 372.7(h) (Register 95, No. 20).

4. Repealer of article 3 heading and section and new article 1 (sections
33001-33015) and section filed 7-19-2001 as an emergency; operative
7-19-2001. A Certificate of Compliance must be transmitted to OAL by
11-1 6-200 1 or emergency language will be repealed by operation of law on the
following day. Exempt from OAL review pursuant to Health and Safety Code
section 105310(h) (Register 2001, No. 29).

5. Repealer of article 3 heading and section and new article 1 (sections
33001-33015) and section refiled 11-14-2001 as an emergency; operative
11-17-2001. A Certificate of Compliance must be transmitted to OAL by
3-18-2002 or emergency language will be repealed by operation of law on the
foilowins day. Exempt for OAL review pursuant to Health and Safety Code sec-
tion 105310(h) (Register 2001, No. 46).

6. Repealer of article 3 heading and section and new article 1 (sections
33001-33015) and secfion refiled 3-12-2002 as an emergency; operative
3-19-2002. A Certificate of Compliance must be transmitted to OAL by
7- 1 7-2002 or emergency language will be repealed by operation of law on the
following day. Exempt for OAL review pursuant to Health and Safety Code sec-
tion 105310(h) (Register 2002, No. 11).

7. Certificate of Compliance as to 3-12-2002 order, including amendment of sec-
tion, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No.
34).

§ 33002. Architectural Coating.

"Architectural coating" means any product which is used as, or usable
as, a coating applied to the interior or exterior surfaces of stationary struc-
tures and their appurtenances, to portable buildings, to pavements, or to
curbs, such as house and trim paints, varnishes, stains, lacquers, indus-
trial maintenance coatings, primers, undercoaters, and traffic coatings.
Note: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operafive 7-19-2001. A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 105310(h) (Reg-
ister 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operative 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

3. New section refiled 3-12-2002 as an emergency; operative 3-19-2002. A Cer-
tificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for

OAL review pursuant to Health and Safety Code section 105310(h) (Register
2002. No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment of
NoTii, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No.
34).

§ 33003. Architectural Coating Distribution.

"Architectural coating distribution" means any of the following:

(a) The manufacturing, producing, blending, or compounding of ar-
chitectural coating in this state, and the sale, donation, barter, or use of
the architectural coating in this state.

(b) The importing of architectural coating into this state with respect
to which there has been no prior distribution subject to the fee, and the
sale, donation, barter, or use of architectural coating in this state.

(c) The receiving in this state by a distributor of architectural coating
with respect to which there has been no prior distribution subject to the
fee, or the receipt in this state by any business entity of architectural coat-
ing with respect to which there has not been a prior distribution on which
a fee has been paid pursuant to this section, and the sale, donation, barter,
or use of the architectural coating in this state.

(d) The sale of architectural coatings by any business entity required
to be registered pursuant to Revenue and Taxation Code Section 6001 et
seq., when it is shipped into this state by the seller or delivered by the sell-
er to a carrier, customs broker, or forwarding agent, whether hired by the
order of the purchaser or not, for shipment into this state for subsequent
sale, donation, barter, or use in this state.

NOTE: Authority cited: Secfion 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operative 7-1 9-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 1 053 10(h) (Reg-
ister 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operative 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-1 8-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section r053 10(h)
(Register2001,No. 46).

3. New section refiled 3-12-2002 as an emergency; operafive 3-19-2002. A Cer-
tificate of Compliance must be transmitted to OAL by 7-1 7-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code section 105310(h) (Register
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment of sub-
sections (c)-(d) and amendment of Note, transmitted to OAL 7-16-2002 and
filed 8-22-2002 (Register 2002, No. 34).

§ 33004. Architectural Coating Distributor.

"Architectural coating distributor" means each business entity that
distributes or has distributed architectural coatings, excluding each busi-
ness entity that the Department has:

(a) Currently granted an exemption pursuant to section 33040;

(b) Determined to be insolvent; or

(c) Determined did not distribute architectural coatings in or about
1978, and is not historically associated with an architectural coating dis-
tributor which distributed architectural coatings in or about 1978.
NOTE: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1. New section filed 7-19-2001 as an emergency; operative 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 105310(h) (Reg-
ister 2001, No. 29).

2. New secdon refiled 1 1-14-2001 as an emergency; operative i 1-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-1 8-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

3. New section refiled 3-12-2002 as an emergency; operative 3-1 9-2002. A Cer-
tificate of Compliance must be transmitted to OAL by 7-1 7-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code .section 105310(h) (Register
2002, No. 11).

Page 247

§ 33005

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Certificate of Compliance as to 3-12-2002 order, includins amendment of sec-
tion, transmitted to OAL 7-16-2002 and filed 8-22-2002''(Resister 2002, No.
34).

§ 33005. Appurtenance.

"Appurtenance" means accessories to an architectural structure, such
as hand railings, cabinets, bathroom and kitchen fixtures, fences, deck-
ing, furniture, rain-gutters and down spouts, window screens, lamp-
posts, heating and air conditioning equipment, other mechanical equip-
ment, large fixed stationary tools and concrete forms.
NOTE; Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and I24I65, Health and Safety Code.

History

1 . New section filed 7-1 9-2001 as an emergency; operad ve 7-1 9-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operaUon of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 1 053 1 0(h) (Reg-
ister 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operative 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-1 8-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL
7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§ 33006. Business Entity.

"Business entity" means any natural person, or form of business orga-
nization, including, but not Hmited to, a corporation, trust, firm, joint
stock company, business concern, partnership, limited liabihty compa-
ny, or association.

NOTE: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-1 9-2001 as an emergency; operative 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 105310(h) (Reg-
ister 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operative 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-1 8-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001. No. 46).

3. New section refiled 3-1 2-2002 as an emergency; operative .3-19-2002. A Cer-
fificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code section 105310(h) (Register
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL
7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§ 33007. Department.

"Department" means the State Department of Health Services.
NOTE; Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105280(c), 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-1 9-2001 as an emergency; operadve 7-1 9-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 105310(h) (Reg-
ister 2001, No. 29).

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL
7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§ 33008. Environmental Lead Contamination.

"Environmental lead contamination" means the persistent presence of
lead in the environment, in quantifiable amounts, that results in ongoing
and chronic exposure to children.

NOTE; Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105280(g), 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operative 7-1 9-2001. A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 105310(h) (Rec-
ister2001,No. 29).

2. New section refiled 1 1-14-2001 as an emergency; operafive 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-1 8-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

3. New section refiled 3-1 2-2002 as an emergency; operative 3-1 9-2002. A Cer-
tificate of Compliance must be transmitted to OAL by 7-1 7-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code section 105310(h) (Register
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL
7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§ 33009. Fee.

"Fee" means a fee imposed under Health and Safety Code section
105310 and implementing regulations.

Note; Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operative 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 105310(h) (Reg-
ister 2001, No. 29).

3. New section refiled 3-12-2002 as an emergency; operafive 3-19-2002. A Cer-
fificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code section 105310(h) (Register
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL
7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§ 33010. Historically Associated.

"Historically Associated" means that the business entity has a signifi-
cant relationship to another business entity, such as a business entity
which:

(a) Is the alter ego, successor, successor-in-interest, or predecessor,
in full or part, of another business entity;

(b) Purchased controlling or significant interest in another business
entity;

(d) Exists by way of a merger, consolidation, or reorganization of
another business entity;

(e) Acquired the products of another business entity, unless the busi-
ness entity from which the products were acquired is assessed a fee for
the same products;

(f) Acquired the goodwill of another business entity, unless the busi-
ness entity from which the goodwill was acquired is assessed a fee for the
same products.

NOTE; Authority cited; Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 2-1-93 as an emergency; operative 2-1-93 (Register 93, No.
6). A Certificate of Compliance must be transmitted to OAL 6-1-93 or emer-
gency language will be repealed by operation of law on the following day,

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and
filed 7-12-93 (Register 93, No. 29).

3. Repealer and new section filed 7-19-2001 as an emergency; operative
7-19-2001. A Certificate of Compliance must be transmitted to OAL by

Page 248

Title 17

State Department of Health Services

§ 33015

•

1 1-16-2001 or emergency language will be repealed by operation of law on the
following day. Hxempt from OAL review pursuant to Health and Safety Code
section 105310(h) (Register 2001, No. 29).

4. Repealer and new section refiled 11-14-2001 as an emergency; operative
11-17-2001. A Certificate of Compliance must be transmitted to OAL by
3-18-2002 or emergency language will be repealed by operation of law on the
following day. Hxempt for OAL review pursuant to Health and Safety Code sec-
tion 105310(h) (Register 2001, No. 46).

5. Repealer and new section refiled 3-12-2002 as an emergency; operative
3-19-2002. A Certificate of Compliance must be transmitted to OAL by
7-17-2002 or emergency language will be repealed by operation of law on the
following day. Exempt for OAL review pursuant to Health and Safety Code sec-
tion 105310(h) (Register 2002, No. 11).

6. Certificate of Compliance as to 3-12-2002 order, including amendment of first
paragraph and amendment of Noti;, transmitted to OAL 7-16-2002 and filed
8-22-2002 (Register 2002, No. 34).

§33011. Industry.

"Industry" means motor vehicle fuel distributors, architectural coating
distributors, or facilities releasitig lead into ambient air in California.

NOTE: Authority cited: Section 1053 10, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operative 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code secfion 105310(h) (Reg-
ister 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operafive 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-1 8-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

4. Certificate of Compliance as to 3-12-2002 order transmitted to OAL
7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

§ 3301 2. Motor Vehicle Fuel.

"Motor vehicle fuel" means gasoline, natural gasoline, blends of gaso-
line and alcohol containing more than 15 percent gasoline, and any in-
flammable liquid, by whatever name the liquid may be known or sold,
which is used or is usable for propelling motor vehicles operated or suit-
able for operation on the highway. "Motor vehicle fuel" does not include
kerosene, liquefied petroleum gas, natural gas in liquid or gaseous form,
ethanol, methanol, or inflammable liquids specifically manufactured for
racing motor vehicles which do not contain gasoline or natural gasoline
and which are distributed and used for racing motor vehicles at a race-
track.

NOTE: Authority cited: Secfion 1 053 1 0, Health and Safety Code. Reference: Sec-
fions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operafive 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 11 -16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code secfion 105310(h) (Reg-
ister 2001, No. 29).

2. New section refiled 1 1-14-2001 as an emergency; operative 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emer-
gency language will be repealed by operadon of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

3. New section refiled 3-12-2002 as an emergency; operafive 3-19-2002. A Cer-
tificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency
language will be repealed by operafion of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code secfion 10531()(h) (Register
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment of
N()Ti-„ transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register 2002, No.

34).

§ 33013. Motor Vehicle Fuel Distribution.

"Motor vehicle fuel distribution" means any of the following:

(a) The refining, manufacturing, producing, blending, or compound-
ing of motor vehicle fuel in this state, and the sale, donation, barter, or
use of motor vehicle fuel in this state.

(b) The importing of motor vehicle fuel into this state with respect to
wliich there has been no prior distribution subject to the fee, and the sale,
donation, barter, or use of motor vehicle fuel in this state.

(c) The receiving in this state by a motor vehicle fuel distributor of mo-
tor vehicle fuel with respect to which there has been no prior distribution
subject to the fee, or the receipt in this state by any business entity oi' mo-
tor vehicle fuel with respect to which there has not been a prior distribu-
tion on which a fee has been paid pursuant to this section, and the sale,
donation, barter, or use of the motor vehicle fuel in this state.

(d) The sale of motor vehicle fuel by any business entity required to
be registered pursuant to Revenue and Taxation Code Section 6001 et
seq., when it is shipped into this state by the seller or delivered by the sell-
er to a carrier, customs broker, or forwarding agent, whether hired by the
order of the purchaser or not, for shipment into this state for subsequent
sale, donation, barter, or use in this state.

NOTE: Authority cited: Secfion 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Heahh and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operative 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Hxempt
from OAL review pursuant to Health and Safety Code section 1 053 1 0(h) ( Reg-
ister 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operafive 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-1 8-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

3. New secfion refiled 3-12-2002 as an emergency; operative 3-1 9-2002. A Cer-
fificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code section 105310(h) (Register
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment of sub-
sections (c)-(d) and amendment of Notl, transmitted to OAL 7-16-2002 and
filed 8-22-2002 (Register 2002, No. 34).

§ 33014. Motor Vehicle Fuel Distributor.

"Motor vehicle fuel distributor" means each business entity that dis-
tributes or has distributed motor vehicle fuel excluding each business en-
tity that the Department has:

(a) CurrenUy granted an exemption pursuant to section 33040;

(b) Determined to be insolvent; or

(c) Determined did not distribute motor vehicle fuel in or about 1991,
and is not historically associated with a motor vehicle fuel distributor
which distributed motor vehicle fuel in or about 1991.

NOTE; Authority cited: Secfion 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1. New secfion filed 7-19-2001 as an emergency; operative 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code secfion 105310(h) (Reg-
ister 2001, No. 29).

2. New section refiled 11-14-2001 as an emergency; operafive 11-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section l053 10(h)
(Register 2001, No. 46).

3. New section refiled 3-1 2-2002 as an emergency; operafive 3- 1 9-2002. A Cer-
tificate of Compliance must be transmitted to OAL by 7- 1 7-2002 or emergency
language will be repealed by operation of law on the following day. Hxempt for
OAL review pursuant to Health and Safety Code section 105310(h) (Register
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment of .sec-
fion and Note, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register
2002, No. 34).

§ 33015. Ongoing and Chronic Exposure.

"Ongoing and chronic exposure" means exposure to lead that has been
dispersed into the environment by industry which has not been abated in
accordance with Titie 17, CaUfomia Code of Regulations, Division 1,
Chapter 8, section 35001 et seq.

Page 248.1

§ 33020

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTE: Authority cited: Section lO.'S.^iO, Health and Safety Code. Reference: Sec-
tions 105250. 105310, 124160(b) and 124165. Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operative 7-19-2001. A Certifi-
cate of Compliance must be transmitted to OAL by 1 1-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code section 1 053 1 0(h) (Reg-
ister 2001. No. 29).

2. New section refilcd 11-14-2001 as an emergency: operative 1 1-17-2001. A
Certificate of Compliance must be transmitted to OAL by 3-18-2002 or emer-
gency language will be repealed by operation of law on the following day. Ex-
empt for OAL review pursuant to Health and Safety Code section 105310(h)
(Register 2001, No. 46).

3. New section refiled 3-1 2-2002 as an emergency: operative 3-1 9-2002. A Cer-
tificate of Compliance must be transmitted to OAL by 7-1 7-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code section ]053]()(h) (Reeister
2002. No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment of sec-
tion, transmitted to OAL 7-16-2002 and filed 8-22-2002 (Redster 2002, No.

34).

Article 2. Fees

§ 33020. Fees Attributable to Leaded Architectural
Coatings.

(a) Each architectural coating distributor shall pay a fee assessed and
collected by the Board of Equalization pursuant to Health and Safety
Code section 105310 and calculated as follows:

A
X D

WHERE:

A = Total gallons of architectural coatings distributed in or about 1 978
by each architectural coatings distributor, as estimated by the Depart-
ment based upon the best available data compiled and held by the Depart-
ment.

B = Total gallons of architectural coating distributed in or about 1978
by all architectural coating distributors, as estimated by the Department
based upon the best available data compiled and held by the Department.

D = $2,260,000.00 + the annual adjustment pursuant to Health and
Safety Code section 105310(c).

(b) The fee is due on or before April 1 of each year.

NOTE: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and
filed 7-12-93 (Register 93, No. 29).

3. New article 2 (sections 33020-33030) and amendment of section and Note filed
7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Com-
pliance must be transmitted to OAL by 11-16-2001 or emergency language
will be repealed by operation of law on the following day. Exempt from OAL
review pursuant to Health and Safety Code section 105310(h) (Register 2001,
No. 29).

4. New article 2 (sections 33020-33030) and amendment of section and Note re-
filed 11-14-2001 as an emergency; operative 11-17-2001. A Certificate of
Compliance must be transmitted to OAL by 3-1 8-2002 or emergency language
will be repealed by operation of law on the following day. Exempt for OAL re-
view pursuant to Health and Safety Code section 1 053 1 0(h) (Register 2001 , No.
46).

5. New article 2 (sections 33020-33030) and amendment of section and Note re-
filed 3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Com-
pliance must be transmitted to OAL by 7-17-2002 or emergency language will
be repealed by operation of law on the following day. Exempt for OAL review
pursuant to Health and Safety Code section 1053 10(h) (Register 2002, No. 1 1).

6. Certificate of Compliance as to 3-12-2002 order, including amendment of sub-
section (a), transmitted to OAL 7-16-2002 and filed 8-22-2002 (Register
2002, No. 34).

§ 33025. Fees Attributable to Leaded Gasoline.

(a) Each motor vehicle fuel distributor shall pay a fee, assessed and
collected annually by the Board of Equalization pursuant to Health and
Safety Code section 105310 and calculated as follows:

A
X D

WHERE:

A = Total gallons of motor vehicle fuel distributed in or about 1 99 1 by
each motor vehicle fuel distributor, as estimated by the Department based
upon the best available data compiled and held by the Department.

B = Total gallons of motor vehicle fuel distributed in or about 1 99 1 by
all motor vehicle fuel distributors, as estimated by the Department based
upon the best available data compiled and held by the Department.

D = $13,640,000.00 -i- the annual adjustment pursuant to Health and
Safety Code section 105310(c).

(b) The fee is due on or before April 1 of each year.

NOTE: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

1 . New section filed 7-19-2001 as an emergency; operafive 7-19-2001 . A Certifi-
cate of Compliance must be transmitted to OAL by 11-16-2001 or emergency
language will be repealed by operation of law on the following day. Exempt
from OAL review pursuant to Health and Safety Code secdon 105310(h) (Reg-
ister 2001, No. 29).

3. New section refiled 3-1 2-2002 as an emergency; operafive 3-1 9-2002. A Cer-
fificate of Compliance must be transmitted to OAL by 7-17-2002 or emergency
language will be repealed by operation of law on the following day. Exempt for
OAL review pursuant to Health and Safety Code section 1 053 1 0(h) (Reaister
2002, No. 11).

4. Certificate of Compliance as to 3-12-2002 order, including amendment subsec-
tion (a) and amendment of Note, transmitted to OAL 7-16-2002 and filed
8-22-2002 (Register 2002, No. 34).

§ 33030. Fees Attributable to Facilities Releasing Lead into
Ambient Air in California.

(a) Facilities currently reporting releases of lead into ambient air in
California pursuant to the Superfund Amendments and Reauthorization
Act, Title III, Section 313, shall pay a fee, assessed by the Board of Equal-
ization pursuant to Health and Safety Code section 105310 and calcu-
lated as follows:

A
X C

WHERE:

A = The total pounds of lead reported to be released by each facility
into the Cahfomia ambient air in the most recent calendar year for which
data are available, as reported pursuant to the Superfund Amendments
and Reauthorization Act, Title III, Section 313.

B = The total pounds of lead reported to be released by all facilities into
California ambient air in the most recent calendar year for which data are
available, as reported pursuant to the Superfunds Amendments and
Reauthorization Act, Title III, Section 313.

C = $100,000 + the annual adjustment pursuant to Health and Safety
Code section 105310(c).

(b) The fee is due on or before April 1 of each year.

NOTE: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105310 and 124165, Health and Safety Code.

History

2. Certificate of Compliance as to 2-1-93 order transmitted to OAL 6-1-93 and
filed 7-12-93 (Register 93, No. 29).

Page 248.2

Title 17

State Department of Health Services

§ 33040

3. Amendment of section heading, section and NoTi-; filed 7-19-2001 as an emer-
gency: operative 7-19-2001. A Certificate of Compliance must be transmitted
to OAL hy I I-I6-200I or emergency language will be repealed by operation
of law on the followina day. Kxempt from OAL review pursuant to Health and
Safety Code section 10.S3 10(h) (Register 2001, No. 29).

4. Amendment of section heading, section and NoTH refiled 11-14-2001 as an
emergency; operative 1 1-17-2001 . A Certificate of Compliance must be trans-
mitted to OAL by 3- 1 8-2002 or emergency language wil 1 be repealed by opera-
tion of law on tiie following day. tlxempt for OAL review pursuant to Health
and Safety Code section 105310(h) (Register 2001, No. 46).

5. Amendment of section heading, section and Notk refiled 3-12-2002 as an
emergency; operative 3-19-2002. A Certificate of Compliance must be trans-
mitted to OAL by 7-1 7-2002 or emergency language will be repealed by opera-
tion of law on the following day. Exempt for OAL review pursuant to Health
and Safety Code section 105310(h) (Register 2002, No. 1 1 ).

6. Certificate of Compliance as to 3-12-2002 order transmitted to OAL
7-16-2002 and filed 8-22-2002 (Register 2002, No. 34).

Article 3. Exemption from Fees

§ 33040. Exemption From Fees.

(a) An exemption from the fee imposed under Health and Safety Code
section 1053 10 shall be granted to an applicant who can demonstrate, as
determined by the Department, that all of the following are true:

( 1 ) The industry with which the applicant is associated is not currently
engaged in the stream of commerce of lead or products containing lead;

(2) The industry with which the applicant is associated was not histori-
cally engaged in the stream of commerce of lead or products containing
lead;

(3) The industry with which the applicant is associated is not otherwise
responsible for identifiable sources of lead which currently contribute to
environmental lead contamination;

(4) The industry with which the applicant is associated is not otherwise
responsible for identifiable sources of lead which have historically con-
tributed to environmental lead contamination.

(b) An applicant who does not seek or who fails to demonstrate entitle-
ment to an exemption under subsection (a) shall qualify for an exemption
if the applicant can demonstrate, as determined by the Department, that
either;

(1 ) The applicant's industry did not contribute in any manner to envi-
ronmental lead contamination, or

(2) the applicant's lead, or products containing lead, with which the
applicant is currently, or was historically, associated does not currently,
or did not historically, result in environmental lead contamination.

(c) It shall be presumed that the applicant is subject to the fee until the
applicant establishes the contrary to the satisfaction of the Department.
The presumption may be rebutted by providing a complete application
and any other documentation that the Department requires to establish
the applicant's entitlement to the exemption. Contents of an application
shall include, but are not Mmited to:

(1) A thorough statement, made under penalty of perjury, which dem-
onstrates the applicant' s entitlement to the exemption. The sworn state-
ment shall also contain the declarant's basis of knowledge for making the
statements contained therein. If the person making the statement is not
reasonably available to the applicant, a certified copy of a transcript of
sworn testimony may be submitted. If such prior sworn testimony is used,
the applicant must also provide a declaration as to why the declarant is
not available. More than one statement may be submitted when necessary
to prove the elements of the exemption.

(2) Records providing the information specified below shall be sub-
mitted in duplicate with a sworn statement under penalty of perjury estab-
lishing the reliability and completeness of the records, including a de-
scription of their mode of preparation and maintenance:

(A) The formulation for all products manufactured and all products
sold by the applicant, including the International Union of Pure and Ap-
plied Chemical (lUPAC) name and Chemical Abstract Service (CAS)
number for all ingredients used;

(B) The total amount of lead manufactured, distributed, and sold each
year in the applicant's products;

(C) Any actions taken by the applicant to abate the lead dispersed into
the environment by the applicant's products in accordance with Title 17,
California Code of Regulations, Division 1, Chapter 8, section 35001 el
seq;

(D) Each business entity from whom the applicant purchased lead pig-
ments, lead dryers, and any other lead-containing ingredients used to
manufacture the applicant's products, including name, address, contact
name, phone number, type of lead-containing ingredient, total amount
of lead-containing ingredients purchased, and year purchased;

(E) Any records, or portion thereof which the applicant wants to pro-
tect as a trade secret shall be submitted in a separate sealed envelope
clearly marked on the outside as "Trade Secret Material." For purposes
of this section, "trade secret" shall have the same meaning as in the Uni-
form Trade Secrets Act, Civil Code section 3426 et seq. The application
shall contain a declaration under penalty of perjury describing why the
applicant believes the material is a trade secret. After review, the Depart-
ment will either grant the trade secret request and keep the material confi-
dential, or deny the request, return all copies of the trade secret material
to the applicant, and not consider the trade secret material in its determi-
nation. The Department's refusal to grant a requested claim of trade se-
cret does not excuse the applicant from establishing all elements of the
claim for exemption. Any material which the Department agrees to con-
sider as a trade secret shall be exempt from disclosure under the Public
Records Act, Government Code secfion 6250 et seq. Records for which
the Department has denied protection as a trade secret shall also be ex-
empt from disclosure under the Public Records Act during the time the
records are in the possession of the Department.

(3) A cover letter containing the name and address of the applicant, the
applicant's Board of Equalization account number, the name, address
and telephone number of the person to contact about the application, a
summary of the basis for the exemption , and a listing of all items included
with the application.

(d) The application shall be delivered to the Department at the follow-
ing address:

FEE EXEMPTION REQUEST

CHILDHOOD LEAD POISONING PRIiVENTION BRANCH

DEPARTMENT OF HEALTH SERVICES

1515 CLAY STREET #1801

OAKLAND, CA 94612

(e) An exemption granted under this section is valid for a period speci-
fied by the Department of at least one calendar year.

(f) A business entity seeking to continue an exemption under this sec-
tion shall re-apply to the Department at least 30 days prior to the end of
the period specified by the Department pursuant to section 33040(e).

( 1 ) If the facts underlying the business entity ' s previous application for
exemption have not changed, then an appUcation for continued exemp-
tion shall consist of a sworn declaration stafing there has been no change
and the declarant's basis of knowledge for making such statement.

(2) If there has been a change in the facts underlying the business enti-
ty's previous application for exemption, then a sworn declaration shall
address in detail the nature of the changes. In addition, the application for
continued exemption shall include records proving the applicant's en-
titlement for the exemption, as specified in section 33040(c)(2).

(g) The Department may, in its sole discretion, decide the application
for exemption or continued exemption based upon the information sub-
mitted, or may request the submission of additional information prior to
making a written decision. If the applicant does not provide the additional
material requested by the Department, then the Department may decide
the matter based upon the material already presented.

(h) The Department shall either grant or deny the exemption or contin-
ued exemption.

(1) If the applicafion for exemption or continued exemption is denied.
the applicant may, within 30 days after receipt of the Department" s writ-
ten decision, request reconsideration of the decision from the Depart-

Page 248.3

§ 33050

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

meni. The request for reconsideration shall be in writing, and shall detail
the reasons why the applicant believes the original decision was in error.

(2) The Department may decide the matter based upon the record sub-
mitted in the application, or may request the submission of additional in-
formation. The Department's decision on the reconsideration shall be in
writing, and shall either grant the exemption or continued exemption, or
specify the reasons for its denial.

(i) An applicant who has paid the fee, and thereafter been granted an
exemption by the Department, may apply for a refund to the Board of
Equalization. The request for a refund must be in writing and mailed to:

ST ATI-; HOARJ) OF KQUAITZATION
lTIi;i. TAXi;S DIVISION. MlCi.^O
!>.(). BOX 942879
SAfRAMKNTO. CA 94279-0001

NOTI-.: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 103250, 105310, 124160(b) and 124165, Health and Safety Code.

History

1 . New section filed 5-1 5-95; operative 6-14-95. Exempt from OAL review pur-
suant to Health and Safety Code section 372.7(h) (Register 95, No. 20).

2. New article 3 (section 33040) and amendment of section and NoTi-, filed
7-19-2001 as an emergency; operative 7-19-2001. A Certificate of Com-
pliance must be transmitted to OAL by 11-1(3-2001 or emergency language
will be repealed by operation of law on the following day. Exempt from OAL
review pursuant to Health and Safety Code section 105310(h) (Register 2001,
No. 29).

3. New article 3 (section 33040) and amendment of section and Note refiled
11-14-2001 as an emergency; operative 11-17-2001. A Certificate of Com-
pliance must be transmitted to OAL by 3-1 8-2002 or emergency language will
be repealed by operation of law on the following day. Exempt for OAL review
pursuant to Health and Safety Code section 105310(h) (Register 2001, No. 46).

4. New article 3 (section 33040) and amendment of secfion and Note refiled
3-12-2002 as an emergency; operative 3-19-2002. A Certificate of Com-
pliance must be transmitted to OAL by 7-17-2002 or emergency language will
be repealed by operation of law on the following day. Exempt for OAL review
pursuant to Health and Safety Code section 1 053 1 0(h) (Register 2002, No. 1 1 ).

5. Certificate of Compliance as to 3-12-2002 order, including amendment of sub-
section (c)(2)(C) and amendment of Note, transmitted to OAL 7-16-2002 and
filed 8-22-2002 (Register 2002, No. 34).

Article 4. Application to Reassess Fee

§ 33050. Application to Reassess Fee.

(a) An applicant requesting a reassessment of the fee imposed under
Health and Safety Code section 1053 10 shall submit an application to the
Department which contains:

(1) A statement or statements, made under penalty of perjury, which
demonstrates the applicant's entitlement to a reassessed fee, and which
includes a statement that the applicant has paid in full any and all fees as-
sessed by the Board of Equalization pursuant to this Chapter. The sworn
statement(s) shall also contain the basis of knowledge for making the
statements contained therein.

(2) Records identifying the total gallons of motor vehicle fuel distrib-
uted by the applicant in or about 1991 or the total gallons of architectural
coatings distributed by the applicant in or about 1978. Records, such as
sales data, annual reports, or other information, shall be submitted in du-
plicate with a sworn statement under penalty of perjury establishing the
reliability and completeness of the records, including a description of
their mode of preparation and maintenance. Any records, or portion
thereof, which the applicant wants to protect as a trade secret shall be sub-
mitted in a separate sealed envelope clearly marked on the outside as
"Trade Secret Material." For purposes of this section, "trade secret" shall
have the same meaning as in the Uniform Trade Secrets Act, Civil Code
section 3426 et seq. The application shall contain a declaration under
penalty of perjury describing why the applicant believes the material is
a trade secret.

(3) A cover letter containing the name and address of the applicant, the
applicant's Board of Equalization account number, the name, address
and telephone number of the person to contact about the application, a
summary of the basis for the exemption, and a listing of all items included
with the application.

(b) If the application is denied, the applicant may, within 30 days after
receipt of the Department's written decision, request reconsideration of
the decision from the Department. The request for reconsideration shall
be in writing, and shall detail the reasons why the applicant believes the
original decision was in error.

(c) Any claim for refund shall be submitted to the Board of Equaliza-
tion by the applicant within the statutory time frames established by Rev-
enue and Taxation Code Section 4345 1 et seq.

NOTE: Authority cited: Section 105310, Health and Safety Code. Reference: Sec-
tions 105250, 105310, 124160(b) and 124165, Health and Safety Code.

History

1. New article 4 (section 33050) and section filed 8-22-2002; operative
8-22-2002 pursuant to Government Code section 1 1343.4 (Reeister 2002, No.
34).

Chapter 7. Health Facilities Planning

History

1 . Repealer of Chapter 7 (Secfions 40500-40532, not consecufive) filed 1 1-12-76
as an emergency; effective upon filling (Register 76, No. 46). For prior history
see Registers 70, No. 43; 71, No. 4; and 76, No. 34.

2. Certificate of Compliance filed .3-8-77 (Register 77, No. 11).

Chapter 7.5. Eminent Domain Procedures
for Nonprofit Hospitals

History

1 . New Chapter 7.5 (Secfions 43000-43050, not consecutive) filed 1 1-24-75; ef-
fective thirtieth day thereafter (Register 75, No. 48).

2. Repealer of Chapter 7.5 (Secfions 43000-43050) filed 7-25-77; effecfive thir-
tieth day thereafter (Register 77, No. 31).

Chapter 7.7. Fire Protection Loans

NOTE; Authority cited: Sections 208 and 13111.3, Health and Safety Code.

History

1 . New Chapter 7.7 (Secfions 44000-44100, not consecufive) filed 7-25-75 as an
emergency; effective upon fifing (Register 75, No. 6).

2. Certificate of Compliance filed 5-2-75 (Register 75, No. 18).

3. Repealer of Chapter 7.7 (Sections 44000-44100, not consecufive) filed
7-25-78; effective thirtieth day thereafter (Register 78, No. 30). For prior histo-
ry, see Registers 75, No. 6; 75, No. 18; 75, No. 19; 75, No. 52; 76, No. 12 and
76, No. 18.

Chapter 8. Accreditation, Certification and

Work Practices for Lead-Based Paint and

Lead Hazards

Article 1. Definitions

§ 35001 . Abatement.

"Abatement" means any set of measures designed to reduce or elimi-
nate lead hazards or lead-based paint for public and residential buildings,
but does not include containment or cleaning.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New chapter 8, article 1 and section filed 6-27-94 as an emergency; operative
6-27-94 (Register 94, No. 26). A Certificate of Compliance must be transmitted
to OAL by 10-25-94 or emergency language will be repealed by operation of
law on the following day.

2. New chapter 8, article 1 and section refiled 10-21-94 as an emergency; opera-
tive 1 0-26-94 (Register 94, No . 42) . A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment of chapter heading, section and Note filed 3-30-98 as an emergen-
cy; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must
be transmitted to OAL by 7-28-98 or emergency language will be repealed by
operation of law on the following day.

Page 248.4

Title 17

State Department of Health Services

§ 35006

5. Amendment of chapter heading, section and NoTli refiled 7-20-98 as an emer-
gency; operative 7-29-98 pursuant to Government Code section 11346.1(d)
(Register 9H, No. 30). A Certificate of Compliance mu.st be transmitted to OAL
by 1 1-27-98 or emergency language will be repealed by operation of law on
the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of chapter
headine and section, transmitted to OAL 1 1-23-98 and" filed 1-8-99 (Register
99. No? 2).

7. Amendment of NoTi-; filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35002. Accreditation.

"Accreditation" means the Department has reviewed and finds accept-
able a training provider's written application for accreditation, and has
conducted and finds acceptable, an on-site audit as specified in subsec-
tion 35078(e).

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 13 1051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment of NoTB filed 3-30-98 as an emergency; operative 3-30-98 (Reg-
ister 98. No. 14). A Certificate of Compliance must be transmitted to OAL by
7-28-98 or emergency language will be repealed by operation of law on the fol-
lowing day,

5. Amendment of Note refiled 7-20-98 as an emergency; operative 7-29-98 pur-
suant to Government Code section 1 1346.1(d) (Register 98. No. 30). A Certifi-
cate ofCompliance must be transmitted to OAL by 11-27-98 or emergency lan-
guage will be repealed by operation of law on the following day.

6. Certificate ofCompliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Noth filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35003. Accredited Training Provider.

"Accredited training provider" means any individual, corporation,
partnership or other unincorporated association or public entity to which
the Department has granted accreditation or provisional accreditation to
offer lead-related construction courses and continuing education in-
struction.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 1 05250, 1 241 60 and 1 3 1 05 1 , Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate ofCompliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24—94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate ofCompliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment of Note filed 3-30-98 as an emergency; operative 3-30-98 (Reg-
ister 98, No. 14). A Certificate of Compliance must be transmitted to OAL by
7-28-98 or emergency language will be repealed by operation of law on the fol-
lowing day.

5. Amendment of Note refiled 7-20-98 as an emergency; operative 7-29-98 pur-
suant to Government Code secUon 1 1 346. 1 (d) (Register 98, No. 30). A Certifi-
cate ofCompliance must be transmitted to OAL by 1 1-27-98 or emergency lan-
guage will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35004. CDPH-Approved Course.

"CDPH-approved course" means any lead-related construction
course that satisfies the requirements specified in sections 35056, 35057,

35061, 35065, 35066, or 35067 as determined by CDPH pursuant to sec-
tions 35076 and 35078.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051 , Health and Safety Code.

History
1. Amendment of section heading, new section and amendment of Note filed

4-30-2008; operative 5-30-2008 (Recister2008. No. 18). For prior history, .see

§ 35005. Certified Lead Inspector/Assessor.

"Certified lead inspector/assessor" means an individual who has re-
ceived a certificate or an interim cert:ificate from the Department as a
"certified lead inspector/assessor".

NOTE; Authority cited: Sections 105250. 124160 and 131200. Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate ofCompliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate ofCompliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35005 to new section 35015, and renumbering
of former section 35018 to new section 35005, including amendment of section
heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98
(Register 98. No. 14). A Certificate ofCompliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

5. Renumbering of former section 35005 to new section 35015. and renumbering
of former section 3501 8 to new section 35005, including amendment of section
heading, section and Note, refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate ofCompliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35005.1. Certified Lead Project Designer.

"Certified lead project designer" means an individual who has re-
ceived a certificate from the Department as a "certified lead project de-
signer."

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Secdons 105250, 124160 and 131051, Health and Safety Code.

History
1. New section filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).
For prior history, see Register 99, No. 2.

§ 35006. Certified Lead Project Monitor.

"Certified lead project monitor" means an individual who has received
a certificate or an interim certificate from the Department as a "certified
lead project monitor."

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate ofCompliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35006 to new section 35018. and renumbering
of former section 35019 to new section 35006, including amendment of section
heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 14). A Certificate ofCompliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

5. Renumbering of former section 35006 to new section 35018, and renumbering
of former section 35019 to new section 35006, including amendment of section
heading, section and Note, refiled 7-20-98 as an emergency; operative

Page 248.5

§ 35007

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 11-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section heading, section and NoTt-: filed 4-30-2008; operative
3-30-2008 (Register 2008, No. 18).

§ 35007. Certified Lead Sampling Technician.

"Certified lead sampling technician" means an individual who has re-
ceived a certificale or an interim certificate from the Department as a
"certified lead sampling technician".

NOTF: Authority cited; Sections 105250. 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35007 to new section 35019, and renumbering
of former section 35020 to new section 35007, including amendment of secfion
heading, section and Note, filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operafion of law on the
following day.

5. Renumbering of former section 35007 to new section 35019, and renumbering
of former section 35020 to new section 35007, including amendment of secfion
heading, secfion and Note, refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of secfion,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of secfion heading, secfion and Note filed 4-30-2008; operative
5-30-2008 (Register 2008, No. 18).

§ 35008. Certified Lead Supervisor.

"Certified lead supervisor" means an individual who has received a
certificate or an interim certificate from the Department as a "certified
lead supervisor".

Note; Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Secfions 105250, 124160 and 1 3 1 05 1 , Health and Safety Code.

History

2. New secfion refiled 10-21-94 as an emergency; operafive 10-26-94 (Register
94, No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35008 to new secfion 35020, and renumbering
of former secfion 3502 1 to new section 35008, including amendment of secfion
heading, section and NOTE, filed 3-30-98 as an emergency; operafive 3-30-98
(Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operafion of law on the
following day.

5. Renumbering of former secfion 35008 to new secfion 35020, and renumbering
of former secfion 35021 to new section 35008, including amendment of secfion
heading, section and Note, refiled 7-20-98 as an emergency; operafive
7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of secfion,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operafive 5-30-2008 (Register 2008,
No. 18).

§ 35009. Certified Lead Worker.

"Certified lead worker" means an individual who has received a certif-
icate from the Department as a "certified lead worker".

Note: Authority cited: Sections 105250. 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94. No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35009 to new section 3502 1 , and renumbering
of former section 35023 to new section 35009, including amendment of section
heading, section and Noti-., filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

5. Renumbering of former section 35009 to new section 35021 , and renumbering
of former section 35023 to new section 35009, including amendment of secfion
heading, section and Note, refiled 7-20-98 as an emergency; operative
7-29-9"8 pursuant to Government Code section 1 1346.1(d) (Register 98. No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of secfion,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operafive 5-30-2008 (Register 2008,
No. 18).

§35010. Certificate.

"Certificate" means the document issued by the Department to an indi-
vidual who meets the requirements for certification as described in sec-
tions 35083, 35085, 35087, 35089, or 35091.

NOTE: Authority cited: Secfions 105250, 124160 and 131200, Health and Safety
Code. Reference: Secfions 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New secfion refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94. No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sec-
tion transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35010 to new secfion 35023 and new section
35010 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Comphance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35010 to new section 35023 and new section
35010 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Gov-
ernment Code section 1 1 346. 1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 3501 1 . Guest Instructor.

NOTE: Authority cited: Sections 208, 309.76 and 429.16, Health and Safety Code.
Reference: Sections 208, 309.76 and 429.16, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New secfion refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 3501 1 to new section 35025 filed 3-30-98 as
an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Com-
pliance must be transmitted to OAL by 7-28-98 or emergency language will be
repealed by operafion of law on the following day.

5. Renumbering of former secfion 3501 1 to new secfion 35025 refiled 7-20-98 as
an emergency; operative 7-29-98 pursuant to Government Code section

Page 248.6

Title 17

State Department of Health Services

§ 35016

1 1346.1(d) (Register 98, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 i-27-98 or emergency language will be repealed by opera-
tion of law on the following day.

6. Certificate of Connpliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

§ 35012. Certified Industrial Hygienist.

"Certified industrial hygienist" (CIH) means a person who has met the
education, experience, and examination requirements of an industrial hy-
giene certification organization governed by the American Board of In-
dustrial Hygiene.

NOTH: Authority cited: Sections 103250, 124160 and 131200. Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35012 to new section 35026, and renumbering
of former section 35004 to new secfion 35012, including amendment of Note,
filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A
Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operation of law on the following day.

5. Renumbering of former section 35012 to new section 35026, and renumbering
of former section 35004 to new secfion 35012, including amendment of Note,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code secfion 1 1346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98
and filed 1-8-99 (Register 99. No. 2).

7. Amendment of Note filed 4-30-2008; operafive 5-30-2008 (Register 2008,
No. 18).

§ 35013. Clearance Inspection.

"Clearance inspection" means an on-site limited investigation, as de-
scribed in Chapter 15: Clearance, sections II-VI, "Guidelines for the
Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S.
Department of Housing and Urban Development, June 1995.
NOTE: Authority cited: Secfions 10525()(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Secfions 105250(a), 105250(b), 124160(b)
and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35013 to secfion 35014 and new section transmitted to OAL
2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35013 to new section 35027 and new secfion
35013 filed 3-30-98 as an emergency; operafive 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former secfion 35013 to new section 35027 and new secfion
35013 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Gov-
ernment Code secfion 1 1346.1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§35014. Component.

"Component" means a structural element or fixture, such as a wall,
floor, ceiling, door, window, molding, trim, trestle, tank, stair, railing,
cabinet, gutter, or downspout.

NOTIi: Authority cited: Secfions 105250(a), 10525()(b), 124160(b) and 131200,
Health and Safety Code. Reference: Secfions 105250(a), 1052.50(b), 12416()(b)
and 131051, HeaUh and Safety Code.

History

1 . New secfion filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section retlled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Ceilificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35013 to secfion 35014 and former section 35014 to secfion 35015
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former secfion 35014 to new section 35028 and new section
35014 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98. No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28 98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former secfion 35014 to new section 35028 and new section
35014 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Gov-
ernment Code section 1 1346.1(d) (Register98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of secfion,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§35015. Contact Hour.

"Contact hour" means 60 minutes of lead-related construction train-
ing which may include a break of not more than ten minutes.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New secfion filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Comphance as to 10-21-94 order including renumbering of for-
mer secfion 35014 to secfion 35015 and former section 35015 to secfion 35016
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former secfion 35015 to new section 35029, and renumbering
of former secfion 35005 to new section 35015, including amendment of NoTi;,
filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A
Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operafion of law on the following day.

5. Renumbering of former section 35015 to new section 35029, and renumbering
of former secfion 35005 to new secfion 35015, including amendment of Note,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the follow ing day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§35016. Containment.

"ContainiTient" means a system, process, or barrier used to contain
lead hazards inside a work area such as described in "Guidelines for the
Evaluation and Control of Lead-Based Paint Hazards in Housing," U.S.
Department of Housing and Urban Development. June 1 995, Chapter 8.
"Containment and Barrier Systems," Table 8. 1 . Table 8.2, and Table 8.3,
or "Guide for Containing Surface Preparation Debris Generated During
Paint Removal Operations," Society for Protective Coatings, Technolo-
gy Guide 6, October 1, 2004.

NOTE; Authority cited; Secfions 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Secfions 105250(a), 105250(b), 124160(b),
124165 and 131051, Health and Safety Code.

Page 248.7

§ 35017

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1. New section filed 6-27-94 as an emergency: operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35015 to section 35016 and former section 35016 to section 35017
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35016 to new section 35030 and new section
35016 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35016 to new secfion 35030 and new section
35016 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Gov-
ernment Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and NoTi-: filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§35017. Job Tasks.

NOTE: Authority cited: Sections 208, 309.76 and 429. 16, Health and Safety Code.
Reference: Sections 208, 309.76 and 429.16, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 1 0-2 1 -94 order including renumbering of for-
mer section 35016 to section 35017 and former section 35017 to section 35018
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35017 to new section 35032 filed 3-30-98 as
an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Com-
pliance must be transmitted to OAL by 7-28-98 or emergency language will be
repealed by operation of law on the following day.

5. Renumbering of former section 35017 to new section 35032 refiled 7-20-98 as
an emergency; operative 7-29-98 pursuant to Government Code secfion
1 1346.1(d) (Register 98, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-98 or emergency language will be repealed by opera-
tion of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

§35018. Continuing Education.

"Continuing education" means lead-related constinction instinction,
other than a course as described in section 35004, that satisfies the re-
quirements specified in section 35070 or 35072.

NOTE: Authority cited: Secfions 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operafive (3-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including renumbering and
amendment of former secfion 3501 7 to section 35018 and former section 35018
to section 35019 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95,
No. 14).

4. Renumbering of former section 35018 to new section 35005, and renumbering
of former secfion 35006 to new section 3501 8, including amendment of section
and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former secfion 35018 to new section 35005, and renumbering
of former section 35006 to new section 3501 8, including amendment of section
and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to

Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and NoTi-; filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35019. Course Completion Form.

"Course Completion Form" means documentation, on CDPH Form
8493 (6/07), issued by an accredited training provider to an individual
and the Departinent as proof of successful completion of a CDPH-ap-
proved lead-related construction course or continuing education instruc-
tion.

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250. 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including renumbering and
amendment of former section 3501 8 to section 35019 and former section 3501 9
to section 35020 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95,
No. 14).

4. Renumbering of former section 35019 to new section 35006. and renumbering
of former section 35007 to new section 35019, including amendment of secfion
and Note, filed 3-30-98 as an emergency; operafive 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35019 to new section 35006, and renumbering
of former section 35007 to new section 35019, including amendment of section
and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35020. Demonstration Testing.

"Demonstration testing" means the observation and scoring by an in-
structor or a guest instructor of an individual student' s job task and equip-
ment use skills taught during a course or continuing education instruc-
tion.

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including renumbering and
amendment of former section 35019 to section 35020 and former section 35020
to section 35021 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95,
No. 14).

4. Renumbering of former section 35020 to new section 35007, and renumbering
of former section 35008 to new section 35020, including amendment of section
and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35020 to new section 35007, and renumbering
of former section 35008 to new section 35020, including amendment of section
and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

Page 248.8

Title 17

State Department of Health Services

§ 35025

§ 35021 . Department.

"Department" means the California Department of Public Health
(CDPH).

NOTH: Authority cited: Sections 105250, 124 160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance m\ist be transmitted to GAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-21-94 as an einergency; operative 10-26-94 (Register
94, No. 42). A Ceitificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including renumbering and
amendment of former section 35020 to section 3502 1 and former section 3502 1
to section 35022 transmitted to OAL 2-23-95 and filed 4-5-95 (Recister 95,
No. 14).

4. Renumbering of former section 35021 to new section 35008, and renumbering
of former section 35009 to new section 35021, including amendment of Note,
filed 3-30-98 as an emergency; operative 3-30-98 (R^egister 98, No. 14). A
Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operation of law on the following day.

5. Renumbering of former section 35021 to new section 35008, and renumbering
of former section 35009 to new section 35021, including amendment of Note,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code section 11346.1(d) (Register 98, No. 30). A Ceitificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35022. Deteriorated Lead-Based Paint.

"Deteriorated lead-based paint" means lead-based paint or presumed
lead-based paint that is cracking, chalking, flaking, chipping, peeling,
non-intact, failed, or otherwise separating from a component.
NOTE: Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b)
and 131051, Health and Safety Code.

History

2. New section refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Certificate of Comphance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35021 to section 35022 and former section 35022 to section 35023
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35022 to new section 35040 and new section
35022 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35022 to new section 35040 and new section
35022 refilled 7-20-98 as an emergency; operafive 7-29-98 pursuant to Gov-
ernment Code section 1 1346. 1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operafion of law on the following day.

6. Certificate of Comphance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35023. DHS-Approved Course. [Repealed]

NOTE: Authority cited: Sections 100275, 105250 and 124160, Health and Safety
Code. Reference: Secfions 100275, 105250 and 124160, Health and Safety Code.

History

2. New section refilled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Certificate of Comphance must be transmitted to OAL by

2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including renumbering and
amendment of former section 35022 to section 35023 and former section 35023
to section 35024 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95,
No. 14).

4. Renumbering of former section 35023 to new section 35009, and renumbering
of former secfion 35010 to new section 35023, including amendment of section
and Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28 98 or
emiergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35023 to new section 35009, and renumbering
of former section 35010 to new section 35023, including ainendment of section
and Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Repealer filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§ 35024. Photo Identification Number.

Note: Authority cited: Sections 208, 309.76 and 429. 1 6, Health and Safety Code.
Reference: Sections 208, 309.76 and 429.16, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New secfion refiled 10-21-94 as an emergency; operative 1 0-26-94 (Register
94, No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35023 to section 35024 and former section 35024 to section 35025
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35024 to new section 35041 filed 3-30-98 as
an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Com-
pliance must be transmitted to OAL by 7-28-98 or emergency language will be
repealed by operation of law on the following day.

5. Renumbering of former section 35024 to new section 35041 refiled 7-20-98 as
an emergency; operative 7-29-98 pursuant to Government Code section
1 1346.1(d) (Register 98, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-98 or emergency language will be repealed by opera-
tion of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

§ 35025. Guest Instructor.

"Guest instructor" means an individual who is responsible for provid-
ing less than 30% of training in any course.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Secfions 105250, 124160 and 1 3 1 05 1 , Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Comphance as to 10-21-94 order including renumbering of for-
mer secfion 35024 to secfion 35025 and former section 35025 to secfion 35026
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35025 to new section 35042, and renumbering
of former section 3501 1 to new section 35025, including amendment of Note;,
filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A
Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operation of law on the following day.

5. Renumbering of former secfion 35025 to new section 35042, and renumbering
of former section 3501 1 to new section 35025, including amendment of Nim.,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transnutted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operafive 5-30-2008 (Register 2008,
No. 18).

Page 248.9

§ 35026

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 35026. Hands-on Training.

"Hands-on training" means training during which students practice
skills that they will be expected to perform at the worksite.
NOTIi: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35026 to section 35027 and former section 35027 to section 35028
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35026 to new section 35044, and renumbering
of former section 35012 to new section 35026, including amendment of NoTti,
filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A
Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operation of law on the following day.

5. Renumbering of former secfion 35026 to new section 35044, and renumbering
of former secfion 35012 to new section 35026, including amendment of Note,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35027. Industrial Building.

"Industrial building" means a structure that is used primarily for indus-
trial activity, which is generally not open to the public, including but not
limited to, warehouses, factories, and storage facilities. "Industrial build-
ing" does not include any structure which fits the definition of a public
building or a residential building.

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operafive 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Comphance as to 10-21-94 order including renumbering and
amendment of former section 35026 to secfion 35027 and former section 35027
to section 35028 transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95,

No. 14).

4. Renumbering of former section 35027 to new section 35045, and renumbering
of former section 35013 to new section 35027, including amendment of Note,
filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A
Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operation of law on the following day.

5. Renumbering of former section 35027 to new section 35045, and renumbering
of former section 35013 to new section 35027, including amendment of Note,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35028. Instructor.

"Instructor" means an individual who is responsible for providing
30% or more of training in any course or continuing education instruc-
tion.

Note; Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35027 to section 35028 and former section 35028 to section 35029
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35028 to new section 35046, and renumbering
of former section 35014 to new section 35028, including amendment of Note;,
filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A
Certificate of Comphance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operation of law on the following day.

5. Renumbering of former section 35028 to new section 35046, and renumbering
of former section 35014 to new section 35028, including amendment of NoTi;,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35029. Interactive/Participatory Teaching l\/lethods.

"Interactive/participatory teaching methods" mean instruction which
consists of active participation of the students, such as brainstorming,
hands-on training, demonstration and practice, small group problem-
solving, learning games, discussions, risk mapping, field visits, walk-
throughs, problem-posing, group work assignments, homework review
sessions, question-and-answer periods, skits, or role-playing sessions.
Lecture is not considered an interactive/participatory teaching method.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94.
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Comphance as to 10-21-94 order including renumbering of for-
mer section 35028 to section 35029 and former section 35029 to section 35030
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35029 to new section 35048, and renumbering
of former section 35015 to new section 35029, including amendment of Note,
filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A
Certificate of Compliance must be transmitted to OAL by 7-28-98 or emergen-
cy language will be repealed by operation of law on the following day.

5. Renumbering of former section 35029 to new section 35048, and renumbering
of former section 35015 to new section 35029, including amendment of Note,
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code section 11346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 1 1-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35030. Interim Certificate.

"Interim certificate" means the document issued by the Department to
an individual who meets the requirements for interim certification as de-
scribed in section 35093.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Comphance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Certificate of Comphance must be transmitted to OAL by

Page 248.10

Title 17

State Department of Health Services

§ 35035

2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer section 35029 to section 35030 transmitted to OAL 2-23-95 and filed
4-5-95 (Register 95. No. 14).

4. Renumbering of former section 35030 to new section 35049, and renumbering
of former section 3501 6 to new section 35030, including amendment of section
and NoTi;, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35030 to new section 35049, and renumbering
of former section 350 1 6 to new section 35030, including amendment of section
and NoTi;, refiled 7-20-9H as an emergency; operative 7-29-98 pursuant to
Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§35031. Job Tasks.

"Job tasks" mean the specific activities performed in the context of
work.

NOTi:: Authority cited: Secfions 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124 160 and 131051, Health and Safety Code.

History
1 . Amendment of section heading, new section and amendment of Note filed

4-30-2008; operative 5-30-2008 (Register 2008, No. 1 8). For prior history, see

§ 35032. Lead Activities.

"Lead activities" means abatement, lead hazard evaluation, lead-re-
lated construction work, or any activity which disturbs lead-based paint,
presumed lead-based paint, or creates a lead hazard.
Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New article 2 and secdon filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 2 and section refiled 10-21-94 as an emergency; operative
10-26-94 (Register 94, No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment moving article 2 to precede new section 35051, renumbering for-
mer secdon 35032 to new section 3.5052, and renumbering former secdon
35017 to new secdon 35032, including amendment of Note, filed 3-30-98 as
an emergency; operative 3-30-98 (Register 98, No. 14). A Certificate of Com-
pliance must be transmitted to OAL by 7-28-98 or emergency language will be
repealed by operation of law on the following day.

5. Amendment moving article 2 to precede new secdon 35051, renumbering for-
mer section 35032 to new section 35052 and renumbering former section 3501 7
to new section 35032, including amendment of secdon and Note, refiled
7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code
secdon 1 1346.1(d) (Register 98, No. 30). A Certificate of Compliance must be
transmitted to OAL by 1 1-27-98 or emergency language will be repealed by
operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section heading, repealer and new section and amendment of
Note filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§ 35033. Lead-Based Paint.

"Lead-based paint" means paint or other surface coatings that contain
an amount of lead equal to, or in excess of:

(a) one milligram per square centimeter ( 1 .0 mg/cm2); or

(b) half of one percent (0.5%) by weight.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

I. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New secdon refiled with amendment of subsection (b)( 1 ) 1 0-2 1 -94 as an emer-
gency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance
must be transmitted to OAL by 2-24-94 or emergency language will be re-
pealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
sections (b)(3) and (d) transmitted to OAL 2-23-95 and filed 4-5-95 (Register
95, No. 14).

4. Renumbering of former section 35033 to new section 35053 and new section
35033 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98. No.
14). A Certificate of Comphance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35033 to new section 35053 and new section

35033 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Gov-
ernment Code section 11346.1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-2.3 98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35034. Lead Certification Examination.

"Lead certification exainination" means the statewide examination of-
fered by the Department to applicants for certification.
Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New secdon filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-2.5-94
or emergency language will be repealed by operation of law on the following
day.

2. New secdon refiled 10-21-94 as an emergency; operative 10-26-94 (Register
94, No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24—94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sec-
tion transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former section 35034 to new section 35054 and new section

35034 filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No.
14). A Certificate of Compliance must be transmitted to OAL by 7-28-98 or
emergency language will be repealed by operation of law on the following day.

5. Renumbering of former section 35034 to new section 3.5054 and new section
35034 refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Gov-
ernment Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35035. Lead-Contaminated Dust.

"Lead-contaminated dust" means dust that contains an amount of lead
equal to, or in excess of:

(a) forty micrograms per square foot (40 |J.g/ft-) for interior floor sur-
faces; or

(b) two hundred and fifty micrograms per square foot (250 jig/ft^) for
interior horizontal surfaces; or

floor and exterior horizontal surfaces.

NOTE: Authority cited: Sections 1052.50(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b),
124165 and 131051, Health and Safety Code.

History

1. New article 3 and secdon filed 6-27-94 as an emergency; operative 6-27 94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 3 and secdon refiled 10-21-94 as an emergency; operative
l()-26-94 (Register 94, No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
sections (a)(3)-(a)(3)(A) transmitted to OAL 2-2.3-95 and filed 4^5-95 (Regis-
ter 95, No. 14).

4. Amendment moving article 3 heading formerly preceding section 35035 to pre-
cede secdon 35055, renumbering of former section 35035 to new section 35055
and new section 35035 filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL

Page 248.11

§ 35036

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

5. Amendment moving article 3 heading formerly preceding section 35035 to pre-
cede section 35055, renumbering of former section 35035 to new section 35055
and new section 35035 refiled 7-20-98 as an emergency; operative 7-29-98
pursuant to Government Code section 1 1 346. 1 (d ) (Register 98. No. 30). A Cer-
tificate of Compliance must be transmitted to OAL by 1 1 -27-98 or emergency
language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, includina amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and NoTi- filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35036. Lead-Contaminated Soil.

"Lead-contaminated soil" means bare soil that contains an amount of
lead equal to. or in excess of, four hundred parls per million (400 ppm)
in children's play areas and one thousand parts per million (1000 ppm)
in all other areas.

NOTI:: Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b),
124165, and 131051, Health and Safety Code.

History

1. New section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. New section refilled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35037. Lead Hazard.

"Lead hazard" means deteriorated lead-based paint, lead contami-
nated dust, lead contaminated soil, disturbing lead-based paint or pre-
sumed lead-based paint without containment, or any other nuisance
which may result in persistent and quantifiable lead exposure.

NOTE: Authority cited: Sections 105250(a), 105250(b), 124160(b), 124165 and
131200, Health and Safety Code. Reference: Sections 17920(/), 17920.3(c) and
(k), 105250(a), 105250(b), 105280(g), 124160(b), 124165 and 131051, Health
and Safety Code; Sections 1941, 3479, 3480 and 3481, Civil Code; Section
17274(b), Revenue and Taxation Code; and Section 1 1349(c) and 1 1349(e), Gov-
ernment Code.

History

1 . New section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transnutted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35038. Lead Hazard Evaluation.

"Lead hazard evaluation" means the on-site investigation, for com-
pensation, of lead-based paint or lead hazards for public and residential
buildings, but does not include:

(a) activities intended to determine adequacy of containment; or

(b) air monitoring for lead, as specified in Title 8, California Code of
Regulations, section 1532.1, and Title 17, California Code of Regula-
tions, sections 70100 and 70200; or

(c) testing components removed from a residential or public building
for lead to determine the applicability of hazardous waste requirements
specified in Title 22, California Code of Regulations, Division 4.5, Chap-
ters 10, 11,12, 13, and 18, and California Health and Safety Code, section
25163, subdivision (c).

NOTE: Authority cited: Sections 105250(a). 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b)
and 131051, Health and Safety Code.

History

2. New section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Noth filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35039. Lead Inspection.

"Lead inspection" means a surface by surface investigation to deter-
mine the presence of lead-based paint as described in Chapter 7: Lead-
Based Paint Inspection. "Guidelines for the Evaluation and Control of
Lead-Based Paint Hazards in Housing," U.S. Department of Housing
and Urban Development, 1997 Revision.

NOTE: Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b)
and 131051, Health and Safety Code.

History
\. New section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,

No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98

or emergency language will be repealed by operation of law on the following

day.

2. New section refilled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35040. Lead-Related Construction Work.

"Lead-related construction work" means any construction, alteration,
painting, demolition, salvage, renovation, repair, or maintenance of any
residential or public building, including preparation and cleanup, that, by
using or disturbing lead-containing material or soil, may result in signifi-
cant exposure of adults or children to lead.

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. Renumbering of former section 35022 to new section 35040, including amend-
ment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35022 to new section 35040, including amend-
ment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code section 1 1346.1 (d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1 -27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and fUed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35041 . Photo Identification Number.

"Photo identification number" means the number listed on a form of
photo identification, such as a passport or California Department of Mo-
tor Vehicles driver's hcense or identification card, which matches a
trained individual with a Course Completion Form.
Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former section 35024 to new section 35041 , including amend-
ment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35024 to new section 35041, including amend-
ment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code section 1 1 346. 1 (d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

Page 248.12

Title 17

State Department of Health Services

§ 35048

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Noth filed 4-30-2008; operative 5-30-2008 (Reaister 2008,
No. 18).

§ 35042. Postsecondary Education.

"Postsecondary education" means education completed at a junior
college, college, or university accredited by a national or regional accred-
iting agency which is recognized by the U.S. Department of Education
or a state agency authorized to approve such institutions.
Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Secfions 105250, 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former section 35025 to new section 35042, including amend-
ment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35025 to new section 35042, including amend-
ment of NoTi:, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of NoTii filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35043. Presumed Lead-Based Paint.

"Presumed lead-based paint" means paint or surface coating affixed
to a component in or on a structure constructed prior to January 1, 1978.
"Presumed lead-based paint" does not iticlude paint or surface coating
that has been tested and found to contain an amount of lead less than one
milligram per square centimeter ( 1 .0 mg/cm-) or less than half of one per-
cent (0.5%) by weight.

NOTE: Authority cited: Sections 105250(a), 105250(b), 124160(b), 124165 and
131200, Health and Safety Code. Reference: Sections 105250(a), 105250(b).
124160(b), 124165 and 131051, Health and Safety Code.

History

2. New secfion refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code secfion 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of secfion,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of secfion and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35044. Provisional Accreditation.

"Provisional accreditation" means the Department has reviewed and
finds acceptable a training provider's written application for accredita-
tion, but has not conducted an on-site audit as specified in subsection
35078(e).

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former section 35026 to new secfion 35044, including amend-
ment of Note, filed 3-30-98 as an emergency; operafive 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35026 to new secfion 35044, including amend-
ment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code secfion 11 346. 1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35045. Public Building.

"Public building" means a structure, or part of a structure, and its land,
which is generally accessible to the public, including but not limited to.
schools, daycare centers, museums, airports, hospitals, stores, conven-
tion centers, government facilities, office buildings and any other build-
ing which is not an industrial building or a residential building.
Note: Authority cited: Secfions 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former section 35027 to new section 35045, including amend-
ment of Ncm-;, filed 3-30-98 as an emergency; operafive 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35027 to new section 35045. including amend-
ment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code secfion 1 1346.1(d) (Register 98. No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35046. Residential Building.

"Residential building" means a structure, or part of a structure, and its
land, which is used or occupied, or intended to be used or occupied, in
whole or in part, as the home or residence of one or more persons.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131 051 , Health and Safety Code.

History

1 . Renumbering of former section 35028 to new section 35046, including amend-
ment of Note, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35028 to new section 35046, including amend-
ment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code section 1 1346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1 -27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35047. Risk Assessment.

"Risk Assessment" means an on-site investigation to determine the
existence, nature, severity, and location of lead hazards, as described in
Chapter 5: Risk Assessment, section II (A), (B), (C) and (D), "Guidelines
for the Evaluation and Control of Lead-Based Paint Hazards in Hous-
ing," U.S. Department of Housing and Urban Development, June 1995.
NOTE: Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 105250(a), 105250(b), 124160(b)
and 131051, Health and Safety Code.

History

2. New section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code secfion 11346.1(d) (Register 98, No. 30). A Certificate of
Comphance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35048. Train-the-Trainer Course.

"Train-the-trainer course" means a course that includes, but is not
limited to, instruction in the planning and teaching of adult education,
adult learning principles, designing training objectives, selecting and de-
signing training activities, creating an effective learning environment,
facilitating group involvement and discussions, and strategies for dealing
with difficult training situations and diifficult learners.

Page 248.13

§ 35049

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250. 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former section 35029 to new section 35048, including amend-
ment of NoTF-;, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance miist be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35029 to new section 35048, including amend-
ment of NoTii, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code secfion 1 1346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35049. Training Director.

"Training Director" means the individual, designated by an accredited
training provider, who monitors the performance and qualifications of
instructors and guest instructors, the quantity and quality of training pro-
vided, and who is responsible for ensuring that an accredited training pro-
vider complies with the requirements for accreditation.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Secdons 105250, 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former secfion 35030 to new section 35049. including amend-
ment of Noti:, filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

2. Renumbering of former section 35030 to new secfion 35049, including amend-
ment of Note, refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code section 11 346. 1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operafion of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35050. Work Area.

"Work area" means an area where lead activities are conducted.

NOTE: Authority cited: Secfions 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Secfions 105250(a), 105250(b), 124160(b)
and 131051, Health and Safety Code.

History

1 . New article 4 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 4 and secfion refiled with amendment of subsecfion (d)(9)(B)
10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Cer-
tificate of Comphance must be transmitted to OAL by 2-24-94 or emergency
language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
secfion (d)(9) transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No.

14).

4. Amendment moving article 4 heading to precede section 35056, renumbering
of former secfion 35050 to new section 35056 and new section 35050 filed
3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14). A Certifi-
cate of Comphance must be transmitted to OAL by 7-28-98 or emergency lan-
guage will be repealed by operafion of law on the following day.

5. Amendment moving article 4 heading to precede section 35056, renumbering
of former secfion 35050 to new secfion 35056 and new section 35050 refiled
7-20-98 as an emergency; operative 7-29-98 pursuant to Government Code
section 11 346. 1(d) (Register 98, No. 30). A Certificate of Compliance must be
transmitted to OAL by 1 1-27-98 or emergency language will be repealed by
operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of secfion and Note filed 4-30-2008; operafive 5-30-2008 (Reg-
ister 2008, No. 18).

Article 2. Eligibility Requirements for
Accreditation and Course Approval

§ 35051. Representation of Accreditation Status.

Unless accredited pursuant to the requirements of this chapter, no per-
son shall represent himself or herself as, or do business as, an accredited
training provider.

Note: Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 1 6240 and 1 7200, Business and Pro-
fessions Code; and Secfion 131051, Health and Safety Code.

History

1. Amendment moving article 2 heading formerly preceding section 35032 to pre-
cede section 35051 and new section filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transinitted
to OAL by 7-28-98 or emergency language will be repealed by operation of law
on the following day.

2. Amendment moving article 2 heading formerly preceding section 35032 to pre-
cede section 35051 and new section refiled 7-20-98 as an emergency; opera-
five 7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98,
No. 30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35052. Eligibility Requirements.

To qualify for and maintain accreditation, a training provider shall
conduct at least one CDPH-approved course in California at least once
during each calendar year, satisfy the applicable requirements specified
in sections 35053 and 35054 and comply with all applicable require-
ments specified in sections 35076 and 35078.

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference : Sections 1 05250, 1 24 1 60 and 1 3 1 05 1 , Health and Safety Code.

History

1. Renumbering of former section 35032 to new secfion 35052, including amend-
ment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

2. Renumbering of former secfion 35032 to new secfion 35052, including amend-
ment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98
pursuant to Government Code section 1 1346.1(d) (Register 98, No. 30). A Cer-
tificate of Compliance must be transmitted to OAL by 1 1 -27-98 or emergency
language will be repealed by operation of law on the following day.

3 . Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35053. Personnel Requirements.

(a) Each course shall be administered by a Training Director with the
following minimum qualifications:

(1) Two years of experience administering training programs or two
years of experience teaching or training adults;

(2) Successful completion of a 40 hour train-the-trainer course, or two
years experience teaching or training adults, or an associate degree or
higher in education from a postsecondary educational institution;

(3) A bachelor or graduate-level degree in building construction tech-
nology, engineering, industrial hygiene, safety, or health, or two years of
experience managing an environmental or occupational health and safety
program; and

(4) Successful completion of 24 contact hours of lead-related con-
struction training from any of the required topics listed in sections 35056,
35057, 35061, or 35065.

(b) Each course shall be taught by an instructor with the following
minimum qualifications:

( 1 ) Successful completion of a 40 hour train-the-trainer course, or one
year of experience teaching or training adults, or an associate degree or
higher in education from a postsecondary educational institution;

Page 248.14

Title 17

State Department of Health Services

§ 35054

(2) Successful completion of 24 contact hours of lead-related con-
struction training from any of the required topics listed in sections 35056,
35057, 35061, or 35065;

(3) One year of experience related to health, safety, or regulatory as-
pects of lead-related construction in the topic area of the lead-related
construction course they will be teaching or one year of lead-related con-
stmction experience in the topic area of the lead-related construction
course they will be teaching, or CDPH certification in the discipline of
the course in which they will be teaching. Except that, instructors of
hands-on training must have two years of lead-related constaiction or
related experience in the topic area of the lead-related construction
course they will be teaching; and

(4) Successful completion of seven contact hours of continuing educa-
tion instruction annually.

(c) Only an instructor receiving a satisfactory annual performance re-
view by the Training Director shall provide course or continuing educa-
tion instruction, unless the instructor is also the Training Director.

(d) Each qualified guest instructor shall have a minimum of one year
of experience related to the subject matter that they teach. Except that,
guest instaictors of hands-on training shall have a minimum of two years
of lead-related construction or related experience.

NOTE: Authority cited: Sections 105250, 124160 and 131200. Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Healthand Safety Code.

History

1 . Renumbering of former section 35033 to new section 35053, including amend-
ment of section and Note, filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 1 4). A Certificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

2. Renumbering of former section 35033 to new section 35053, including amend-
ment of section and Note, refiled 7-20-98 as an emergency; operative 7-29-98
pursuant to Government Code section 1 1346. 1(d) (Register 98, No. 30). A Cer-
tificate of Compliance must be transmitted to OAL by 1 1-27-98 or emergency
language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tion (b)(3), transmitted to OAL 1 1-2.V98 and filed 1-8-99 (Register 99, No.

2).

4. Amendment of subsection (b)(3) and Note filed 4-30-2008; operative
5-30-2008 (Register 2008, No. 18).

§ 35054. Operational Requirements.

(a) An accredited training provider shall provide facilities for clas-
sroom instruction, hands-on training, and simulated field visits. The
training provider shall also provide equipment, instructional material,
and instructor personnel to provide training needed to achieve the objec-
tives for which the course or continuing education instruction is offered.
Equipment shall be maintained in proper working condition and licensed
and stored in compliance with applicable requirements and regulations.

(b) A student-to-instructor rado of not greater than ten to one shall be
maintained during hands-on training and instructors shall provide atten-
tion to and observation of each student's activities.

(d) An accredited training provider shall administer a final examina-
tion to eligible students seeking a Course Completion Form in each
course or continuing education instruction.

(e) A minimum score of 70% shall be considered a passing score on
a final examination.

(0 An accredited training provider shall allow a student who fails to
attain a passing score on a final examination to retake the examination
up to two more times within 30 calendar days from the date the original
examination was given. These examinations shall be different from, but
equivalent to, the original final examination.

(g) Within 30 calendar days of a student passing a final examination,
an accredited training provider shall issue a completed Course Comple-
tion Form to the student and the Department.

(h) A final examination shall be designed to test a student's knowledge
of information and ability to perform job tasks taught in a course or con-
tinuing education instruction. This examination may be administered

verbally or in written form, shall be given to student's individually, shall
include demonstration testing if hands-on training is done, and shall con-
sist of the following:

( 1 ) Demonstration testing shall comprise a minimum of 1 5% and shall
not exceed 35% of the final examination, except for the lead-related con-
struction work course which shall not exceed 50%; and

(2) A minimum of 100 questions for the lead-related constaiction in-
spection and assessment course and the lead-related construction super-
vision and project monitoring course; or

(3) A minimum of 75 questions for the lead-related construction Certi-
fied Industrial Hygienist course; or

(4) A minimum of 50 questions for the lead-related construction work
course and the lead-related construction supplemental supervision and
project monitoring course; or

(5) A minimum of 30 questions for the lead-related construction sam-
pling technician course; or

(6) A minimum of five questions for each contact hour of continuing
education instruction.

(i) CDPH Form 8493 (6/07), Course Completion Form, shall contain
the following information:

(1) Student's name, residence address (and mailing address, if differ-
ent), telephone number, and date of birth;

(2) Student's photo identificafion number and description of type of
identificadon document;

(3) Student's authorization to release, to the Department, information
contained on CDPH Form 8493 (6/07), Course Completion Form;

(4) Student's verificafion of understanding that possession of the
Course Complefion Form does not consUtute cerfification by CDPH;

(5) Student' s verification of understanding that, to be eligible for inter-
im certification or certification renewal, an application for interim certifi-
cation or certification shall be made to CDPH within one year of succes-
sful completion of the final examination;

(6) Student's signature and date;

(7) Accredited training provider's name;

(8) Tide and number of the course or continuing education instruction;

(9) Number of contact hours completed;

(10) Dates and location(s) of the course or continuing education in-
struction and CDPH Form 8493 (6/07), Course Completion Form Num-
ber and date of student's completion of core instruction if different;

(1 1) Date the student passed the course or continuing education final
examination; and

(12) Training Director's name, printed or typed, signature, and date
verifying, under penalty of perjury, that all information contained on
CDPH Form 8493 (6/07), Course Completion Form, is true and correct.

(j) An accredited training provider shall maintain, at its principal place
of business in California, for at least :Five years, accurate records of the
following:

(1) Daily student attendance;

(2) Examination results for each student, including results of demon-
stration testing;

(3) Completed Course Completion Forms;

(4) Training Director and instructor qualifications;

(5) Documentation of approval or authority to operate granted by the
Bureau for Private Postsecondary and Vocational Education;

(6) Cuaent course curriculum materials and documents reflecting any
changes made to these materials;

(7) Examinations for each course, including demonstration testing
protocol; and

(8) Completed student evaluation forms for each course.

(k) An accredited training provider shall notify CDPH at least 48 hours
prior to offering or canceling a course or continuing education training.
The notification shall include type of course or training, instructor(s),
date(s), time(s), and location(s), including street address.

(0 An accredited training provider shall submit documentation of in-
structor qualifications as specified in §35053(b) to CDPH at least 48
hours prior to an instructor teaching a course or continuing education.

Page 248.15

§ 35055

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(m) An accredited training provider shall maintain approval or author-
ity to operate granted by the Bureau for Private Postsecondary and Voca-
tional Education.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former section 35034 to new section 35054, including amend-
ment of section and NoTi;, filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 1 4). A Certificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

2. Renumbering of former section 35034 to new section 35054, including amend-
ment of section and NOTi:, refiled 7-20-98 as an emergency; operative 7-29-98
pursuant to Government Code section 1 1346.1(d) (Register 98, No. 30). A Cer-
tificate of Compliance must be transmitted to OAL by 1 1-27-98 or emergency
language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tions (j)(5) and (m), transmitted to OAL 1 1-23-98 and'filed 1-8-99 (Reeister
99, No. 2).

4. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

Article 3. Core Instruction

§ 35055. Core Instructional Requirements.

(a) Each course, except the lead-related construction work course and
the lead-related construction sampling technician course, shall include
a minimum of five contact hours of the following core instructional re-
quirements:

( 1 ) At least one contact hour of background information on lead and
health effects related to lead exposure, including:

(A) Identification of sources of environmental lead such as surface
dust, soil, water, air, and food;

(B) History of uses and locations of lead and leaded paint in buildings;

(D) Summary of lead abatement control options, including interim
controls;

(E) The nature of lead-related diseases;

(F) Pathways of exposure in children and adults;

(G) Dose-response relationships, and blood lead levels in children and
adults;

(H) Effects on the nervous, reproductive (male and female), musculo-
skeletal, cardiovascular, and blood-forming systems and kidneys;

(1) Different effects on children and adults, including women during
pregnancy;

(J) Symptoms and diagnosis of poisoning in children and adults and
CDPH-reportable blood lead levels;

(K) Medical treatment for lead poisoning, including, chelation thera-
py; and

(L) How lead in the body is absorbed, distributed, and eliminated.

(2) At least one contact hour on relevant federal, state and local regula-
tory requirements including:

(A) Requirements for the identification, management, transport, re-
cord keeping, and disposal of hazardous waste set forth in Title 22, Cah-
fomia Code ofRegulations, Division 4.5, Chapters 10, 11, 12, 13, and 18,
Health and Safety Code section 25163, subdivision (c), and Chapter 6.5,
Article 10.8, of the Health and Safety Code;

(B) Ambient Air Quahty Standards for lead set forth in Title 1 7, CaU-
fomia Code of Regulations, sections 70100 and 70200;

(C) Injury and Illness Prevention Program requirements set forth in
Title 8, California Code ofRegulations, sections 1509 and 3203;

(D) Cahfomia's Construction Safety Orders set forth in Title 8, Cali-
fornia Code ofRegulations, section 1532.1; and

(E) Standards for hazard communication in the work place set forth in
the "Clear and Reasonable Warnings," Title 22, California Code ofReg-
ulations, subsections 12601(c) & (d) and in "Hazard Communication,"
Title 8, California Code ofRegulations, section 5194.

(3) At least one contact hour on respiratory protection and personal
protective equipment including:

(A) Standards and criteria for establishing a respiratory protection pro-
gram set forth in Title 8, California Code ofRegulations, sections 5141
and 5144 and Occupational Safety and Health Administration (OSHA)
respirator requirements set forth in 29 Code of Federal Regulations, sec-
tion 1910.134(1998);

(B) Classes and characteristics of respirators;

(D) Proper selection, inspection, donning, doffing, use, maintenance,
and storage procedures for respirators;

(E) Methods for field testing the face piece seal (user seal check proce-
dures);

(F) Qualitative and quantitative fit testing procedures;

(G) Factors that alter respirator fit, e.g. facial hair;
(H) Selection and use of personal protective clothing;

(I) Storage and handling of non-disposable clotliing; and
(J) Proper use of protective clothing and equipment set forth in the
Construction Safety Orders, California Code ofRegulations, title 8, sec-
tion 1532.1.

(4) Discussion of the roles and responsibilities of the interim certified
individual, the need for further on-the-job training and the need to work
with other personnel during lead-related construction activities, includ-
ing public health and housing agency officials.

(b) Individuals in possession of a CDPH Form 8493 (6/07), Course
Completion Form in any course, except a lead-related construction Work
course, shall not be required to retake the core instructional requirements
when seeking a Course Completion Form in another course, provided the
course begins no more than three years after the date of the final examina-
tion on the initial Course Completion Form.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . Amendment moving article 3 heading formerly preceding section 35035 to pre-
cede secfion 35055, and renumbering former section 35035 to new section
35055, including amendment of secfion and Note, filed 3-30-98 as an emer-
gency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance
must be transmitted to OAL by 7-28-98 or emergency language will be re-
pealed by operation of law on the following day.

2. Amendment moving article 3 heading formerly preceding section 35035 to pre-
cede section 35055, and renumbering former section 35035 to new section
35055, including amendment of secfion and Note, refiled 7-20-98 as an emer-
gency; operafive 7-29-98 pursuant to Government Code secfion 11346.1(d)
(Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-27-98 or emergency language will be repealed by operation of law on
the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tions (a)(1), (a)(1)(C), (a)(1)(F), (a)(1)(G), (a)(l)(J), (a)(l)(K), (a)(2), (a)(3),
(a)(3)(A) and (a)(3)(E), transmitted to OAL 1 1-23-98 and filed 1-8-99 (Regis-
ter 99, No. 2).

4. Amendment of subsections (a), (a)(l)(J) and (b) and Note filed 4-30-2008; op-
erafive 5-30-2008 (Register 2008, No. 18).

Article 4. Lead-Related Construction
Inspection and Assessment Course

§ 35056. Course Requirements.

(a) A lead-related construction Inspection and Assessment course
shall consist of a minimum of 40 contact hours which includes core in-
structional requirements specified in section 35055, methodology re-
quirements specified in subsection 35056(b), hands-on training, as spe-
cified in subsection 35056(c), and classroom instruction, as specified in
subsection 35056(d).

(b) At least 1 6 of the 40 required contact hours shall be taught using
interactive/participatory teaching methods, which includes at least ten
contact hours of hands-on training.

(1) Inspection and hazard assessment techniques as specified in
"Guidelines for the Evaluation and Control of Lead-Based Paint Hazards

Page 248.16

Title 17

State Department of Health Services

§ 35057

in Housing", U.S. Department of Housing and Urban Development, June
1995. or most recent revision;
(2) Participation in a simulated field visit which includes:

(A) Walk-through building inspection;

(B) Discussion of data collection, including sample location determi-
nation; and

( 1 ) Federal guidelines as specified in "Guidelines for the Evaluation
and Control of Lead-Based Paint Hazards in Housing", U.S. Department
of Housing and Urban Development, June 1995, or most recent revision.

(2) State regulations specified in Title 17, California Code of Regula-
tions, Division 1. Chapter 8, Sections 36000 and 36100.

(3) Roles and responsibilities of local health officials versus private
sector Inspector/Assessors when conducting lead hazard assessments.

(4) Potential hazard exposure circumstances, including, but not lim-
ited to, electrical, heat stress, fire, explosion, and chemical air contami-
nants, slips, trips, falls and disturbances of friable asbestos.

(5) At least one contact hour on radiation information and safety train-
ing requirements as follows:

(A) CDPH radiation safety training requirements as specified in Title
17, California Code of Regulations, sections 30100-30355;

(B) Ionizing radiation including atomic structure, units of radiation,
radioactivity, radioactive decay, ionization, radiation absorption in mat-
ter, and radiation detection; and

(C) Safe use of X-ray florescent (XRF) analyzers, including direct and
indirect analyzers and limitations (substrate interference), transporta-
tion, storage, record keeping and license requirements.

(6) At least five contact hours on job tasks associated with lead hazard
inspection procedures as follows:

(A) Review and interpretation of previous inspection records, includ-
ing sample collection and analysis, abatement activities, and source in-
formation;

(B) Inspection plan development, including notification of property
owners and occupants, building access, use of warning signs, and disrup-
tion minimization.

(C) Hazard communication with property owners, occupants, and
neighbors relative to the reduction or elimination of sources of lead at the
job site such as paint, dust, soil, water, imported ceramic pottery, home
remedies, or occupational take-home sources;

(D) Visual inspections and clearance inspections;

(E) Sample collection including equipment, procedures, quality assur-
ance and contamination factors before, during and after abatement, as de-
scribed in "Guidelines for the Evaluation and Control of Lead-Based
Paint Hazards in Housing", U.S. Department of Housing and Urban De-
velopment, June 1995, or most recent revision;

(F) Sample analysis, including selection of an EPA recognized labora-
tory under the National Lead Laboratory Accreditation Program to test
paint, dust, soil samples and other media and quality assurance proce-
dures; and

(G) Post-inspection procedures and written reports.

(7) At least five contact hours on job tasks associated with lead hazard
risk assessment as follows:

(A) HUD protocol for risk assessment and interim controls as speci-
fied in "Guidelines for the Evaluation and Control of Lead-Based Paint
Hazards in Housing", U.S. Department of Housing and Urban Develop-
ment, June 1995, or most recent revision;

(B) Assessment of leaded paint surface damage, including disturbance
potential of lead-related construction work;

(D) Public and lead-related construction work personnel health con-
siderations, including medical confidentiality.

(8) Record keeping as specified in CDPH radiation materials control
regulations in the California Code of Regulations, title 17, sections
30100-30355; and "Guidelines for the Evaluation and Control of Lead-

Based Paint Hazards in Housing", U.S. Department of Housing and Ur-
ban Development, June 1995, or most recent revision.

(9) Lead-related construction techniques in residential and public
buildings as follows:

(A) Abatement options, including interim controls;

(B) Clean-up and disposal procedures, contamination prevention and
dust minimization, including high efficiency particulate air (HEPA) vac-
uums as described in "Guidelines for the Evaluation and Control of
Lead-Based Paint Hazards in Housing", U.S. Department of Housing
and Urban Development, June 1995, or most recent revision; and

(10) Inspector/Assessor qualifications, responsibilities, legal obliga-
tions and conflicts of interest.

(11) Insurance issues relating to lead-related constaiction, work and
abatement including liability insurance, claims-made and occurrence
policies, and environmental and pollution liability policy clauses, and
bonding.

(12) Classroom discussion of a simulated field visit.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 1 3 1 05 1 . Health and Safety Code.

History

1. New article 5 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 5 and section refiled with amendment of subsection (c)(2)
10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Cer-
tificate of Compliance must be transmitted to OAL by 2-24-94 or emergency
language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
sections (d)(l)(A)-(B), (d)(5)(A), and (d)(5)(J) and new subsection (d)(1)(C)
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment moving article 4 heading formerly preceding section 35050 to pre-
cede section 35056 and moving article 5 heading formerly preceding section
35056 to precede section 35057, renumbering former section 35056 to new sec-
tion 35057, and renumbering former section 35050 to new section 35056, in-
cluding amendment of section and Notl, filed 3-30-98 as an emergency; op-
erafive 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be
transmitted to OAL by 7-28-98 or emergency language will be repealed by op-
eration of law on the following day.

5. Amendment moving article 4 heading formerly preceding secUon 35050 to pre-
cede section 35056 and moving article 5 heading formerly preceding section
35056 to precede secfion 35057, renumbering former section 35056 to new sec-
tion 35057, and renumbering former section 35050 to new section 35056, in-
cluding amendment of section and NoTi:, refiled 7-20-98 as an emergency; op-
erative 7-29-98 pursuant to Government Code section 1 1 346. 1 (d) (Register 98,
No. 30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98
or emergency language will be repealed by operation of law on the following
day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsecfions (c)(5)(A) and (c)(8) and Note filed 4-30-2008; op-
erative 5-30-2008 (Register 2008, No. 18).

Article 5. Lead-Related Construction
Supervision and Project Monitoring Course

§ 35057. Course Requirements.

(a) A lead-related construction supervision and project monitoring
course shall consist of a minimum of 40 contact hours which includes
core instructional requirements specified in section 35055, methodology
requirements specified in subsection 35057(b), hand,s-on training, as
specified in subsection 35057(c), classroom instruction, as specified in
subsection 35057(d), and a demonstration of respirator fit testing as spe-
cified in the Construction Safety Orders, California Code of Regulations,
title 8, section 1532.1.

(b) At least 1 6 of the 40 required contact hours shall be taught using
interactive/participatory teaching methods, which includes at least eight
contact hours of hands-on training.

Page 248.17

§ 35057

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1) Exposure assessment including paint chip collection and air moni-
toring and worker protection practices including personal protective
equipment as specified in the Construction Safety Orders, California
Code of Regulations, title 8, section 1532.1;

(2) Clearance inspections such as specified in "Guidelines for the
Evaluation and Control of Lead-Based Paint Hazards in Housing", U.S.
Department of Housing and Urban Development, June 1 995, or most re-
cent revision; and

(3) Lead-related construction supervision and project monitoring, in-
cluding, use of engineering controls, construction and use of contain-
ment and barrier systems for at least two worksite preparation levels, re-
moval methods, interim control methods, clean-up including high
efficiency particulate air (HEPA) vacuums, use of negative air machines,
and waste disposal as specified in, "Guidelines for the Evaluation and
Control of Lead-Based Paint Hazards in Housing", U.S. Department of
Housing and Urban Development, June 1995, or most recent revision.

(d) Classroom instruction shall include:

( 1 ) Regulatory requirements as specified in:

(A) National Emission Standards for Hazardous Air Pollutants set
forth in Title 40. Code of Federal Regulations, section 50.12 (1992);

(B) Relevant State Contractor Licensing Board requirements for con-
ducting work as a contractor set forth in section 7026 and following of
the Business and Professions Code;

(C) Permitting requirements for lower risk treatment activities set
forth in Health and Safety Code. Chapter 6.5, Article 9, sections 25200.3,
25201.5, and Title 22, California Code of Regulations. Division 4.5,
Chapter 45; and

(D) Work practice requirements set forth in Title 17, California Code
of Regulations, sections 36000 and 36100.

(2) Identification and prevention of hazards encountered during lead-
related construction as follows:

(A) Emergency procedures for sudden releases; and

(B) Electrical, heat stress, fire, explosion and other hazards, chemical
air contaminants, slips, trips, falls and disturbances of friable asbestos.

(3) Job tasks associated with sample collection and analysis proce-
dures as follows:

(A) Sample collection equipment, and procedures, quality assurance
methods and contamination factors before, during and after abatement,
as described in "Guidelines for the Evaluation and Control of Lead-
Based Paint Hazards in Housing", U.S. Department of Housing and Ur-
ban Development, June 1995, or most recent revision;

(B) Sample analysis, including interpretation and quality assurance
procedures; and

(4) At least five contact hours on job tasks associated with lead-related
construction including the following:

(A) Interior and exterior leaded paint, soil and dust abatement methods
(including chemical, enclosure, hand, mechanical, blasting, encapsula-
tion), interim control methods, use of engineering controls, clean-up
techniques (including high efficiency particulate air (HEPA) vacuums),
and worksite preparation (including use of negative air machines), as
specified in "Guidelines for the Evaluation and Control of Lead-Based
Paint Hazards in Housing", U.S. Department of Housing and Urban De-
velopment, June 1995, or most recent revision;

(B) Lead-related construction work and abatement as a portion of a
renovation project;

(D) Work practices as follows:

1. Construction, use, and maintenance of containment and barrier sys-
tems;

2. Warning signs and their placement; and

3. Electrical and ventilation systems lockout.

(E) Meeting housing codes and standards;

(F) Special lead-related construction procedures for occupied build-
ings, including strategies for occupant education, occupant and furniture
relocation, and lead exposure minimization;

(G) Development of detailed schedules to comply with project design
requirements and execution of tasks, including but not limited to, resi-
dent notification, building access, warning signs, and occupant disrup-
tion minimization;

(H) Identification and implementation of personal hygiene practices
including, but not limited to, entry and exit procedures for the work area,
provision and use of showers; and avoidance of eating, drinking, smok-
ing, chewing, and applying cosmetics in the work or changing area;

(I) Hazard communication with property owners, occupants and
neighbors relative to the reduction or elimination of sources of lead at the
job site such as paint, lead dust, soil, water, imported ceramic pottery,
home remedies, and occupational take-home exposures; and

(J) Administrative tasks associated with supervision and project moni-
toring:

1. Contract specifications, preparation and administration;

2. Cost estimation, including strategies for cost reduction;

3. Development and administration of an illness and injury prevention
program; and

4. Record keeping as specified in the Construction Safety Orders, Cali-
fornia Code of Regulations, title 8, section 1532.1.

(5) Supervision and project monitoring job tasks associated with lead-
related construction project design as follows:

(A) Review of inspection reports;

(B) Performance of clearance testing methods as described in "Guide-
lines for the Evaluafion and Control of Lead-Based Paint Hazards in
Housing", U.S. Department of Housing and Urban Development, June
1995, or most recent revision; and

(6) Conflicts of interest related to the performance of supervision, in-
spection, and project monitoring tasks.

(7) Medical surveillance and removal protection as specified in the
Construction Safety Orders, California Code of Regulations, title 8, sec-
tion 1532-. 1 , including but not limited to, issues involved in selecting and
using medical services;

(8) Insurance issues relating to lead-related construction including:

(A) Workers' compensation coverage and exclusions; and

(B) Liability insurance, claims-made and occurrence policies, envi-
ronmental and pollution liability policy clauses, and bonding.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . Amendment moving article 5 heading formerly preceding section 35056 to pre-
cede section 35057, and renumbering former section 35056 to new section
35057, including amendment of section and Note, filed 3-30-98 as an emer-
gency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance
must be transmitted to OAL by 7-28-98 or emergency language will be re-
pealed by operation of law on the following day.

2. Amendment moving article 5 heading formerly preceding section 35056 to pre-
cede section 35057, and renumbering former section 35056 to new section
35057, including amendment of section and NOTE, re filed 7-20-98 as an emer-
gency; operative 7-29-98 pursuant to Government Code section 11346.1(d)
(Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-27-98 or emergency language will be repealed by operation of law on
the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

4. Amendment of NOTE filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

Page 248.18

Title 17

State Department of Health Services

§ 35065

Article 6. Lead-Related Construction
Sampling Technician Course

§35061. Course Requirements.

(a) A lead-related constmction sampling technician course shall con-
sist of a minimum of 8 contact hours, with at least 5 contact hours taught
using interactive/participatory teaching methods. The course shall in-
clude:

( 1 ) At least thirty minutes of classroom instruction on lead and health
effects related to lead exposure, including:

(A) Identification of sources of lead hazards;

(B) Numerical standards for lead-contaminated dust, lead-contami-
nated soil, and lead-based paint; and

(2) At least one contact hour of classroom instruction on lead hazard
evaluation activities and requirements specified in Title 17, California
Code of Regulations, section 36000. Classroom instruction shall delin-
eate the responsibilities of an inspector/assessor and sampling technician
as specified in section 36000(d).

(3) At least one contact hour on job tasks associated with lead hazard
evaluation as follows:

(A) Professional responsibilities and limitations as specified in Health
and Safety Code sections 105253 through 105256, inclusive.

(B) Sampling or testing soil, dust, and paint only when an inspector/as-
sessor identifies the specific locations where soil, dust, and paint are to
be sampled or tested, interprets the results, and complies with the record
keeping and reporting requirements;

(D) Sample collection and testing procedures for paint, dust, and soil;
and

(E) Post-sampling and post-testing procedures.

(4) At least three and one half contact hours of hands-on training in-
cluding:

(A) Sample collection, including equipment, procedures, and quality
assurance, as described in:

1. Chapter 5: Risk Assessment, section II (D), and Appendix 13.3
"Guidelines for the Evaluation and Control of Lead-Based Paint Hazards
in Housing," U.S. Department of Housing and Urban Development, June
1995; and

2. Chapter 7: Lead-Based Paint Inspection, "Guidelines for the Evalu-
ation and Control of Lead-Based Paint Hazards in Housing," U.S. De-
partment of Housing and Urban Development, 1997.

(B) Participation in simulated field visit, including visual inspections,
collection of dust, paint and soil samples, and practice with an X-ray
Fluorescence (XRF) analyzer.

(5) At least thirty minutes of classroom instruction on radiation in-
formation and safety training requirements specified in Title 1 7, Califor-
nia Code of Regulations, division 1, chapter 5, subchapter 4, groups 1,
1 .5, and 2. This instruction shall emphasize that sampling technicians are
required to complete an additional eight hours of training prior to operat-
ing an X-ray Fluorescence (XRF) analyzer for lead hazard evaluation.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code, Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New article 6 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 6 and section refiled with amendment of subsection (d)(2)
10-21-94 as an emergency; operative 10-26-94 (Register 94, No. 42). A Cer-
tificate of Compliance must be transmitted to OAL by 2-24-94 or emergency
language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
sections (e)(])(A)-(B), (e)(5)(B) and (e)(5)(J) and new subsection (e)(1)(C)
transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment of section and Note filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted

to OAL by 7-28-98 or emergency language will be repealed hy operation of law
on the following day.

5. Amendment of section and NoTi:, refiled 7-20-98 as an emergency; operalive
7-29-98 pursuant to Government Code section 11 346.1(d) (Register 98. No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27 98 or
emergency language will be repealed by operation of law on the foll()v\ ing day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tion (c)(1), transinitted to OAL 1 1-23-98 and filed l-8~99 (Reei.ster 99, No.
2).

7. Amendment of article heading, repealer and new section and amendment of
NoTi-; filed 4-30-2008; operalive 5-30-2008 (Register 2008. No. 18).

Article 7. Lead-Related Construction Work
Course

§ 35065. Course Requirements.

(a) A lead-related construction work course shall consist of a mini-
mum of 24 contact hours which includes methodology requirements spe-
cified in subsection 33065(b), hands-on training, as specified in subsec-
tion 35065(c), classroom instruction, as specified in subsection
35065(d), and a demonstration of respirator fit testing as specified in the
Construction Safety Orders, California Code of Regulations, title 8, sec-
tion 1532.1.

(b) At least 12 of the 24 required contact hours shall be taught using
interactive/participatory teaching methods, which includes at least ten
contact hours of hands-on training.

(1) Exposure assessment including air monitoring and worker protec-
tion practices including personal protective equipment as specified in the
Construction Safety Orders, California Code of RegulaUons, title 8, sec-
tion 1532.1; and

(2) Lead-related construction work, including, construction and use
of containment and barrier systems for at least two worksite preparation
levels, removal methods, interim control methods, waste disposal, use
of high efficiency particulate air (HEPA) vacuums, electrical and venfila-
tion system lockout, clean-up, and personal hygiene.

(d) Classroom instruction shall include:

(1) At least one contact hour of regulatory requirements as specified
in:

(A) Injury and Illness Prevention Program requirements set forth in
Title 8, California Code of Regulations, sections 1509 and 3203;

(B) California's Construction Safety Orders set forth in Titie 8, Cali-
fornia Code of Regulations, section 1532.1;

(C) Standards for hazard communication in the work place set forth in
the "Clear and Reasonable Warnings," Title 22, California Code of Reg-
ulations, subsections 12601(c) and (d) and in "Hazard Communication,"
Titie 8, CaUfomia Code of Regulations, section 5194; and

(D) Work practice standards set forth in Titie 17, California Code of
Regulations, sections 36000 and 36100.

(2) At least one contact hour of background information on lead, in-
cluding:

(A) Identification of sources of environmental lead contamination
such as surface dust, soil, water, air, and food;

(B) History of uses and locations of lead and leaded paint in buildings;

(D) Health effects related to lead exposure, including but not limited
to:

1 . Pathways of exposure in children and adults;

2. Dose-response relationsliips and blood lead levels in children and
adults;

3. Effects on the nervous, reproductive (male and female), musculo-
skeletal, cardiovascular, and blood-forming systems and kidneys;

4. Different effects on children and adults, including women during
pregnancy;

5. Symptoms and diagnosis of poisoning in children and adults and
CDPH-reportable blood lead levels; and

6. Medical treatment for lead poisoning, including chelation therapy.

Page 248.18(a)

§ 35066

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(3) Al least two contact hours on respiratory protection and personal
protective equipment, including:

(A) Elements of a respiratory protection program set forth in Title 8,
California Code of Regulations, sections 5141 and 5 144 and Occupation-
al Safety and Health Administration (OSHA) respirator requirements set
forth in 29 Code of Federal Regulations, section 1910.134 (1998);

(B) Classes and characteristics of respirators;

(D) Proper selection, inspection, donning, doffing, use, maintenance,
and storage procedures for respirators;

(E) Methods for field testing the face piece seal (user seal check proce-
dures);

(F) Qualitative and quantitative fit testing procedures;

(G) Factors that alter respirator fit, e.g. facial hair;
(H) Selection and use of personal protective clothing;

(I) Storage and handling of non-disposable clothing; and

(4) At least eight contact hours on job tasks associated with lead-re-
lated constiTJCtion including:

(A) Tasks as described in, "Guidelines for the Evaluation and Control
of Lead-Based Paint Hazards in Housing", U.S. Department of Housing
and Urban Development, June 1995, or most recent revision as follows:

1. Sampling methods for paint, dust, and soil;

2. Construction and use of containment and barrier systems for all inte-
rior and exterior worksite preparation levels;

3. Interior and exterior leaded paint, soil and dust abatement methods
(including chemical, enclosure, hand, mechanical, blasting, encapsula-
tion), and interim control methods;

4. Use of administrative and engineering controls; and

5. Clean-up techniques (including high efficiency particulate air
(HEPA) vacuums);

(B) Construction, use and maintenance of containment and barrier sys-
tems;

(D) Electrical and ventilation systems lockout;

(E) Hazardous and non-hazardous waste characterization and dispos-
al;

(F) Personal hygiene, including entry and exit procedures for the work
area, use of showers, avoidance of eating, drinking, smoking, chewing,
and applying cosmetics in the work or changing area, avoidance of take-
home exposures; and

(G) Identification and prevention of hazards as follows:

1 . Emergency procedures for sudden releases; and

2. Electrical, heat, stress, fire, explosion and other hazards, chemical
air contaminants, slips, trips, falls and disturbances of friable asbestos.

(5) Medical monitoring requirements as specified in the Construction
Safety Orders, California Code of Regulations, title 8, section 1532. 1 , in-
cluding:

(A) Discussion of the need for medical monitoring of lead toxicity and
disclosure of medical history for lead-related construction work; and

(B) Treatment of lead poisoning cases, including medical removal
procedures and the issue involved in selecting medical services.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New article 7 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 1 0-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 7 and section refiled with amendment of subsection (c)(2) 10-21-94
as an emergency; operative 10-26-94 (Register 94, No. 42). A Certificate of
Compliance must be transmitted to OAL by 2-24-94 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment of section and NoTi; filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted
to OAL by 7-28-98 or emergency language will be repealed by operation of law
on the following day.

5. Amendment of section and NoTi:, refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Ceilificale of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsection (d)(2)(D)5. and NoTi-; filed 4-30-2008; operative
5-30-2008 (Register 2008, No. 18).

Article 8. Lead-Related Construction

Supplemental Supervision and Project

Monitoring Course

§ 35066. Course Requirements.

(a) A lead-related construction supplemental supervision course shall
consist of a minimum of 1 6 contact hours which includes methodology
requirements specified in subsection 35066(b), hands-on training, as
specified in section 35066(c), and classroom instruction, as specified in
subsection 35066(d).

(b) At least four of the 16 required contact hours shall be taught using
interactive/participatory teaching methods, which includes at least one
contact hour of hands-on training.

(1) Exposure assessment including paint chip collection and air moni-
toring as specified in the Construction Safety Orders, Title 8, California
Code of Regulations, section 1532.1; and

(d) Classroom instruction shall include:

(1) Regulatory requirements as specified in:

(A) California's Construction Safety Orders set forth in Title 8, Cali-
fornia Code of Regulations, section 1532.1;

(B) Section 35055(a)(2)(A) and (B); and

(2) Job tasks associated with sample collection and analysis proce-
dures as specified in section 35057(d)(3).

(3) At least five contact hours on job tasks associated with lead-related
construction as specified in section 35057(d)(4).

(4) Supervision and project monitoring job tasks associated with lead-
related construction project design as specified in 35057(d)(5).

(5) Supervision and project monitoring issues as specified in
35057(d)(6)(7) and (8).

(6) Discussion of the roles and responsibilities of the interim certified
individual as specified in 35055(a)(4).

Note-. Authority cited: Sections 105250, 124160 and 131200. Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . Renumbering of former article 8 to new article 9, new article 8 (secfion 35066)
and new section filed 3-30-98 as an emergency; operative 3-30-98 (Register
98, No. 14). A Certificate of Compliance must be transmitted to OAL by
7-28-98 or emergency language will be repealed by operation of law on the fol-
lowing day.

2. Renumbering of former article 8 to new article 9, new article 8 (section 35066)
and new section refiled 7-20-98 as an emergency; operative 7-29-98 pursuant
to Government Code secfion 1 1 346. 1 (d) (Register 98. No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

Page 248.18(b)

Title 17

State Department of Health Services

§ 35067

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

Article 9. Lead-Related Construction
Certified Industrial Hygienist Course

§ 35067. Course Requirements.

(a) A lead-related construction certified industrial hygienist course
shall consist of a minimum of 24 contact hours which includes methodol-
ogy requirements specified in subsection 35067(b), hands-on training,
as specified in subsection 35067(c), and classroom instruction, as speci-
fied in subsection 35067(d).

(b) At least eight of the 24 required contact hours shall be hands-on
training.

(1) Inspection and hazard assessment techniques as specified in
"Guidelines for the Evaluation and Control of Lead-Based Paint Hazards
in Housing", U.S. Department of Housing and Urban Development, June
1995, or most recent revision.

(2) Simulated field visit associated with lead-related construction in-
spection and assessment which includes:

(A) Walk-through building inspection;

(B) Discussion of data collection, including sample location determi-
nation; and

(3) Simulated field visit associated with developing lead-related con-
struction project designs which includes:

(A) Building walk-through for development of project design; and

(B) On-site discussion of project design.

(d) Classroom instruction shall include:

( 1 ) Background information on lead, including:

(A) Identification of sources of environmental lead such as surface
dust, soil, water, air, and food;

(B) History of uses and locations of lead and leaded paint in buildings;

(D) Summary of lead abatement control options, including interim
controls.

(2) Relevant federal, state and local regulatory requirements:

(A) Requirements for the identification, management, transport, re-
cord keeping, and disposal of hazardous waste set forth in Title 22, Cali-
fornia Code of Regulations. Division 4.5, Chapters 10, 11, 12, 13, and 18,
and Health and Safety Code section 25163, subdivision (c), and Chapter
6.5, Article 10.8;

(B) Ambient Air Quality Standards for lead set forth in Title 17, Cali-
fornia Code of Regulations, sections 70100 and 70200;

(D) National Emission Standards for Hazardous Air Pollutants set
forth in 40 Code of Federal Regulations, section 50.12 (1992);

(E) Relevant State Contractor Licensing Board requirements for con-
ducting work as a contractor set forth in section 7026 and following of
the Business and Professions Code;

(F) Permitting requirements for lower risk treatment activities set forth
in Health and Safety Code, Chapter 6.5, Article 9, sections 25200.3,
25201.5. and Title 22, California Code of Regulations, Division 4.5,
Chapter 45; and

(G) Work practice requirements set forth in Title 17, California Code
of Regulations, sections 36000 and 36100.

(3) Federal guidelines as specified in "Guidelines for the Evaluation
and Control of Lead-Based Paint Hazards in Housing", U.S. Department
ofHou-singandUrbanDeveJopment, June 1995, ormost recent revision.

(4) Roles and responsibiUties of local health officials versus private
sector Inspector/Assessors when conducting lead hazard assessments.

(5) Job tasks associated with lead hazard inspection procedures as fol-
lows:

(A) Review and interpretation of previous inspection records;

(B) Inspection plan development, including notification of property
owners and occupants, building access, use of vv'arning signs, and disrup-
tion minimization;

(D) Visual inspections and clearance inspections;

(E) Investigation protocol for assessing multiple sources of lead expo-
sure;

(F) Sample collection including equipment, procedures, quality assur-
ance and contamination factors before, during and after abatement, as de-
scribed in "Guidelines for the Evaluation and Control of Lead-Based
Paint Hazards in Housing", U.S. Department of Housing and Urban De-
velopment, June 1995, or most recent revision;

(G) Sample analysis, including selection of an EPA recognized labora-
tory to test paint, dust, soil samples and other media and quality assurance
procedures; and

(H) Post-inspection procedures and written reports.

(6) Job tasks associated with lead hazard risk assessment as follows:

(B) Assessment of leaded paint surface damage, including disturbance
potential of lead-related construction activities;

(D) Public and lead-related construction personnel health consider-
ations, including medical confidentiality.

(7) Lead-based paint abatement techniques in residential and public,
buildings as follows:

(A) Abatement options, including interim controls;

(8) Inspector/Assessor quaHfications, responsibilities, legal obliga-
tions and conflicts of interest.

(9) Insurance issues relating to lead-related construction including:

(A) Workers' compensation coverage and exclusions; and

(B) Liability insurance, claims-made and occurrence policies, and en-
vironmental and pollution liability policy clauses, and bonding.

(10) Job tasks associated with lead-related construction including, but
not not limited to, the following:

(A) Abatement as a portion of a renovation project;

(B) Notification of other contractors working at the construction site;

1. Construction and maintenance of containment barriers;

2. Warning signs and their placement; and

3. Electrical and ventilation systems lockout;

(D) Meeting housing codes and standards;

(E) Procedures for occupied buildings, including strategies for occu-
pant education, occupant and furniture relocation, and exposure minimi-
zation;

(F) Development of detailed schedules to comply with project design
requirements and execution of tasks, including but not limited to, resi-
dent notification, building access, warning signs, and occupant disrup-
tion minimization; and

(G) Administrative tasks associated with supervision and project mon-
itoring:

1. Contract specifications, preparation and administration;

Page 248.18(c)

§ 35070

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Cost estimation, including strategies for cost reduction.

(11) Supervision and project monitoring job tasks associated with
project design as follows:

(A) Review of inspection reports;

(B) Performance of clearance testing methods as described in "Guide-
lines for the Evaluation and Control of Lead-Based Paint Hazards in
Housing", U.wS. Department of Housing and Urban Development, June
1995, or most recent revision; and

(12) Conflicts of interest related to the performance of supervision, in-
spection, and project monitoring tasks.

(13) Job tasks associated with lead-related construction project design
as follows:

(A) Development and modification of project design specifications:

1. Working with other consultants such as industrial hygienists, con-
stmction journeymen, engineers, and housing specialists;

2. Prescriptive and performance specifications;

3. Drawing preparation, including interpretation of as-built drawings;

4. Structure modification;

5. Special design procedures for occupied buildings, including strate-
gies for occupant education, occupant and furniture relocation, and expo-
sure minimization;

6. Selection of abatement and interim control methods;

7. Cost estimation for budgeting purposes, including strategies for cost
reduction; and

8. Scheduling parameters, including resident notification, building ac-
cess, warning signs, and occupant disruption minimization.

(14) Classroom discussion of simulated field visits.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 13 1051. Health and Safety Code.

History

1 . Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer article 8 to article 9, new article 8 (section 35067) and new section trans-
mitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

2. Renumbering of former article 8 to new article 9 and amendment of section and
NoTH filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14).
A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emer-
gency language will be repealed by operation of law on the following day.

3. Renumbering of former article 8 to new article 9 and amendment of section and
Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Govern-
ment Code section 11346.1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

4. Certificate of Compliance as to 7-20-98 order, including amendment of section,
transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

5. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

Article 10. Continuing Education

§ 35070. Continuing Education for Workers Requirements.

(a) Continuing education for workers shall only be provided by an ac-
credited training provider approved by the Department to offer the lead-
related construction work course.

(b) Continuing education instruction shall be designed to increase or
enhance skills and knowledge necessary to perform the job tasks and job
functions associated with certification and shall be offered in minimum
increments of one contact hour.

(c) At least 40% of continuing education instruction for workers shall
be taught using interactive/participatory teaching methods.

(d) Continuing education topics shall include:

( 1 ) An overview of safety practices relevant to tasks conducted by cer-
tified lead workers;

(2) An update on federal, state, or local statutes or regulations relevant
to tasks conducted by certified lead workers; and

(3) An update on new lead-related construction techniques or technol-
ogies relevant to tasks conducted by certified lead workers.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New article 8 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transinitted to OAL
by 1 0-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 8 and section refiled 10-21-94 as an emergency; operative
10-26-94 (Register 94. No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer article 8 to article 9 and former article 9 to article 10 transmitted to OAL
2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering of former article 9 to new article 10 and amendment of section
heading, section and Noth filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 14). A Ceilificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

5. Renumbering of former article 9 to new article 10 and amendment of section
heading, section and Note refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 11346.1(d) (Register 98. No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tions (a) and (d)(1), transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register
99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35072. General Continuing Education Requirements.

(a) General continuing education shall only be provided by an accred-
ited training provider approved to offer one of the following lead-related
construction courses: inspection and assessment, supervision and project
monitoring, supplemental supervision and project monitoring, project
design, sampling technician, or Certified Industrial Hygienist.

(b) General continuing education instruction shall be designed to in-
crease or enhance skills and knowledge necessary to perform the job
tasks and job functions associated with certification or interim certifica-
tion and shall be offered in minimum increments of one contact hour.

(c) At least 25% of general continuing education instruction shall be
taught using interactive/participatory teaching methods.

(d) General condnuing education topics shall include:

(1) An overview of safety practices in lead-related construction;

(2) An update on federal, state, or local statutes or regulations relevant
to tasks conducted by certified lead inspector/assessors, project design-
ers, sampling technicians, project monitors, and supervisors; and

(3) An update on lead-related construction techniques or technologies
relevant to tasks conducted by certified lead inspector/assessors, project
designers, sampling technicians, project monitors, and supervisors.
Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History
L New section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Comphance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Comphance as to 7-20-98 order, including amendment of subsec-
tion (d)(2), transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99. No.
2).

4. Amendment of subsections (a) and (d)(2)-(3) and Note filed 4-30-2008; op-
erative 5-30-2008 (Register 2008, No. 18).

Article 11. Application Requirements and

Procedures for Training Provider
Accreditation, Renewal, or Course Approval

§ 35076. Application Requirements.

(a) A complete application for provisional accreditation or provisional
course approval shall consist of a completed CDPH Form 8487 (6/07),

Page 248.18(d)

Title 17

State Department of Health Services

§ 35076

Application for Training Provider Accreditation and Course Approval,
and required documentation as follows:
{ 1 ) Type of application:

(A) Accreditation; or

(B) Course Approval.

(2) Type of course or training applicant seeks to provide:

(A) Lead-related construction inspection and assessment course;

(B) Lead-related construction supervision and project monitoring
course;

(D) Lead-related construction work course;

(E) Lead-related construction supplemental supervision course;

(F) Lead-related construction Certified Industrial Hygienist course;

(G) Lead-related construction general continuing education and num-
ber of contact hours; or

(H) Lead-related construction continuing education for workers and
number of contact hours.

(3) Applicant information:

(A) Training provider's name, street address (principal place of busi-
ness), mailing address (if different from street address), telephone num-
ber, and fax number, if applicable; and

(B) Training Director's name, street address and mailing address (if
different from street address).

(4) Operational information:

(A) Description of training facility (including classroom and field
site), equipment, and equipment storage;

(B) Description of record keeping procedures;

(C) One copy of the entire course or continuing education instruction
curriculum, including, but not limited to, learning objectives, documen-
tation of the length and sequence of topics to be covered during the
course(s) or continuing education instruction, student and instructor
manuals, handouts, quizzes, and homework;

(D) Student-to~instructor ratio during hands-on training;

(E) Description of the amount and type of hands-on training;

(F) Description of the teaching methods to be used for each major topic
and for hands-on training;

(G) Description of the audio/visual aids to be used for each major top-
ic; and

(H) List of languages, other than English, in which training will be of-
fered.

(5) Personnel information:

(A) Documentation of Training Director's qualifications pursuant to
paragraphs 35053(a)(l)-(4);

(B) Name(s) of instructor(s);

(D) Documentation of instructors' qualifications pursuant to para-
graphs 35053(b)(])-(4);

(E) Name(s) of guest instructor(s);

(F) Course(s) or topic(s) guest instructor(s) will teach; and

(G) Documentation of guest instructors' qualifications pursuant to
subsection 35053(d).

(6) Final examination information:

(A) List of skills and knowledge to be tested;

(B) One copy of the entire final examination and correct answers, in-
cluding demonstration testing criteria and protocol;

(D) One copy of each retake examination and correct answers.

(7) Compliance with other relevant regulations:

(A) Documentation of approval under Section 94915, or exemption
under Section 94739, or disclosure under Section 9493 L of the Califor-
nia Education Code, as applicable; and

(B) Documentation of compliance with any radiological licensing,
storage, and use requirements of the California Department of Public
Health Radiologic Health Branch set forth in Title 17, California Code
of Regulations, Division 1, Chapter 5, Subchapter 4, 4.5, and 4.6; and

(8) AppHcant's name, printed or typed, signature, title, and date, veri-
fying under penalty of perjury, that all information contained on and sub-
mitted with CDPH Form 8487 (6/07), Application for Training Provider
Accreditadon, is true and correct.

(b) A training provider seeking to renew accreditation shall submit a
completed CDPH Form 8557 (6/07) Renewal of Training Provider Ac-
creditation and Course Approval, and required documentation as fol-
lows:

( 1 ) Type of course(s) or training applicant is currently approved to of-
fer:

(A) Lead-related construcdon inspection and assessment course;

(B) Lead-related construction supervision and project monitoring
course;

(D) Lead-related construction work course;

(E) Lead-related construcdon supplemental supervision course;

(F) Lead-related construcdon Certified Industrial Hygienist course;

(G) Lead-related construction general continuing education and num-
ber of contact hours; or

(H) Lead-related construcdon condnuing education for workers and
number of contact hours.

(2) Applicant information:

(A) Training provider's name, street address (principal place of busi-
ness), mailing address (if different from street address), telephone num-
ber, and fax number, if applicable;

(B) Training Director's name, street address and mailing address (if
different from street address);

(D) Current course or continuing education instruction number(s); and

(3) A description of the training facility (including classroom and field
site), equipment, and equipment storage, if changed since the original
application for accreditation;

(4) Personnel information:

(A) Documentation of instructor's qualifications pursuant to para-
graphs 35053(b)(l)-(4);

(B) Name(s) of instructor(s);

(D) Name(s) of guest instructor(s);

(E) Course(s) or topic(s) guest instructor(s) will teach; and

(F) Documentation of guest instructors' qualifications pursuant to
subsection 35053(d).

(5) Final examination information:

(A) One copy of the entire final examination and correct answers, in-
cluding demonstration testing;

(B) One copy of the student examination scoresheet or other record;
and

(6) Compliance with other relevant regulations:

(A) Documentation of approval under Section 94915, or exemption
under Section 64739, or disclosure under Section 9493 1 , of the Califor-
nia Education Code, as applicable; and

(B) Documentation of compliance with any radiological licensing,
storage, and use requirements of the Cahfomia Department of Public
Health Radiologic Health Branch set forth in Title 17, California Code
of Regulations, Division 1, Chapter 5, Subchapter 4, 4.5, and 4.6; and

(7) Applicant's name, printed or typed, signature, title, and date, veri-
fying under penalty of perjury, that all information contained on and sub-
mitted with CDPH Form 8557 (6/07), Application for Renewal of Train-
ing Provider Accreditation, is true and correct.

(c) An accredited training provider seeking CDPH approval to offer
an additional course shall submit a completed CDPH Form 8487 (6/07).
Application for Training Provider Accreditation, and required documen-

Page 248.18(e)

§ 35078

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

tation, except an applicant need not re-submit unciianged information
and documentation that was submitted with the original application for
accreditation.

(d) An accredited training provider shall notify the Department within
30 calendar days of a change of address.

NOTE: Authority cited: Sections 105250, 124160 and 131200. Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New article 9 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94. No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 9 and section refiled 10-21-94 as an emergency; operative
10-26-94 (Register 94, No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer article 9 to article 10 and former article 10 to article 1 1 and amendment of
section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering and amendment former article 10 to new article 1 1 and amend-
ment of section and Note filed 3-30-98 as an emergency; operative 3-30-98
(Register 98, No. 14). A Certificate of Compliance must be transmitted to OAL
by 7-28-98 or emergency language will be repealed by operation of law on the
following day.

5. Renumbering and amendment of former article lOto new article 11 and amend-
ment of section and Note refiled 7-20-98 as an emergency; operative 7-29-98
pursuant to Government Code secdon 1 1 346. 1 (d) (Register 98, No. 30). A Cer-
tificate of Compliance must be transmitted to OAL by 1 1-27-98 or emergency
language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsecfions (a), (a)(2)(C), (a)(7)(B), (a)(8), (b), (b)(1)(C),
(b)(6)(B), (b)(7) and (c) and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35078. Accreditation Procedures.

(a) Within 30 calendar days of receipt of an application for accredita-
tion, renewal, or course approval, the Department shall inform the appU-
cant in writing that the application is either complete or incomplete and
what additional information documentation is required to complete the
application.

(1) If an applicant submits required information or documentation
within 30 days from the issuance date of the notice of incompleteness, the
Department shall issue a written notice of completeness.

(2) If an applicant fails to submit required information or documenta-
tion within 30 days from the issuance date of the notice of incomplete-
ness, the application shall be deemed to be abandoned and reapplication
shall be required.

(3) An application may be withdrawn by written request to the Depart-
ment.

(b) Within 60 calendar days from the issuance date of the notice of
completeness, the Department shall grant or deny provisional accredita-
tion, renewal, or provisional course approval.

(1) If denied, the Department shall state, in writing, the reasons for de-
nial.

(2) If granted, a written notice containing an accreditation number and
course number(s), shall be sent to the applicant.

(A) The issuance date of the written notice shall be the effective date
of provisional accreditation, renewal, or provisional course approval.

(B) Upon issuance of the written notice granting provisional accredita-
tion or course approval, an accredited training provider may commence
offering a CDPH-approved course(s).

(1) Pursuant to the Permit Reform Act, Government Code section
15376, the minimum, median, and maximum elapsed time to process an
application for accreditation, renewal, or course approval, and issue a
written notification of approval shall be as follows:

(A) Minimum: 15 calendar days.

(B) Median: 30 calendar days.

(2) The Department may exceed the maximum time as provided above
if the applicant requests in writing a delay of consideration of the applica-
tion or issuance of a written notification of provisional accreditation, re-
newal, or provisional course approval.

(d) In making a determination of whether to grant or deny provisional
accreditation, renewal, or provisional course approval, the Department
may take into consideration various factors, including, but not limited to
the following:

(1) Failure to satisfy eligibility requirements for accreditation;

(2) Failure to satisfy eligibility requireinents for course approval;

(3) Past history of revocation of accreditation;

(4) False statements in the application; or

(5) Failure to provide further required documentation or information
requested by the Department.

(e) Provisional status shall be removed if an accreditation audit indi-
cates that requirements for accreditation are satisfied.

(1) A provisionally accredited training provider shall permit the De-
partment to conduct an accreditation audit without charge to the Depart-
ment. Advance notice shall not be required prior to conducting an accred-
itation audit.

(2) An accreditation audit shall be conducted within 365 calendar days
following the issuance of provisional accreditation.

(3) An accreditation audit shall be performed on site and shall include,
but not be limited to, a review of: records, including Course Completion
Forms and attendance records; facilities; instructional curriculum; ex-
amination design, administration and security procedures, and results,
including those of demonstration testing; classroom instruction; audio-
visual materials; course content; and coverage.

(f) Provisional status shall be removed if a course audit indicates that
requirements for CDPH course approval are satisfied.

(1) A provisionally accredited or accredited training provider shall
permit the Department to conduct a course audit without charge to the
Department. Advance notice shall not be required prior to conducting a
course audit.

(2) A course audit shall be conducted within 365 calendar days follow-
ing the issuance of provisional course approval.

(3) A course audit shall be performed on site and shall include, but not
be limited to, a review of: instructional curriculum; examination design,
administration and security procedures, and results, including those of
demonstration testing; classroom instruction; audio-visual materials,
course content; and coverage.

(g) If an accreditation or course audit indicates that requirements for
accreditation or course approval are not satisfied, the Department shall
issue, within seven working days of completion of the accreditation or
course audit, written notice of required modifications.

(1) Written notice shall include an explanation of the Department's au-
dit process, a statement of inadequacies found upon audit, possible ac-
tions that may be imposed, a descripUon of procedures available if the
training provider desires an opportunity to explain or justify the findings
of the audit, steps that must be taken to correct any inadequacies, and any
applicable deadlines.

(h) If an accreditation or course audit indicates that requirements for
accreditation or course approval are satisfied, a written notice removing
provisional accreditadon or provisional course approval shall be issued
within seven working days after completion of an accreditation or course
audit.

( 1 ) Accreditation shall be valid for a period of three years and shall not
be transferable.

(2) Renewal applications shall be required at least 120 calendar days
prior to the expiration dale of accreditation.

(i) An accredited training provider shall permit the Department to con-
duct on-site investigations at any time. Advance notice shall not be re-
quired. On-site investigations may include, but are not limited to, a re-
view of: records, including Course Completion Forms and attendance
records; facilities; training curriculum; examination design, administra-
tion and security procedures, and results, including those of demonstra-

Page 248.18(f)

Title 17

State Department of Health Services

§ 35082

tion testing; classroom instruction; audio-visual materials; course con-
tent; and coverage.

NOTi:: Authority cited: Sections 103250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
.sections (c)( 1 ), (e)(2) and (f)(2) transmitted to OAL 2-23-95 and filed 4-5-95
(Register 95. No. 14).

4. Amendment of section and Notk filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted
to OAL by 7-28-98 oremergency language will be repealed by operation of law
on the following day.

5. Amendment of section and Ncm-: refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code secfion 11346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transnndtted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (b)(2)(B) and (1) and Note filed 4-30-2008; opera-
tive 5-30-2008 (Register 2008, No. 18).

Article 12. Suspension or Revocation of

Accreditation, Provisional Accreditation, or

DHS Course Approval

§ 35080. Action to Suspend or Revoke Accreditation,

Provisional Accreditation, or Course Approval.

(a) Accreditation, provisional accreditation, or course approval may
be suspended or revoked by the Department for:

( 1 ) Failure to adhere to the standards and requirements for accredita-
tion, provisional accreditation, or course approval;

(2) Failure to properly administer, score, or maintain security of a re-
quired examination, examination answers, or results;

(3) Failure to maintain approval or authority to operate granted by the
Council For Private Postsecondary and Vocational Education;

(4) Falsification of accreditation records, instructor qualifications, or
other accreditation information;

(5) Failure to provide the required course contact hours, course con-
tent, or coverage;

(6) Misrepresentation of the contents of a course;

(7) Failure to submit required information or notifications in a timely
manner;

(8) Failure to maintain required records;

(9) Failure to comply with relevant federal, state, or local leaded paint
statutes or regulations;

( 1 0) Failure to make modifications required by the Department within
30 days from the issuance date of the written notice of required modifica-
tions; or

(11) Other conditions revealed by any means which would warrant
suspension or revocation.

(b) Suspension or revocation and an appeal of any suspension or revo-
cation shall be conducted in compliance with Chapter 5 (commencing
with Section 1 1500) of Part 1 of Division 3 of Title 2 of the Government
Code.

(c) Prior to suspension or revocation, an accredited or provisionally
accredited training provider will be given an opportunity, except in the
case of willful violation or threat to public health and safety, to remedy
deficiencies that may result in suspension or revocation.

(1 ) The accredited or provisionally accredited training provider shall
be given a statement which includes the Department's findings, an expla-
nation of what the accredited or provisionally accredited training provid-

er must do to comply with the regulations, and the time period in which
the accredited or provisionally accredited training provider must act.

(2) The accredited or provisionally accredited training provider must
remedy the deficiencies within a reasonable time specified by the Depart-
ment which shall be no more than 30 calendar days after the issuance date
of the statement of deficiencies.

(d) A training provider shall not offer course training when accredita-
tion, provisional accreditation, or CDPH course approval is suspended
or revoked, except, the Department, at its discretion, may permit the
training provider to continue to offer training to students already en-
rolled. If training is not permitted to continue, a refund of all tuition and
other charges shall be provided to students already enrolled, if applica-
ble.

NOTE: Authority cited: Sections 105250, 124160 and 131200. Health and Safety
Code. Reference: Sections 105250, 124 160 and 131051, Health and Safety Code.

History

1. New article 10 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 10 and secUon refiled 10-21-94 as an emergency; operative
10-26-94 (Register 94, No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer article 10 to article 11 and former article 11 to article 12 transmitted to OAL
2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering and amendment former article 1 1 to new article 12 and amend-
ment of Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

5. Renumbering of former article 1 1 to new article 12 and amendment of Notk
refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to Government
Code secfion 1 1346.1(d) (Register 98, No. 30). A Certificate of Compliance
must be transmitted to OAL by 11-27-98 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsection (d) and Note filed 4-30-2008; operative 5-30-2008
(Register 2008, No. 18).

Article 13. Eligibility Requirements and

Application Procedures for Certification or

Interim Certification

§ 35081. Representation of Cerlification Status.

Unless certified pursuant to the requirements of this chapter, no person
shall represent themselves as, or do business as, a certified lead-inspec-
tor/assessor, certified lead project designer, certified lead sampling tech-
nician, certified lead project monitor, certified lead supervisor, or certi-
fied lead worker.

NOTE: Authority cited: Sections 105250(a), 105250(b), 124160(b) and 131200,
Health and Safety Code. Reference: Sections 16240 and 17200, Business and Pro-
fessions Code; and Secfion 131051, Health and Safety Code.

History

1. Renumbering and amendment former article 12 to new article 13 and new .sec-
tion filed 3-30-98 as an emergency; operative 3-30-98 (Register 98, No. 14).
A Certificate of Compliance must be transmitted to OAL by 7-28-98 or emer-
gency language will be repealed by operation of law on the following day.

2. Renumbering and amendment of former article 12 to new article 13 and new
section refiled 7-20-98 as an emergency; operafive 7-29-98 pursuant to Gov-
ernment Code secfion 11346.1(d) (Register 98, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 1 1-27-98 or emergency language will
be repealed by operation of law on the following day.

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23 98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of secfion and Note filed 4-30-2008: operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35082. Application Timeliness.

(a) Applicants for certification or interim certification shall apply to
the Department within one year from the issuance date of CDPH Form
8493 (6/07), Course Completion Form.

Page 248.18(g)

§ 35083

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) Applicants failing to apply within one year from the issuance date
of CDPH Form 8493 (6/07), Course Completion Form, shall complete a
minimum of seven contact hours of:

( 1 ) General continuing education in order to be eligible to apply for in-
spector/assessor, project designer, sampling technician and/or project
monitor certification or interim certification;

(2) General continuing education or continuing education for workers
in order to be eligible to apply for supervisor certification or interim certi-
fication; or

(3) Continuing education for workers in order to be eligible to apply
for worker certification.

(c) Applicants failing to apply within three years from the issuance
date of CDPH Form 8493 (6/07), Course Completion Form, shall retake
the appropriate CDPH-Approved course to be eligible to apply for certi-
fication.

(d) Applications for certification or interim certification renewal shall
be submitted at least 1 20 calendar days prior to the expiration date indi-
cated on the certificate or interim certificate.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code, Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New article 1 1 and section filed 6-27-94 as an emergency; operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 1 0-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 11 and section refiled 10-21-94 as an emergency; operative
10-26-94 (Register 94, No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer article 1 1 to article 12 and former article 12 to article 13 and amendment
of section transmitted to OAL 2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Amendment of subsections (a) and (b), new subsections (c) and (d), and amend-
ment of NOTH filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day.

5. Amendment of subsecfions (a) and (b), new subsections (c) and (d), and amend-
ment of Note, refiled 7-20-98 as an emergency; operafive 7-29-98 pursuant
to Government Code secfion 1 1346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tion (b) and new subsections (b)( 1 )-(3), transmitted to OAL 1 1-23-98 and filed
l-8-99(Register99, No. 2).

7. Amendment of section and Note filed 4-30-2008; operative 5-30-2008 (Reg-
ister 2008, No. 18).

§ 35083. Inspector/Assessor.

To qualify for certification as a certified lead inspector/assessor, an in-
dividual shall comply with all applicable requirements specified in sec-
tions 35095 and 35096 and meet the following minimum eligibility re-
quirements:

(a) Possess CDPH Form 8493 (6/07), Course Completion Form, from
a lead-related construction inspection and assessment course; and

(b) Pass the lead certification examination for inspector/assessors of-
fered by the Department; and either:

(1) Have a bachelor's degree in biological, chemical, or physical sci-
ence, or a related field and one year of experience in lead-related con-
struction or a related field (e.g., asbestos, or environmental remediation
work) conducting environmental inspections and assessing environmen-
tal health, occupational safety, or environmental hazards, or designing
projects in environmental health, occupational safety, or environmental
hazard reduction; or

(2) Have an associate degree in biological, chemical, or physical sci-
ence, or a related field, or 20 semester or 30 quarter units in biological,
chemical, or physical science, or a related field, and two years of experi-
ence in lead-related construction or a related field (e.g. , asbestos, or envi-
ronmental remediation work) conducting environmental inspections and
assessing environmental health, occupational safety, or environmental

hazards, or designing projects in environmental health, occupational
safety, or environmental hazard reduction; or

(3) Have a high school diploma or equivalent and at least three years
of experience in lead-related construction or a related field (e.g., asbes-
tos, or environmental remediation work) conducting environmental in-
spections and assessing environiTiental health, occupational safety, or en-
vironiTiental hazards, or designing projects in environmental health,
occupational safety, or environmental hazard reduction; or

(4) Be a certified industrial hygienist and possess CDPH Form 8493
(6/07), Course Complefion Form, from a lead-related construction Certi-
fied Industrial Hygienist course.

NOTE: Authority cited: Sections 105250, 124160 and 13 1200. Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transinitted to OAL by 10-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
sections (b) and (c) and new subsection (d) transmitted to OAL 2-23-95 and
filed 4-5-95 (Register 95, No. 14).

4. Amendment of section and Note filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 1 4). A Certificate of Compliance must be transmitted
to OAL by 7-28-98 or emergency language will be repealed by operation of law
on the following day.

5. Amendment of section and Note refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98, No.
30). A Certificate of Comphance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (a) and (b)(4) and Note filed 4-30-2008; operative
5-30-2008 (Register 2008, No. 18).

§ 35085. Supervisor.

To qualify for cerfificafion as a certified lead supervisor, an individual
shall comply with all applicable requirements specified in secfions 35095
and 35096 and meet the following minimum eligibility requirements;

(a) Possess CDPH Form 8493 (6/07), Course Complefion Form, from
a lead-related construcfion supervision and project monitoring course or
possess CDPH Forms 8493 (6/07), Course Completion Forms, from a
lead-related construcfion work course and a lead-related construction
supplemental supervision and project monitoring course; and

(b) Pass the lead cerfificafion examinafion for supervisors offered by
the Department; and either:

(1) Have one year of experience as a cerfified lead worker; or

(2) Have two years of experience in lead-related construction or a re-
lated field (e.g., asbestos, the building trades, or environmental remedi-
afion work) conducfing environmental health, occupafional safety, or en-
vironmental hazard control.

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Comphance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-21-94 as an emergency; operative 10-2(5-94 (Register
94, No. 42). A Certificate of Compliance must be transmitted to OAL by
2-24-94 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

5. Amendment of section and Note refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 11346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

•

Page 248.18(h)

Title 17

State Department of Health Services

§ 35091

•

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsection (a) and NOTE filed 4-30-2008; operative 5-30-2008
(Register 2008, No. 18).

§ 35087. Project Monitor.

To qualify for certification as a certified lead project monitor, an indi-
vidual shall comply with all applicable requirements specified in sections
35095 and 35096 and meet the following minimum eligibility require-
ments:

(a) Possess CDPH Form 8493 (6/07), Course Completion Form, from
a lead-related construction supervision and project monitoring course or
possess CDPH Forms 8493 (6/07), Course Completion Forms, from a
lead-related construction work course and a lead-related construction
supplemental supervision and project monitoring course; and:

(b) Pass the lead certification examination for project monitors offered
by the Department; and either:

(1) Have a bachelor's degree in biological, chemical, or physical sci-
ence, or a related field and one year of experience in lead-related con-
stniction or a related field (e.g., asbestos, environmental remediation
work, or other construction) conducting or monitoring environmental
health, occupational safety, or environmental hazards, or designing proj-
ects in environmental health, occupational safety, or environmental haz-
ard reduction; or

(2) Have an associate degree in biological, chemical, or physical sci-
ence, or a related field, or 20 semester or 30 quarter units in biological,
chemical, or physical science, or a related field and one year of experi-
ence as a certified lead supervisor or two years of experience in lead-re-
lated construction or a related field (e.g., asbestos, or environmental re-
mediation work) conducting or monitoring environmental health,
occupational safety, or environmental hazard reduction projects or de-
signing projects in environmental health, occupafional safety, or envi-
ronmental hazard reduction; or

(3) Have a high school diploma or equivalent plus two years experi-
ence as a certified lead supervisor, or three years of experience in lead-re-
lated construction or a related field (e.g., asbestos, or environmental re-
mediation work) conducting or monitoring environmental health,
occupational safety or environmental hazard reduction projects, or de-
signing projects in environmental health, occupational safety, or envi-
ronmental hazard reduction; or

(4) Be a certified industrial hygienist and possess CDPH Form 8493
(6/07), Course Completion Form, from a lead-related construction Certi-
fied Industrial Hygienist course.

NOTH: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
sections (b) and (c) and new subsecfion (d) transmitted to OAL 2-23-95 and
filed 4-5-95 (Register 95, No. 14).

4. Amendinent of section and Note filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted
to OAL by 7-28-98 or emergency language will be repealed by operation of law
on the following day.

5. Amendment of section and Note refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code secfion 11346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of subsections (a) and (b)(4) and Note filed 4-30-2008; operafive
5-30-2008 (Register 2008, No. 18).

§ 35088. Project Designer.

(a) To qualify for certification renewal as a certified lead project de-
signer, a certified lead project designer shall comply with all applicable
requirements specified in sections 35095(b), 35095(c), and 35096.

(b) Certification applications for project designer are no longer ac-
cepted by the Department. Only a certification renewal application from
a cerUfied lead project designer will be accepted by the Department.
NOTE: Authority cited: Sections 105250. 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History
1. New section filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§ 35089. Sampling Technician.

To qualify for certification as a certified lead sampling technician, an
individual shall comply with all applicable requirements specified in sec-
tions 35095 and 35096 and possess CDPH Forin 8493 (6/07), Course
Completion Form, from the lead-related construction sampling techni-
cian course or the lead-related construction inspection and assessment
course.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 1 3 1 05 1 , Health and Safety Code.

History

1. New secfion filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-21-94 order including amendment of sub-
secfions (a)-(c) and new subsection (d) transmitted to OAL 2-23-95 and filed
4-5-95 (Register 95, No. 14).

4. Amendment of section and Note filed 3-30-98 as an emergency; operative
3-30-98 (Register 98. No. 14). A Certificate of Compliance must be transmitted
to OAL by 7-28-98 or emergency language will be repealed by operation of law
on the following day.

5. Amendment of secfion and Note refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98, No.
30). A Certificate of Compliance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operafion of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
fion (a), transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section heading, section and Note filed 4-30-2008; operative
5-30-2008 (Register 2008. No. 18).

§35091. Worker.

To qualify for certification as a certified lead worker, an individual
shall comply with all applicable requirements specified in secdons 35095
and 35096 and possess CDPH Form 8493 (6/07), Course Completion
Form, from a lead-related construcfion work course.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 13105L Health and Safety Code.

History
L New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,

No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94

or emergency language will be repealed by operation of law on the following

day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment of section and Note filed 3-30-98 as an emergency: operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted
to OAL by 7-28-98 or emergency language will be repealed by operation of law
on the following day.

5. Amendment of secfion and Note refiled 7-20-98 as an emergency; operative
7-29-98 pursuant to Government Code section 1 1346.1(d) (Register 98. No.
30). A Certificate of CompHance must be transmitted to OAL by 1 1-27-98 or
emergency language will be repealed by operafion of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of section and Note filed 4-30-2008: operative 5-30-2008 ( Reg-
ister 2008, No. 18).

Page 248.18(i)

§ 35093

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 35093. Interim Certification and Renewal.

(a) Applications for interim certification shall be accepted through
August 30, 1998. Applications for renewal of interim certification shall
be accepted through December 31, 1998. Individuals who possess inter-
im certificates with expiration dates after April 30. 1999 shall not be eh-
gible to renew their interim certificate(s) and must take and pass the De-
partment's certification examination to be eligible to apply for
certification.

(b) To qualify for interim certification as a lead inspector/assessor, an
individual shall comply with all applicable requirements specified in sec-
tions 35083. 35095 and 35096. except for the certification examination
requirements specified in subsection 35083(b).

(c) To qualify for interim certification as a lead supervisor an individu-
al shall comply with all applicable requirements specified in sections
35085, 35095 and 35096, except for the certification examination re-
quirements specified in subsection 35085(b).

(d) To qualify for interim certification as a lead project monitor an in-
dividual shall comply with all applicable requirements specified in sec-
tions 35087, 35095 and 35096, except for the certification examination
requirements specified in subsection 35087(b).

(e) To qualify for interim certification as a lead project designer an in-
dividual shall comply with all applicable requirements specified in sec-
tions 35089, 35095 and 35096, except for the certification examination
requirements specified in subsection 35089(b).

(f) Individuals failing to apply for renewal within one year after the ex-
piration date of an interim certificate, shall comply with applicable sub-
sections (b) of sections 35083, 35085, 35087, and 35089, and subsections
35095(b), and 35096(f)(1) to be eligible to apply for certification.
NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Comphance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operation of law on the following
day,

3. Certificate of Compliance as to 7-20-98 order transmitted to OAL 11-23-98
and filed 1-8-99 (Register 99, No. 2).

4. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

§ 35095. Application Requirements.

(a) A complete appHcation for certification or interim certification
shall consist of a non-refundable $75.00 application fee per certificate
or interim certificate requested and a completed CDPH Form 8488
(6/07), Application for Lead Certification, with required documentation:

( 1 ) Type of certification or interim certification requested and amount
of fee(s) paid:

(A) Certified lead inspector/assessor;

(B) Certified lead supervisor;

(D) Certified lead project monitor; or

(E) Certified lead worker.

(2) Applicant's name, residence address, (and mailing address, if dif-
ferent), telephone number, date of birth, gender, race/ethnicity and photo
identification number with a description of the photo identification docu-
ment.

(3) Documentation of applicant's education, training, and experience,
including:

(A) Original Course Completion Form, CDPH Form 8493 (6/07), for
a course issued by an accredited training provider.

(B) A Proof of Experience CDPH Form 8539 (6/07) for each employer
providing documentation of completion of lead-related construction or
other applicable experience. Each Proof of Experience form shall con-
tain:

1 . The applicant' s name;

2. The name and address of the applicant's employer;

3. The name and telephone number of the applicant's supervisor, or the
names and phone numbers of three client references, if self-employed;

4. The applicant's employment dates;

5. Descriptions of specific lead-related construction or other applica-
ble activities performed;

6. Estimated percentage of time associated with lead-related construc-
tion or other applicable activities; and

7. The name, title, and signature of the applicant's supervisor or em-
ployer, or the applicant's signature, if self-employed, verifying, under
penalty of perjury, that the information contained on the Proof of Experi-
ence CDPH Form 8539 (6/07) is true and correct.

(D) Certified Industrial Hygienists, who possess a Course Completion
Form from a lead-related construction Certified Industrial Hygienisl
course, may substitute a copy of their American Board of Industrial Hy-
giene Certificate, or its equivalent, for evidence of both experience and
postsecondary education documentation.

(4) Two passport style, 1 inch by 1 inch, photographs.

(5) Applicant's signature and date signed, verifying, under penalty of
perjury, that all information contained on and submitted with CDPH
Form 8488 (6/07), Applicadon for Lead CerUficafion, is true and correct.

(b) A complete application for cerfification or interim certificafion re-
newal shall consist of a completed CDPH Form 8553 (6/07), Renewal of
Lead Certificafion, and a non-refundable seventy-five dollar application
fee for each cerfificate or interim certificate renewal requested with the
following required documentation:

(1) If not submitted to the Department in the previous year, an original
Course Completion Form CDPH Form 8493 (6/07) issued by an accred-
ited training provider for:

(A) General continuing education, if the application is for renewal of
inspector/assessor, project designer, sampling technician, or project
monitor certification or interim certification; or

(B) General continuing education or continuing education for work-
ers, if the application is for renewal of supervisor certification or interim
certification; or

(2) Documentation specified in sections 35095(a)(2), and
35095(a)(5); and

(3) Certificate or interim certificate number(s), expiration date(s) and
amounts of fee(s) paid.

(c) Certified or interim certified individuals shall notify the Depart-
ment within 30 calendar days of a change of address.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250. 124160 and 131051, Health and Safety Code.

History

1. New section filed 6-27-94 as an emergency; operative 6-27-94 (Register 94,
No. 26). A Certificate of Compliance must be transmitted to OAL by 1 0-25-94
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled with amendment of subsection (a)(4) 10-21-94 as an emer-
gency; operative 10-26-94 (Register 94, No. 42). A Certificate of Compliance
must be transmitted to OAL by 2-24-94 or emergency language will be re-
pealed by operation of law on the following day.

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment of section and Note filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be trans-
mitted to OAL by 7-28-98 or emergency language will be repealed by opera-
tion of law on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tion (b)(1) and new subsections (b)(l)(A)-(C), transmitted to OAL 11-23-98
and filed 1-8-99 (Register 99, No. 2).

Page248.18(j)

Title 17

State Department of Health Services

§ 35097

•

7. Amendment of subsections (a). (a)(1)(C), (a)(3)(A)-(B). (a)(3)(B)7. and
(a)(5)-(b)(l)(A) and NoTi- filed 4-30-2008; operative 5-30-2008 (Register
2008. No. 1 8).

§ 35096. Certification, Interim Certification, and Renewal
Procedures.

(a) Within 30 calendar days of receipt of an application for certifica-
tion, interim certification or renewal, the Department shall inform the
applicant in writing that the application is either complete or incomplete
and what additional information or documentation is required to com-
plete the application.

( 1 ) If an applicant submits required information or documentation
within 30 days from the issuance date of the notice of incompleteness, the
Department shall issue a written notice of completeness.

(2) If an applicant fails to submit required information or documenta-
tion within 1 80 days from the issuance date of the notice of incomplete-
ness, the application shall be deemed to be abandoned and reapplication
shall be required.

(3) An application may be withdrawn or amended only by written re-
quest to the Department.

(b) Within 60 calendar days from the issuance date of the notice of
completeness, the Department shall grant or deny interim certification,
renewal, or permission to sit for the Department's lead certification ex-
amination in the certification discipline applied for.

( 1 ) If denied, the Department shall state, in writing, the reasons for de-
nial.

(2) If granted, an interim certificate, renewal, or permission notice
shall be sent to the applicant and the issuance date of the interim certifi-
cate, renewal, or permission notice shall be the effective date of interim
certification, renewal, or permission notice.

(c) Within 30 calendar days from the date an individual passes the lead
certification examinaUon in the certification discipline applied for, the
Department shall grant or deny certification.

(1) Individuals who fail to pass the lead certificafion examination in
the certification discipline applied for within 180 days from the issuance
date of the permission notice, shall retake the CDPH-approved lead-re-
lated construction course in that discipline, and comply with Section
35095, excepting subsecfions 35095(a)(3)(B), 35095(a)(3)(C),
35095(a)(3)(D), and 35095(a)(4), to be eligible to re-apply for permis-
sion to sit for the lead cerfification examination.

(2) An individual shall take the lead certification examination no more
than three fimes within 1 80 days from the issuance date of the permission
nodce.

(d) Processing Time:

(1) Pursuant to the Permit Reform Act, Government Code section
15376, the minimum, median, and maximum elapsed time to process a
completed application for a certificate or interim cerfificate and issue a
written nofification of approval shall be as follows:

(A) Minimum: 15 calendar days.

(B) Median: 120 calendar days.

(2) The Department may exceed the maximum fime as provided above
if the applicant requests in writing a delay of consideration of the applica-
tion or issuance of a certificate or interim certificate.

(e) In making a determinafion of whether to grant, deny, or renew certi-
fication or interim certification, or permission to sit for a lead certifica-
tion examination, the Department may take into consideration various
factors, including, but not limited to, the following:

( 1 ) Failure to satisfy eligibility requirements for certification or inter-
im certification;

(2) Type and amount of lead-related construction training;

(3) Failure to provide further required documentation or information
requested by the Department;

(4) Past history of citations or violations of existing regulations or
standards;

(5) Past history of revocation of a Certificate or Interim Certificate; or

(6) False or misleading statements in the application.

(f) Certification or interim certification shall be non-transferable and
shall be effective for a period of one year.

( 1 ) Certified or interim certified individuals shall complete a rninimum
of seven contact hours of continuing education instruction every two
years to be eligible to apply for certification or interim certification re-
newal.

(2) Certified individuals applying for renewal more than three years
after the expiration date of the certificate or interim certificate shall re-
take the required CDPH-approved lead-related construction course and
comply with section 35095(a)(3)(A), 35095(b) to be eligible to apply for
certification renewal.

NOTE: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

3. Certificate of Compliance as to 10-21-94 order transmitted to OAL 2-23-95
and filed 4-5-95 (Register 95, No. 14).

4. Amendment of section and Note filed 3-30-98 as an emergency; operative
3-30-98 (Register 98, No. 14). A Certificate of Compliance must be transmitted
to OAL by 7-28-98 or emergency language will be repealed by operation of law
on the following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tion (c)(2), transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register 99, No.
2).

7. Amendment of subsections (c)(1) and (f)(2) and Note filed 4-30-2008; opera-
tive 5-30-2008 (Register 2008, No. 18).

Article 14. Suspension or Revocation of
Certification or Interim Certification

§ 35097. Action to Suspend or Revoke Certification or
Interim Certification.

(a) Certification or interim certification may be suspended or revoked
by the Department for:

(1) Any false statement in the application;

(2) Violations of relevant local, state, or federal statutes or regulations;

(3) Misrepresentation, failure to disclose relevant facts, fraud, or is-
suance by mistake;

(4) Failure to comply with California Code of Regulations, Titie 17.
sections 36000 or 36100; or

(5) Failure to comply with any relevant regulation or order of the De-
partment.

(c) Prior to suspension or revocation, a certified or interim certified
individual shall be given an opportunity, except in the case of willful vio-
lation or threat to public health and safety, to remedy deficiencies that
may result in suspension or revocation.

(1) The certified or interim certified individual shall be given a state-
ment which includes the Department's findings, an explanation of what
the certified or interim certified individual must do to comply with the
regulations, and the time period in which the certified or interim certified
individual shall act.

(2) The certified or interim certified individual must remedy the defi-
ciencies within a reasonable time specified by the Department which
shall be no more than 30 calendar days after the issuance date of the state-
ment of deficiencies.

Page 248.18(k)

§ 35099

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(d) Any individual whose certification or interim certification has
been suspended or revoked shall not be eligible to perform activities
which require CDPH lead certification.

NOTK. Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1. New article 12 and section filed 6-27-94 as an einergency: operative 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 12 and section refiled 10-21-94 as an emergency; operative
10-26-94 (Register 94, No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer article 12 to article 1 3 and former article 13 to article 14 transmitted to OAL
2-23-95 and filed 4-5-95 (Register 95, No. 14).

4. Renumbering and amendment former article 13 to new article 14 and amend-
ment of section heading, section and Note filed 3-30-98 as an emergency; op-
erative 3-30-98 (Register 98, No. 14). A Certificate of Compliance must be
transmitted to OAL by 7-28-98 or emergency language will be repealed by op-
eration of law on the following day.

5. Renumbering and amendment of former article 1 3 to new article 14 and amend-
ment of section heading, secfion and Note refiled 7-20-98 as an emergency;
operative 7-29-98 pursuant to Government Code section 11346.1(d) (Register
98. No. 30). A Certificate of Compliance must be transmitted to OAL by
1 1-27-98 or emergency language will be repealed by operation of law on the
following day.

6. Certificate of Compliance as to 7-20-98 order, including amendment of subsec-
tion (d), transmitted to OAL 11-23-98 and filed 1-8-99 (Register 99, No. 2).

7. AiTiendment of subsection (d) and Note filed 4-30-2008; operative 5-30-2008
(Register 2008, No. 18).

Article 15. Enforcement

§ 35099. Funding for Enforcement.

The amount of $100,000.00 shall be allocated to the Division of Occu-
pational Safety and Health annually to be expended for the division's
costs of enforcing compliance with training and certification require-
ments.

Note: Authority cited: Sections 105250, 124160 and 131200, Health and Safety
Code. Reference: Sections 105250, 124160 and 131051, Health and Safety Code.

History

1 . New article 13 and secUon filed 6-27-94 as an emergency; operafive 6-27-94
(Register 94, No. 26). A Certificate of Compliance must be transmitted to OAL
by 10-25-94 or emergency language will be repealed by operation of law on
the following day.

2. New article 13 and section refiled 10-21-94 as an emergency; operative
10-26-94 (Register 94, No. 42). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-94 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 10-21-94 order including renumbering of for-
mer article 13 to new article 14 transmitted to OAL 2-23-95 and filed 4-5-95
(Register 95, No. 14).

4. Renumbering and amendment former article 14 to new article 15 and amend-
ment of Note filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by 7-28-98
or emergency language will be repealed by operafion of law on the following
day.

5. Renumbering and amendment of former article 14 to new article 15 and amend-
ment of Note refiled 7-20-98 as an emergency; operative 7-29-98 pursuant to
Government Code section 11346.1(d) (Register 98, No. 30). A Certificate of
Compliance must be transmitted to OAL by 1 1-27-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 7-20-98 order transmitted to OAL 1 1-23-98
and filed 1-8-99 (Register 99, No. 2).

7. Amendment of Note filed 4-30-2008; operative 5-30-2008 (Register 2008,
No. 18).

Article 16. Work Practice Standards

§ 36000. Requirements for Lead Hazard Evaluation for
Public and Residential Buildings.

(a) Lead hazard evaluation for public and residential buildings shall:

( 1 ) Be conducted only by a certified lead inspector/assessor or as spe-
cified in Subsections (c)(3)(A) or (d). The certified lead inspector/asses-
sor, certified lead project monitor, and certified lead sampling technician
conducting lead hazard evaluation shall not conduct abatement on the
same structure.

(2) Be conducted in a manner in which paint, dust, and soil is tested
in accordance with the procedures described in Chapter 5: Risk Assess-
ment, section II (A)(B)(C)(D), "Guidelines for the Evaluation and Con-
trol of Lead-Based Paint Hazards in Housing," U.S. Department of
Housing and Urban Development, June 1995 and Chapter 7: Lead-
Based Paint Inspection, "Guidelines for the Evaluation and Control of
Lead-Based Paint Hazards in Housing," U.S. Department of Housing
and Urban Development, 1997 Revision, and which provides quantita-
tive results.

(3) Be conducted in a manner in which paint, dust, and soil samples
taken for laboratory analysis are analyzed by a laboratory that is recog-
nized by the U.S. Environmental Protection Agency pursuant to United
States Code, Title 15, Section 2685(b).

(4) Be documented in a lead hazard evaluation report which shall in-
clude a completed California Department of Public Health (CDPH) Form
8552 (6/07) and the following attachments:

(A) A foundation diagram, site map, or sketch of the structure, indicat-
ing the specific locations of each lead hazard or presence of lead-based
paint, and results of the visual inspection, if applicable;

(B) A summary of each testing method, device, and sampling proce-
dure used;

(D) The results of laboratory analysis on collected samples, if applica-
ble, including the name, address, and telephone number of each laborato-
ry.

(b) The certified lead inspector/assessor conducting the lead hazard
evaluation for a public or residential building shall retain the original
completed copy of CDPH Form 8552 (6/07) and attachments for a mini-
mum of three years and distribute copies as follows;

( 1 ) A copy of the completed CDPH Form 8552 (6/07) and attachments
to the person who ordered the lead hazard evaluation;

(2) A copy of the completed CDPH Form 8552 (6/07) to the Depart-
ment within thirty days of completion; and

(3) A copy of the attachments to the Department upon request.

(1) A lead inspection shall be conducted in accordance with proce-
dures described in Chapter 7: Lead-Based Paint Inspection, "Guidelines
for the Evaluation and Control of Lead-Based Paint Hazards in Hous-
ing," U.S. Department of Housing and Urban Development, 1997 Revi-
sion.

(2) A risk assessment shall be conducted in accordance with proce-
dures described in Chapter 5: Risk Assessment, section 11(A), (B), (C),
and (D), "Guidelines for the Evaluation and Control of Lead-Based Paint
Hazards in Housing," U.S. Department of Housing and Urban Develop-
ment, June 1995 and shall include a written description of abatement op-
tions for each identified lead hazard, a suggested prioritization for ad-
dressing each lead hazard, and recommendations for a maintenance and
monitoring schedule.

(3) A clearance inspection shall be conducted:

(A) By a certified lead inspector/assessor or a certified lead project
monitor.

(B) In accordance with procedures such as described in Chapter 15:
Clearance, sections II-VI, "Guidelines for the Evaluation and Control of
Lead-Based Paint Hazards in Housing," U.S. Department of Housing
and Urban Development, June 1995.

(d) A sampling technician shall only conduct visual inspections and
sample or test soil, dust, and paint provided an inspector/assessor identi-
fies the specific locations where soil, dust, and paint is sampled or tested,
interprets the results, and complies with the record keeping and reporting
requirements in section 36000(b). A sampling technician is prohibited

Page 248.18(1)

Title 17

State Department of Health Services

§36100

from conducting visual inspections, or sampling or testing paint, dust,
and soil, if those activities are:

( 1 ) conducted as an "appropriate case management" activity, as de-
fined in Health and Safety Code section 105280(a); or

(2) conducted in a structure that is inhabited by an individual with a
blood lead level equal to or greater than 10 micrograms per deciliter.

(e) Individuals operating an X-ray Fluorescence (XRF) analyzer to
conduct lead hazard evaluation shall comply with regulatory require-
ments specified in Title 17, California Code of Regulations, division 1,
chapter 5, subchapter 4, such as obtaining a license and completing an
additional eight hours of training.

Note: Authority cited: Sections 105250(a), 105250(b), 124160(b), 124165 and
131200. Health and Safety Code. Reference: Sections 100170, 105250(a),
105250(b), 124160(b), 124165 and 131051, Health and Safety Code; Sections
17200, 17203 and 17205, Business and Professions Code; and Sections 11 180 and
11181, Government Code.

History

1 . New article 16 (sections 36000-36100) and section filed 3-30-98 as an emer-
gency; operative 3-30-98 (Register 98, No. 14). A Certificate of Compliance
must be transmitted to OAL by 7-28-98 or emergency language will be re-
pealed by operation of law on the following day.

2. Editorial con-ection of History 1 (Register 98, No. 30).

3. New article 1 6 (sections 36000-361 00) and section refiled 7-20-98 as an emer-
gency; operative 7-29-98 pursuant to Government Code section 11346.1(d)
(Register 98, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-27-98 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 7-20-98 order, including amendment of section
heading and section, transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register
99, No. 2).

5. Amendment of subsections (a)(1), (a)(4) and (b)-(b)(2), new subsections
(d)-(e) and amendment of Note filed 4-30-2008; operative 5-30-2008 (Regis-
ter 2008, No. 18).

§ 36050. Lead-Safe Work Practices.

(a) Any individual conducting lead activities, excluding lead hazard
evaluation, shall:

( 1 ) Use containment;

(2) Ensure that the work area has no visible dust or debris following
the completion of a project;

(3) Demonstrate compliance with (a)(1) and (a)(2) to the Department
or local enforcement agency, as defined in section 105251 of the Health
and Safety Code, upon request.

NOTE: Authority cited: Sections 105250, 105255, 105256, 124160, 124165 and
131200, Health and Safety Code. Reference: Sections 105250, 105251, 105255,
105256, 124160, 124165 and 131051, Health and Safety Code.

History
1. New section filed 4-30-2008; operative 5-30-2008 (Register 2008, No. 18).

§ 361 00. Requirements for Abatement for Public and
Residential Buildings.

(a) Abatement for public and residential buildings which is designed
to reduce lead paint or lead hazards for a minimum of twenty years shall
be conducted:

( 1 ) Only by a certified lead supervisor or a certified lead worker. A cer-
tified lead supervisor shall be onsite during all work site preparation and
during the post-abatement cleanup of work areas. At all other times when
abatement is conducted, the certified lead supervisor shall be onsite or
available by telephone, pager or answering service, and able to be present
at the work area in no more than two hours.

(2) According to the procedures specified in Chapter 12: Abatement,
"Guidelines for the Evaluation and Control of Lead-Based Paint Hazards
in Housing," U.S. Department of Housing and Urban Development, June
1995.

(3 ) Using containment and in a manner which does not result in contai-
mination of non-work areas with lead-contaminated dust, lead-conta-
minated soil, or lead-based paint debris.

(4) In accordance with an abatement plan prepared by a certified lead
supervisor, certified lead project monitor, or certified lead project de-
signer which shall:

(A) Include the following information:

1 . A detailed written description of the measures and managenicnl pro-
cedures, including containment, that will be utilized during abatement to
prevent exposure to lead hazards;

2. A detailed written description of abatement, including methods of
abatement and locations of rooms and components where abatement is
planned;

3. A recommended schedule for re-inspection, based upon the type of
abatement; and

4. Instnictions on how to maintain potential lead hazards in safe condi-
tion.

(B) Be retained and made available to the Department upon request for
a period of at least three years by the preparer.

(5) After notification is posted and delivered pursuant to subsection
(c), the certified lead supervisor conducUng abatement shall retain re-
cords of notification for at least three years.

(6) In a manner in which after abatement is completed, a clearance in-
spection is conducted in accordance with Section 36000(a) and Section
36000(c)(3) of this Chapter.

(b) Abatement for public and residential buildings which is designed
to reduce lead paint or lead hazards for less than twenty years shall be
conducted:

(A) According to procedures specified in Chapter 1 1 : Interim Con-
trols, "Guidelines for the Evaluation and Control of Lead-Based Paint
Hazards in Housing," U.S. Department of Housing and Urban Develop-
ment, June 1995.

(2) Using containment and in a manner which does not result in con-
tamination of non-work areas with lead-contaminated dust, lead-conta-
minated soil, or lead-based paint debris.

(3) In a manner to ensure that the work area has no lead contaminated
dust following the completion of abatement.

(4) In a manner to ensure that a clearance inspection is conducted fol-
lowing the completion of abatement, if abatement was conducted in re-
sponse to an identified case of lead poisoning as defined in Section
105280(b) of the California Health and Safety Code.

(5) After notification is posted and delivered pursuant to subsection
(c).

(c) Prior to conducting abatement, the individual conducting abate-
ment shall provide notification by completing an Abatement of Lead
Hazards Notification, CDPH 8551 (6/07), form and:

(1 ) Posting at all entrances to the work area a copy of the completed
form which shall not be removed until abatement has been completed
and, for abatement conducted pursuant to subsecdon (a), a clearance in-
spection has been completed; and

(2) Delivering a copy of the completed form to the Department. Except
for abatement conducted in response to an identified case of lead poison-
ing as defined in Section 105280(b) of the Health and Safety Code, the
completed form shall be delivered to the Department at least five days
prior to conducting abatement.

(d) Any individual conducfing abatement or disturbing lead-based
paint without containment shall permit the Department, or enforcement
agencies, as specified in the California Health and Safety Code Sections
17960, 17961, and 17965, to access work areas to determine compliance
with the requirements of this section.

NOTE: Authority cited: Sections 105250(a), 10525()(b), 124160(b). 124165 and
131200, Health and Safety Code. Reference: Sections 17960. 17961, 17964,
17970, 17972, 17980, 100170, 100175, 105250(a), 105250(b). 105280(a).
124160(b), 124165 and 131050, Health and Safety Code; Section 3494. Civil
Code; Section 17200, Business and Professions Code; Section 1 7274(b), Revenue
and Taxation Code; and Secfions 1 1 180 and 11181, Government Code.

History

1. New section filed 3-30-98 as an emergency; operative 3-30-98 (Register 98,
No. 14). A Certificate of Compliance must be transmitted to OAL by"7-28-98
or emergency language will be repealed by operation of law on the following
day.

Page 248.18(m)

§ 37000

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

3, Certificate of Compliance as to 7-20-98 order, including amendment of section
heading and section, transmitted to OAL 1 1-23-98 and filed 1-8-99 (Register
99, No. 2).

4. Amendment of subsection (c) and NOTH filed 4-30-2008; operative 5-30-2008
(Register 2008, No. 18).

Chapter 9.

Screening for Childhood Lead
Poisoning

Petilioners in the lawsuit Healthy Children Organizing Project, et al.
V. Department of Health Services, et al, Superior Court of California in
and for the City and County of San Francisco, Case No. 313012, chal-
lenged the validity of the emergency regulations, "Screening for Child-
hood Lead Poisoning". The court found that the regulations did not com-
ply with the statutory requirements. In response to the court order and
comments received during the open comment period, the Department re-
vised the regulations. The revised regulations were submitted to the court
and made available for public comment. The following regulations re-
flect changes made in response to public comments already received and
further changes that will be made available for an additional public com-
ment period. The Department sought adoption of these emergency regu-
lations for the purpose of avoiding the lapse of the medical standard of
care and avoiding confusion among impacted health care providers dur-
ing the period between the normal expiration of the prior emergency reg-
ulations and the completion of the regulatory process.

Article 1. Definitions

§ 37000. Health Care Provider.

"Health care provider" means a person licensed to practice medicine
pursuant to Article 3 (commencing with Section 2050) of Chapter 5 of
Division 2 of the Business and Professions Code; a person licensed to
practice as a nurse practitioner pursuant to Article 8 (commencing with
Section 2834) of Chapter 6 of Division 2 of the Business and Professions
Code; or a person licensed to practice as a physician's assistant pursuant
to Article 3 (commencing with Section 3513) of Chapter 7.7 of Division
2 of the Business and Professions Code.

NOTE: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safe-
ty Code. Reference: Section 105285, Health and Safety Code.

History

1. New chapter 9 (articles 1-2, sections 37000-37100), article 1 (sections
37000-37025) and section filed 10-10-2000 as an emergency; operative
10-10-2000 (Register 2000, No. 41). A Certificate of Compliance must be
transmitted to OAL by 2-7-2001 or emergency language will be repealed by
operation of law on the following day . For prior history of chapter 9. see Regis-
ter 77, No. 26.

2. New chapter 9 (articles 1-2, sections 37000-37100), article 1 (sections
37000-37025) and section refiled 2-8-2001 as an emergency; operative
2-8-2001 (Register 2000, No. 6). A Certificate of Compliance must be trans-
mitted to OAL by 6-8-2001 or emergency language will be repealed by opera-
tion of law on the following day.

3. Repealed by operation of Government Code section 1 1 346. 1 (g) (Register 2001 ,
No. 23).

4. New chapter 9 (articles 1-2, sections 37000-37100), article 1 (sections
37000-37025) and section filed 6-4-2001 as an emergency; operative
6-9-2001 (Register 2001, No. 23). A Certificate of Compliance must be trans-
mitted to OAL by 10-9-2001 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 6-4-2001 order transmitted to OAL 10-4-2001
and filed 1 1-19-2001 (Register 2001, No. 47).

§ 37005. Physician.

NOTE: Authority cited: Secdons 100275(a), 105285 and 105300, Health and Safe-
ty Code. Reference: Section 105285, Health and Safety Code.

History

1 . New section filed 1 0-10-2000 as an emergency; operative 10-10-2000 (Regis-
ter 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by
2-7-2001 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 2-8-2001 as an emergency; operative 2-8-2001 (Register
2000, No. 6). A Certificate of Compliance must be transmitted to OAL by

6-8-2001 or emergency language will be repealed by operation of law on the
following day.
3. Repealed by operation of Government Code section 1 1346.1(g) (Reeister2001,

No. 23).

§37010. Physician's Assistant.

NOTE: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safe-
ty Code. Reference: Section 105285, Health and Safety Code.

History

1 . New section filed 1 0-1 0-2000 as an emergency; operative 1 0-1 0-2000 (Regis-
ter 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by
2-7-2001 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 2-8-2001 as an emergency; operative 2-8-2001 (Register
2000, No. 6). A Certificate of Compliance must be transmitted to OAL by
6-8-2001 or emergency language will be repealed by operation of law on the
following day.

3. Repealed by operation of Government Code section 1 1346. 1 (g) (Register 2001 ,
No. 23).

§ 37015. Primary Medical Care.

NOTE: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safe-
ty Code. Reference: Section 105285, Health and Safety Code.

History

1 . New section filed 10-10-2000 as an emergency; operative 10-10-2000 (Regis-
ter 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by
2-7-2001 or emergency language will be repealed by operation of law on the
following day.

3. Repealedby operation of Government Code section 1 1346.1(g) (Register 2001,
No. 23).

§ 37020. Publicly Funded Program for Low Income
Children.

"Publicly funded program for low income children" means:

(a) Medi-Cal, as defined in Chapter 7 (commencing with Section
14000) and Chapter 8 (commencing with Section 14200) of Part 3 of Di-
vision 9 of the Welfare and Institutions Code;

(b) Child Health and Disability Prevention program, as defined in Ar-
ticle 6 (commencing with Section 1 24025) of Chapter 3 of Part 2 of Divi-
sion 106 of the Health and Safety Code;

(d) Special Supplemental Nutrition Program for Women, Infants and
Children, as defined in Article 2 (commencing with Section 123275) of
Chapter 1 of Part 2 of Division 106 of the Health and Safety Code; or

(e) Any federally funded or State of California funded program that
provides medical services or preventive healthcare to children in families
whose income is equal to or less than the maximum qualifying income
level for participation in any of the programs specified in subsections (a)
through (d).

NOTE: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safe-
ty Code. Reference: Section 105285, Health and Safety Code.

History

1 . New section filed 1 0-1 0-2000 as an emergency; operative 10-1 0-2000 (Regis-
ter 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by
2-7-2001 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 2-8-2001 as an emergency; operative 2-8-2001 (Register

2000, No. 6). A Certificate of Compliance must be transmitted to OAL by
6-8-2001 or emergency language will be repealed by operation of law on the
following day.

3. Repealed by operation of Government Code section 1 1346.1(g) (Register 2001,
No. 23).

4. New section filed 6-4-2001 as an emergency; operative 6-9-2001 (Register

2001, No. 23). A Certificate of Compliance must be transmitted to OAL by
1O-9-2001 or emergency language will be repealed by operation of law on the
following day.

5. Certificate of Compliance as to 6-4-2001 order, including amendment of sub-
section (d), transmitted to OAL 10-4-2001 and filed 11-19-2001 (Register
2001, No. 47).

§ 37025. Screening.

"Screening" means testing an asymptomatic child for lead poisoning
by analyzing the child's blood for concentration of lead.

Page 248.18(n)

Title 17

State Department of Health Services

§ 38001

NOTH: Authority cited: Sections 100275(a)J 05285 and 105300, Health and Safe-
ty Code. Reference: Section 105285, Health and Safety Code.

History

1 . New section filed 1 0- 1 0-2000 as an emergency; operative 1 0-1 0-2000 (Regis-
ter 2000, No. 41). A Certificate of Compliance must be transmitted to OAL by
2-7-2001 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 2-8-2001 as an emergency; operative 2-8-2001 (Register

2000, No. 6). A Certificate of Compliance must be transmitted to OAL by
6-8-2001 or emergency language will be repealed by operation of law on the
following day.

3. Repealed by operation of Government Code section 1 1 346. 1 (c) (Register 2001 ,
No. 23).

4. New section filed 6-4-2001 as an emergency; operative 6-9-2001 (Register

2001, No. 23). A Certificate of Compliance must be transmitted to OAL by
1 0-9-200 1 or emergency language will be repealed by operation of law on the
following day.

5. Certificate of Compliance as to 6-4-2001 order transmitted to OAL 10-4-2001
and filed 1 1-19-2001 (Register 2001, No. 47).

Article 2. Standard of Care on Screening
for Childhood Lead Poisoning

§37100. Requirements.

(a) Except as provided in subsections (c) and (d), every health care pro-
vider who performs a periodic health assessment of a child, at the ages
specified in subsection (b), shall comply with the following standard of
care:

( 1 ) Provide oral or written anticipatory guidance to a parent or guard-
ian of the child, including, at a minimum, the information that children
can be harmed by exposure to lead, especially deteriorating or disturbed
lead-based paint and the dust from it, and are particularly at risk of lead
poisoning from the time the child begins to crawl until 72 months of age.

(2) If the child receives services from a publicly funded program for
low-income children, order the child screened for lead poisoning as the
child is presumed to be at risk of lead poisoning.

(3) If the child does not receive services from a publicly funded pro-
gram for low-income children, evaluate the child's risk of lead poisoning
by asking a parent or guardian of the child the following question: "Does
your child live in, or spend a lot of time in, a place built before 1978 that
has peeling or chipped paint or that has been recently renovated?" If the
parent or guardian answers "yes" or "don't know" to the question, order
the child screened for lead poisoning.

(b) Except as provided in subsections (c) and (d), the health care pro-
vider shall perform the actions specified in subsection (a) at each of the
following times:

(1) The anticipatory guidance required by subsection (a)(1) shall be
performed at each periodic health assessment, starting at 6 months of age
and continuing until 72 months of age.

(2) The screening and evaluation required by subsections (a)(2) or (3)
shall be performed:

(A) When the child is 12 months of age.

(B) When the child is 24 months of age.

(C) Whenever the health care provider performing a periodic health
assessment becomes aware that the child is 1 2 months to 24 months of
age and the actions specified in subsections (a)(2) or (3) were not taken
at 1 2 months of age or thereafter.

(D) Whenever the health care provider performing a periodic health
assessment becomes aware that the child is 24 months to 72 months of
age and the actions specified in subsections (a)(2) or (3) were not taken
when the child was 24 months of age or thereafter.

(E) Whenever the health care provider performing a periodic health as-
sessment of a child 12 to 72 months of age becomes aware that, in the pro-
fessional judgment of the health care provider, a change in circumstances
has put the child at risk of lead poisoning.

(c) The health care provider shall have no duty to order a child
screened for lead poisoning if a parent or guardian of the child, or other

person with legal authority to withhold consent, refuses to consent to tiic
screening.

(d) The health care provider shall have no duty to order a child
screened for lead poisoning, if and so long as the risk of screening is a
greater risk to the child's health than the risk of lead poisoning, in the pro-
fessional judgment of the health care provider. The health care provider
shall document the reasons for not screening in the child's medical re-
cord.

(e) Upon receiving the results of a blood lead analysis in which the
blood lead level is equal to or greater than 1 0 micrograms of lead per deci-
liter of blood, the health care provider shall take those actions that are rea-
sonable and medically necessary to reduce, to the extent possible, the
child's blood lead level below 10 micrograms of lead per deciliter of
blood, such as the following:

( 1 ) Education of a parent or guardian on lead hazards and lead poison-
ing;

(2) Clinical evaluation for complications of lead poisoning;

(3) Follow-up blood lead analyses:

(A) At one- to two-month intervals until the blood lead level has re-
mained less than 15 micrograms of lead per deciliter of blood for at least
six calendar months and the source of the lead poisoning has been re-
moved or remediated; and

(B) Thereafter, unless the child has received additional lead-hazard
exposure, at three-month intervals until the child is 36 months of age;

(4) Referring the family to the local childhood lead poisoning preven-
tion program or, if none, the local health jurisdiction; and

(5) Chelation therapy, if appropriate in the professional judgment of
the health care provider.

(f) A health care provider who fails to comply with this standard of
care may be subject to the disciplinary provisions of Article 12 (com-
mencing with Section 2220) of Chapter 5 of Division 2 the Business and
Professions Code.

NOTE: Authority cited: Sections 100275(a), 105285 and 105300, Health and Safe-
ty Code. Reference: Section 105285, Health and Safety Code.

History

1. New article 2 (section 37100) and section filed 10-10-2000 as an emergency;
operative 10-10-2000 (Register 2000, No. 41). A Certificate of Compliance
must be transmitted to OAL by 2-7-2001 or emergency language will be re-
pealed by operadon of law on the following day.

2. New article 2 (section 37100) and section refiled 2-8-2001 as an emergency;
operative 2-8-2001 (Register 2000, No. 6). A Certificate of Compliance must
be transmitted to OAL by 6-8-2001 or emergency language will be repealed by
operation of law on the following day.

3. Repealed by operation of Government Code section 1 1346.1(g) (Register 2001,
No. 23).

4. New article 2 (section 37100) and section filed 6-4—2001 as an emergency; op-
erative 6-9-2001 (Register 2001 , No. 23). A Certificate of Compliance must be
transmitted to OAL by 10-9-2001 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 6-4-2001 order, including amendment of sub-
section (f) and new Note, transmitted to OAL 10-4-2001 and filed
1 1-19-2001 (Register 2001, No. 47).

Chapter 11. Occupational Lead Poisoning
Prevention Program

Article 1. Definitions

§ 38001. Occupational Lead Poisoning Prevention
Program: Definitions.

(a) "Altered or disturbed" means subjected to a process that may result
in the release of dust, mist, fume, or other particles; such processes may
include, but are not limited to, cutting, welding, grinding, polishing, ma-
chining, scraping, melting, sanding, spraying or pressure blasting.

(b) "De minimus amount" means any of the following:

(1) Lead present in materials which are altered or disturbed and have
a lead concentration less than 0.5% (5000 ppm) by weight;

Page 248.18(0)

§ 38002

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) Lead present in materials where the total weight of such materials
altered or disturbed during the calendar year is known to be 16 ounces
(one pound) or less by weight;

(3) Lead present in materials where no such material is altered or dis-
turbed at any individual employee's place of employment on more than
one day during the calendar year. i.e.. if no employee works on more than
one day during the calendar year in any location where lead-containing
materials are being altered or disturbed, then the amount is de minimus.

(c) "Employee" means any individual employed for at least 160 hours
in the prior calendar year, regardless of whether the individual's specific
job involved potential exposure to lead or lead-containing materials.

(d) "Lead evaluation" means a review of the place of employment and
the materials and processes involved in the operation of an employer's
business, including but not limited to review of Material Safety Data
Sheets or other manufacturer-supplied data, product labeling, or analyti-
cal testing results for presence of lead in materials of unknown composi-
tion.

(e) "Lead was not present at the place of employment" means that no
amount of lead or lead-containing material was present at the place of
employment or in the materials and processes used in the operation of the
employer's business, with the following exceptions:

( 1 ) Lead that was not altered or disturbed during the operation of the
employer's business and was present in a form, or contained in such a
manner, that it could not be inhaled or ingested (examples are undis-
turbed building materials, unused materials and supplies, intact lead stor-
age batteries); or

(2) Lead present as a result of general environmental contamination
which was not the result of the operation of the employer's business.

(0 "Metal work" means the machining or casting of metals or metal
alloys.

(g) "Occupational Lead Poisoning Fee" means a fee pursuant to sec-
tion 1 05 1 90 of the Health and Safety Code which is assessed annually by
the State Board of Equalization on employers with 10 or more employees
in industries identified by the Department of Health Services as having
documented evidence of potential occupational lead poisoning. These in-
dustries are listed by four-digit Standard Industrial Classification (SIC)
Code in Section 38005.

(h) "Place of employment" means any location, not limited to a fixed
site, where employees carry out work duties which are a part of a business
operation.

(i) "Prior calendar year" means the time period from January 1 to De-
cember 3 1 of the year preceding that year in which the Occupational Lead
Poisoning Fee is due.

(i) "Standard Industrial Classification (SIC) Code" means a system of
four-digit numerical codes to designate the acfivities of a business opera-
tion, set forth by the U.S. Office of Management and Budget in the Stan-
dard Industrial Classification Manual, 1987.

Note: Authority cited: Sections 105185 and 105191, Health and Safety Code.
Reference: Sections 105185, 105190, 105191 and 105195, Health and Safety
Code.

History

1 . New chapter 1 1 and section filed 1-15-93 as an emergency; operative 1-15-93
(Register 93, No. 3). A Certificate of Compliance must be transmitted to OAL
5-17-93 or emergency language will be repealed by operation of law on the fol-
lowing day.

2. Certificate of Compliance as to 1-1 5-93 order including amendment of subsec-
tions (a), (b) and (h) transmitted to OAL 4-28-93 and filed 6-10-93 (Register
93, No. 24).

3. Amendment of section and Note filed 5-1-97 as an emergency; operative
5-1-97 (Register 97, No. 1 8). A Certificate of Compliance must be transmitted
to OAL by 8-29-97 or emergency language will be repealed by operation of law
on the following day.

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and
filed 9-17-97 (Register 97, No. 38).

Article 2. Waivers of the Occupational
Lead Poisoning Fee

§ 38002. Fee Waiver Eligibility.

(a) An employer in an industry listed in section 38005 is eligible for
a waiver of the Occupational Lead Poisoning Fee if the employer can
demonstrate, by completing the procedures specified in section 38003,
that:

( 1 ) Lead was not present at the place of employment during the prior
calendar year; or

(2) Lead was present at the place of employment during the prior cal-
endar year only in a de minimus amount.

(b) An employer in an industry listed in section 38005 is not required
to pay the Occupational Lead Poisoning Fee if the employer had fewer
than 10 employees during the previous year.

(c) An employer in an industry listed in section 38005 that involves
painting, including but not limited to Standard Industrial Classification
Code 1721. "Painting and Paper Hanging," is not eligible for a fee waiver
if, in the operafion of the employer's business in the prior calendar year,
any employees altered or disturbed paint in or on a building constructed
prior to 1 978 or on a painted metal structure, unless the employer demon-
strates that lead was not present in any of the altered or disturbed paint,
or was present only in a de minimus amount.

(d) An employer in an industry listed in section 38005 that involves
demolifion, including but not limited to Standard Industrial Classifica-
tion Code 1795, "Wrecking and Demolition Work," is not eUgible for a
fee waiver if, in the operation of the employer' s business in the prior cal-
endar year, any employees altered or disturbed a painted metal structure,
or a building with painted surfaces that was constructed prior to 1 978, un-
less the employer demonstrates that lead was not present in any of the dis-
turbed paint, or was present only in a de minimus amount.

(e) An employer in an industry listed in section 38005 that involves
handling or processing of scrap metal, including but not limited to Stan-
dard Industrial Classification Code 5093, "Scrap and Waste Materials,"
is not eligible for a fee waiver if, in the operation of the employer' s busi-
ness in the prior calendar year, any employees altered or disturbed mate-
rials that may contain lead or have a lead-containing coating, unless the
employer demonstrates that lead was not present in any of the altered or
disturbed materials, or was present only in a de minimus amount.

(f) An employer's request for a fee waiver may be denied for any of
the following reasons:

(1) Identification of the presence of lead in a greater than de minimus
amount at the place of employment or in the materials or processes used
in the operafion of the employer's business; or

(2) Failure of an employer to request a fee waiver and supply the docu-
mentation required in section 38003(d) within 180 days following the
due date of the Occupational Lead Poisoning Fee; or

(3) Failure of an employer to provide sufficient and accurate informa-
tion by which to evaluate the request for a fee waiver.

(g) The Department shall give written notice to the employer of the de-
nial of an employer's request for a fee waiver and the reason or reasons
for the denial.

(h) An employer whose request for a fee waiver is denied shall have
15 working days from receipt of notice of the denial to request a reconsid-
eradon of the denial and to supply any additional facts which the employ-
er believes support the granting of the fee waiver request.
NOTE: Authority cited: Sections 105185 and 105191, Health and Safety Code.
Reference: Sections 105190(e) and 105191(b), Health and Safety Code.

History
1. New secfion filed 1-15-93 as an emergency; operadve 1-15-93 (Register 93,
No. 3). A Certificate of Compliance must be transmitted to OAL 5-17-93 or
emergency language will be repealed by operation of law on the following day.

Page248.18(p)

Title 17

State Department of Health Services

§ 38003

2. Certificate of Compliance as to 1-15-93 order including of amendment of sub-
sections (a), (g)(l)-(2), (h) and (i) transmitted to OAL 4-28-93 and filed
6-10-93 (Register 93, No. 24).

3. Amendment of section and Note filed 5-1-97 as an emergency; operative
5-1-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted
to OAL by 8-29-97 or emergency language will be repealed by operation of law
on the following day.

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and
filed 9-17-97 (Register 97. No. 38).

§ 38003. Procedures for Application of a Waiver.

(a) An employer requesting a fee waiver shall conduct a lead evalua-
tion of the premises, materials and processes used in the operation of the
employer's business during the prior calendar year to determine whether
lead was present. This evaluation shall include, but not be limited to, re-
view of Material Safety Data Sheets or other manufacturer-supplied
data, product labeling, or analytical testing results for presence of lead in
materials of unknown composition.

(b) An employer requesting a fee waiver shall establish that lead was
not present, or was present only in a de minimus amount, at the place of
employment during the prior calendar year.

(c) An employer requesting a fee waiver shall have 1 80 days following
the due date of the Occupational Lead Poisoning Fee to submit documen-
tation that lead was not present, or was present only in a de minimus
amount, at the place of employment during the prior calendar year.

(d) An employer requesting a fee waiver shall demonstrate that lead
was not present, or was present in a de minimus amount, at the place of
employment by providing documentation that includes:

(1) A Request for a Waiver of the Occupational Lead Poisoning Fee

[DHS Form 8484 (4/97)], which is hereby incorporated by reference,
containing the following information:

(A) Name, title, and affiliation of the person who conducted the lead
evaluation of the employer's business operation as outlined in section
38003(a) and, if a consultant, also telephone number and address.

(B) Statement signed by the person conducting the lead evaluation that
attests that, to the best of the person's knowledge, no lead or lead-con-
taining materials were present in any amount, or were present only in a
de minimus amount (as defined in section 38001 ) during the prior calen-
dar year, in the premises, materials and processes used in the operation
of the business.

(C) Description of the nature of the employer's business, including a
description of the products manufactured and/or services provided.

(D) The employer's Board of Equalization-designated, 8-digit ac-
count number provided to the employer at the time the Occupational
Lead Poisoning Fee is assessed.

(E) Name, title, company, address, telephone number, and signature
of an authorized representative of the employer who is requesting the fee
waiver.

(F) An employer in an industry listed in section 38005 that involves
construction work, who wishes to apply for a fee waiver, shall identify
the extent to which the company's operations involved altering or dis-
turbing painted surfaces by completing Part B of Form DHS 8484 (4/97).

(G) An employer in an industry listed in section 38005 that involves
detective, guard, armored car or other security services, who wishes to
apply for a waiver, shall identify the extent to which the company ' s oper-
ations involved altering or disturbing lead materials by discharging
weapons on company time by completing Part C of Form DHS 8484
(4/97).

[The next page is 248.19.]

Page 248.18(q)

Title 17

State Department of Health Services

§ 38005

•

(H) An employer in an industry listed in section 38005 that involves
metal work who wishes to apply for a fee waiver, shall identify the extent
to which the company's operations involved altering or disturbing lead-
containing metals or alloys (including lead-containing brass or bronze)
by completing Part D of Form DHS 8484 (4/97).

(1) An employer in an industry listed in section 38(X)5 that involves the
handling or processing of scrap metal who wishes to apply for a fee waiv-
er, shall identify the extent to which the company's operations involved
altering or disturbing lead-containing or lead-painted scrap metal by
completing Part E of Form DHS 8484 (4/97).

(2) Correspondence from an employer, workers' compensation repre-
sentative, or consultant that includes all of the information outlined in
section 38003(d)(1).

(e) An employer requesting a fee waiver may be required to provide
additional information describing the nature of the employer's business,
including the premises, materials or processes used in the operation of the
employer's business.

(f) Results of industrial hygiene monitoring tests that show non-de-
tectable concentrations of lead in workplace air shall not be considered
sufficient documentation that lead was not present at the place of employ-
ment.

NOTK: Authority cited: Sections 105185 and 105191, Health and Safety Code.
Reference: Sections 105190(e) and 105191(b), Health and Safety Code.

History

1. New section filed 1-15-93 as an emergency; operative 1-15-93 (Register 93,
No. 3). A Certificate of Compliance must be transmitted to OAL 5-17-93 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 1-1 5-93 order transmitted to OAL 4-28-93 and
filed 6-10-93 (Register 93, No. 24).

3. Amendment of section and Note filed 5-1-97 as an emergency; operadve
5-1-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted
to OAL by 8-29-97 or emergency language will be repealed by operation of law
on the following day.

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and
filed 9-17-97 (Register 97, No. 38).

§ 38004. Periods for Which Fee Waivers Are Granted.

(a) The Department shall have the discretion to grant a permanent or
annual waiver of the Occupational Lead Poisoning Fee to an employer
who has provided acceptable documentation that lead was not present at
the place of employment, or was present only in a de minimus amount.
The decision to grant a permanent waiver or annual waiver shall be based
on:

(1) A description of the employer's business operation;

(2) The potential for lead use within the industries classified under the
employer's Standard Industrial Classification Code;

(3) The likelihood that the employer's business operation may change
over time, causing lead to become present at the place of employment in
a greater than de minimus amount.

(b) The Department shall, at the timer a fee waiver is granted, inform
the employer of whether the waiver is granted on a permanent or annual
basis.

(c) The Department shall rescind a company's permanent waiver of
the Occupational Lead Poisoning Fee if the Department obtains evi-
dence, including but not limited to a substantiated case report of occupa-
tional lead poisoning in an employee, that indicates that lead is present
in a greater than de minimus amount at the place of employment.

(d) The Department shall rescind a company's annual waiver of the
Occupational Lead Poisoning Fee if the Department obtains evidence,
including but not limited to a substantiated case report of occupational
lead poisoning in an employee, that indicates that lead was present in a
greater than de minimus amount at the place of employment during the
calendar year for which the annual waiver was granted.

(e) An employer who is granted a permanent fee waiver shall notify
the Department within 30 days of any changes in the premises, materials
or processes used in the operation of the business that result in lead being
present in a greater than de minimus amount at the place of employment.

(f) An employer who is granted an annual waiver shall notify the De-
partment within 30 days if the employer becomes aware that lead was
present in a greater than de minimus amount at the place of employment
during the calendar year for which the annual waiver was granted.
NOTE: Authority cited: Sections 105185 and 105191. Health and Safety Code.
Reference: Sections 105190(e) and 105191(b), Health and Safety Code.

History

1. New secfion filed 1-15-93 as an emergency; operative 1-15-93 (Register 93,
No. 3). A Certificate of Compliance must be transmitted to OAL 5-17-93 or
emergency language will be repealed by operation of law on the following day.

2. Certificate of Compliance as to 1-15-93 order transmitted to OAL 4-28-93 and
filed 6-10-93 (Register 93, No. 24).

3. Amendment of section and Note filed 5-1-97 as an emergency; operative
5-1-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted
to OAL by 8-29-97 or emergency language will be repealed by operation of law
on the following day.

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and
filed 9-17-97 (Register 97, No. 38).

Article 3. Applicable Industries

§ 38005. Occupational Lead Poisoning Fee: Applicable
Industries.

(a) The list of industries in section 1 05 1 95 of the California Health and
Safety Code for which the Occupational Lead Poisoning Fee is applica-
ble is hereby modified as follows:
SIC Code Industry

(1) 1041 Gold ores

(2) 1521 General contractors — Single-family houses

(3) 1541 General contractors — Industrial buildings and

warehouses

(4) 1542 General contractors — Nonresidential buildings,

other than industrial buildings and warehouses

(5) 1611 Highway and street construction, except elevated

highways

(6) 1622 Bridge, tunnel, and elevated highway construction

(7) 1623 Water, sewer, pipeline and communications and

power line construiction

(8) 1629 Heavy construction, not elsewhere classified

(9) 1711 Plumbing, heating, and air-conditioning

(10) 1721 Painting and paper hanging

(11) 1761 Roofing, siding and sheet metal work

(12) 1791 Structural steel erection

(13) 1795 Wrecking and demolition work

(14) 1796 Installation or erection of building equipment, not

elsewhere classified

(15) 1799 Special trade contractors, not elsewhere classified

(16) 2759 Commercial printing, not elsewhere classified

(17) 2782 Blankbooks, looseleaf binders and devices

(18) 2816 Inorganic pigments

(19) 2819 Industrial inorganic chemicals, not elsewhere

classified

(20) 2821 Plastics material, synthetic resins, and

nonvulcanizable elastomers

(21) 2851 Paints, varnishes, lacquers, enamels, and allied

products

(22) 2869 Industrial organic chemicals, not elsewhere

classified

(23) 2891 Adhesives and sealants

(24) 2892 Explosives

(25) 2899 Chemicals and chemical preparations, not

elsewhere classified

(26) 3053 Gaskets, packing, and sealing devices

(27) 3069 Fabricated rubber products, not elsewhere classified

(28) 3087 Custom compounding of purchased plastics resins

(29) 3089 Plastics products, not elsewhere classified

(30) 3229 Pressed and blown glass and glassware, not

elsewhere classified

Page 248.19

§ 38005

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(31)

3231

(32)

3253

(33)

3261

(34)

3262

(35)

3269

(36)

3312

(37)

3313

(38)

3315

(39)

3316

(40)

3317

(41)

3321

(42)

3325

(43)

3331

(44)

3339

(45) 3341

(46)

3351

(47)

3356

(48)

3357

(49)

3363

(50)

3364

(51)

3365

(52)

3366

(53)

3369

(54)

3398

(55)

3399

(56)

3411

(57)

3429

(58)

3431

(59)

3432

(60)

3433

(61)

3441

(62)

3444

(63)

3463

(64)

3479

(65)

3484

(66)

3491

(67)

3492

(68)

3494

(69)

3496

(70)

3497

(71)

3532

(72) 3544

(73)
(74)
(75)

3561
3567
3585

(76) 3599

Glass products, made of purchased glass

Ceramic floor and wail tile

Vitreous china plumbing fixtures and china and

earthenware fittings and bathroom accessories

Vitreous china table and kitchen articles

Pottery products, not elsewhere classified

Steel works, blast furnaces (including coke ovens),

and rolling mills

Electrometallurgical products, except steel

Steel wiredrawing and steel nails and spikes

Cold-rolled steel sheet, strip and bars

Steel pipe and tubes

Gray and ductile iron foundries

Steel foundries, not elsewhere classified

Primary smelting and refining of copper

Primary smelting and refining of nonferrous metals,

except copper and aluminum

Secondary smelting and refining of nonferrous

metals

Rolling, drawing, and extruding of copper

Rolling, drawing, and extruding of nonferrous

metals, except copper and aluminum

Drawing and insulating of nonferrous wire

Aluminum die-castings

Nonferrous die-castings, except aluminum

Aluminum foundries

Copper foundries

Nonferrous foundries, except aluminum and copper

Metal heat treating

Primary metal products, not elsewhere classified

Metal cans

Hardware, not elsewhere classified

Enameled iron and metal sanitary ware

Plumbing fixture fittings and trim

Heating equipment, except electric and warm air

furnaces

Fabricated structural metal

Sheet metal work

Nonferrous forgings

Coating, engraving, and allied services, not

elsewhere classified

Small arms

Industrial valves

Fluid power valves and hose fittings

Valves and pipe fittings, not elsewhere classified

Miscellaneous fabricated wire products

Metal foil and leaf

Mining machinery and equipment, except oil and

gas field machinery and equipment

Special dies and tools, die sets, jigs and fixtures, and

industrial molds

Pumps and pumping equipment

Industrial process furnaces and ovens

Air-conditioning and warm air heating equipment

and commercial and industrial refrigeration

equipment

Industrial and commercial machinery and

(81)

3671

(82)

3674

(83)

3678

(84)

3679

(85)

3691

(86)

3692

(87)

3699

(88)

3711

(89)

3714

(90)

3721

(91)

3728

equipment, not elsewhere classified

(77) 3624 Carbon and graphite products

(78) 3661 Telephone and telegraph apparatus

(79) 3663 Radio and television broadcasting and

communications equipment

(80) 3669 Communications equipment, not elsewhere

classified

Electron tubes

Semiconductors and related devices

Electronic connectors

Electronic components, not elsewhere classified

Storage batteries

Primary batteries, dry and wet

Electrical machinery, equipment and supplies, not

elsewhere classified

Motor vehicles and passenger car bodies

Motor vehicle parts and accessories

Aircraft

Aircraft parts and auxiliary equipment, not

elsewhere classified

(92) 3812 Search, detection, navigation, guidance,
aeronautical, and nautical systems and instruments

(93) 3825 Instruments for measuring and testing of electricity
and electrical signals

(94) 3829 Measuring and controlling devices, not elsewhere
classified

(95) 3844 X-ray apparatus and tubes and related irradiation
apparatus

Silverware, plated ware, and stainless steel ware
Sporting and athletic goods, not elsewhere classified
Marking devices

Fasteners, buttons, needles, and pins
Telephone communications, except radiotelephone
Electric services

Electrical appliances, television and radio sets
Scrap and waste materials
Sporting goods stores and bicycle shops
Detective, guard, and armored car services
General automotive repair shops
Automotive repair shops, not elsewhere classified
Membership sports and recreation clubs
Amusement and recreation services, not elsewhere

classified
(110) 8734 Testing laboratories
NOTE: Authority cited: Sections 105185 and 105195, Health and Safety Code.
Reference: Section 105195, Health and Safety Code.

History

2. Certificate of Compliance as to 1 -1 5-93 order transmitted to OAL 4-28-93 and
filed 6-10-93 (Register 93, No. 24).

3. Amendment of section and Note filed 5-1-97 as an emergency; operative
5-1-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted
to OAL by 8-29-97 or emergency language will be repealed by operation of law
on the following day.

4. Certificate of Compliance as to 5-1-97 order transmitted to OAL 8-8-97 and
filed 9-17-97 (Register 97, No. 38).

(96)

3914

(97)

3949

(98)

3953

(99)

3965

(100)

4813

(101)

4911

(102)

5064

(103)

5093

(104)

5941

(105)

7381

(106)

7538

(107)

7539

(108)

7997

(109)

7999

* * *

Page 248.20

.A.

Barclays Official

California

Code of
Regulations

Title 17. Public Health

Division 2. Health and Welfare Agency — Department of Developmental

Services Regulations

THOIVISOIM

* ^

\A/EST

Barclays Official California Code of Regulations

425 Market Street • Fourth Floor • San Francisco, CA 94105
800-888-3600

Title 17

Health and Welfare Agency — Department of Developmental Services

Table of Contents

Division 2. Health and Welfare Agency — Department of
Developmental Services Regulations

Table of Contents

Page

Chapter 1 . General Provisions 249

Subchapter 2. Monthly Parental Fee 249

Article 1 . General 249

§50201. Authority.

§ 50203. Forms.

Article 2. Definitions 249

§ 50205. Ability to Pay.

§ 50207. Gross Family Income.

§ 50209. Eligible Dependent.

§50211. Parental Fee.

§ 502 1 3. Parental Fee Schedule.

§ 50215. Parents.

Article 3. Administrative Provisions 250

§ 50221 . Centralized Parental Fee Program.

Article 4. Determination of Ability to

Pay 250

§ 50223. Services Requiring Ability to Pay

Determinations.
§ 50225. Regional Center Responsibilities.

§ 50227. Notification to Parents.

§ 50229. Parent(s) Disclosure of Financial

Information.
§ 50230. Determination of Amount of

Monthly Parental Fee.

Article 5. Determining Required Levels

of Payment 251

§ 50231. Gross Family Income Adjustments.

§ 50233. Major Unusual Expense Allowance.

§ 50235. Transportation Expense Allowance.

§ 50237. Substantiation of Determination

Data.
§ 50239. Termination of Required Payments.

§50241. Appeal.

Subchapter 2.5. Family Cost

Participation 252

Article 1 . General 252

§ 50243. Purpose.

Article 2. Definitions 252

§ 50245. Developmental Disability.

§ 50247. Medi-Cal Eligible Consumers.

§ 50249. Family Cost Participation Schedule.

§ 50251. Gross Annual Income.

§ 50253. Persons Living in the Family Home.

Articles. Administrative Provisions 252.1

§ 50255. Parent Responsible for Cost

Participation.
§ 50257. Program Administration.

Article 4. Assessment of the Family

Cost Participation 252. l

§ 50259. Assessment of the Family Cost

Participation.
§ 50261. Maximum Family Cost Participation

Assessment.

Page

§ 50262.

Confidentiality and Retention of
Income Documentation.

§ 50263.

Waiver Exemption.

§ 50265.

Adjustment by Regional Center
Executive Director.

§ 50267.

Assessment and Reassessment of
Cost Participation.

Subchapter 3.

Department of
Developmental Services —
Conflict of Interest

Code

252.2

Subchapter 4.

Rules for Conducting

Research

252.3

Article L

Definitions

252.3

§50401.

Definitions.

Article 2.

Rules for the Conduct of

Research

. . 253

§ 50403.

Scope of Subchapter.

§ 50405.

Institutional Review Boards (IRBs).

§ 50407.

Review Structure for Research
Protocol.

§ 50409.

Continuing Review of Research
Acdvities at State Hospitals.

§50411.

Composition of the IRB at State
Hospitals.

§ 50413.

Responsibilities of the Researcher.

§ 50415.

Responsibihties of the IRB at State
Hospitals.

§ 50417.

Criteria for State Hospital IRB
Approval of Research Protocols.

§ 50419.

Appealing an IRB Decision.

§50421.

Confidentiality of Client
Information and Records Used in
Research.

§ 50423.

Informed Consent.

§ 50425.

Basic Elements of Informed
Consent.

§ 50427.

Waiver of Requirement of Informed
Consent at State Hospitals.

§ 50429.

Documentation of Informed
Consent.

Subchapters.

Clients' Rights

. 257

Article L

Purpose and Definitions

. 257

§ 50500.

Intent and Purpose.

§50501.

Definitions.

Article 2.

Rights of Persons with

Developmental Disabilities

. 258

§ 50510.

Application of This Subchapter.

§ 50515.

Use of Seclusion or Restraint, "Time
Out."

Article 3.

Notification of Rights

. 259

§ 50520.

Notification of Rights.

Article 4.

Denial of Rights

. 259

§ 50530.

Denial of Rights.

§ 50532.

Documentation of Rights Denials.

Page i

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§ 50534.

Access to Denial of Rights

Subchapter 8.

Peer Review of Behavior

§ 50536.

Information.

Reporting Good Cause Denials of

Rights.

Modification
Interventions That Cause

§ 50538.

Quarterly Reports on the Denial of
Rights for Good Cause.

Pain or Trauma, and
Electroconvulsive

Article 5.

Complaint Procedure

. 261

Therapy

.. 274

§ 50540.

Complaint Procedure.

Article 1.

General Provisions

.. 274

Article 6.

Clients' Rights Advocate

. 261

§ 50800.
§50801,
§ 50802.

Meaning of Words.
Definitions.

§ 50550.

Assignment of Clients' Rights

Limitations on Use of Behavior

Advocate.

Modificafion Interventions That
May Cause Pain or Trauma.

Subchapter 6.

Service Provider

Article 2.

Review by Qualified

Accountability

. 261

Professional

. . 275

Article 1.

General Provisions

. 261

§ 50810.

Designation of Qualified
Professionals.

§50601.

Meaning of Words.

§50811.

Procedures for Review of Proposed

§ 50602.

Definitions.

Treatment Plans.

§ 50603.

Access to Service Provider Records.

§ 50604.

Service Provider Record
Maintenance Requirements.

Article 3.

Review of Behavior
Modification Treatment

§ 50605.

Service Provider Record Retention
Requirements.

Plans . . '.

. . 275

§ 50606.

Regional Center Auditing

Requirements.

Regional Center Contracting

§ 50820.

Establishment of Behavior
Modification Review Committees.

§ 50607.

§50821.

Procedures for Review by Behavior

Requirements.

Modification Review Committee.

§ 50608.

Contract Duties and
Responsibilities.

§ 50822.

Criteria for Approval of Behavior
Modificafion Programs Involving

§ 50609.

Contract Fiscal Provisions.

Pain or Trauma.

§ 50610.

Contract Fiscal Audit.

§ 50823.

Behavior Modification Reporting

§50611.

Contract Termination.

Requirements.

§ 50612.

Regional Center Purchase of Service

Article 4.

Electroconvulsive Therapy

Requirements.

(ECT)

.. 276

Subchapter 7.

Fiscal Audit Appeals

. . 267

§ 50830.
§50831.

Limitations on the Use of ECT.
Procedure for Seeking Approval to

Article 1.

General

. . 267

§ 50832.

Use ECT.

Electroconvulsive Therapy (ECT)

§ 50700.

Purpose and Scope.

Review Committee.

§50701.

Definitions.

§ 50833.

Criteria for Approval of ECT.

§ 50702.

Revised Audit Report.

§ 50834.

Procedures for Review of Proposed

§ 50703.

Department Mailings.

ECT.

§ 50704.

Disqualification of Appeals Review

§ 50835.

Reporting Requirements.

§ 50705.

Officer or Hearing Officer.
Recovery of Overpayments.

Subchapter 9.

Fair Hearings

.. 277

§ 50706.

Costs and Attorneys Fees.

Article 1.

General Provisions and

§ 50707.
§ 50708.

Consolidafion of Appeals.
Additional Parties.

§ 50900.

Definitions

Intent and Purpose.

.. 277

Article 2.

Administrative Review

. . 269

§ 50902.

Definitions.

§ 50730.
§50731.

Request for Administrative Review.
Informal Conference.

§ 50904.

Computation of Time for
Performance of Act.

§ 50732.

Letter of Findings.

Article 2.

§ 50920.

Adequate Notice

Appeal to Be Filed with Service

.. 278

Article 3.

Formal Hearing

. . 270

Agency.

§ 50750.

Request for Formal Hearing.

§ 50922.

Notice to Clients' Rights Advocate

§50751.

Time and Place of Formal Hearing.

Regarding Adult Without

§ 50752.

Severance of Issues.

Conservator.

§ 50753.

Discovery.

§ 50924.

Notice to Regional Center Director

§ 50754.

Subpoenas and Witnesses.

for Conservatee of Director of

§ 50755.

Depositions.

Developmental Services.

§ 50756.

Affidavits.

Article 3.

Procedures for Fair

§ 50757.

Preparation for Formal Hearing.

§ 50758.

Conduct of Formal Hearing.

Hearings

. . 278

§ 50759.

Official Notice.

§ 50930.

Notice of Right to Request

§ 50760.

Continued or Further Hearings.

Consolidation.

§50761.

Introduction of New Evidence.

§ 50932.

Notice of and Consent to

§ 50762.

Representation at a Formal Hearing.

Consolidation.

§ 50763.

Oral Arguments and Briefs.

§ 50934.

Claimant Objection to Authorized

§ 50764.

Decision.

Representative.

§ 50765.

Dismissal.

§ 50936.

Notice of Documents Provided to

§ 50766.

Reconsideration.

Hearing Officer.

§ 50767.

Judicial Review.

§ 50938.

Submission of Written Argument.

Page

(7-25-2008)

Title 17

Health and Welfare Agency — Department of Developmental Services

Table of Contents

Article 4.

§ 50960.
§ 50962.

§ 50964.
§ 50966.

Article 5.

§ 50980.
§ 50984.
§ 50988.

§ 50992.

Page

Miscellaneous Provisions 278

Internal Grievance Procedure.

Hearing Procedure in Nonteciinicai

Language.

Regulations to Be Posted.

Receipt of Fair Hearing Request by

Office of Administrative Hearings.

Page

Chapter 2. I

Subchapter 1.

Article 1.

§ 52000.

Article 2.

§ 52020.
§ 52022.

Subchapter 2.

Article 1.

§ 52040.
§ 52060.

Article 2.

§ 52082.

§ 52084.
§ 52086.

Subchapter 3.

Article 1.

§ 52100.

Article 2.

§ 52102.

§ 52104.

§ 52106.
§ 52107.
§ 52108.

§ 52109.
§52110.

Article 3.

§52111.
§52112.

Subchapter 4.
Article 1.

Mediation 278.1

Confidentiality of Mediation.

Continuances in Mediation.

Mediation Request Made

Subsequent to Fair Hearing

Request.

Time and Place of Mediation;

Nonadversarial.

Early Intervention Services 278.1

General Provisions 278.1

Definitions 278.1

Meaning of Words.

Eligibility for California's

Early Start Program 278.3

General.

Eligibility Criteria.

Program and Service

Components 278.4

Child Find & Referral 278.4

Child Find.
Referral.

Evaluation and Assessment 278.5

Procedures for Evaluation to
Determine Eligibility.
Assessment for Service Planning.
Time Lines for Completion of
Evaluation and Assessment.

Individualized Family

Service Plan 278.6

General 278.6

Individualized Family Service Plan
(IFSP).

Content and Procedures for

the IFSP 278.6

Procedures for IFSP Development,

Review and Evaluation.

Participants in Initial and Annual

IFSP Meetings and Periodic

Reviews.

Content of IFSP

Interim IFSP

Designation of Services on the

IFSP

Basis for the Provision of and

Payment for Services Through

Regional Centers.

Basis for the Provision of Services

Through LEAs.

Transfer and Transition

Procedures 278.9

Transfer.

Transition from Early Intervention

Services.

Service Coordination and

Interagency Agreements 278.1 1

Service Coordination 278.11

§ 52120.

General.

§52121.

Service Coordination
Responsibilities.

§ 52122.

Service Coordinator Qualifications.

Article 2.

Interagency Agreements

278.11

§ 52140.

Local Interagency Agreements.

Subchapter 5.

Procedural Safeguards

278.12

Article 1.

Notice and Consent

278.12

§ 52160.

Initial and Annual Notice.

§52161.

General Notice Requirements.

§ 52162.

Consent.

Article 2.

Access Rights

278.13

§52164.

Access Rights.

§52165.

Documentation of Access.

§52166.

Records on More Than One Infant
or Toddler.

§ 52167.

Fees for Copies of Records.

§52168.

Amendment of Records at Parental
Request.

§ 52169.

Consent for Release of Information.

Article 3.

Complaint Process

278.14

§ 52170.

Complaint Procedures.

§52171.

Complaint Investigation.

Article 4.

Mediation and Due Process

§52172.

§52173.
§ 52174.

Article 5.

§52175.

Procedures 278.16

Procedures That Apply to Both
Mediation and Due Process.
Mediation Procedures.
Due Process Hearing Procedures.

Surrogate Parents 278.17

Surrogate Parents.

Chapter 3. Community Services 278.17

Subchapter 1. General 278.17

Article 1. Definitions 278.17

§ 54000. Developmental Disability.

§ 54001 . Substantial Disability.

§ 54002. Cognitive.

Article 2. Eligibility 278.18

§ 54010. Eligibihty for Regional Center

Services.

Subchapter 2. Vendorization 278.18

Article 1.

§ 54300.

Article 2.

§ 54302.
§ 54306.
§ 54308.

§ 54310.
§ 54312.

§54314.
§ 54316.
§ 54318.

§ 54319.
§ 54320.

§ 54322.

§ 54324.
§ 54326.

§ 54327.

Definitions 278.18

Meaning of Words.

Vendorization Process 279

Definitions.

Service Bank Application.

Determination of Need and Notice

Requirements.

Vendor Application Requirements.

Applicants Exemipted from the

Application Process.

Ineligibility for Vendorization.

Generic Agencies.

Vendorization of Out-of-State

Applicants and Manufacturers or

Distributors.

Group Practices.

Regional Center Review of Vendor

Application.

Regional Center Approval/Denial of

Vendorization.

Emergency Vendorization.

General Requirements for Vendors

and Regional Centers.

Requirements for Special Incident

Reporting by Vendors and

Long-Term Health Care Facilities.

Page iii

17 :.s 2()0S)

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§54327.1,

Requirements for Special Incident

§ 54526.

Reporting by Regional Centers.

§ 54527.

§ 54327.2.

Regional Center Risk Management,

§ 54528.

Assessment and Planning

§ 54529.

Committee and Risk Management

and Mitigation Plans.

Subchapter 3.5.

§ 54330.

Changes in Vendor Ownership,
Location, or Program/Service

Design.

Article 1.

§ 54332.

Regional Center Files.

§ 54600.

§ 54334.

Statewide Vendor Panel.

§54601.

Article 3.

Vendor Numbers and Service

Codes 282.9

Article 2.

§ 54340.

Vendor Identification Numbers,

§ 54620.

Service Codes, and Subcodes.

§ 54621.

§ 54342.

Types of Services.

Article 3.

§ 54344.
§ 54346.

Other Services: Nonmedical

Services.

Other Services: Medical Services.

§ 54640.
§54641.
§ 54642.
§ 54643.

§ 54348.

Prevention Services/Infant

Development Services.

§ 54349.

Supported Living Service.

§ 54644.

§ 54350.

Supportive Services.

§54351.

Habilitation Services.

Article 4.

§ 54352.

Transportation Services.

§ 54660.

§ 54354.

Service Codes for Residential,

§54661.
§ 54662.

Intermediate Care and Nursing

Facility Services.

§ 54663.

§ 54355.

Vouchers.

§ 54664.

§ 54356.

Miscellaneous Services.

§ 54665.

§ 54358.

Exempted Services.

§ 54666.

Article 4.

Vendor Compliance and

§ 54667.
§ 54668.

Prohibitions 282.20

§ 54669.

§ 54370.

Termination of Vendorization for

§ 54670.

Noncompliance.

§54671.

§ 54372.

Review of Existing Vendors.

§ 54672.

§ 54374.

Use of Planned Behavior

§ 54673.

Modification Interventions That

§ 54674.

Cause Pain or Trauma.

§ 54675.
§ 54676.

Article 5.

Vendorization Appeal 282.21

§ 54380.

Vendorization Appeal.

Subchapter 4.

§ 54382.

Contents of Appeal and Decision.

§ 54384.

Appeal of the Regional Center's
Decision.

§ 54386.

Effective Date of Decision.

Article 1.

§ 54388.

Good Cause.

§56001.

§ 54390.

Review of Documents Only.

§ 56002.

Subchapter 3.

Regional Center

Article 2.

Administrative Practices
and Procedures

282.23

Article 1.

§ 54500.
§ 54505.
§ 54510.
§54511.
§54512.
§ 54520.

§ 54521.
§ 54522.

§ 54523.
§ 54524.
§ 54525.

Regional Center Conflict of

Interest Standards and

Procedures 282.23

Authority and Scope.

Definitions.

Regional Center.

Contracting Agency.

Regional Center Employee.

Conflict of Interest Standards for

Regional Center Governing Board

Members.

Conflict of Interest Standards for

Regional Center Employees.

Conflict of Interest

Disclosure — Content of Statements,

Procedures and Actions Required

for Resolution.

Requests for Waiver.

Response to Requests for Waiver.

Sanctions.

§ 56003.
§ 56004.
§ 56005.

§ 56009.

Article 3.

§ 56013.

Article 4.

§ 56016.

§ 56017.

§ 56018.
§ 56019.
§ 56020.

Article 5.

§ 56022.
§ 56026.

§ 56027.

Purchases.
Records.
Board Meetings.
Sanctions.

Regional Center Budget

Deficit Controls 282.26

Definitions 282.26

Definitions.
Expiration.

Service Authorization and

Review 282.26

Service Purchase Authorizations.

Review of Service Authorizations.

Plans of Action 282.27

Projecting Deficits.
Content of Plans of Action.
Review of Plans of Action.
Modification and Implementation of
Plans of Action.
Noncompliance.

Service Standards 283

Eiu^ly Intervention Services.

Preschool Services.

Education.

Day Program Services.

Independent Living Skills Training.

Extended Day Programs.

Social Recreafion Services.

Special Services.

Behavior Modification.

Sensory Motor Development.

Education Training.

Independent Living Skills Training.

Vocational Training.

Work Activity.

Respite Care.

Transportation.

Exceptions.

Residential Services and

Quality Assurance

Regulations 284

Definitions 284

Meaning of Words.
Definitions.

General Requirements 286

Residential Services Orientation.

Facility Service Levels.

Facility Service Level Approval

Process.

Regional Center Compliance.

Program Design 288

Program Design Requirements.

Consumer Placement and
Relocation 289

Placement and Relocation

Requirements.

Consumer Placement and

Relocation Assistance.

Preadmission Visits.

Consumer Admission.

Emergency Placement and

Relocation.

Consumer Services 291

Consumer IPP Objectives.
Consumer Notes, Quarterly and
Semi- Annual Reports.
Special Incidents.

Page iv

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Title 17

Health and Welfare Agency — Department of Developmental Services

Table of Contents

Page

Article 6. Welfare and Institutions

Code Section 4695.2 Direct

Care Staff Training

Regulations

292

§56031.

Definitions.

§ 56032.

Purpose.

§ 56033.

Direct Care Staff
Competency-Based Training and
Testing Requirements.

§ 56034.

Waiver Requirements for Facilities.

§56034.1.

Foster Family Agency Waiver
Requirements.

§ 56035.

Waiver for Prevailing Rate
Facilities.

Article 7.

Personnel

292.3

§ 56036.

Training Plans.

§ 56037.

Administrator Qualifications and

Continuing Education.
§ 56038. Direct Care Staff QualificaUons and

Continuing Education

Requirements.
§ 56040. Consultant Qualifications.

Article 8.

Monitoring and Evaluation 292.5

§ 56046.

Quality Assurance Plans.

§ 56047.

Regional Center Monitoring of the

IPP Objectives.

§ 56048.

Facility Liaison Quality Assurance

(QA) Monitoring of the Facility.

§ 56049.

Quality Assurance Evaluation

Team.

§ 56050.

Preparation for the Quality

Assurance Evaluation.

§56051.

Quality Assurance Evaluation.

§ 56052.

Post-Evaluation Activities.

Article 9.

Corrective Action Plans and

Sanctions 292.8

§ 56053.
§ 56054.
§ 56055.
§ 56056.
§ 56057.

Article 10.

§ 56058.
§ 56059.
§ 56060.

Article 11.

§56061.
§ 56062.
§ 56063.
§ 56064.

§ 56065.
§ 56066.

§ 56067.

Article 3.

§ 56082.

§ 56083.

Article 4.

§ 56084.

Article 5.

§ 56085.

Article 6.

§ 56086.

Article 7.

§ 56087.

§ 56088.

§ 56089.

Article 8.

§ 56090.

Article 9.

§56091.

Article 10.

§ 56092.

Article 11.

Immediate Danger.

Substantial Inadequacies.

Insufficiencies.

Corrective Action Plan (CAP).

Sanctions.

Records Maintenance 292.8(b)

Confidentiality.

Residential Services Records.

Regional Center Records.

Facility Appeals Process . . . 292.8(b)(2)
Appeal Process.

Contents of Appeal and Hearing.
Decision.

Appeal of the Regional Center's
Decision.

Decision by the Director.
Implementation of Regional Center
Actions During Appeal.
Good Cause.

§ 56093.

Article 12.

§ 56094.

Article 13.

§ 56095.

Article 14.

§ 56096.
§ 56097.
§ 56098.
§ 56099.

Subchapter 4.2.

Subchapter 4.1 . Family Home Agency (FHA)

Regulations 292.8(b)(3)

Article 1.

Definitions

. . . 292.8(b)(3)

§ 56075.
§ 56076.

Article 2.

Meaning of Words.
Definitions.

Competitive

Article 1.

§ 56100.
§56101.

Procurement

. . . 292.8(b)(4)

Article 2.

§ 56077.
§ 56078.
§ 56079.
§ 56080.
§56081.

Determination of Need.
Public Notice.
Application.
Selection of FHA.
Notice of Intent.

§ 56102.
§ 56103.
§ 56104.
§ 56105.

Page

Contract and

Vendorization 292.8(d)

Contract and Vendorization.

Residential Services Orientation and

Training.

Program Design 292.8(d)

Program Design Requirements.

Criminal Record

Clearance 292.8(e)

Fingerprints and Criminal History.

The FHA 292.8(f)

The FHA.

The Family Home 292.8(g)

Home Visit.
Certificate of Approval.
Prohibited Interventions and
Treatment.

Referral for Service 292.8(h)

Referral for Service.

Consumer Funds and

Property 292.8(h)

Consumer Funds and Property.

Health-Related Services 292.8(i)

Health-Related Services.

Abuse and Special Incident
Reporting 292.8(i)

Abuse and Special Incident

Reporting.

Termination of Residency 292.8(j)

Termination of Residency.

Monitoring and Sanctions 292.8(j)

Monitoring and Sanctions.

Appeals 292.8(k)

Appeals.

Content of Appeal and Decision.

Good Cause.

Review of Documents Only.

Intermediate Care
Facility (ICF);
Intermediate Care
Facility /Developmentally
Disabled (ICF/DD);
Intermediate Care
Facility /Developmentally
Disabled-Habilitative
(ICF/DD-H); Intermediate
Care Facility/

Developmentally Disabled-
Nursing (ICF/DD-N);
Skilled Nursing Facility
(SNF) Monitoring
Requirements 292.8(n)

Definitions 292. 8(n)

Meaning of Words.
Definitions.

Monitoring 292. 8(n)

State Developmental Centers.
Service Delivery Monitoring.
Suspension of Placements.
Termination of Consumer(s)
Residence.

Page V

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Page

§56610.

Compliance.

§ 56798.

)chapter 5.

Standards for

§ 56800.

Nonresidential Services 292. 8(o)

§ 56802.

Article 1.

Definitions 292.8(o)

Subchapter 6.

§ 56702.

Terms Defined in Other
Subchapters.

§ 56704.

Additional Terms Defined.

Article 2.

Standards for All Community-

Article 1.

Based Day Programs 292. 8(p)

§ 56900.
§56901.

§ 56710.

General Requirements.

§56711.

Waiver of Service Standards.

Article 2.

§56712.

Program Design.

§ 56902.

§56714.

Vendor Entrance and Exit Criteria

for Consumers.

Article 3.

§ 56716.

Consumer Placement Procedures.

§ 56903.

§56718.

Consumer Placement and Funding
Termination Procedures.

§ 56904.

§ 56720.

Consumer IPP Documentafion.

§ 56905.

§ 56722.

Personnel Requirements.

§ 56906.

§ 56724.

Personnel Functions and

§ 56908.

Qualifications.

§ 56909.

§ 56726.

Staff Training.

§ 56728.

Program Records.

Article 4.

§ 56730.

Consumer Records.

§ 56732.

Program Evaluation.

§56910.

§ 56734.

Effective Date of Compliance.

Article 3.

Additional Standards for

§56911.

Adult Day Programs 292.13

§ 56912.
§ 56913.

§ 56740.

General Requirements.

§ 56742.

Program Curriculum and

§ 56914.

Components.

§ 56915.

§ 56744.

Consumer EligibiUty for Services.

§ 56746.

Vendor Entrance and Exit Criteria

Article 5.

for Consumers.

§ 56916.

§ 56748.

Consumer Placement Procedures.

§ 56750.

Consumer Placement and Funding

Article 6.

Termination Procedures.

§ 56917.

§ 56752.

Personnel Requirements.

§ 56918.

§ 56754.

Personnel Functions and

Qualifications.

§ 56919.

§ 56756.

Staffing Ratio.

Article 4.

Additional Standards for
Infant Development

Article 7.

Programs 292.16

§56931.

§ 56760.

General Requirements.

§ 56932.

§ 56762.

Program Design.

§ 56933.

§ 56764.

Program Curriculum and
Components.

§ 56934.

§ 56766.

Consumer Eligibility for Services.

§ 56935.

§ 56768.

Consumer Placement Termination
Procedures.

§ 56936.

§ 56770.

Personnel Functions and
Qualifications.

§ 56937.

§ 56772.

Staffing Ratio.

§ 56774.

Staff Training.

Subchapter 7.

Article 5.

Standards for In-Home

Respite Services Agencies 292.18

§ 56776.

Definitions.

§ 56778.

Waiver of Service Standards.

Article 1.

§ 56780.

Service Design.

§ 57200.

§ 56782.

Consumer Eligibility for Services.

§ 56784.

Identification of Consumers Served.

§ 57210.

§ 56786.

Procedures for Service

Authorization.

Article 2.

§ 56788.

Service Termination Procedures.

§ 57300.

§ 56790.

Personnel Requirements.

§ 56792.

Personnel Functions and
Qualifications.

§ 56793.

Staffing Ratio.

Article 3.

§ 56794.

Staff Training.

§ 57310.

§ 56796.

Required Agency Records.

Page

Consumer Records.

In-Home Respite Services

Evaluation.

Effective Date of Compliance.

Ratesetting Procedures

for Residential

Services 292.22(a)

Definitions 292.22(a)

Meaning of Words.
Definitions.

General Provisions 292.23

General Provisions.

Cost Studies 292.24

Facility Cost Study.

Cost Study Records Maintenance

Requirements.

Depreciation.

Cost Allocation Methods.

Allowable Costs.

Costs Not to Be Reported.

Rates Development

Methodology 292.26

General Provisions for Rate

Proposals.

Basic Living Needs.

Indirect Costs.

Direct Supervision and Special

Services.

Proprietary Fee.

Cost Data Update Methodology.

Rate Proposals 292.28

Proposed Rates.

Reimbursement Policies 292.29

Payment of Established Rates.
Reimbursement for Residential
Respite Services.
Usual and Customary Fees and
Prevailing Rates.

Verification of Use of Rate

Increase Funds 292.30

Definitions.

Purposes.

Verification Requirement.

Rate Increase Funds Verification

Procedures.

Failure to File.

Criteria for Approving Rate Increase

Funds Use for Other Purposes.

Procedures for Approving the Use

of Rate Increase Funds for Other

Purposes.

Nonresidential Service

Vendor Rate-Setting

Provisions 292.33

Definitions 292.33

Terms Defined In Other

Subchapters.

Additional Terms Defined.

General Provisions 292.34

Rate-Setting Requirements
Applicable to All Nonresidential
Service Vendors.

Vouchers 292.35

Method of Reimbursement for
Voucher Services.

Page vi

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Title 17

Health and Welfare Agency — Department of Developmental Services

Table of Contents

Page

Article 5. Rates of Reimbursement Based

on the Schedule of Maximum

Allowances or the Vendor's

Usual and Customary Rate

§ 57330.

Generic Agencies.

§57331.

Group Practices.

§ 57332.

Maximum Rates of Reimbursement

for Non-Residential Services.

§ 57333.

Other Services: Medical Services.

§ 57334.

Prevention Services/Infant

Development Services.

§ 57335.

Supportive Services.

§ 57336.

Miscellaneous Services.

Subchapter 8.

Rate-Setting Procedures

§57518.

§ 57519.

292.35

Step Eight: Adjusting the Amount
Computed in Step Seven for Budget
Act Adjustment.

Adjusting the Rate Methodology for
COLAS "

Article 1.
Article 2.

§ 57422.

Article 3.

§ 57430.
§57431.

§ 57432.

§ 57433.
§ 57434.
§ 57436.
§ 57438.

§ 57439.

Article 4.

§ 57440.

§ 57442.
§ 57444.

Subchapter 9.

Article 1.

§ 57500.
§57510.

§57511.

§ 57512.
§ 57513.

§ 57514.

§57515.

§ 57517.

for Community-Based Day

Programs 292.36(b)

(Reserved) 292.36(b)

General Provisions . . .
General Requirements.

292.36(b)

Submission of Required

Information 292.36(b)

Submission of Information.

Reporting Periods for Submission of

Information.

Required Due Dates for Submission

of Information.

Required Program Information.

Required Cost Information.

Costs Not to Be Reported.

Required Vendor Income

Information.

Required Regional Center Payment

and Vendor Cost Reduction

Information.

Review Requirements 292.37

Vendoring Regional Center Review

Procedures.

Department Review Procedures.

Determination of the Direct Service

Hours Allowed or Required to

Maintain the Approved Staffing

Ratio.

Rate-Setting Methodology
for Community-Based Day
Programs

292.39

Permanent Payment Rates 292.39

General Provisions.

Step One: Grouping of Like

Program Vendors.

Step Two: Computing an Amount

Using Allowable Costs and

Consumer Attendance.

Step Three: Computing the Mean

for Each Like Program.

Step Four: Determination of the

Allowable Range of Rates for Each

Like Program.

Step Five: Adjusting the Amount

Computed in Step Two for Gap

Funding.

Step Six: Adjusting the Amount

Computed in Step Five by the Upper

and Lower Limit of the Allowable

Range of Rates.

Step Seven: Adjusting the Amount

Computed in Step Six by Vendor

Income.

Article 2.

Temporary Payment Rate

292.42

§ 57520.

General Provisions.

§ 57522.

Establishment of the Temporary
Payment Rate.

Article 3.

Non-Mobile Supplemental

Rate

292.42

§ 57530.

Supplemental Rate for
Community-Based Day Programs
Serving Non-Mobile Consumers.

§ 57532.

Effective Date.

§ 57534.

Written Notification of the
Supplemental Rate Established for
Community-Based Day Programs
Serving Non-Mobile Consumers.

Article 4.

Service Contracts

292.43

§ 57540.

Service Contracts Between the
Regional Center and
Community-Based Day Program
Vendors.

Subchapter 10.

Schedule of Payment Rates
for Community-Based Day

Programs

292.44

Article 1.

General Provisions

292.44

§ 57600.

General Provisions for Schedule of
Payment Rates for All Fiscal Years.

Article 2.

Schedule of Payment Rates

forFiscal Year 1990-91

292.44

§ 57620.

Vendors Receiving Permanent
Rates.

§ 57622.

Vendors Receiving Provisional
Rates.

§ 57624.

New Vendors.

Article 3.

Schedule of Payment Rates

forFiscal Year 1991-92

292.44

§ 57630.

Vendors Receiving Permanent
Rates.

§ 57632.

Vendors Receiving Temporary
Payment Rates.

§ 57634.

Vendors Receiving Provisional
Rates.

§ 57636.

New Vendors.

Article 4.

Schedule of Payment Rates
for Fiscal Year 1996-97 and
Each Alternate Fiscal Year

Thereafter

292.45

§ 57640.

Vendors Receiving Permanent
Payment Rates.

§ 57642.

Vendors Receiving Temporary
Payment Rates.

§ 57644.

New Vendors.

Article 5.

Schedule of Payment Rates
for Fiscal Year 1997-98 and
Each Alternate Fiscal Year

Thereafter

292.45

§ 57650.

Vendors Receiving Permanent
Payment Rates.

§ 57652.

Vendors Receiving Temporary
Payment Rates.

§ 57654.

New Vendors.

Article 6.

Timelines for Rale
Establishment and Written

Notification

292.46

Page vii

(7 25 2()(IS)

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 57660.

§ 57662.

§ 57664.

§ 57666.

Subchapter 1 1 .

Article 1.

§ 57810.

§ 57812.

Article 2.

J; 57820.

§ 57822.

Subchapter 12.

Article 1.

§ 57910.

Article 2.

§ 57920.
§ 57922.

§ 57924.

Article 3.

§ 57930.

Article 4.

§ 57940.
§57941.
§ 57942.

§ 57944.
§ 57946.
§ 57948.

Subchapter 13.

Article 1.

§ 58000.

§ 58010.

Article 2.

§ 58020.

Page

Timelines for Continuation of the

Permanent Rate and Written

Notification.

Timelines for Extension of the

Provisional Rate and Written

Notification.

Timelines for Establishment of the

Permanent Payment Rate and

Written Notification.

Timelines for Establishment of the

Temporary Payment Rate and

Written Notification.

Reporting Requirements

for Community-Based Day

Programs 292.47

Annual Report to the

Legislature 292.47

The Department's Annual Report to

the Legislature.

The Joint Report to the Legislature

forFiscal Year 1996-97.

Calculation of the Statewide

Fiscal Impact of the Gap 292.47

Determination of the Statewide
Fiscal Impact of the Gap for Fiscal
Year 1997-98, and Each Alternate
Fiscal Year Thereafter.
Determination of the Statewide
Fiscal Impact of the Gap for Fiscal
Year 1993-94, and Each Alternate
Fiscal Year Thereafter.

Rate Adjustments, Audit
Adjustments and Rate
Appeals for Community-
Based Day Programs 292.47

General Provisions 292.47

General Provisions.

Rate Adjustments 292.49

General Provisions.

Submission Requirements for Rate

Adjustments.

Review Procedures for Rate

Adjustments.

Audit Adjustments 292.50

Rate Adjustments Resulting From
Audit Findings.

Rate Appeals 292.50

General Provisions.

Contents of Appeal and Decision.

Appeal of Deputy Director's

Decision.

Effective Date of Decision.

Good Cause.

Review of Documents Only.

Rate-Setting Procedures

for In-Home Respite

Services Agency Vendors 292.62

Definitions 292.62

Terms Defined In Other

Subchapters.

Additional Terms Defined.

General Provisions 292.62

General Requirements.

Article 3.

Submission of Required
Information

Page

292.63

§ 58030.
§58031.

§ 58032.

§ 58033.
§ 58034.
§ 58036.
§ 58038.

§ 58039.

Article 4.

§ 58040.

§ 58042.
Subchapter 14.

Article 1.

§ 58100.
§58111.

§58112.
§58113.

§58114.
§58115.

§58117.
§58118.

§58119.

Article 2.

§ 58120.
§ 58122.

Article 3.

§ 58130.
§ 58132.

Article 4.

§ 58140.

Article 5.

§ 58150.

Submission of Information.

Reporting Periods for Submission of

Information.

Required Due Dates for Submission

of Information.

Required Service Information.

Required Cost Information.

Costs Not to Be Reported.

Required Vendor Income

Information.

Required Regional Center Payment

and Vendor Cost Reduction

Information.

Review Requirements 292.66

Vendoring Regional Center Review

Procedures.

Department Review Procedures.

Rate-Setting Methodology

for In-Home Respite

Services Agency Vendors 292.67

Permanent Payment Rates 292.67

General Provisions.

Step Two: Computing an Amount

Using Allowable Costs and Direct

Service Hours.

Step Three: Computing the Mean.

Step Four: Determination of the

Allowable Range of Rates.

Step Five: Adjusting the Amount

Computed in Step Two for Gap

Funding.

Step Six: Adjusting the Amount

Computed in Step Five by the Upper

and Lower Limit of the Allowable

Range of Rates.

Step Seven: Adjusting the Amount

Computed in Step Six by Vendor

Income.

Step Eight: Adjusting the Amount

Computed in Step Seven for Budget

Act Adjustment.

Adjusting the Rate Methodology for

COLAs.

Temporary Payment Rate 292.69

General Provisions.
Establishment of the Temporary
Payment Rate.

Supplemental Rate for
Respite Worker Travel
Costs 292.69

Supplemental Rate for Respite

Worker Travel Costs.

Written Notification of the

Supplemental Rate for Respite

Worker Travel Costs.

Negotiating the Level of
Payment When Serving More

than One Consumer 292.70

Negotiating the Level of Payment
When Serving More Than One
Consumer.

Payment Rates for Existing

In-Home Respite Services

Agency Vendors 292.70

Payment Rates for Existing
In-Home Respite Services Agency
Vendors.

Page viii

(7-25-2008)

Title 17

Health and Welfare Agency — Department of Developmental Services

Table of Contents

Page

Subchapter 15.

Schedule of Payment Rates
for In-Home Respite

Article 2.

§ 58320.

Article 1.

General Provisions

292.70

§ 58210.

General Provisions for Schedule of

Payment Rates for All Fiscal Years.

§ 58322.

Article 2.

Schedule of Payment Rates

for Fiscal Year 1990-91

292.71

§ 58220.

Vendors Receiving Permanent
Rates.

Subchapter 17.

§ 58222.

Vendors Receiving Provisional
Rates.

§ 58224.

New Vendors.

Article 3.

Schedule of Payment Rates

for Fiscal Year 1991-92

292.71

Article 1.

§ 58230.

Vendors Receiving Permanent
Rates.

§ 58410.

§ 58232.

Vendors Receiving Temporary

Article 2.

Payment Rates.

§ 58420.

§ 58234.

Vendors Receiving Provisional

§ 58422.

Calculation of the Statewide

Fiscal Impact of the Gap

Rate Adjustments, Audit
Adjustments and Rate
Appeals for In-Home
Respite Services Agency
Vendors

General Provisions

General Provisions.

Page

292.74

§ 58236.
Article 4.

Rates.

New Vendors.

Schedule of Payment Rates
for Fiscal Year 1996-97 and
Each Alternate Fiscal Year
Thereafter

292.71

§ 58240.
§ 58242.
§ 58244.

Vendors Receiving Permanent

Payment Rates.

Vendors Receiving Temporary

Payment Rates.

New Vendors.

icle 5.

Schedule of Payment Rates
for Fiscal Year 1997-98 and

Each Alternate Fiscal Year

Thereafter

§ 58250.
§ 58252.
§ 58254.

Vendors Receiving Permanent

Payment Rates.

Vendors Receiving Temporary

Payment Rates.

New Vendors.

§ 58424.

Article 3.

§ 58430.

Article 4.

§ 58440.
§58441.
§ 58442.

§58444.
§ 58446.
§ 58448.

Rate Adjustments 292.74

General Provisions.

Submission Requirements for Rate

Adjustments.

Review Procedures for Rate

Adjustments.

Audit Adjustments 292.74(b)

Rate Adjustments Resulting from
Audit Findings.

Rate Appeals 292.74(b)

General Provisions.

Contents of Appeal and Decision.

Appeal of Deputy Director's

Decision.

Effective Date of Decision.

Good Cause.

Review of Documents Only.

292.72

Article 6. Timelines for Rate

Establishment and Written

Notification 292.73

§ 58260. Timelines for Continuation of the

Permanent Rate and Written

Notification.
§ 58262. Timelines for Extension of the

Provisional Rate and Written

Notification.
§ 58264. Timelines for Establishment of the

Permanent Payment Rate and

Written Notification.
§ 58266. Timelines for Establishment of the

Temporary Payment Rate and

Written Notification.

Subchapter 16. Reporting Requirements
for In-Home Respite
Services Agency Vendors 292.73

Article 1 . Annual Report to the

Legislature 292.73

§ 583 1 0. The Department's Annual Report to

the Legislature.
§ 583 1 2. The Joint Report to the Legislature

for Fiscal Year 1996-97.

Subchapter 18. Transportation Service 292.74(h)(6)

Article 1 . Definitions 292.74(h)(6)

§ 58500. Meaning of Words.

§58501. Definitions.

§ 58502. Terms Defined in Other

Subchapters.

Article 2. General Provisions 292.74(h)(6)

§ 58510. General Requirements Applicable to

Regional Centers.
§58511. Release of Consumer Information.

§ 58512. Record Retention.

§ 58513. General Requirements Applicable to

Transportation Service Vendors.

Article 3. Standards for Transportation

Service Vendors 292.74(h)(7)

§ 58520. Standards for Drivers and

Transportation Aides.
§58521. Consumer Information.

§ 58522. Refusal to Transport.

§ 58523. Vendor Records.

§ 58524. Transportation Service Contracts.

§ 58525. Transportation Service Contract

Amendments.

Article 4. Competitive

Procurement 292.74(h)(9)

§ 58530. Eligibility Requirements.

§58531. Regional Center Requirements.

§ 58532. Public Notice of RFT.

§58533. Contents of RFP.

§ 58534. Contract Award Process.

§ 58535. Reporting Requirements for

Competitive Process.

Page ix

(7-25 2I)(1S)

Table of Contents

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 5.

§ 58540.
§ 58541.

§ 58542.
§ 58543.

Article 6.

§ 58550.
§58551.
§ 58552.
§ 58553.
§ 58554.

§ 58555.

Article 7.

§ 58560.
§58561.
§ 58562.

§ 58563.
§ 58564.
§ 58565.

Article 8.

§ 58570.

Subchapter 19.

Article 1.

§ 58600.
§ 58601.
§ 58602.

Article 2.

§ 58610.
§58611.

§58612.
§ 58613.

§ 58614.
§ 58615.
§ 58616.
§ 58617.

Article 3.

§ 58620.

§ 58621.

Article 4.

§ 58630.
§58631.
§ 58632.

Article 5.

§ 58640.
§ 58641.
§ 58642.
§ 58643.

Article 6.

§ 58650.
§58651.
§ 58652.

§ 58653.

§ 58654.

Page

Noncompetitive

Procurement 292.74(h)(l0)

Negotiated Rates.

Temporary Provision of

Transportation Services.

Standardized Rates.

Standard Rate Schedule.

Noncompetitive Procurement

Based on Cost

Statement 292.74(h)(ii)

Cost Statement.

Vendor Information.

Cost information.

Vendor Income Information.

Rate Calculation Based on Cost

Statement.

Rate of Payment for Transportation

Aide Services.

Appeals 292.74(h)(13)

General Provisions.

Contents of Appeal and Decision.

Appeal of Deputy Director's

Decision.

Effective Date of Decision.

Good Cause.

Review of Documents Only.

Transitory Provisions 292.74(h)(l5)

General Provisions.

Supported Living Service 292.74(m)

Definitions 292.74(m)

Meaning of Words.

Definitions.

Terms Defined in Other

Subchapters.

General Provisions 292.74(n)

Regional Center Responsibilides.

Housing Financial Involvement and

Responsibilities.

Vendor Status Requirements.

Consumer Eligibility

Determination.

Service and Support Components.

Service Records.

Additional General Provisions.

Supported Living Arrangement

Costs.

Consumer Rights 292.76

Consumer Preferences and

Leadership.

Right to Information.

Service Design 292.77

General Requirements.
Service Design Components.
Implementation of SLS Philosophy.

Standards for Vendors 292.78

General Requirements.
Standards for Director Position.
Standards for Supervisory Posifion.
Standards for Direct Service Staff.

Training Requirements 292.79

Regional Center Staff Orientation.

Vendor Orientation Requirements.

Vendor Continuing Training

Requirements.

Vendor SLS Training for

Consumers.

Waiver of Vendor Training

Requirements.

Page

Article 7. Rate Negotiation 292.80

§ 58660. General Requirements.

§ 58661. Direct Service Rates.

§ 58662. SLS Vendor Administration Rates.

§ 58663. Rate Review and Renegotiation.

Article 8. SLS Contract Standards 292.81

§ 58670. General Provisions.

§ 5867 1 . Contract Requirements.

§ 58672. Contract Termination.

Article 9. Performance Evaluations 292.82

§ 58680. Regional Center Requirements.

Subchapter 2 1 . Habilitation Services

Program 292.82

Article 1 . Definitions 292.82

§ 58800. Meaning of Words.

§58801. Definitions.

Article 2. General Requirements for All

Habilitation Services 292.85

§ 58810. General Vendorization

Requirements for Habilitation
Services.
§ 58811. Program Design Requirements for

Habilitation Services.
General Planning Requirements.

Standards for Work Activity
Programs 292.86

General Standards for Work Activity

Programs.

Work Activity Program Day

Length.

Work Activity Program Service

Records Requirements.

Standards for Supported
Employment Programs 292.88

General Standards for Supported

Employment Programs.

Supported Employment Program

Records Requirements.

Supported Employment Group

Formation and Change

Requirements.
§ 58833. Temporary Transfers Between Work

Activity and Supported

Employment Programs.
§ 58834. Additional Requirements for

Supported Employment Programs.

Article 5. Coordination of Services

With the Department of

Rehabilitation 292.90

§ 58840. Referrals to the Department of

Rehabilitation.
§ 58841. Transition to Habilitation Services

Upon Achievement of Stabilization.
§ 58842. Denial of Services Pursuant to Order

of Selection Criteria.

Article 6. Quality Assurance Monitoring

and Corrective Actions for
Habilitation Services

Programs 292.91

§ 58850. Monitoring and Evaluation of

Habilitation Program Services.
§ 58851. Noncompliance Sanctions and

Corrective Action Plans.

Article 7. Work Activity Program

Ratesetting Procedures 292.92

§ 58860. General Provisions.

§ 58812.

Article 3.

§ 58820.

§ 58821.

§ 58822.

Article 4.

§ 58830.

§58831.

§ 58832.

Page

(7-25-2008)

Title 17

Health and Welfare Agency — Department of Developmental Services Table of Contents

Page Page

General Ratesetting Requirements § 58880. Work Activity Programs.

for Work Activity Programs. § 58881. Supported Employment Programs.

Reporting Period for Submission of § 58882. Billing for Temporary Transfers.

Information.

Required Due Dates for Submission Chapter 4. Case Management 292.99

of Information. ^ , , , ^ ,

Required Cost Statement Subchapter 1 . General 292.99

^"f«™^^'°"- Article 1 . Definitions 292.99

Ratesetting Methodology for § 59000. Meaning of Words.

Work Activity Programs 292.94 §59001. Definitions.

General Provisions. Article 2. Case Management Services .. . 292.100

Cost Containment Policies. § 59002. Case Management Services.

Program Expansion Policy and

Procedure. Article 3. Assessment Procedures 292.100

Maximum Daily Rate. § 59003. Fee Determinations.

Reporting Requirements. §59004. Self-Declaration of Income (SDOl).

Non-Allowable Costs. § 59005. Health Insurance/Benefit Plan.

Rale Adjustment and Rate Revision § 59006. Health Insurance/Benefit Plan

Provisions. (HIBP).

Rate Adjustment Due to an Increase § 59007. Reports.

Ra?e Adjustment Due to a Change m Article 4. Billings and Collections 292.100

Staff-to-Consumer Ratio. §59008. Statements.

Rate Appeals. § ^''9009. Billings.

§ 59010. Delinquency.

Billing and Payment 292.98 §59011. Collections.

§58861.
§ 58862.
§ 58863.
§ 58864.

Article 8.

§ 58870.
§58871.
§ 58872.

§ 58873.
§ 58874.
§ 58875.
§ 58876.

§ 58877.

§ 58878.

§ 58879.

Article 9.

Page xi

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50211

Division 2. Health and Welfare

Agency — Department of Developmental

Services Regulations

Chapter 1. General Provisions

(For prior history of former Chapter 1 (sections 50000-50150), see
Register 82, No. 23.)

Subchapter 2. Monthly Parental Fee

Article 1. General

§50201. Authority.

These regulations prescribe financial responsibility procedures for de-
termining ability to pay and the level of payment due from parents of mi-
nor children receiving services provided by the state or purchased with
state funds through regional centers. These regulations implement and
make specific the provisions of Sections 4782 and 4784 of the Welfare
and Institutions Code. Reference is also made to Sections 4648(b) and
4677 of the Code.

NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 4648(b), 4677, 4782 and 4784, Welfai-e and Institutions Code.

History

1. Repealer of Chapter 2 (Sections 50200-50207) and new Chapter 2 (Sections
50201-50227, not consecutive) filed 10-6-78; effective thirtieth day thereafter
(Register 78, No. 40). For prior history, see Register 72, Nos. 1 1 and 27.

2. Editorial reorganization of Part II (Chapters 2, 3. 4, 5 and 8, Sections
50201-59100, not consecutive) to Part II (Chapters 1 and 3, Sections
50201-54529, not consecutive) filed 9-28-83 (Register 83. No. 40). For prior
history, see Registers 82, No. 35; 81, Nos. 52 and 9; 80, No. 26; 79, No. 13; 78,
No. 40; and 76, No. 51.

3. Editorial redesignation of former Chapter 2 (Articles 1-3, Sections
50201-50227, not'consecutive) to Chapter 1, Subchapter 2 (Articles 1-3, Sec-
tions 50201-50227, not consecutive) filed 9-28-83 (Register 83, No. 40). For
prior history, see Registers 80, No. 26 and 78, No. 40.

4. Repealer of Subchapter 2 (Articles 1-3, Sections 50201-50227, not consecu-
tive) and new Subchapter 2 (Articles 1-5, Sections 50201-50241, not consecu-
tive) filed 1-18-84; effective thirtieth day thereafter (Register 84, No. 3).

5. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

6. Amendment filed 8-16-85; effective upon filing pursuant to Government Code
Section 11346.2(d) (Register 85, No. 33).

7. Change without regulatory effect deleting text reference to Welfare and Institu-
tions Code Section 4785, which was repealed by Stats. 1984, c. 1789, Section
4 (Register 86, No. 33).

§ 50203. Forms.

(a) Regional centers shall use parental financial responsibility forms
prescribed by the State Department of Developmental Services.

(b) Other forms shall not be substituted by regional centers unless spe-
cifically approved by the Department.

NOTE: Authority cited: Sections 4409, 4631, 4640 and 4748, Welfare and Institu-
tions Code. Reference: Sections 4631, 4640, 4782 and 4784, Welfare and Institu-
tions Code.

History

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effecdve upon filing pursuant to Govern-
ment Code Section 11346.2(d) (Register 85, No. 33).

Article 2. Definitions

§ 50205. Ability to Pay.

"Ability to Pay" means financial capability to pay the cost of raising
a normal child at home, as determined by the Director of Developmental
Services.

NOTL: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 463 1 (a), 4677, 4782 and 4784, Welfare and Institutions Code.

History

1. Editorial con-ection of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Govern-
ment Code Section 11 346.2(d) (Register 85, No. 33).

§ 50207. Gross Family Income.

Gross family income includes any money or benefit acquired, earned,
or received as payment for labor or services, support, gift or inheritance,
or return on investments by parents or eligible dependents.

Provided however, that the following shall not be considered as gross
family income:

1. Earned income and the return on investment of a minor child living
at home or in 24 hour out of home placement;

2. Child support payment for a minor child eligible for developmental
services to the extent that it is sent or paid to a regional center or state hos-
pital trust office as offset to the cost of services.

Provided further that the parental fee assessment against the noncusto-
dial parent shall be reduced by the amount of child support awarded by
the court on behalf of the client.

Provided further, that the includible income from the operation of a
business or from self-employment is the net income after deducting busi-
ness expenses. However, depreciation, amortization, and depletion shall
not be allowed as business expense deductions.

Provided finally, that the community property interest of a parent in
the gross income of a stepparent, shall be used in determining family in-
come.

Note; Authority cited: Secfions 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 463 1 (a), 4677, 4782 and 4784, Welfare and Institutions Code.

History

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Govern-
ment Code Section 11346.2(d) (Register 85, No. 33).

3. Change without regulatory effect deleting text reference to amounts excluded
from the community property interest of a parent in the gross income of a step-
parent pursuant to Civil Code Section 5127.5, which was repealed by Stats.
1984, c. 1671, Section 14 (Register 86, No. 33).

4. Amendment filed 7-8-87; operative 8-7-87 (Register 87, No. 29).

§ 50209. Eligible Dependent.

Any person who depends on the gross family income for more than
one-half of his or her support shall be considered an eligible dependent
provided such person' s income, other than the earned income of a minor
child living at home, is reported and included in the gross family income.
Provided however, that a child with developmental disabilities who is
living in a community placement or residing in a state hospital shall be
considered an eligible dependent regardless of the extent of his depen-
dency on gross family income. Provided further, that a parent who has
remarried and the stepparent shall be considered as one eligible depen-
dent, and not two, for the purpose of computing the parental fee.

Note; Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 463 1(a), 4677, 4782 and 4784, Welfare and Institutions Code.

History

1. Editorial coiTecdon of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Govern-
ment Code Section 11346.2(d) (Register 85, No. 33).

§50211. Parental Fee.

"Parental Fee" means the determined and/or scheduled sum which
parents are required to pay to the Developmental Disabilities Program
Development Fund.

NOTE: Authority cited: Secfions 4409 and 4631, Welfare and Institutions Code.
Reference: Secfions 4677, 4782 and 4784, Welfare and Institutions Code.

History

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effecdve upon filing pursuant to Go\ ern-
ment Code Secfion 1 1346.2(d) (Register 85, No. 33).

Page 249

§ 50213

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

3. Change without regulatory effect deleting reference to Welfare and Institutions
Code Section 4785", which was repealed by Stats. 1 984, c. 1 789, Section 4 (Reg-
ister 86, No. 33).

§ 50213. Parental Fee Schedule.

"Parental Fee Schedule" means the official table of tabulated and
scaled fees as authorized and established by the Director of Developmen-
tal Services with the approval of the State Council on Developmental
Disabilities.

Note-: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

History

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Govern-
ment Code Section 1 1346.2(d) (Register 85, No. 33).

§50215. Parents.

"Parents'" means the natural or adoptive parents, or either of them, of
a child with developmental disabilities under 18 years of age.
NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

History

1 . Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Govern-
ment Code Section 1 1346.2(d) (Register 85, No. 33).

Article 3. Administrative Provisions

§ 50221. Centralized Parental Fee Program.

(a) The Department of Developmental Services shall determine, as-
sess, bill, revise, adjust and collect determined parental fees. Determina-
tion and assessment shall be in accordance with the Parental Fee Sched-
ule as defined in Section 50213 and parental financial information.
Collection of accounts shall be in accordance with applicable laws and
standard collection procedures.

(b) All parental fees paid to or received by a regional center shall be
recorded and accounted for in accordance with standard accounting prin-
ciples. Such fees shall be reported and remitted monthly by regional cen-
ter to the Department of Developmental Services.

(c) The Department of Developmental Services shall remit all parental
fee payments received from parents or from regional centers to the State
Treasury, within 60 calendar days of receipt, to be deposited in the Devel-
opmental Disabilities Program Development Fund (DDPDF).

(d) Regional Centers shall provide the Department of Developmental
Services with such information and documents as may be required to de-
termine, assess, bill, revise, adjust, and collect parental fees.

NOTE: Authority cited: Sections 4409, 4631, 4640 and 4748, Welfare and Insfitu-
tions Code. Reference: Secfions 4631, 4677, 4782 and 4784, Welfare and Institu-
fions Code.

History

1 . Editorial correcfion of NOTE filed 2-9-84 (Register 84 No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code
Section 11 346.2(d) (Register 85, No. 33).

Article 4. Determination of Ability to Pay

§ 50223. Services Requiring Ability to Pay Determinations.

Conditions requiring an ability to pay determination shall be:

(a) All 24-hour out-of-home community care received through a re-
gional center for children under the age of 18;

(b) 24-hour care for such minor children in state hospitals.
Provided, however, that no ability to pay determination shall be made

for services required by state or federal law, or both, to be provided to
children without charge to their parents.

Provided further, in no case shall the parental fee exceed the net cost
of services purchased by the state or the regional center.

NOTE: Authority cited: Sections 4409, 4631 and 4748, Welfare and Insdtufions
Code. Reference: Sections 4677, 4782 and 4784, Welfare and Institufions Code.

History

1 . Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-1 6-85; effecfive upon filing pursuant to Govern-
ment Code Section 11 346.2(d) (Register 85, No. 33).

§ 50225. Regional Center Responsibilities.

Regional centers shall have the following duties and responsibilities:

(a) Identify all children with developmental disabilities who are re-
ceiving services as specified in Section 50223.

(b) Provide the Department of Developmental Services with a listing
of new placements, terminated cases, and client deaths for those clients
identified in paragraph (a) of this section. Such listing shall be provided
not later than the 20th day of the month following the month of such oc-
currence and shall be provided in the format as determined by the Depart-
ment of Developmental Services.

(c) Inform parents of children who will be receiving services as identi-
fied in Section 50223 that the Department of Developmental Services is
required to determine parents' ability to pay, and to assess, bill, and col-
lect parental fees pursuant to Chapter 9 of Division 4.5 of the Welfare and
Institutions Code.

(d) Within 10 working days after placement of a minor child, provide
the parent(s) a package containing an informational letter, a Family Fi-
nancial Statement (FFS), and a return envelope. The informational letter,
FFS, and envelope shall be provided to the centers by the Department of
Developmental Services.

(e) A copy of each informational letter given or sent to parent(s). indi-
cating the addressee and the date given or mailed, shall be attached to and
submitted with the report identified in paragraph (b) of this section.
NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 4620, 4631. 4677, 4782 and 4784, Welfare and Institufions
Code.

History

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Repealer and new section filed 8-1 6-85; effective upon filing pursuant to Gov-
ernment Code Secfion 1 1346.2(d) (Register 85, No. 33).

3. Change without regulatory effect of subsection (d) (Register 86, No. 33).

§ 50227. Notification to Parents.

(a) The Department of Developmental Services shall notify parents in
writing of parental fee determination results and advise them of their
right to appeal the determination under Section 50241. A copy of the
Confirmation Letter will be sent to the regional center.

(b) Parental fee liability shall be effective on the first day of the month
following the month that the client is placed in a 24— hour out-of-home
facility.

NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Secfions 4620, 4631, 4677, 4748, 4782 and 4784, Welfare and Insfitu-
fions Code.

History

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Repealer and new section filed 8-16-85; effective upon filing pursuant to Gov-
ernment Code Secfion 1 1346.2(d) (Register 85, No. 33).

§ 50229. Parent(s) Disclosure of Financial Information.

The parent(s) of a child who is currently receiving services as specified
in Section 50223, or who has been referred for placement pursuant to the
same section, shall complete and submit to the Department of Develop-
mental Services and annually thereafter, a Client Benefit Questionnaire
and Family Financial Statement. If the parent(s) refuses or fails to com-
plete and submit this form, within 30 days from the date on the informa-
tional letter, the Department of Developmental Services shall assess a fee
for the full cost of services or the maximum allowable fee, whichever is
less. Upon receipt of the properly completed FFS, the Department of De-
velopmental Services will determine the appropriate rate and adjust the
account as necessary.

NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Secfions 4677, 4782 and 4784, Welfare and Institutions Code.

History
1. New section filed 2-9-84; designated effective 2-17-84 pursuant to Govern-
ment Code Secfion 1 1346.2(d) (Register 84, No. 6).

Page 250

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50239

2. Repealer and new seetion filed 8-16-85; effective upon filing pursuant to Gov-
ernment Code Section 1 1346.2(d) (Register 85, No. 33).

3. Change without regulatory effect (Register 86, No. 33).

§ 50230. Determination of Amount of Monthly Parental
Fee.

(a) The maximum parental fee shall be in accordance with the Parental
Fee Schedule as defined in Section 50213.

(b) Parental fees for those families with more than one child having de-
velopmental disabilities and receiving services as specified in Section
50223 shall be made using the fee schedule and the following adjust-
ments.

(A) First Child 100% of the Fee Schedule Amount

(B) Second Child 50% of the Fee Schedule Amount

(D) Fourth Child 25% of the Fee Schedule Amount
NOTE: Authority cited: Sections 4409, 4631 and 4677, Welfare and Institutions
Code. Reference: Sections 4677, 4732 and 4784, Welfare and Institutions Code.

History

1 . F^itorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment filed 10-31-84; designated effective 1-1-85 unless a statute en-
acted before that date supercedes Welfare and Institutions Code Section
4784(b), Statutes of 1984, Chapter 1729, Section 3, which exempts parental fee
schedules from Title 2, Division 3, Part I, Chapter 3.5, Section 1 1340 et seq.,
Government Code, the Administrative Procedure Act (Register 84, No. 44).

Article 5. Determining Required Levels of
Payment

§ 50231 . Gross Family Income Adjustments.

(a) Client related expenditures shall be reported as an annual amount
for the 1 2 months immediately preceding a determination of ability to
pay. Qualified client related expenditures which the Department of De-
velopmental Services may accept to reduce gross family income, subject
to verification, are:

( 1 ) Annual amounts paid from gross family income to reduce or liqui-
date medical debts incurred by parents on behalf of and before a child
with developmental disability began receiving services provided by the
state or secured through a regional center.

(2) Annual amounts paid from gross family income for the current
medical expenses of a child with a developmental disability provided that
such expenses have not been paid or are not currently reimbursable with
state funds, health insurance, health care benefits, or other third party re-
sources.

(3) Annual amounts paid from gross family income for the develop-
mentally disabled child's share of any premium payments paid for an in-
dividual, family, or group health care plan.

(4) Annual amounts paid from gross family income to other govern-
ment agencies as payment for services provided for a child with a devel-
opmental disability.

(5) Annual amounts paid from gross family income for the clothing
needs of a child with a developmental disability.

(6) Annual amounts paid from gross family income for personal needs
and incidentals for the child with a developmental disability.

(7) Annual amounts paid from gross family income for recreation and
entertainment for the child with a developmental disability.

(b) "Qualified client related expenditures" as enumerated in 50231
subsection (a) may be applied as an adjustment to reduce gross family in-
come prior to application of the parental fee schedule for the purpose of
determining ability to pay and assessing the required fee.

(c) Client related expenditures as enumerated in 50231(a) do not in-
clude those that are paid for or are reimbursable by the client's SSI/SSP,
SSA, or other benefits paid to or on behalf of the client.

(d) The maximum monthly parental fee shall be in accordance with the
Parental Fee Schedule as defined in Section 50213.

NOTH: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

History
1. F:ditorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code
Section 1 1346.2(d) (Register 85, No. 33).

§ 50233. Major Unusual Expense Allowance.

The Department of Developmental Services may allow claims for ma-
jor unusual expenses which limit ability to pay and which will create
hardship if a required payment should be imposed. Any qualified allow-
ance shall be applied as an adjustment to reduce the gross family income
used to determine parents' ability and level of payment. In determining
what constitutes a major unusual expense, the Department of Develop-
mental Services shall include for consideration, but not be limited to. the
following factors:

1. Expenditures which consume a substanfial porfion of Gross Family
Income;

2. An expenditure over which parents have no control, e.g., natural di-
saster, catastrophic uninsured casualty loss, death of an immediate fami-
ly member, extreme medical expense.

Hardship, in this sense, implies that the result of imposing the monthly
parental fee, would be privation or lack of what is needed for basic family
necessities, food, shelter, clothing, medical care, etc., not merely a reduc-
tion of the family's standard of Hving.

NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 4677, 4748, 4782 and 4784, Welfare and Institutions Code.

History

1. New secdon filed 2-9-84; designated effective 2-17-84 pursuant to Govern-
ment Code Section 11346.2(d) (Register 84, No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code
Section 1 1346.2(d) (Register 85, No. 33).

§ 50235. Transportation Expense Allowance.

Reasonable transportation expenses incurred by parents to visit a child
with developmental disability in any placement facility may be claimed
as client related expenditures and applied as an adjustment to reduce
gross family income.

NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference: Sections 4677, 4782 and 4784, Welfare and Institutions Code.

History

1. Editorial correcdon of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effective upon filing pursuant to Govern-
ment Code Section 1 1346.2(d) (Register 85, No. 33).

§ 50237. Substantiation of Determination Data.

The Department of Developmental Services may require substanti-
ation of information set forth in the Family Financial Statement. Substan-
tiation may be in the form of State and Federal Income Tax Returns, W-2
Forms, payroll stubs, and copies of bills, receipts, or cancelled checks.
Parents may be required to sign release of information forms for employ-
ment and/or income verification.

NOTE: Authority cited: Secdons 4409 and 4631, Welfare and Institutions Code.
Reference: Secdons 4677, 4782 and 4784, Welfare and Insdtudons Code.

History

1. Editorial correcdon of NOTE filed 2-9-84 (Register 84, No. 6).

2. Repealer and new secdon filed 8-16-85; effective upon filing pursuant to Gov-
ernment Code Secdon 11346.2(d) (Register 85, No. 33).

3. Change without regulatory effect (Register 86, No. 33).

§ 50239. Termination of Required Payments.

Assessment of required payments shall be terminated at the end of the
month in which a child with developmental disabilifies receiving ser-
vices becomes 1 8 years of age. When services terminate because of the
client's death or discharge, the monthly parental fee will be terminated
as of the last day of the month proceeding the month of death or dis-
charge.

Provided however, that parental fees previously assessed and still un-
paid at time of termination of the monthly parental fee shall continue to
be billed until paid in full or adjusted.

NOTE: Authority cited: Sections 4409 and 4631, Welfare and Institutions Code.
Reference Secdons 4677, 4782 and 4784, Welfare and Institutions Code.

History

1. Editorial correcdon of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment of NOTE filed 8-16-85; effecdve upon filing pursuant to Govern-
ment Code Secdon 11346.2(d) (Register 85, No. 33).

Page 251

§ 50241

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§50241. Appeal.

Parents who are dissatisfied with the decision as to the determination
of ability to pay and/or the amount of parental fee may, within 30 days
of receipt of the parental fee confirmation letter, request an appeal of the
determination or the amount of the fee. The appeal must be in writing and
addressed to the Director of Developmental Services, and must state the
reason(s) for the appeal. The Department of Developmental Services will
send a copy of the appeal to the appropriate regional center director with-
in five days of its receipt.

Parents may discontinue making payments of the assessed fee pending
notification of the appeal results. Provided however, that if parents fail
or refuse to provide the Department pertinent financial information with-
in 60 days of the request for an appeal, the appeal shall be deemed with-
drawn and collection activities shall be resumed.

The Director or designee shall, within 30 days after receipt of all perti-
nent financial information requested by the Department, review the ap-
peal and provide written notice of the decision to the appellant and the
appropriate regional center.

All decisions regarding parental fee appeals may be made retroactive
to the date the appealed fee was established.

NOTE: Authority cited: Sections 4409, 4501 and 4631. Welfare and Institutions
Code. Reference: Sections 4512, 4620, 4648(b), 4677, 4782 and 4784, Welfare
and Institutions Code.

History

1. Editorial correction of NOTE filed 2-9-84 (Register 84, No. 6).

2. Amendment filed 8-16-85; effective upon filing pursuant to Government Code
Section 1 1346.2(d) (Register 85, No. 33).

Subchapter 2.5. Family Cost Participation

Article 1. General

§ 50243. Purpose.

These regulations implement and make specific the provisions of Sec-
tion 4783 of the Welfare and Institutions Code related to the Family Cost
Participation Program.

NOTE: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Section 4783, Welfare and Institutions Code.

History

1. New subchapter 2.5 (articles 1-4), article 1 (section 50243) and section filed
12-31-2004 as an emergency; operative 1-1-2005 (Register 2004, No. 53). A
Certificate of Compliance must be transmitted to OAL by 5-2-2005 or emer-
gency language will be repealed by operation of law on the following day.

2. New chapter 2.5 (articles 1-4), article 1 (section 50243) and section refiled
5-2-2005 as an emergency; operative 5-4-2005 (Register 2005, No. 18). A
Certificate of Compliance must be transmitted to OAL by 9-1-2005 or emer-
gency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

Article 2. Definitions

§ 50245. Developmental Disability.

For the purposes of these regulations, the term "developmental dis-
ability" shall have the same meaning as provided in Section 4512 of the
Welfare and Institutions Code.

NOTE: Authority cited: Secfion 4783, Welfare and Insdtutions Code. Reference:
Sections 4512 and 4783, Welfare and Insfitutions Code.

History

1 . New article 2 (sections 50245-50253) and secfion filed 12-3 1-2004 as an emer-
gency; operative 1-1-2005 (Register 2004, No. 53). A Certificate of Com-
pliance must be transmitted to OAL by 5-2-2005 or emergency language will
be repealed by operation of law on the following day.

2. New article 2 (sections 50245-50253) and secfion refiled 5-2-2005 as an emer-
gency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Com-
pliance must be transmitted to OAL by 9-1-2005 or emergency language will
be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

§ 50247. Medi-Cal Eligible Consumers.

Medi-Cal eligible includes consumers who are institutionally
deemed. The term "institutionally deemed" means that the income and
resources of a parent are not deemed to the consumer, therefore making
the consumer eligible for Medi-Cal if all other Medi-Cal eligibility crite-
ria are met.

Note: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Section 1915(c)(3), Social Security Act; and Section 4783, Welfare and Institu-
tions Code.

History

1. New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004. No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register

2005. No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005. No. 29).

§ 50249. Family Cost Participation Schedule.

The Family Cost Participation Schedule means the official table devel-
oped by the Department of Developmental Services and used by the re-
gional centers to determine the amount of family cost participation. This
table is reflective of the Federal Poverty Guidelines as adjusted for family
size and scaled by income levels and establishes the lowest family cost
participation at five percent (5%). The Department of Developmental
Services shall adjust this schedule consistent with changes in the Federal
Poverty Guidelines but not more often than once each calendar year.
NOTE: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Section 4783, Welfare and Institutions Code.

History

1 . New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004, No. 53). A Certificate of Comphance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5^1-2005 (Register

2005, No. 18). A Certificate of Comphance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

§ 50251. Gross Annual Income.

Gross annual income is the income of the parents as reported on their
latest California State or Federal Income Tax return and includes any
money or benefit acquired, earned, or received as payment for labor or
services, support, or return on investments. Income from the operation
of a business or from self-employment is the net income after deducting
business expenses. Depreciation, amortization, and depletion shall not be
allowed as business expense deductions. The regional center executive
director may determine appropriate documentation necessary for family
cost participation consistent with Section 4783(g)(2).
NOTE: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Section 4783, Welfare and Institutions Code.

History

1. New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004, No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register

2005, No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005. No. 29).

§ 50253. Persons Living in the Family Home.

(a) A person living in the family home is any person who depends on
the gross annual income of the parents for more than one-half of his/her
support.

(b) In the case of divorce, legal separation, or established paternity
where income from both parents is used, all persons who depend on the
gross annual income of the parents for more than one-half of his/her sup-
port shall be considered persons living in the family home.

Page 252

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50262

NOTi;: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Section 4783, Welfare and Institutions Code.

History

1 . New section filed 1 2-3 1-2004 as an emergency; operative 1 - 1 -2005 (Register

2004, No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register

2005, No. 18), A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order, includins amendment of sec-
tion, transmitted to OAL 6-9-2005 and filed 7-22-2005^(Resister 2005, No.
29).

Article 3. Administrative Provisions

§ 50255. Parent Responsible for Cost Participation.

(a) The parents of a child who meet the definition under Section
4783(a)(i) of the Welfare and Institutions Code shall be jointly and sev-
erally responsible for the assessed amount of family cost participation.
However, in the case of a divorce, legal separation, or established pater-
nity, the family cost participation assessment shall be computed on the
gross annual income of both parents unless inconsistent with a court or-
der stating otherwise.

(b) In the event that a custodial parent certifies in writing that income
information from the non-custodial parent cannot be obtained by the cus-
todial parent, then only the income of the custodial parent may be used
to determine the cost participation.

(c) This program shall not exempt parents from responsibilities for day
care pursuant to Section 4685(c)(6) of the Welfare and Institutions Code.
NOTE: Authority Cited; Section 4783, Welfare and Institutions Code. Reference:
Sections 4685(c)(6) and 4783, Welfare and Institutions Code.

History

1 . New article 3 (sections 50255-50257) and section filed 1 2-3 1-2004 as an emer-
gency; operative 1-1-2005 (Register 2004, No. 53). A Certificate of Com-
pliance must be transmitted to OAL by 5-2-2005 or emergency language will
be repealed by operation of law on the following day.

2. New article 3 (sections 50255-50257) and section refiled 5-2-2005 as an emer-
gency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Com-
pliance must be transmitted to OAL by 9-1-2005 or emergency language will
be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order, including new subsection (b)
and subsection relettering, transmitted to OAL 6-9-2005 and filed 7-22-2005
(Register 2005, No. 29).

§ 50257. Program Administration.

(a) The Department of Developmental Services shall develop a pam-
phlet describing the Family Cost Participation Program. Regional cen-
ters shall provide the pamphlet to the parents of children, ages 3 through
17 years, during initial intake and assessment and at all subsequent IPP
review meetings where changes occur to day care, camping, or respite
services.

(b) Regional centers shall use all forms and documents developed by
the Department of Developmental Services to administer the Family
Cost Participation Program.

(c) Regional centers are responsible for funding their authorized share
of services without regard to the family's cost participation assessment.
NOTE: Authority cited: Section 4783, Welfare and Institutions Code. Reference;
Sections 4685(c)(6) and 4783, Welfare and Institutions Code.

History

1. New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004, No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register

2005, No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

Article 4. Assessment of the Family Cost
Participation

§ 50259. Assessment of the Family Cost Participation.

(a) The ainount of the family cost participation shall not iinpact any
services other than those identified in Section 4783(c) of the Welfare and
Institutions Code.

(b) Reductions in the assessed amount pursuant to Section
4783(d)(l)(2)(3) and (4) of the Welfare and Institutions Code, because
of multiple minor children receiving services, shall only be applied to the
Family Cost Participation Program assessment, and shall not reduce the
fees for consumers in 24-hour out-of-home placements as determined
pursuant to Sections 4677. 4782, and 4784 of the Welfare and Institutions
Code.

Note: Authority cited: Section 4783, Welfare and Institudons Code. Reference:
Sections 4677, 4782, 4783 and 4784, Welfare and Institutions Code.

History

1 . New article 4 (sections 50259-50267) and section filed 1 2-3 1 -2004 as an emer-
gency; operaUve 1-1-2005 (Register 2004, No. 53). A Certificate of Com-
pliance must be transmitted to OAL by 5-2-2005 or emergency language will
be repealed by operation of law on the following day.

2. New article 4 (secfions 50259-50267) and section refiled 5-2-2005 as an emer-
gency; operative 5-4-2005 (Register 2005, No. 18). A Certificate of Com-
pliance must be transmitted to OAL by 9-1-2005 or emergency language will
be repealed by operation of law on the following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

§ 50261 . Maximum Family Cost Participation Assessment.

(a) Each parent shall provide the regional center with his or her proof
of gross annual income pursuant to Section 4783(g)(2) and (i) of the Wel-
fare and Institutions Code, within ten ( 1 0) working days from the date of
the parents' signatures on the Individual Prograin Plan. The regional cen-
ter may grant a ten (10) working day extension to provide documentation,
if parents have acted in good faith. In no event shall more than one ten
(10) working day extension be granted. Failure to provide the informa-
tion will result in the regional center setting the cost participation at the
maximum amount, pursuant to Section 4783(g)(4) of the Welfare and
Institutions Code.

(b) The Individual Program Plan signature page shall include a state-
ment indicating that the regional center shall fund respite, day care, and
camping services consistent with the Family Cost Participation Program,
if applicable.

NOTE: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Section 4783, Welfare and Institutions Code.

History

1 . New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004, No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-^4-2005 (Register

2005, No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order, including amendment of sub-
section (a), transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005,
No. 29).

§ 50262. Confidentiality and Retention of Income
Documentation.

(a) Any documentation submitted pursuant to Sections 50261, 50265,
or 50267 shall be considered records obtained in the course of providing
intake, assessment, and services and shall be confidential pursuant to
Section 4514 of the Welfare and Institutions Code.

(b) Any documentation submitted pursuant to Sections 50261 . 50265,
or 50267, any documents relied on by the executive director pursuant to
50265, and correspondence from the regional center, shall be retained by
the regional center for 3 years.

NOTE: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Sections 4514 and 4783, Welfare and Institutions Code.

Page 252.1

§ 50263

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1. New section filed 12-3 1-2004 as an emergency; operative 1-1-2005 (Register

2004. No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5^-2005 (Register

2005. No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

§ 50263. Waiver Exemption.

Parents whose child is Institutionally Deemed Medi-Cal eligible shall
be exempt from the Family Cost Participation Program for that child.
NOTE; Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Section 1915(c)(3). Social Security Act; and Section 4783, Welfare and Institu-
tions Code.

History

1. New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004, No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register

2005, No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

§ 50265. Adjustment by Regional Center Executive
Director.

(a) Adjustment to the assessed amount of the family cost participation
may be made by the regional center executive director for a substantiated
unavoidable and uninsured catastrophic loss that would temporarily limit
the ability of the parents to pay and create a direct economic impact if the
amount of the family cost participation were not reduced. Unavoidable
and uninsured catastrophic losses may include, but are not limited to, nat-
ural disasters, an accident or major injuries to an immediate family mem-
ber, or extraordinary medical expenses. The executive director may also
make an adjustment for significant unreimbursed medical costs
associated with the care for a child who is a regional center consumer.

(b) Direct economic impact means that the result of not granting the
adjustment would deprive the family of what is needed for basic family
necessities, including but not limited to, food, shelter, clothing, or medi-
cal care. A direct economic impact is a substantial change that impacts
more than just the family's standard of living.

(c) Adjustments made pursuant to this Section shall be calculated by
deducting the documented non-reimbursed dollar cost of the direct eco-
nomic impact request from the gross annual income, and then re-asses-
sing the amount of family cost participation by applying the Family Cost
Participation Schedule against the reduced income amount.

(d) Family cost participation assessments that have been adjusted as
a result of the regional center executive director granting an adjustment
shall be re-determined at least annually.

Note: Authority cited: Section 4783, Welfare and Institufions Code. Reference:
Section 4783, Welfare and Institutions Code.

History

1. New secfion filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004, No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an emergency; operative 5-4-2005 (Register

2005, No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order, including amendment of sub-
section (a), transmitted to OAL 6-9-2005 and filed 7-22-2005 (Register 2005,
No. 29).

§ 50267. Assessment and Reassessment of Cost
Participation.

(a) The original amount of the family cost participation shall be as-
sessed upon completion of the initial Individual Program Plan and reas-
sessed every third year thereafter to coincide with the review of the con-
sumer's Individual Program Plan, pursuant to Section 4646(b) of the
Welfare and Institutions Code.

(b) Fainily cost participation assessments may be reduced or increased
if there is an ongoing reduction or increase in the gross annual income
upon which the amount of the family cost participation was determined,
or a reduction or increase in the amount of services provided to the con-
suiner pursuant to a change in the Individual Program Plan, or a change
in family size.

Note: Authority cited: Section 4783, Welfare and Institutions Code. Reference:
Sections 4646(b) and 4783, Welfare and Institutions Code.

History

1 . New section filed 12-31-2004 as an emergency; operative 1-1-2005 (Register

2004, No. 53). A Certificate of Compliance must be transmitted to OAL by
5-2-2005 or emergency language will be repealed by operation of law on the
following day.

2. New section refiled 5-2-2005 as an einergency; operative 5^-2005 (Register

2005, No. 18). A Certificate of Compliance must be transmitted to OAL by
9-1-2005 or emergency language will be repealed by operation of law on the
following day.

3. Certificate of Compliance as to 5-2-2005 order transmitted to OAL 6-9-2005
and filed 7-22-2005 (Register 2005, No. 29).

Subchapter 3. Department of
Developmental Services — Conflict of Interest

Code

NOTE: Pursuant to a regulation of the Fair Political Practices Com-
mission (Title 2, CCR, section 18750(k)(2)), an agency adopting a con-
flict of interest code has the options of requesting that the code either be
( 1 ) printed in the CCR in its entirety or (2) incorporated by reference into
the CCR. Here, the adopting agency has requested incorporation by ref-
erence. However, the full text of the regulations is available to the public
for review or purchase at cost at the following locations:
department of developmental services

1600 9TH street, ROOM 240
SACRAMENTO, CA 95814

secretary of state (ARCHIVES)
1020 O STREET
SACRAMENTO, CA 95814

FAIR POLITICAL PRACTICES COMMISSION
428 J STREET, SUITE 800
SACRAMENTO, CA 95814

The Conflict of Interest Code is designated as Subchapter 3, Chapter
1 ofDivision2ofTitle 17of the California Code of Regulations, and con-
sists of sections numbered and titled as follows:

Subchapter 3. Department of Developmental Services —
Conflict of Interest Code

Section

50300. General Provisions

Appendix
NOTE: Authority cited: Sections 87300 and 87304, Government Code. Reference:
Sections 87300, et seq.. Government Code.

History

1. Editorial renumbering of former chapter 8 (section 59100) to chapter 1, sub-
chapter 3 (section 50300) filed 9-28-83 (Register 83, No. 40). For prior history,
see Registers 81, No. 9; and 79, No. 13.

2. Editorial correction of printing error (Register 84, No. 5).

3. Amendment of section and Appendix filed 2-10-93; operative 2-10-93. Ap-
proved by Fair PoUtical Practices Commission 1-15-93 (Register 93. No. 7).

4. Change without regulatory effect amending addresses for the agency and the
Fair Political Practices Commission filed 7-1 5-97 pursuant to section 100, title
1, California Code of Regulations (Register 97, No. 29).

5. Amendment of General Provisions and Appendix filed 12-2-2003; operative
1-1-2004. Approved by Fair Political Practices Commission 9-1 8-20()3 (Reg-
ister 2003, No. 49).

Page 252.2

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50401

Subchapter 4. Rules for Conducting
Research

Article 1. Definitions

§50401. Definitions.

As used in this subchapter, the following words have the specified
meanings.

(a) "Clients Rights Advocate" means the individual or individuals as-
signed by a regional center or state hospital to be responsible for ensuring
that the civil, legal and service rights of persons with developmental dis-
abilities are available and guaranteed to such persons.

(b) "Consultant" means a person who gives expert or professional ad-
vice and who has competence in special areas or who can provide exper-
tise beyond or in addition to that available to the IRB.

(d) "Health and Welfare Agency" means the Health and Welfare
Agency as defined in Section 12800 of the Government Code.

(e) "Human Subject" means a living individual about whom a re-
searcher conducting research obtains ( 1 ) date through intervention or in-
teraction with the individual, or (2) confidential information.

(f) "Informed Consent" means the knowing consent of an individual
or his or her legally authorized representative that is given without undue
inducement or any element of force, fraud, deceit, duress, or other form
of constraint or coercion to participate in an activity. For consent to be
"informed," the individual or his or her legally authorized representative
must possess accurate and complete information about the procedures
which are to be performed, understand the information provided, and
give consent voluntarily.

(g) "Institutional Review Board (IRB)" means a review board consti-
tuted and convened in accordance with the regulations in this subchapter
by a state hospital or regional center servicing persons with developmen-
tal disabilities for the purpose of reviev/ing and approving or disapprov-
ing research involving human subjects.

(h) "Minimal Risk" means that the risk of harm anticipated in the pro-
posed research is not greater, considering probability and magnitude.
than that ordinarily encountered in the daily life of the human subject or
during the performance of routine physical or psychological examina-
tions or tests.

(i) "Regional Center" means a diagnostic, coun.scling, and serxicc
coordination center for persons with developmental disabilities and their
families which is established and operated pursuant to Chapter 5 of Divi-
sion 4.5 of the Welfare and Institutions Code by a private nonprofit com-
munity agency/corporation acting as a contracting agency.

(j) "Research" means the systematic investigation and acquisition of
information for the purpose of developing or contributing to general
knowledge, social programs, or scientific advancement and includes the
collection of data for possible publication. Studies of the effect of routine
treatment services, or the gathering of feedback information about rou-
tine treatment services, shall be considered research only if the data are
collected with the aim of possible publication.

(k) "Researcher" means the principal investigator or project director
who has responsibility for conducting the research.

(/) "Research Protocol" means a written description of the proposed
research activity which is submitted for the appropriate IRB review and
consideration and which is written in accordance with these regulations.

(m) "Risk" means any potential for harm anticipated in the proposed
research which is greater than what might ordinarily be encountered in
the daily life of the human subject or during the performance of routine
physical or psychological examinations or tests.

(n) "State Hospital" means a state hospital serving people with devel-
opmental disabilities.

[The next page is 253.]

Page 252.3

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50409

•

(o) "State Institutional Review Board" (State IRB) means a group of
individuals constituted and convened in accordance with federal regula-
tions (e.g.. Title 45, Code of Federal Regulations, Section 46. 1 01 , et seq.)
and approved as the State IRB by the U.S. Department of Health and Hu-
man Services to review and approve or disapprove research involving
human subjects. For purposes of these regulations, the State IRB shall
mean the federally approved IRB for the Health and Welfare Agency of
the State of California.

(p) "Statistical Data" means aggregate information pertaining to indi-
viduals which is in such a form that it is not traceable back to the individu-
als.

NOTE; Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions
Code. Reference: Sections 4514(e), 4517, 5328(e) and 5329, Welfare and Institu-
tions Code.

History
1. New subchapter 4 (Articles 1-2, Sections 50401-50429, not consecutive) filed

1-22-87; effective thirtieth day thereafter (Register 87, No. 4).

Article 2.

Rules for the Conduct of
Research

§ 50403. Scope of Subchapter.

(a) The.se regulations apply to all research conducted by or at state hos-
pitals, regional centers, or by other persons or at places subject to Section
45 14 of the Welfare and Institutions Code, whenever the researcher re-
quests access to information or records which are confidential under Sec-
tion 4514(e) of the Welfare and Institudons Code.

(b) Research involving the collection or study or existing data, statisti-
cal information, documents, records, or pathological or diagnostic speci-
mens is exempted from these regulations if:

(1) such information is publicly available, or if

(2) the information provided to the investigator is in such a form that
human subjects cannot be identified either directly or through identifiers
linked to the human subjects.

(c) These regulations do not apply to audits, reviews or studies con-
ducted by federal, state, or local government agencies in the exercise of
their management or administrative responsibilities.

(d) The IRB may exempt research activities from the requirements of
these reguladons if the only involvement of human subjects will be in one
or more of the following categories:

(1) research conducted in established or commonly accepted educa-
tional settings, involving normal educational practices, when the data are
recorded in such a manner that the subject cannot be identified such as

(A) research on regular and special education instructional strategies,
or

(B) research on the effecdveness of or the comparison among instruc-
tional techniques, curricula or classroom management methods;

(2) research involving the use of educational tests (cognitive, diagnos-
dc, aptitude, achievement), if information taken from these sources or
through identifiers linked to the subjects; or

(3) research involving survey or interview procedures or the observa-
tion of behavior open to public view.

NOTE; Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions
Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

History
1. New section tiled 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

§ 50405. institutional Review Boards (IRBs).

(a) An IRB shall review all research protocols pertaining to research
involving human subjects who are served by state hospitals or regional
centers.

(b) Each state hospital shall establish an IRB to review and approve or
disapprove research protocols and to assure that the protocols meet the
requirements of this subchapter.

(c) Each regional center may establish an IRB and procedures to re-
view and approve or disapprove research protocols and to assure that
such protocols meet the requirements of Section 4514 of the Welfare and
Institutions Code. The regional center's IRB shall review and approve or
disapprove the research protocols that involve their clients except those
residing in a state hospital in accordance with the procedures established
by the regional center pursuant to this section.

(d) If a regional center does not choose to establish an IRB, the region-
al center shall submit the research protocol directly to the Department.
The Department shall create or designate the IRB that shall review and
approve or disapprove the research protocol, pursuant to Sections 50407
through 50429.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections
4514(e). 479 l(i) and 5328(e), Welfare and Institutions Code. Reference: Sections
4514(e), 4791 and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 50407. Review Structure for Research Protocol.

(a) Before any research involving human subjects may be conducted
at state hospitals, the research protocol shall be reviewed and approved
by the following entities:

(1) the IRB responsible for reviewing research for the particular per-
sons who will be the subjects of the research;

(2) the Executive Director of the state hospital with which the IRB is
affiliated; and

(3) the State IRB if required by federal laws or regulations.

(b) If the research protocol requires obtaining confidential information
about clients of more than one state hospital, the requirement for IRB re-
view shall be met by having the research protocol reviewed and approved
by either:

(1) each IRB individually, or

(2) a joint IRB composed of one or more representatives from each
IRB involved.

(c) If the research protocol involves a statewide sampling of subjects,
or subjects from a regional center with no IRB, the requirement for IRB
review shall be met by submitting the research protocol to the Depart-
ment which shall create or designate the IRB to review the protocol.
NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections
4514(e), 4791(i) and 5328(e), Welfare and Institutions Code. Reference: Sections
4514(e), 4791 and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 50409. Continuing Review of Research Activities at State
Hospitals.

(a) The IRB shall conduct continuing review of approved research at
intervals appropriate to the degree of risk involved in the research but not
less than annually.

(b) At any time the Executive Director of the state hospital or the IRB
shall have authority to revoke approval of the research if it is determined
that any of the following occur:

( 1 ) The research as conducted involves greater risks to the human sub-
jects than had been anticipated when the protocol was approved;

(2) There is a subsequentiy discovered violation of clients' rights;

(3) There is a violation of the oath of confidentiality by the researcher
or his or her agents; or

(4) The protocol is not being appHed as approved.

Page 253

§ 50411

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTE: Authority cited: Chapter 722, Statutes of 1992. Section 147; Sections
4514(e), 479 l(i) and 5328(e), Welfare and Institutions Code. Reference: Sections
4514(e), 4791 and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Resister 87, No.
4).

2. Amendment of section heading and Notk filed as an emergency 6-17-93; op-
erative 6-1 7-93. Submitted to OAL for printing only pursuant to SB485 (Chap-
ter 722, Statutes of 1992) Section 147(a) (Register 93. No. 26).

3. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

§ 5041 1 . Composition of the IRB at State Hospitals.

(a) Each state hospital IRB shall have at least five inembers, including:

( 1 ) Persons with varying educational and professional backgrounds
sufficient to ensure a complete and adequate review of research activities
commonly conducted by or at the facility;

(2) Persons with sufficient expertise and experience to promote re-
spect for their advice and counsel in safeguarding the rights and welfare
of human subjects;

(3) Persons possessing both the professional competence to review
specific research activities and the ability to ascertain the acceptability
of proposed research in terms of facility commitments and regulations,
applicable law, and standards of professional conduct and practice;

(4) Both men and women with diversity of backgrounds, racial, and
cultural characteristics, and with sensitivity to community attitudes;

(5) at least one member whose primary concerns are in nonscientific
areas and who are concerned with the rights or persons with developmen-
tal disabilities; for example, a lawyer, a member of the clergy, a clients'
rights advocate; and

(6) at least one member who is not affiliated with the facility and who
is not part of the immediate family of a person who is affiliated with the
facility.

(b) Excluded from membership are the Executive Director of the state
hospital and the clinical director of the state hospital by which the IRB
was constituted.

(c) Excluded from voting on specific projects are members who have
been or are participants in , or associated with, the research proposal.

(d) If the state hospital does not have a separate committee to review
the technical research design aspects of a research protocol, at least three
members of the IRB shall have sufficient experience and expertise in
conducting and critiquing research methodology to ensure the adequacy
of review of research design and method.

(e) The IRB may call upon consultants as deemed necessary to render
technical advice.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 174; Sections
4514(e), 4791(i) and 5328(e), Welfare and Institutions Code. Reference: Sections
4514(e), 4791 and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 50413. Responsibilities of the Researcher.

Before any research involving human subjects is initiated at a state
hospital, the research shall:

(a) Identify each state hospital in which the human subjects are resi-
dents or with which the human subjects are affiliated.

(b) Prepare a written research protocol containing:

(1) A statement indicating whether the researcher considers the re-
search to be exempt from these regulations as outlined in Section
50403(d) and the reasons for this determination. Even if the researcher
considers the research to be exempt pursuant to Section 50403(d), the re-
quirements of Section 50413 shall be met by the researcher.

(2) A summary of the nature, purpose and design of the research in-
cluding:

(A) the specific questions to be addressed;

(B) the research methods such as sampling, data collection, and data
analysis to be employed to answer these questions; and

(3) A full description of the type of human subjects proposed to be in-
volved in the research, including their characteristics, the total number
anticipated, how they will be selected and the rationale for the use of this
population.

(4) A full description of how the subjects will be used in the activity.
If human remains or material that used to be part of a huinan body are to
be used, details as to their origin, nature and disposition should be given.

(5) A full description and assessment of potential benefits, if any, to
the individual human subjects, the group or class of which the subjects
are members, society in general , and to science as a result of the activity.

(6) A description and assessment of potential risks, if any, to the indi-
vidual human subjects, the group or class of which the subjects are mem-
bers, and to society in general as a result of the activity, whether such
risks by physical, psychological, social or legal. The protocol shall assess
the likelihood, severity and duration of such risks. If the research meth-
ods create potential risks, the protocol shall describe other less risky
methods, if any, which were considered and explain why they will not be
used.

(A) Human subjects shall be considered at risk in research if they are
involved without having given their informed consent.

(B) Human subjects shall not be considered at risk if they are involved
in a research activity which makes use of:

1 . observations of behavior open to public view,

2. materials available to the pubUc, or

3. statistical data.

(7) A description of the means to be taken to minimize such risks, in-
cluding the means by which the subject's personal privacy is to be pro-
tected and the confidentiality of the information obtained from or about
the subject is to be maintained. The protocol shall assess the likely effec-
tiveness of such precautionary measures.

(8) A description of the procedures to be used in obtaining and docu-
menting the prior informed consent of the subject. Copies of the material
to be used in obtaining informed consent shall be attached to the protocol.

(9) A waiver of the requirement for written informed consent, if
sought. The justification for the waiver shall be specified.

(10) The questionnaires or interview schedules, if any are to be used
in the project. If they are not available at the time of submission, an infor-
mative description of their content and of the manner of administration
shall be included in the protocol, along with an assurance that, when com-
pleted, they will be filed with the IRB.

(1 1) A description of any special or unusual circumstances regarding
the research activity which the researcher believes could be relevant or
material to the IRB's decision.

(12) A statement which indicates acceptance of responsibility for en-
suring that the research activity will be conducted by the researcher, and
his or her associated research and staff assistants, in accordance with the
procedures outlines in the research protocol and these regulations.

(d) Submit a copy of his or her vita, including address and telephone
number, and any prior experience in research involving confidential in-
formation.

(e) Include a copy of the application if the researcher is applying for
federal, state or other funds for the research.

(f) Submit the written protocol to IRBs appropriate for the particular
group of human subjects involved.

(g) Send an informational copy of the research protocol after it is ap-
proved by the IRB(s) and Executive Director(s) to the Director of the De-
partment at his office in Sacramento.

(h) Submit to the IRB a supplement to the original protocol approved
by the IRB if the supplement proposes to change the involvement of hu-

•

Page 254

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50421

man subjects in the research in a way that is materially different from that
which was initially approved by the IRB.

(i) The researcher shall be responsible for securing the approval of the
Food and Drug Administration (FDA) and for notifying the IRB of that
approval whenever an investigational new drug or device exemption is
required pursuant to law.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections
4514(e), 479 l(i) and 5328(e). Welfare and Institutions Code. Reference: Sections
4514(e), 4791 and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

4. Change without regulatory effect amending subsections (b)(6), (b)(10) and (e)
filed 1-14-2003 pursuant to section 100, title 1, California Code of Regulations
(Register 2003, No. 3).

§ 50415. Responsibilities of the IRB at State Hospitals.

(a) The IRB shall make available a copy of the regulations in this sub-
chapter to any person inquiring about doing research covered by this sub-
chapter.

(b) The IRB shall meet and review all written research protocols with-
in 3 1 days of receipt.

(c) The IRB shall review the written research protocol and make a de-
termination as to whether or not the research is exempt from these regula-
tions as specified in 50403(d).

(d) The IRB may request from the researcher any additional informa-
tion necessary to complete its review, and may require modifications in
the research activity or protocol before approval may be granted.

(e) The IRB shall approve, disapprove or defer the research protocol
in writing, giving reasons for the disapproval or deferment and any re-
quested modificadons, within 31 days of its review meeting.

(0 The IRB shall give the researcher the opportunity to respond to
these comments in writing or in person and shall re-review protocols
which have been modified at the IRB's request. The IRB shall review re-
submitted research protocols within 3 1 days of resubmission.

(g) The IRB shall prepare and maintain adequate documentation of
IRB activities, including

( 1 ) copies of all submitted protocols, consent documents and other at-
tachments;

(2) minutes of meetings including persons present and a summary of
decisions and actions taken;

(3) records of continuing review activities;

(4) names, occupations, earned degrees, licenses, certifications and
other pertinent information about members' qualifications; and

(5) changes in committee membership.

The IRB shall submit copies of meedng minutes, reports of condnuing
review acUvities, members' qualifications and changes in membership
to the State IRB on an ongoing basis.

(h) The IRB shall review proposed research at convened meedngs at
which a majority of the members are present. In order for the research to
be approved, it shall receive the approval of either three members present
or a majority of those members present at the meeting, whichever is a
larger number.

NOTK: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections
4514(e), 479 l(i) and 5328(e), Welfare and Institutions Code. Reference: Sections
4514(e), 4791 and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 5041 7. Criteria for State Hospital IRB Approval of
Research Protocols.

In order to approve research covered by these regulations the IRB shall
determine that all of the following requirements are satisfied:

(a) Risks to human subjects are minimized by using procedures, when
possible, which are:

( 1 ) Consistent with sound research design and which do not unneces-
sarily expose subjects to risk; and

(2) Already being performed on the subjects for diagnostic or treat-
ment purposes.

(b) Risks to subjects are reasonable in relation to andcipated benefits,
if any, to subjects, and to the importance of the knowledge that may rea-
sonably be expected to result. In evaluating risks and benefits, the IRB
shall consider only those risks and benefits that may result from the re-
search as distinguished from risks and benefits of therapies subjects
would receive even if not participaUng in the research. The IRB shall not
consider possible long-range effects of applying knowledge gained in
the research, such as the possible effects of the research on public policy
as among those research risks that fall within the purview of its responsi-
bility.

(c) Selection of subjects is appropriate and equitable. In making this
assessment, the IRB shall take into account the purposes of the research
and the setfing in which the research will be conducted.

(d) The procedures described in the protocol for obtaining and docu-
menting prior informed consent from each prospecfive subject or the sub-
ject's legally authorized representadve are in accordance with these reg-
ulaUons.

(e) The material is to be used in obtaining informed consent are in ac-
cordance with these reguladons.

(O There are adequate provisions to protect the privacy of subjects and
to maintain the confidendality of data.

(g) The researcher possesses professional qualifications, competence
and integrity.

(h) If the state hospital does not have a separate endty to review the
technical aspects of research protocols, the IRB also shall review the re-
search for:

( 1 ) scientific merit and relevance, including relevance to the missions
of the state hospital, or facility; and

(2) adequacy of research design and appropriateness of research meth-
odology.

Note: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections
4514(e), 4791 (i) and 5328(e), Welfare and Institutions Code. Reference: Sections
4514(e), 4791 and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 50419. Appealing an IRB Decision.

Any researcher may appeal an unfavorable decision of an IRB to the
State IRB in writing within 3 1 days of the date of the written notice of
disapproval.

Note: Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions
Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

History
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87. No.

4).

§ 50421 . Confidentiality of Client Information and Records
Used in Research.

(a) All client data and information obtained in the course of the re-
search shall be confidential and shall be disclosed only to qualified pro-
fessional persons providing services to the client or to other research per-
sonnel operating pursuant to the approved protocol.

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) Prior to obtaining access to any confidential records or information
for the purpose of doing research, each researcher, inckiding but not lim-
ited to employees of the facility maintaining the records or information,
shall sign an oath of confidentiality as follows:

Date

As a condition of doing research concerning persons with develop-
mental disabilities who have received services from

(fill in the facility, agency or person),

, agree to obtain the prior informed consent

of such persons who have received services to the maximum degree pos-
sible as determined by the appropriate institutional review board or
boards for protection of human subjects reviewing my research, or such
person's parents, guardian, or conservator, and I further agree not to di-
vulge any information obtained in the course of such research to unautho-
rized persons and not to publish or otherwise make public any informa-
tion regarding persons who have received services such that the person
who received services is identifiable.

I recognize that the unauthorized release of confidential information
may make me subject to a civil action under provisions of the Welfare and
Institutions Code.

Signed
NOTE: Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions
Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

History
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

§ 50423. Informed Consent.

(a) Before confidential records or information may be released or dis-
closed to a researcher, the researcher must obtain prior informed consent
from the person about whom the records or information pertain, or the
person's legally authorized representative, to the maximum degree pos-
sible as determined by the appropriate IRB.

(b) The researcher shall seek such consent only after the appropriate
IRB has approved the research protocol, and only in the manner pre-
scribed by the IRB, which shall be under circumstances that provide the
prospective subject or representative sufficient opportunity to consider
whether to participate, and that minimize the possibility of coercion or
undue influence.

(c) The information that is given to the subject or the representative
shall be in language understandable to the subject or the representative.

(d) No informed consent, whether oral or written, may include any lan-
guage through which the research subject or the representative waives or
appears to waive any of the research subject's legal rights, or any lan-
guage which releases or appears to release the researcher, the facility, or
its agents or any other person or entity from liability for negligence.
Note-. Authority cited; Section 4514(e) and 5328(e), Welfare and Institutions
Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

History
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

§ 50425. Basic Elements of Informed Consent.

(a) Except as provided in Sections 50427, 50429(c), in seeking in-
formed consent, the researcher shall ensure that the following informa-
tion is provided to each subject or representative:

( 1 ) An explanation of the research, including its purposes, the duration
of the subject's participation, a description of the procedures to be fol-
lowed, and identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts
to the subject;

(3) A description of any benefits to the subject or to others which may
reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject;

(5) A statement describing how the confidentiality of records which
identify the subject will be maintained;

(6) For research involving more than minimal risk, an explanation as
to whether any compensation will be provided, and a description of any
medical treatments that will be provided if a research-related injury oc-
curs;

(7) A listing of the name, address and phone number of the persons to
contact for answers to questions about the research, research subjects'
rights, and possible research-related injury to the subject;

(8) A statement that participation is voluntary, refusal to participate
will involve no penalty or loss of benefits to which the subject is other-
wise entitled, and the subject may discontinue participation at any time
without penalty or loss of benefits to which the subject is otherwise en-
titled;

(9) A statement that the confidentiality of the subjects shall be main-
tained in any report of the findings of the research project, unless express-
ly consented to by the client or his or her legally authorized representa-
tive.

(b) When appropriate, one or more of the following elements of infor-
mation shall be provided to each subject:

( 1 ) A statement of anticipated circumstances under which the sub-
ject's participation may be terminated by the researcher without regard
to the subject's consent;

(2) An explanation of any costs to the subject that may result from par-
ticipation in the research;

(3) A description of the consequences of a subject's decision to with-
draw from the research and procedures for orderly termination of partici-
pation by the subject; and

(4) A statement indicating that the subject will be advised of any sig-
nificant new findings developed during the course of the research which
may relate to the subject's willingness to continue participation.
NOTE; Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions
Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

2. Change without regulatory effect amending subsection (b)(2) filed 1-14-2003
pursuant to section 100, title 1, California Code of Regulations (Register 2003,
No. 3).

§ 50427. Waiver of Requirement of Informed Consent at
State Hospitals.

A state hospital IRB may approve a consent procedure which does not
include, or which alters, some or all of the elements of informed consent
or waive the requirements to obtain informed consent, provided the IRB
finds and documents that:

(a) The research involves no more than minimal risk to the subjects and
involves no procedures for which written consent is normally required;

(b) The waiver or alteration will not adversely affect the rights and
welfare of the subjects;

(d) The only record linking the subject and the research would be the
consent document and the principal risk would be potential harm result-
ing from a breach of confidentiality;

(e) Whenever appropriate, the subjects will be provided with addition-
al pertinent information after participation.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Secdons
4514(e), 4791(i) and 5328(e), Welfare and Institutions Code. Reference: Secdons
4514(e), 4791 and 5328(e), Welfare and Institudons Code.

History

1. New secdon filed 1-22-87; effecdve thirtieth day thereafter (Register 87, No.
4).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prindng only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3 . Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 50429. Documentation of Informed Consent.

(a) Except as provided in Section 50427, informed consent shall be
documented by the use of a written consent form that:

•

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Health and Welfare Agency — Department of Developmental Services

§ 50501

(1) embodies the elements of informed consent required by Section
50425;

(2) is approved by the appropriate IRB or IRBs; and

(3 ) is signed by the subject or tiie subject's legally authorized represen-
tative.

(b) Research investigators shall ensure that each person signing the
written consent form is given a copy of that form.

(1) a written consent document that embodies the elements of in-
formed consent required by Section 50425. This form may be read by or
read to the subject or the subject's legally authorized representative, but,
in any event, the researcher shall give either the subject or the representa-
tive adequate opportunity to read and understand the form before signing
it; or,

(2) a "short form" written consent document stating that the elements
of informed consent required by Section 50425 have been presented oral-
ly to the subject or the subject's legally authorized representative. When
the "short form" is used, the researcher shall insure that:

(A) a witness is present at the oral presentation,

(B) the short form is signed by the subject or the representative,

(D) the person obtaining consent signs a copy of the summary,

(E) a copy of both the short form and summary is given to the subject
or the representative, and

(F) the written summary of what is to be said to the subject or the repre-
sentative receives the prior approval of the IRB.

(d) In cases where the documentation requirement is waived, the IRB
may require the researcher to provide subjects with a written statement
regarding the research.

NOTE: Authority cited: Sections 4514(e) and 5328(e), Welfare and Institutions
Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.

History

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No.
4).

Subchapter 5. Clients' Rights

Article 1. Purpose and Definitions

§ 50500. Intent and Purpose.

The intent and purpose of this subchapter is to implement, interpret,
and make specific the statutory provisions of the Lanterman Develop-
mental Disabilities Services Act (Division 4.5 of the Welfare and Institu-
tions Code, commencing with Section 4500) relative to the rights of per-
sons receiving services pursuant to said Act.

NOTE: Authority cited: Section 11152, Government Code. Reference: Sections
4416, 4441, 4502, 4503, 4504 and 4648, Welfare and Institutions Code.

History

1. New Subchapter 5 (Articles 1-6, Sections 50500-50550, not consecutive) filed
12-23-81; effective thirtieth day thereafter (Register 81, No. 52).

2. Editorial redesignation of former Chapter 4 (Subchapters 5 and 6, Sections
50500-50667, not consecutive) to Chapter 1, Subchapters 5 and 6 (Sections
50500-50667, not consecutive) filed 9-28-83 (Register 83, No. 40).

§50501. Definitions.

(a) As used in this subchapter the following words and phrases have
the specified meaning:

(1) Client. "Client" means any person with a developmental disability
who is receiving services, is an appUcant for services, or has been re-
ferred for services pursuant to the Lanterman Developmental Disabilities
Services Act.

(2) Clients' rights advocate. "Clients' rights advocate" means the indi-
vidual or individuals assigned by a regional center or state hospital to be
responsible for clients' rights assurance for persons with developmental
disabilities.

(3) Clients' Rights Assurance. "Clients' Rights Assurance" refers to
the comprehensive program of ensuring that the civil, legal and service
rights of persons with developmental disabilities are available and guar-
anteed to such persons.

(4) Clients' Rights Officer. "Clients' Rights Officer" is the person as-
signed by the director to implement the department's clients' rights as-
surance endeavors on a statewide basis and to provide technical assis-
tance and functional supervision to the network of clients' rights
advocates throughout California.

(5) Community care facility. "Community care facility" means any li-
censed facility defined in Health and Safety Code Section 1502.

(6) Department. "Department" means the State Department of Devel-
opmental Services.

(7) Developmental disability. "Developmental disability" means any
condition included within the definition of this term by Welfare and Insti-
tutions Code Section 45 1 2(a) and applicable regulations promulgated by
the Director.

(8) Director. "Director" means the Director of the State Department of
Developmental Services.

(9) Health facility. "Health facility" means any licensed facility de-
fined in Health and Safety Code Section 1250.

(10) Postural support. "Postural support" refers to any device other
than orthopedic braces used to assist clients in achieving proper body po-
sition and balance. These devices are distinguished from restraints.

(11) Physician. "Physician" means a person licensed as a physician
and surgeon by the California Board of Medical Quality Assurance or
California Board of Osteopathic Examiners.

(12) Professional person in charge of the facility. "Professional person
in charge of the facility" means:

(A) In a health facility, a physician, psychiatrist, psychologist, social
worker, or registered nurse who is designated by the licensee as the pro-
fessional person clinically in charge of the facility.

(B) In a community care facility, the administrator of the facility as
designated by the licensee.

(13) Psychiatrist. "Psychiatrist" means a person who is licensed as a
physician and surgeon by the California Board of Medical Quality Assur-
ance or the California Board of Osteopathic Examiners and who is certi-
fied or eligible for certificadon by the American Board of Psychiatry and
Neurology, or the American Osteopathic Board of Neurology and Psy-
chiatry, or is a physician who is licensed by the California Board of Medi-
cal Quality Assurance or the California Board of Osteopathic Examiners
and has specialized training and/or experience in psychiatry.

(14) Psychologist. "Psychologist" means a person licensed by the Cal-
ifornia Board of Medical Quality Assurance and (1) who possesses an
earned doctorate degree in psychology from an educational institution
meeting the criteria of subdivision (c) of Secfion 2914 of the Business
and Professions Code and (2) has not less than two years of clinical expe-
rience in a muUidisciplinary facility licensed or operated by this or anoth-
er state, or by the U.S. to provide health care, or is listed in the National
Register of Health Service Providers in Psychology, as adopted by the
Council for the NaUonal Register of Health Service Providers in Psychol-
ogy.

(15) Registered nurse. "Registered nurse" means a person licensed as
such by the California Board of Registered Nursing.

(16) Restraint. "Restraint" means control of the client's behavior or
acfivities through the use of physical or pharmaceutical means other than
postural supports. For the purpose of these regulations, restraint is distin-
guished from the temporary constraint of a client by direct physical con-
tact only, where there is clear evidence for believing the existence of an
imminent danger to either the client or others if such constraint is not ac-
complished.

(17) Seclusion. "Seclusion" is the involuntary isolation of a client in
a locked room. As used in this subchapter, seclusion does not include iso-
lation of a client for the purpose of containing any contagious disease
when written order of a physician directs such isolafion for this limited

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§ 50510

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

puqjose. Such medical isolation shall not be in a locked room unless the
physician's order expressly directs it on the basis of a finding that, if not
locked, the particular client's isolation cannot be maintained.

(18) Service catchment area. "Service catchment area" refers to that
geographical area within which a regional center provides services speci-
fied in its contract with the Department as required by Welfare and Insti-
tutions Code Section 4640.

(19) Social worker. "Social worker" means a person who is a graduate
of a school of social work accredited or approved by the Council on So-
cial Work Education and has one year of social work experience in a
health care setting or who is licensed as such by the California Board of
Behavioral Science Examiners.

(20) Services. "Services" means anything included within the defini-
tion of services set forth in Welfare and Institutions Code Section
4512(b) and in regulations promulgated by the Director.

(21 ) State hospital. "State hospital" means any of the licensed state op-
erated health facilities designated in Welfare and Institutions Code Sec-
tion 4440.

(b) Any word, term, or phrase not specifically defined but used in this
subchapter shall have the meaning ascribed by common, contemporary
accepted usage unless to do so would result in absurd interpretation or
otherwise be inconsistent with its context. In cases of conflict in con-
staiction, words, phrases, or terms of art shall have the meaning apparent
by their context and most reconcilable with the intent of this subchapter.

(c) Use of the masculine gender in this subchapter shall be understood
as including the feminine and use of the singular as including the plural.
NOTE: Authority cited: Section 11152, Government Code. Reference: Sections
4415 and 4416, Welfare and Institutions Code.

Article 2. Rights of Persons with
Developmental Disabilities

§ 5051 0. Application of This Subchapter.

Each person with a developmental disability, as defined by this sub-
chapter, is entitled to the same rights, protections, and responsibilities as
all other persons under the laws and Constitution of the State of Califor-
nia, and under the laws and the Constitution of the United States. Unless
otherwise restricted by law, these rights may be exercised at will by any
person with a developmental disability. These rights include, but are not
limited to, the following:

(a) Access Rights.

( 1 ) A right to treatment and habilitation services. Treatment and habil-
itation services shall foster the developmental potential of the person.
Such services shall protect the personal liberty of the individual and shall
be provided under conditions which are the least restrictive necessary to
achieve the purposes of treatment.

(2) A right to dignity, privacy, and humane care.

(3) A right to participate in an appropriate program of publicly-sup-
ported education, regardless of the degree of handicap.

(4) A right to religious freedom and practice, including the right to at-
tend services or to refuse attendance, to participate in worship or not to
participate in worship.

(5) A right to prompt and appropriate medical care and treatment.

(6) A right to social interaction and participation in community activi-
ties.

(7) A right to physical exercise and recreational opportunities.

(8) A right to be free from harm, including unnecessary physical re-
straint, or isolation, excessive medication, abuse or neglect. Medication
shall not be used as punishment, for convenience of staff, as a substitute
for program, or in quantities that interfere with the treatment program.

(9) A right to be free from hazardous procedures.

(10) A right to advocacy services, as provided by law, to protect and
assert the civil, legal, and service rights to which any person with a devel-
opmental disability is entitled.

( 1 1 ) A right to be free from discrimination by exclusion from partici-
pation in, or denial of the benefits of, any program or activity which re-
ceives public funds solely by reason of being a person with a develop-
mental disability.

( 1 2) A right of access to the courts for purposes including, but not lim-
ited to the following:

(A) To protect or assert any right to which any person with a develop-
mental disability is entitled;

(B) To question a treatment decision affecting such rights, once the ad-
ministrative remedies provided by law, if any, have been exhausted;

(C) To inquire into the terms and conditions of placement in any com-
munity care or health facility, or state hospital, by way of a writ of habeas
corpus, and

(D) To contest a guardianship or conservatorship, its terms, and/or the
individual or entity appointed as guardian or conservator.

(b) Personal Rights. Each person with a developmental disability who
has been admitted or committed to a state hospital, community care facil-
ity, or health facility shall have rights which include, but are not hmited
to, the following:

( 1) To keep and be allowed to spend one' s own money for personal and
incidental needs.

(2) To keep and wear one's own clothing.

(3) To keep and use one's own personal possessions, including toilet
articles.

(4) To have access to individual storage space for one's private use.

(5) To see visitors each day.

(6) To have reasonable access to telephones, both to make and receive
confidential calls, and to have calls made for one upon request.

(7) To mail and receive unopened correspondence and to have ready
access to letter- writing materials, including sufficient postage in the
form of United States postal stamps.

(8) To refuse electroconvulsive therapy ("ECT").

(9) To refuse behavior modification techniques which cause pain or mj^k
trauma. ^^jF

(10) To refuse psychosurgery. Psychosurgery means those operations
currently referred to as lobotomy, psychiatric surgery, and behavioral
surgery and all other forms of brain surgery if the surgery is performed
for any of the following purposes:

(A) Modification or control of thoughts, feelings, actions, or behavior
rather than treatment of a known and diagnosed physical disease of the
brain.

(B) Modification of normal brain function or normal brain tissue in or-
der to control thoughts, feelings, actions, or behavior.

(C) Treatment of abnormal brain function or abnormal brain tissue in
order to modify thoughts, feelings, actions, or behavior when the abnor-
mality is not an established cause for those thought, feehngs, actions, or
behavior.

(11) Other rights as specified by administrative regulations of any fed-
eral, state, or local agency.

(c) Rights of State Hospital Residents. In addition to all of the other
rights provided for in this subchapter, each person with a developmental
disability who resides in a state hospital shall be accorded the following
rights:

(1) If involuntarily detained, to have access to a current and up-to-
date copy of the California Welfare and Institutions Code. This right in-
cludes the right to have assistance from the Clients' Rights Advocate in
the reading and understanding of the Code.

(2) To give or withhold consent for treatments and procedures, in the
absence of a judicial order or other provision of law which provides for
the exercise of this right to devolve to another party.

(3) To be provided with the amount of funds specified in Welfare and
Institutions Code Section 4473 for personal and incidental use if, follow-
ing the initial thirty (30) days of state hospital residency, the person is not
receiving an amount of income for such use which is equal to or greater
than the amount authorized by Section 4473.

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Title 17

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§ 50530

NOTH: Authority cited: Section 11152, Government Code. Reference: Sections
4423. 4473, 4503 and 4504, Welfare and Institutions Code.

§ 50515. Use of Seclusion or Restraint, "Time Out."

(a) Seclusion. No person with a developmental disability shall be
placed in seclusion. The use of "time out" procedures may be employed
only under the following circumstances:

( 1 ) State Hospital. The procedure used complies with regulations pro-
mulgated by the director pursuant to Welfare and Institutions Code Sec-
tion Vs05.

(2) Community Care or Health Facility. A written agreement exists be-
tween the placing regional center and the facility which complies with
regulations promulgated by the director pursuant to Welfare and Institu-
tions Code Section 4505.

(b) Restraint(s). Restraint(s) shall not be used on any person with a de-
velopmental disability unless:

( 1 ) In a state hospital or other health facility, there is full compliance
with applicable licensing regulations governing the use of restraints, and
where such use does not continue for any period longer than that neces-
sary to control the behavior for which such restraint is employed.

(2) In a community care facility, there is full compliance with the re-
quirements of Title 22, California Administrative Code, Section
80403(f) and any other applicable licensing regulations, and where such
use does not continue for any period longer than that necessary to control
the behavior for which such restraint is employed.

Postural supports may only be used upon written order of a physician
and may only include soft ties, seat belts, spring release trays or cloth
sheeting and shall only be used to improve a client's mobility and inde-
pendent functioning rather than to restrict movement.
NoTH: Authority cited: Section 11152, Government Code; Sections 4416 and
4441 , Welfai'e and Institutions Code. Reference: Section 4502(h), Welfare and In-
stitutions Code.

Article 3. Notification of Rights

§ 50520. Notification of Rights.

(a) State Hospital.

(1) Posting of Rights. The rights contained in Section 50510 of this
subchapter shall be prominently posted in both English and Spanish, on
forms provided by the Department, in each living area serving persons
with a developmental disability. The posted form shall contain the name,
office location within the hospital, and phone number of the clients'
rights advocate. It shall be the responsibility of the chief executive officer
to assure compliance with the posting requirements of this section.

(2) Personal Notification of Rights. Within twenty-four (24) hours af-
ter entry into the hospital as a resident, annually thereafter, and at any oth-
er point in time when the client's legal status changes, each person with
a developmental disability shall be personally informed and served with
a printed copy of all rights in Section 505 10 and shall have these rights
explained in a language or modality he understands. If the resident cannot
be effectively informed of such rights because of his physical or mental
condition at the time such notification is otherwise due, a good faith effort
having been made to inform him, notation of this fact shall be entered into
the resident's treatment record at the hospital, accompanied by a descrip-
tion of the manner in which such notification was attempted, and signed
by a third party witnessing the attempt at notification. Additionally, a
copy of the rights listing provided the resident shall be signed by the resi-
dent, or his authorized representative, and placed in the resident's file at
the facility.

(3) Written Notice to Representative. A written notice shall be sent to
or otherwise served upon the resident's parent, guardian, conservator, or
legally authorized personal representative, as applicable (e.g., if a minor,
the parent or guardian; if a conservatee, the conservator; if neither, or if
the resident expresses a preference for, the person designated by the resi-
dent as his personal representative, if any), at any time notification pur-

suant to subsection (a), (2), above, is made. This notice shall include: a
copy of the rights in Section 505 10 and information noting the date of the
resident's most recent notification of same, as well as the name, address
and phone number of the clients' rights advocate of both the hospital and
the regional center which was involved in the resident's placement at the
hospital, if any.

(b) Community Care or Health Facility.

(1) Posting. The rights contained in Section 50510 (a) and (b) of this
subchapter shall be prominently posted in both English and Spanish on
forms provided through the regional center by the department, in each
community care or health facility serving any person with a developmen-
tal disability. The posted form shall contain the name, address and phone
number of the clients' rights advocate of the regional center within whose
service catchment area the facility is located. It shall be the responsibility
of the professional person in charge of the facility to assure compliance
with the posting requirement of this subsection.

(2) Personal Notification of Rights. Within twenty-four (24) hours of
entry into the facility as a resident or program participant, annually there-
after, and at any other point in time that the client's legal status changes,
each person with a developmental disability shall be personally informed
of the rights in Section 505 10 (a) and (b) and shall have these rights ex-
plained to him in a language or modality he understands. If the person
cannot be effectively informed of such rights because of his physical or
mental condition at the time such notification is otherwise due, a good
faith effort having been made to inforrri him, notation of this fact shall be
entered into the person's treatment record at the facility, accompanied by
a description of the manner in which such notification was attempted,
signed by a third party who has witnessed the attempt at notification. Ad-
ditionally, a copy of the rights listing provided the resident shall be signed
by the resident, or his authorized representative, and placed in the resi-
dent's file at the facility.

(3) Written Notice to Representative. A written notice shall be sent to
or otherwise served upon the person's parent, guardian, conservator or
legally authorized personal representative, as applicable (e.g., if a minor,
the parent or guardian; if a conservatee, the conservator; if neither, or if
the resident expresses a preference for. the person nominated by the cli-
ent as his personal representative, if any), at the time notification pur-
suant to subsection (b), (2), above, is made or attempted. Tliis notice shall
include: a copy of the rights in Section 505 10 (a) and (b) and information
noting the date of the person's most recent notification of same, as well
as the name, address and phone number of the clients' rights advocate in
the regional center in whose service catchment area the facihty is located.
NOTE: Authority cited: Section 11152, Government Code; and Sections 4415,
4416 and 4503, Welfare and Institutions Code. Reference: Sections 4415, 4416,
4648(b) and (c), Welfai-e and Institutions Code.

Article 4. Denial of Rights

§ 50530. Denial of Rights.

(a) Except as provided in this article, no right specified in Section
505 1 0 shall be denied any client. In the absence of a court order, the terms
of which expressly provide for Hmitation of a particular right to which a
given client is otherwise entitled, no right contained in Section 505 1 0
shall be denied unless there is full compliance with this article. Only
those rights listed in Section 50510(b), (1) through (7), may be denied
pursuant to this article.

(b) Only the professional person in charge of the facility or his desig-
nee may deny a right for good cause. The name of the professional person
in charge of the facility, for the purposes of this article, shall be on file
at the facility. If a designee of the professional person in charge of the fa-
cility is authorized to deny rights for good cause, a written formal desig-
nafion naming the designee shall be signed by the professional person in
charge of the facihty and shall be on file at the facility.

(c) Good cause for the denial of any right in Section 50510 (b), ( I )
through (7), inclusive, exists only when the professional person in charge

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Title 17

of the facility, or his duly authorized designee, makes an express finding
that:

( 1 ) The exercise of the specific right sought to be denied would be inju-
rious to the individual otherwise entitled to exercise it; or

(2) There is evidence that the specific right sought to be denied if exer-
cised by that individual, would seriously infringe on the rights of others;
or

(3) The institution or facility would suffer serious damage to the physi-
cal plant if the specific right is not denied; and

(4) There is no less restrictive means of protecting the specific interest
listed in ( I), (2), or (3) of this subsection.

(d) The reason used to justify the denial for good cause of any right
must be related to the specific right denied. A right shall not be withheld
or denied as a punitive measure, nor shall any right be considered a privi-
lege to be earned.

(e) A treatment modality, approach or plan shall not constitute good
cause for the denial of any right specified in this subchapter.

(f) A right shall not continue to be denied when the good cause for its
denial no longer exists. Each denial for good cause shall be reviewed at
a minimum of each thirty (30) days, beginning from the first date when
the denial takes place, for assessment of the continued validity of the
good cause upon which the denial is predicated. Upon expiration of the
good cause, any denied right shall be promptly reinstated. At each review
a specific finding shall be made that the good cause for continuing the
denial exists, including that it is still the least restrictive means, or the de-
nial shall terminate.

(g) At the time any good cause denial commences, the person who is
being denied any right shall be informed of the right to appeal the denial
decision either by way of the complaint process established by Section
50540 of this subchapter or by way of a fair hearing as provided in Wel-
fare and Institutions Code Sections 4700-4725. If the person is unable
to comprehend such information, the notification of the right to appeal
shall be made to such person's parent or guardian, if a minor, conserva-
tor, personal or legal representative.

(h) When, for good cause as defined in this section, the professional
person in charge of the facility proposes to deny any right to any person
who is lawfully entitled to leave the facility at will, the professional per-
son in charge of the facility shall first advise such person or, if the person
is unable to comprehend, the person's parent or guardian, if a minor, con-
servator, personal or legal representative, of the right to elect to leave the
facility without submitting to the proposed denial or to submit to the de-
nial but appeal its basis. In no case shall any person who is lawfully en-
titled to leave the facility at will have any right denied him without first
being advised of this right of choice.

(i) Waiver of any right guaranteed by this subchapter must be know-
ing, intelligent, voluntary and made by the person to whom the right le-
gally devolves. No waiver is valid unless it satisfies these elements, is in
writing, and is approved by signature of the clients' rights advocate hav-
ing responsibility for the facility. The clients' rights advocate of the re-
gional center in whose service catchment area the facility is located is the
responsible party for all community care and health facilities other than
state hospitals.

NOTE: Authority cited: Section 11152, Government Code; and Section 4416,
Welfare and Institutions Code. Reference: Sections 4503, 4504 and 4648(b), Wel-
fare and Institutions Code.

§ 50532. Documentation of Rights Denials.

(a) Each denial of a right for good cause, as provided in Section 50530
of this arficle, shall be noted in the facility's treatment record of the per-
son whose right has been denied. This documentation shall take place im-
mediately upon the denial of any right or, in the event of an emergency,
in no case later than twenty-four (24) hours from the fime of the denial.
If an emergency does not permit immediate documentation, a Special In-
cident Report shall be submitted to the department setting forth the par-
ticulars of such emergency. In state hospitals, this Report shall be sub-
mitted through the clients' rights advocate. In any licensed health or

community care facility, this Report shall be submitted through the cli-
ents' rights advocate for the regional center in whose service catchment
area the facility is located.

(b) The treatment record notation shall be on forms provided by the de-
partment and shall include:

(1) Date and fime the right vv'as denied.

(2) Specific right denied.

(3) Specific good cause rationale of Secfion 50530(c) which permits
denial.

(4) Name(s) of any staff member(s) involved in the denial decision.

(5) Signature of the professional person in charge of the facility, or his
designee, authorizing the denial.

(6) A special incident report, to the director of the department in the
event of an emergency not permitfing documentafion immediately upon
the denial of any right.

(7) If the person appealed the denial of the right, the date of the request
and the outcome, if any, of the appeal.

(c) Each denial notafion shall include the dates of the thirty (30) day
reviews and documentation of the continuing good cause basis for the de-
nial of right, required by Secfion 50530 (c).

(d) If the person lawfully enfitled to leave the facility at the fime of the
denial elects to remain in the facility, it shall be recorded in the treatment
record that the person was informed of his rights pursuant to Section
50530 (g) and (h). The notafion shall be signed by the staff member who
informed the person.

(e) The restoration date of any previously denied right shall be entered
in the treatment record.

NOTE: Authority cited: Section 11152, Government Code; and Section 4504,
Welfare and Institutions Code. Reference: Sections 4504 and 6005, Welfare and
Institutions Code; Aden v. Younger (1976) 57 C.A. 3d 662, at pps. 681-682.

§ 50534. Access to Denial of Rights Information.

Informafion pertaining to any denial of rights for good cause contained
in an individual's treatment record shall be made available upon request,
to such individual, his attorney, his parent or guardian if the individual
whose right is denied is a minor, his conservator, the clients' rights advo-
cate, and the State Department of Developmental Services.
NOTE: Authority cited: Section 11152, Government Code; and Section 4504,
Welfare and Institutions Code. Reference: Sections 4422 and 4504, Welfare and
Institutions Code.

§ 50536. Reporting Good Cause Denials of Rights.

(a) Except for state hospitals having a fuU-fime clients' rights advo-
cate, each facility serving regional center clients shall forward a copy of
all documentafion of any denial of rights for good cause required by Sec-
tion 50532 (a) through (f) to the regional center in whose service catch-
ment area the facility is located as promptly as possible, but not to exceed
ten (10) days from the effecfive day of such denial.

(b) Upon receipt of the documentafion of good cause right denial, the
clients' rights advocate shall review for compliance with Secfion 50530
and use it as reference in the compilation of the quarterly reports required
by Secfion 50538.

NOTE: Authority cited: Section 11152, Government Code, and Sections 4416,
4504, Welfare and Institutions Code. Reference: Section 4504, Welfare and Insti-
tutions Code.

§ 50538. Quarterly Reports on the Denial of Rights for
Good Cause.

As described in Welfare and Insfitufions Code Secfion 4504, each state
hospital and each regional center shall, by the last day of each January,
April, July, and October, report on forms provided by the department all
of the following informafion concerning any good cause denial of rights
which has transpired during the preceding quarter:

(a) An appropriate identification number or other code which will en-
able the state hospital or regional center to idenfify the person(s) whose
rights have been denied for good cause. A different number or code shall
be used for each person and such person's number or code shall remain
constant on all future reporting about that person.

(b) The date that the right was denied.

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§ 50602

•

(c) The specific right denied and the specific rationale of Section
50530 (c), ( 1 ) through (4), inclusive, for the denial.

(d) The date that the right was restored or, if not restored the date(s)
of each thirty (30) day review conducted as required by Section 50530

(f).

State hospital reports shall provide the information by living unit. Re-
gional centers shall submit the information by facility. The forms shall
be mailed to the Director of Developmental Services.
NoTH: Authority cited: Section 11152, Government Code, and Sections 4416,
4.504, Welfare and Institulions Code. Reference: Section 4504, Welfare and Insti-
tutions Code; Aden w Younger {\91b) 57 Cal. App. 3d 662, pps. 681-682.

Article 5. Complaint Procedure

§ 50540. Complaint Procedure.

(a) Each client or any representative acting on behalf of any client, who
believes that any right to which the client is entitled has been abused, pu-
nitively withheld, or improperly or unreasonably denied, may pursue a
complaint as provided in this section.

(b) Initial referral of any complaint taken pursuant to this section shall
be to the clients' rights advocate responsible for the facility in which such
person is a resident or of which such person is a client.

Except for state hospitals, the responsible clients' rights advocate shall
be the person assigned such duties by the regional center within whose
service catchment area the facility is geographically located.

The clients' rights advocate shall, within ten working days of receiv-
ing a complaint, investigate the complaint and send a written proposed
resolution to the complainant.

(c) If the complainant expresses dissatisfaction with the action taken
or proposed by the clients' rights advocate, the complaint shall be re-
ferred, by the clients' rights advocate, within five (5) working days, to the
director of the state hospital or of the regional center in whose service
catchment area the facility is located.

(d) If the complaint is not resolved to the satisfaction of the complain-
ant within ten (10) working days by the director of the state hospital or
regional center, it shall be referred by that director to the Department of
Developmental Services' clients' rights officer, whose responsibility it
shall be to make a recommendation to the director of the State Depart-
ment of Developmental Services for final administrative decision.
NOTE: Authority cited: Section 4503, Welfare and Institutions Code; and section
1 11 52, Government Code. Reference: Sections 4502, 4503, Welfare and Institu-
tions Code.

History
1. Amendment of subsections (b) and (d) and Note filed 2-25-92; operative
3-6-92 (Register 92, No. 12).

(5) To assist residents in the pursuit of administrative and legal reme-
dies. If the complaint is against an employee, a policy, or the operations
of the state hospital, the clients' rights advocate may refer the resident to
an agency which can provide independent representation.

(6) To monitor and review all reports of denial of rights for good cause
of any resident of the hospital, as required by Section 50536.

(7) To advise the state hospital execufive officer on the development,
implementation and maintenance of a clients' rights assurance program
in the state hospital.

(8) To serve as a consultant and resource person on issues relative to
the rights of persons with developmental disabilities for all persons with-
in the hospital.

(9) To act as liaison between the state hospital and the Clients' Rights
Office.

(b) Regional Center Clients' Rights Advocate.

(1) To assure that the rights of each developmentally disabled client
served by the regional center, including applicants and individuals re-
ferred for services, are guaranteed, protected, and asserted as requested
by or on behalf of the client.

(2) To monitor compliance with the posting requirements of Section
50520 (b), and the notification of rights provisions of Section 50520 in
any licensed facility which serves clients of the regional center.

(3) To investigate and to facilitate resoludon of all complaints involv-
ing violation, withholding or punitive denial of rights which are brought
by or on behalf of any client served by the regional center.

(4) To inifiate inquiry into any violafion, withholding or punitive de-
nial of any right to which a regional center client is entitled where the cli-
ent is unable to do so.

(5) To assist clients in the pursuit of administrative and legal remedies.
If the complaint is against an employee, a policy, or the operations of the
regional center, the clients' rights advocate may refer the client to any
agency which can provide representation.

(6) To advise the regional center director on the development and im-
plementation of the regional center clients' rights assurance program.

(7) To serve as local consultant and resource person on the issue of
rights for individuals with developmental disabilifies to clients, families,
regional center staff and other interested persons within the area served
by the regional center.

(8) To act as the liaison between the regional center and the Clients'
Rights Office.

(9) To review and monitor all reports concerning the denial of rights
for good cause which are submitted as required by Section 50536.
NOTE: Authority cited: Section 11152, Government Code, and Sections 4415,
4416, 4503, 4504, Welfare and Institutions Code. Reference: Sections 4503, 4504,
4648(b) and (c). Welfare and Institutions Code.

Article 6. Clients' Rights Advocate

§ 50550. Assignment of Clients' Rights Advocate.

Each state hospital and regional center shall have at least one (1) staff
member, or the functional equivalent thereof, who is assigned on a full-
time basis to fulfill the duties of the chents' rights advocate. Such duties
shall include, but not be limited to, the following:

(a) State Hospital Clients' Rights Advocate.

(1) To assure that the rights of each person with a developmental dis-
ability who resides in the hospital are guaranteed, protected and asserted
as requested by or on behalf of any resident.

(2) To monitor compliance with the posting requirements and the noli-
ficafion of rights provisions of Section 50520.

(3) To invesfigate and facilitate resolution of complaints concerning
any violation, withholding, or punitive denial of any right, which is
brought by or on behalf of any resident.

(4) To initiate inquiry into any right's violation, withholding, or puni-
tive denial of any right to which any hospital resident with a developmen-
tal disability is entitled where such resident is unable to do so because of
physical or mental condition.

Subchapter 6. Service Provider
Accountability

Article 1. General Provisions

§ 50601 . l\/leaning of Words.

Words shall have their usual meaning unless the context or a definition
clearly indicates a different meaning. Words used in their present tense
include the future tense and words in the singular form include the plural
form. Use of the word "shall" denotes mandatory conduct.
NOTE: Authority cited: Section 4648.2, Welfare and Institutions Code. Reference:
Section 4648.1, Welfare and Institutions Code.

History

1. New subchapter 6 (article 1, sections 50601-50612) filed 9-22-89; operative
10-22-89 (Register 89, No. 40). For prior history, see Register 88, No. 29.

2. Editorial correction of article heading (Register 92, No. 21).

§ 50602. Definitions.

The following definitions govern the construction of sections within
this subchapter unless the context requires otherwise:

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§ 50603

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(a) "Administrative Overhead Allocations" means the division of ad-
ministrative overhead among the various affiliate or commonly-owned
programs and/or services. Administrative overhead includes such ex-
penses as salaries for management staff and accountants, legal fees, of-
fice space and equipment, and utility costs.

(b) "Affiliate or Commonly-Owned Organizations" means two or
more programs and/or services that are owned by the same person, corpo-
ration or entity.

(c) "Auditing" means any examination of records and source docu-
mentation, pertaining to the service program and/or the provision of ser-
vices to persons with developmental disabilities of any individual, group,
or entity by the Department, regional center, or any authorized agency
representative. This examination is conducted for purposes of determin-
ing compliance with fiscal or fiscally related program or service provi-
sions of applicable statute, regulations, contracts, or agreements govern-
ing the service program and/or the provision of services to persons with
developmental disabilities. Such examination shall include any proce-
dures as considered necessary by the auditor under the circumstances to
perform the examination.

(d) "Authorized Agency Representative" means a person authorized
to act on behalf of the Department or regional center by law, by court or-
der, or by a written statement signed by the Director of the Department
or the executive director of a regional center.

(e) "Department" means the State Department of Developmental Ser-
vices.

(f) "Draft Audit Report" means the written document summarizing the
audit findings and recommendations that is prepared by the regional cen-
ter and is forwarded to the service provider for response pursuant to Sec-
tion 50606(d)(1).

(g) "Emergency Services" means those services which must be pro-
vided or purchased by a regional center in order to protect a consumer
from immediate danger to his/her physical or mental health or safety.

(h) "Final Audit Report" means the written document prepared by the
regional center pursuant to Section 50606(f). "Final audit report" is syn-
onymous with "audit report" as defined in Section 50701(g).

(i) "Parent Organization" means a separate and distinct corporation or
entity which operates two or more programs and/or services.

(j) "Preliminary Audit Report" means the written document prepared
by the regional center and forwarded to the Department pursuant to Sec-
tion 50606(e)( 1 ) when the audit involves the review of documentation re-
lied upon as the basis for establishing a rate of payment for a service pro-
vider. Preliminary audit reports include the following items:

(1) The regional center's draft audit report;

(2) The service provider's response to the draft audit report; and

(3) The regional center's reply to the service provider's response.

(k) "Record" means any book or document evidencing operational, fi-
nancial, and service activities of a service provider or regional center per-
taining to the service program and/or the provision of services to persons
with developmental disabilities. Examples include books of account,
general ledgers, subsidiary ledgers, check registers, canceled checks,
contracts, correspondence, financial statements, internal reports, bank
statements, standard cost statements, consumer files, purchase of service
authorizations, and documents evidencing consumer services. All con-
sumer records shall be treated as confidential.

(/) "Service" means the process by which the regional center, or ser-
vice provider, delivers a service directed towards the alleviation of a de-
velopmental disability or toward the social, personal, physical, or eco-
nomic habihtation or rehabihtation of an individual with such a
disability, and consistent with the requirements set forth in Title 17, Cali-
fornia Code of Regulations Section 56551(d) and Welfare and Institu-
tions Code, Sections 4646.5(a)(4) and 4648(a). Such services include,
but are not Umited to those specified in Section 45 12 of the Welfare and
Institutions Code.

(m) "Service Provider" means a person, program, or any other entity,
or any other person connected therewith, vendored to provide services to

regional center consumers. Service providers do not include those appli-
cants specified in Title 17, California Code of Regulations, Section
54310(d) and (e).

(n) "Service Record" means a book or document evidencing the ser-
vice activities provided by a service provider or regional center.

(0) "Source Documentation" means the medium upon which evidence
of a transaction is initially recorded. Examples of source documents in-
clude, but are not limited to, purchase requisitions, purchase orders, pur-
chase of service authorizations, staffing schedules, employee hourly
time reports, invoices and attendance documents for regional center con-
sumers and all other persons provided services. Source documents are
used to prepare records and reports.

(p) "Unique Consumer Identifier" means a unique number assigned to
identify each regional center consumer which is used instead of the con-
sumer name to maintain confidentiality.

(q) "Units of Service" means increments of service provided to region-
al center consumers which are used to charge and invoice the regional
center for services provided. The increment of service is specified as
hours, days or transportation mileage or any other increment of service
agreed to by the Department, regional center and service provider. It is
used by the Department to determine a rate of reimbursement.

(r) "Vendored" means the successful completion of the process used
to determine whether an applicant meets all legal and regulatory require-
ments to provide service to regional center consumers. This process must
be completed in order for a person, program or facility to receive payment
from a regional center for services rendered a regional center consumer.

(s) "Vendoring Regional Center" means the regional center in the ser-
vice catchment area in which the service provider is located, and to which
a potential service provider must submit an application for vendoriza-
tion. Service catchment area is defined in Section 50501 (a)( 18).
NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4648(a), 4648.2 and 4791(i), Welfare and Institutions Code. Reference: Sections
4512(b), 4646.5, 4648, 4648.1 and 4791, Welfare and Institutions Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsection (m) and Note filed 1 1-5-91 as an emergency; opera-
tive 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be trans-
mitted to OAL by 3-4-92 or emergency language will be repealed by operation
of law on the following day.

3. Amendment of subsection (m) and Note refiled 3-4-92 as an emergency; op-
erative 3^-92 (Register 92, No. 25). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Certificate of Compliance as to 3^^92 order including amendment of NOTE and
History 3 transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

5. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

6. Amendment of subsection (m) filed 4-22-94; operadve 4-22-94. Submitted
to OAL for printing only (Register 94, No. 16).

7. Amendment of subsecfion (m) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94. No. 25).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order, including amendment of subsec-
tion (m), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 1 3).

10. Change without regulatory effect amending subsections (g), (k), (m), and
(o)-(r) filed 1-17-97 pursuant to section 100, title 1, California CodeofRegula-
fions (Register 97, No. 3).

§ 50603. Access to Service Provider Records.

(a) The service provider shall permit right of access to:

(1) Any books, documents, papers, computerized data, source docu-
ments, consumer records, or other records of the service provider pertain-
ing to the service program and/or provision of services to persons with
developmental disabilities. All consumer records shall be treated as con-
fidential.

(2) Any facilities belonging to or used by the service provider pertain-
ing to the service program and/or the provision of services to persons
with developmental disabilities.

Page 262

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50604

(b) The right of access referred to in Section 50603(a) shall be applica-
ble to the Department, regional center, or any other authorized agency
representative and to the California Department of Health Services and
the United States Department of Health and Human Services when feder-
al government funds are involved in the payment for services.

(d) The right of access in this section shall be used to audit, review, ex-
amine, excerpt, reproduce, and/or make transcripts.

(e) The rights of access in this section shall not be limited to the re-
quired record retention period as specified in Section 50605(a).

(f) All service provider records, including corporate records, shall be
made immediately available to persons specified in Section 50603(b) for
purposes specified in Section 50603(d) above.

(g) The rights of access in this section shall not be Umited by a require-
ment of prior notice. Access without prior notice shall be limited to situa-
tions where the Department or regional center determines that the pur-
pose of the access would be thwarted if advance notice were given such
as in the case of suspected fraud, imminent destruction of records or simi-
lar circumstances.

(h) Access to any records pertaining to any regional center consumer
in the facility or to the operation of the facility, to the extent such opera-
tion pertains to the service program and/or the provision of services to
persons with developmental disabilities, shall be provided upon request
and in accord with confidentiality statutes.

(i) If requested by regional center staff, the service provider shall make
provision for a regional center consumer to be interviewed in private. The
written consent of the consumer or, where appropriate, the parent, guard-
ian or conservator shall be obtained before the interview is conducted. A
third party of the consumer's choice may be present during the interview
if the consumer so desires.

NOTK: Authority cited: Sections 4405 and 4648.2, Welfare and Institutions Code;
and Section 1 11 52, Government Code. Reference: Section 4648.1, Welfare and
Institutions Code; Section 11152, Government Code; and Section 1902(a)(4) and
(a)(27). Social Security Act, Title 42 CFR, Code of Federal Regulations, CFR
431.107(b).

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsection (b) and Note filed 1 1-5-91 as an emergency; opera-
tive 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

3. Amendment of subsection (b) and Note refiled 3-4-92 as an emergency; opera-
tive 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of Note and
History 3 transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

5. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

6. Editorial correcfion of printing error delefing duplicate section (Register 94, No.
17).

7. Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsections (a)(1), (h) and (i) filed
1-17-97 pursuant to section 100, fide 1, California Code of RegulaUons (Regis-
ter 97, No. 3).

§ 50604. Service Provider Record Maintenance
Requirements.

(a) Service providers shall maintain financial records which consis-
tently use a single method of accounting. These financial records shall
clearly reflect the nature and amounts of all costs and all income. All
transactions for each month shall be entered into the financial records
within 30 days after the end of that month.

(b) Subsection (a) shall apply to residential facilities for the purposes
described in subsection (c). day programs, transportation companies, and
other non-medical service providers which provide ongoing services to
regional center consumers on a regular basis each month, except that the
following service providers shall be exempt:

( 1 ) Residential facilities in which regional center consumers represent
less than ten percent of the total consumers served by the facility during
the last 1 2 month period.

(2) Residential facilities in which regional center consumers represent
more than ten percent of the total consumers served by the facility: how-
ever, no Departmental funds are received for the care and services pro-
vided to those consumers.

(c) Subsection (a) shall apply to residential facilities not exempted pur-
suant to subsections (b)(1) and (2) only for the following purposes:

( 1 ) To facilitate residential cost studies performed by the Department
or authorized agency representative;

(2) To ensure that staffing schedules in conformance with staffing lev-
el requirements, if any, are supported by payroll records and source docu-
ments;

(3) To ensure that revenue and cost information are available to sup-
port administrative overhead allocations of parent organizations, if appli-
cable; and

(4) To ensure that revenue and cost information are available to sup-
port intercompany transactions with affiliate or commonly-owned orga-
nizations, if applicable.

(d) All service providers shall maintain complete service records to
support all billing/invoicing for each regional center consumer in the pro-
gram. Service records used to support service providers' billing/invoic-
ing shall include, but not be Umited to:

(1) Information identifying each regional center consumer including
the Unique Consumer Identifier and consumer name;

(2) Documentation for each consumer reflecting the dates for program
entrance and exit, if applicable, as authorized by a regional center.

(3) A record of services provided to each consumer. The record shall
include:

(A) For the purchase of medical equipment and/or supplies, and/or
other merchandise, the date of the purchase, name of the entity/individual
from whom the equipment, supplies, and/or merchandise is purchased,
the item(s) purchased, and the cost of each item; or

(B) For transportation services, the dates of service, city or county
where service was provided, and the number of miles driven or trips pro-
vided; or

(C) For community-based day programs, the dates of service, place
where service was provided, the start and end fimes of service provided
to the consumer, and the daily or hourly units of service provided. For
community-based day program services provided solely in natural envi-
ronments, the city and county where service was provided shall be re-
ported as the place where service was provided. For community-based
day programs whose services are provided at the facility only or at both
the facility and in the community, the street address of the facility shall
be reported as the place where service was provided; or

(D) For all other services, the date, the start and end times of service
provided to the consumer, street address where service was provided, and
daily or hourly units of service provided.

(E) For goods and/or services purchased utilizing a voucher, in addi-
tion to the informafion specified above, the name of the actual provider
of the goods and/or services. For services provided by an individual se-
lected by the consumer or family member, the date of birth, social securi-
ty number (or a copy of any document accepted by the federal govern-
ment which establishes identity and employment eligibility which has
been compared to the original by the vendored family member and de-
clared under penalty of perjury to be a true and correct copy), address,
and telephone number of the individual who actually provided the ser-
vice must also be maintained.

(F) For contracts reimbursed based on units of service other than as
specified above, units of service shall also be maintained pursuant to (A),
(B), (C), or (D) above, as applicable.

(e) All service providers' records shall be supported by source docu-
mentation.

(f) Nothing specified in this section shall be construed as superseding
other record maintenance requirements set forth in statute or regulation.

Page 263

§ 50605

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTIi: Authority cited: Chapter \57, Statutes of 2003; and Sections 4631(a)(2)
and 4648.2, Welfare and Institutions Code. Reference: Sections 463 1 and 4648.1 ,
Welfare and Institutions Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Change without regulatory effect amending subsections (b)-(b)(2) and
(d)-(d)(2) tiled 1-17-97 pursuant to section 100, title 1, California Code of
Regulations (Register 97, No. 3).

3. Amendment of subsections (d)(2)-(3), new sub.sections (d)(3)(A)-(E) and
amendment of NoTi-: filed 10-9-2003 as an emergency; operative 10-9-2003
(Register 2003, No. 41). A Certificate of Compliance must be transmitted to
OAL by 2-6-2004 or emergency language will be repealed by operation of law
on the following day.

4. Amendment of subsections (d)(2)-(3), new subsections (d)(3)(A)-(E) and
amendment of NoTii refiled 2-3-2004 as an emergency; operative 2-3-2004
(Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL
by 6-2-2004 or emergency language will be repealed by operation of law on
the following day.

5. Amendment of subsections (d)(2)-(3). new subsections (d)(3)(A)-(E) and
amendment of Ncm-; refiled 6-1-2004 as an emergency; operafive 6-1-2004
(Register 2004, No. 23). A Certificate of Compliance must be transmitted to
OAL by 9-29-2004 or emergency language will be repealed by operation of
law on the following day.

6. Amendment of subsecfion (d)(3)(D) filed 8-27-2004 as an emergency; opera-
tive 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be
transmitted to OAL by 1 2-27-2004 or emergency language will be repealed by
operation of law on the following day.

7. Certificate of Compliance as to 6-1-2004 order, including amendment of sub-
section (d)(3)(B), new subsection (d)(3)(C), subsection relettering and amend-
ment of newly designated subsections (d)(3)(D) and (F), transmitted to OAL
9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

8. Refiling of 8-27-2004 order, including incoi-poration of relettering of subsec-
tion (d)(3)(D) to (d)(3)(E) in intervening action, 12-22-2004 as an emergency;
operative 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance
must be transmitted to OAL by 4-21-2005 or emergency language will be re-
pealed by operation of law on the following day.

9. Certificate of Compliance as to 12-22-2004 order, including futher amendment
of subsecfion (d)(3)(E), transmitted to OAL 4-19-2005 and filed 5-18-2005
(Register 2005, No. 20).

§ 50605. Service Provider Record Retention Requirements.

(a) All service providers' financial and service records, including
source documentation, shall be retained for a minimum of five years from
the date of final payment for the State fiscal year in which services were
rendered.

(b) If an audit is in progress or an appeal pursuant to Subchapter 7
(commencing with Section 50700) is pending at the end of the time speci-
fied in Section 50605(a), the service providers' records shall be retained
until all audit exceptions have been resolved.

(c) Copies made by microfilming or electronic data processing meth-
ods may be substituted for any original record with the exception of
source documentation.

NOTE; Authority cited: Secdon 4648.2, Welfare and Institutions Code. Reference:
Secfion 4648.1, Welfare and Institutions Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsecfion (a) filed 8-27-2004 as an emergency; operafive
8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be trans-
mitted to OAL by 1 2-27-2004 or emergency language will be repealed by op-
eration of law on the following day.

3. Amendment of subsecfion (a) refiled 12-22-2004 as an emergency; operative
12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be
transmitted to OAL by 4-21-2005 or emergency language will be repealed by
operafion of law on the following day.

4. Certificate of Compliance as to 12-22-2004 order transmitted to OAL
4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

§ 50606. Regional Center Auditing Requirements.

(a) To the extent that regional centers determine that it is necessary,
regional centers shall audit records of service providers. Such audits shall
be:

(1) Performed utilizing existing personnel resources; and

(2) Commenced within three years following the final payment for the
fiscal year under audit.

(b) Audits shall be performed to accomplish any or all of the following
objectives as applicable to the specific service provider:

(1) Verification that the service provider's documentation submitted
to the regional center as a basis for establishing a rate of payment by the
Department is:

(A) Complete, including other sources of revenue related to the service
program or provision of services to persons with developmental disabili-
ties;

(B) Accurate; and

(2) Verification that the service billings/invoices submitted by the ser-
vice provider to the regional center for payment are supported by the ser-
vice providers' consumer attendance and service records.

(3) Verification that the service providers' handling and accounting of
the consumers' personal and incidental funds is in accordance with appli-
cable regulations including, but not limited to. Title 1 7, California Code
of Regulations, Sections 56557(b)(3)(G) and 56602(d), and Title 22,
California Code of Regulations, Section 80026.

(4) Verification through analysis of payroll and consumer service re-
cords that staff-to-consumer ratios required by regulation, contract, or
agreement are met.

(A) Verification that the required staff-to-consumer ratios are being
met shall be determined as follows:

1 . For activity centers, adult development centers, and behavior man-
agement programs:

a. For each month of the audit period multiply the number of actual
consumer days of attendance by the number of direct service hours oper-
ated per day;

b. Divide the total computed in a. by the approved staffing ratio to
compute the number of direct care staff hours required during the ap-
proved program hours each month to maintain the approved staffing ra-
tio; and

c. Compare the number of direct care staff hours actually provided
during the approved program hours for each month with the number of
direct care staff hours required for each month computed pursuant to b.

2. For social recreation programs, independent living programs, and
infant development programs:

a. For each month of the audit period determine the actual hours of
consumer attendance for each month;

b. Divide the actual hours of attendance pursuant to a. by the approved
staffing ratio to compute the number of direct care staff hours required
during the approved program hours each month to maintain the approved
staffing ratio; and

(B) If a determination is made that the approved staff-to-consumer ra-
tio has not been met, the amount of any overpayments shall be deter-
mined as follows:

1 . Subtract the number of direct care staff hours actually provided dur-
ing the audit period from the number of direct care staff hours required
pursuant to (A)l. or (A)2.;

2. Multiply the amount computed in 1. by the average hourly salary
and wage and fringe benefit costs reported pursuant to Sections
57434(a)(1)(A) and (a)(2) and which were utiHzed to calculate the ven-
dor's rate of reimbursement received during the audit period.

(5) Verification of compliance with other provisions of applicable
statute, regulations, contracts, or agreements governing the service pro-
gram and/or the provision of services to persons with developmental dis-
abilities.

(c) If an audit of a service provider not vendored by the auditing re-
gional center is proposed, such audit shall be coordinated with the ven-
doring regional center. If the service provider has already been audited
for the same time period, the auditing regional center shall rely, to the ex-
tent possible, on the work performed by the vendoring regional center.

Page 264

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50607

(d) Upon completion of an audit, the regional center shall process the
audit findings and/or recommendations defined in Title 17. California
Code of Regulations, Section 50701, as follows:

( 1 ) A draft of the audit report shall be forwarded to the service provider
for comment within sixty (60) days of completion of work performed at
the service provider's location.

(2) The service provider shall be given thirty (30) days in which to re-
spond to the audit report draft from time of its receipt.

(e) If an audit of a service provider involves review of documentation
submitted to either the regional center or the Department and relied upon
as the basis for establishing a rate of payment for that service provider,
the regional center shall forward its preliminary audit report to the De-
partment.

( 1 ) The preliminary audit report shall include the service providers' re-
sponse to the audit findings and/or recommendations as an attachment.

(2) The preliminary audit report shall include the regional center's re-
ply to the providers' response as an attachment.

(3) The Department shall consider the preliminary audit report in es-
tablishing a rate. If an adjustment to the rate is proposed:

(A) The effective date of the adjusted rate of payment shall be deter-
mined by the Department based on information contained in the prelimi-
nary audit report and supporting audit working papers.

(B) The adjusted rate of payment shall be calculated and submitted by
the Department to the regional center for use in determining any amounts
which may be due from or due to the service provider.

(4) The Department shall notify the regional center if it is determined
that an adjustment to the rate of payment is not necessary after consider-
ing the preliminary audit report.

(f) The final audit report shall be issued by the regional center, within
90 days of the deadline for the service provider's response.

( 1 ) The final report shall notify the service provider of its right to ap-
peal the audit findings pursuant to Title 17, California Code of Regula-
tions, Section 50730.

(2) The final report shall incorporate the response of the service pro-
vider and the regional center's reply to the response.

(3) A copy of the rate letter issued by the Department adjusting the rate
of payment shall be enclosed with the final report, if applicable.

(4) The final report shall include a breakdown of any amounts due the
regional center and Department by fiscal year and require remittance in
accordance with Section 50705. If an amount is due the service provider,
the final report shall include a breakdown of any amounts due by State
fiscal year. Procedures for requesting payment of the amount due from
the regional center shall also be included.

(5) When a remittance pursuant to subsection (4) is made, a copy of
the check and any transmittal document shall be sent to the Department.

(6) Upon issuance, a copy of the final report shall be sent to the Depart-
ment.

(g) The auditing work performed by the regional center shall, to the
maximum extent that the auditor determines practicable, follow the stan-
dards for financial and compliance audits, as listed in the "Standards for
Audit of Governmental Organizations, Programs, Activities and Func-
tions," 1981 Revision, sued by the Comptroller General of the United
States, United States General Accounting Office, which is incorporated
by reference herein.

( 1 ) The auditing work performed by the regional center shall, at a mini-
mum, meet the following standards:

(A) In all matters relating to the audit work, the regional center staff
involved shall be free from conflicts of interest as defined in Title 17, Cal-
ifornia Code of Regulations, Section 54521, and in Section 4627 of the
Welfare and Institutions Code.

(B) Due professional care shall be used in conducting the audit and in
preparing related reports.

(C) When factors external to the audit organization and the auditor re-
strict the audit or interfere with the auditor's ability to form objective
opinions and conclusions, the auditor shall attempt to remove the limita-
tion or, failing that, disclose the limitation in the audit report.

(D) A review shall be made of compliance with apphcable statutes and
regulations governing the service program and/or the provision of ser-
vices to persons with developmental disabilities.

(E) A written record of the auditor's work shall be retained in the form
of working papers.

(F) Final audit reports shall be submitted to the appropriate officials
of the organization audited and to the appropriate officials of the regional
center and the Department. Copies of the reports shall also be:

1 . Sent to the other officials who may be responsible for taking action
and to others authorized to receive such reports.

2. Made available for public inspection, unless restricted by law or reg-
ulations; and

3. Accompanied by a transmittal document which specifies that the re-
port is subject to appeal and includes the status of any such appeal.

(G) For purposes of subsection (F) ""other officials" and ""others" au-
thorized to receive such reports include, but shall not be limited to, those
designated by law or regulafion to receive such reports, legislators, and
those of other levels of government that have provided funds to the au-
dited entity.

(h) The reports specified in this section shall be written reports.
NOTE; Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405,
463 1 . 4648.2. 479 1 (i). Welfare and Institutions Code: and Section 11152, Govern-
ment Code. Reference; Sections 4629(f), 4631 , 4648. 1 and 479 1 , Welfare and In-
stitutions Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93. No. 26).

3. New subsections (b)(4)(A)-(B)2 filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printins only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to
secdon 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 50607. Regional Center Contracting Requirements.

When a regional center enters into a contract with a service provider,
the contract shall include, but not be limited to, the following general pro-
visions.

(a) Contract provisions stating the parties, the general purpose, the ser-
vices to be provided, the date of execution, and the applicable statutes and
regulations applying to the contract.

(b) A contract provision requiring a signature by authorized represen-
tatives of all contracting parties.

(d) Contract provisions to include the definitions of terms unique to the
contract or contracted service.

(e) A contract provision stafing that the execution of any amendment
or modification to the regional center/service provider contract shall
comply with the requirements of applicable statutes and regulations.

(f) A provision stating that the service provider and the agents and em-
ployees of the service provider, in the performance of the contract, shall
act in an independent capacity, and not as officers or employees or agents
of the State of California or the regional center.

(g) A provision stating that assignment of the contract for consumer
services shall not be allowed.

(h) A contract provision indicating that all services shall be rendered
in accordance with specifically idenfified provisions of statute, and Fed-
eral and State regulations.

(i) A contract provision stating that the terms of the contract shall not
be construed to excuse compliance with existing statutes or regulations.

(j) A contract provision stating that subcontracting of services for
which the service provider is vendored shall not be permitted except for
contracts for transportation services or community-based day program

Page 265

§ 50608

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

services pursuant to Title 17, California Code of Regulations, Section

56710(b).

NOTE: Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions

Code; and Section 1 1 132. Government Code. Reference: Sections 4629(f), 4631,

4648.1, 4690.1 and 4691, Welfare and Institutions Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of subsection (k) filed 9-26-91; operative 9-26-91 pursuant to
Government Code section 1 1346.2(d) (Register 92, No. 10).

3. Repealer of subsection (h) and relettering, amendment of subsection (j) and
NoTi; filed 11-5-91 as an emergency: operative 1 1-5-91 (Register 92, No. 21).
A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency
language will be repealed by operation of law on the following day.

4. Repealer of subsection (h) and relettering, amendment of subsection (j) and
NoTii refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25).
A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency
language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3^-92 order includine amendment of Note and
History 4 transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (g) filed 1-17-97 pur-
suantlo secfion 100, title 1, California Code of Regulations (Register 97, No.
3).

§ 50608. Contract Duties and Responsibilities.

When a regional center enters into a contract with a service provider,
the contract shall include, but not be limited to, the following provisions
specifying the duties and responsibilities of the service provider.

(a) A contract provision requiring that the level of service provided
shall, at a minimum, be consistent with the service provider's program
design, if applicable, and any other program related documentation relied
upon by the Department as a basis for establishing rates of payment.

(1) The service provider's program design shall be made a part of the
contract.

(2) The service provider's program design shall include, but not be
limited to:

(A) A written statement of the facility's purpose and goals;

(B) A description of the services provided;

(D) Consumer entrance and exit criteria;

(E) Job descriptions of all positions;

(F) Staff qualifications for each job description;

(G) A staffing plan which indicates the staff-to-consumer ratio for de-
livery of direct care services for all hours the consumers are under the su-
pervision of the facility;

(H) A staff training plan, if any; and
(I) Hours and location of service.

(b) A contract provision requiring the service provider to maintain
books, records, documents and other evidence pertaining to all income,
expenses, and services relating to and/or affecting the performance of the
contract.

(c) A contract provision requiring the service provider to maintain ser-
vice records to support all billings/invoicing as specified in Section
50604(d)( 1 ) through (3)(F), as applicable.

(d) A contract provision requiring the service provider to submit to the
regional center with their billings/invoices the information specified in
(c) above for the billing period.

(e) A contract provision requiring the service provider to adopt and pe-
riodically review, a written internal procedure to resolve consumer griev-
ances pursuant to Welfare and Institutions Code Section 4705.

NOTE: Authority cited: Chapter 157, Statutes of 2003; Sections 4405, 4631 and

4648.2, Welfare and Institutions Code; and Secfion 11152, Government Code.
Reference: Sections 4525, 4629(f), 4631 and 4648.1, Welfare and Institutions
Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40.)

2. Amendment of Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

3. Change without regulatory effect amending subsections (a)(2)(D), (a)(2)(G)
and ( c) filed 1-1 7-97 pursuant to section 1 00, title 1 , California Code of Regula-
tions (Register 97, No. 3).

4. New subsections (c)-(d), subsection reletterina and amendment of Note filed
10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No. 41). A
Certificate of Compliance must be transmitted to OAL by 2-6-2004 or emer-
gency language will be repealed by operation of law on the following day.

5. New subsections (c)-(d), subsection relettering and amendment of NoTi-: refiled
2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6). A Cer-
tificate of Compliance must be transmitted to OAL by 6-2-2004 or emergency
language will be repealed by operation of law on the following day.

6. New subsections (c)-(d), subsection relettering and amendment of Note refiled
6-1-2004 as an emergency; operative 6-1-2004 (Register 2004. No. 23). A
Certificate of Compliance must be transmitted to OAL by 9-29-2004 or emer-
gency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 6-1-2004 order, including amendment of sub-
section (c), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register
2004. No. 44).

§ 50609. Contract Fiscal Provisions.

The regional center/service provider contract shall include, but not be
limited to, the following fiscal or fiscally related provisions:

(a) Provisions specifying details for the payment of services rendered
including, but not limited to:

( 1 ) The method of payment;

(2) The time of payment;

(3) a requirement that the rate of payment, in accordance with refer-
enced contract exhibits, contains one of the following:

(A) An exhibit displaying Departmental or regional center documen-
tation reflecting the proposed rate of payment per unit of service; the defi-
nition of a unit of service; and the necessary data and mathematical com-
putation used to establish the proposed rate of payment per unit of
service.

(B) An exhibit displaying Departmental documentation reflecting the
various ranges of proposed rates of payment for residential care services
and other applicable services subject to such maximum limitations.

(4) A detailed description of the method to be used in determining the
units of service allowed for billing/invoicing in accordance with the ref-
erenced contract exhibits required under Section 50609(a)(3).

(b) A provision specifying the basis used by the Department to estab-
lish the rate of payment for services.

(1) A provision identifying a contract exhibit which shall contain the
service provider's fiscal and program related documentation relied upon
as the basis for establishing the rate of payment.

(A) A provision indicating that both parties to the contract have come
to a full understanding and agreement of a specified method used to accu-
mulate data contained in the service provider's documentation.

1 . A provision indicating that the service provider attests that the meth-
od referred to in Section 50609(b)(1)(A) was used to accumulate data
contained in the service provider's documentation.

(B) A provision indicating that the service provider attests that such
fiscal and program related documentation is:

1 . complete;

2. accurate to the best of the service provider's knowledge;

3. supported by records and source documentation;

4. prepared in accordance with the instructions provided by the De-
partment and;

5. subject to audit.

(d) A provision specifying that the consideration to be paid the service
provider, as provided herein, shall be the total compensation for perform-
ance of the contract and its requirements, unless otherwise expressly pro-
vided.

(e) When Federal Government funds are involved, a provision requir-
ing service provider compliance with all Federal rules including, but not
limited to the applicable sections of the Code of Federal Regulations.

(f) A provision specifying the maximum amount which can be paid un-
der this contract.

•

Page 266

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50612

NOTI:: Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions
Code; and Section 1 1 152. Government Code. Reference: Section 4629(f), 4631
and 4648.1, Welfare and Institutions Code.

History
1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

§ 50610. Contract Fiscal Audit.

(a) The regional center/service provider contract shall include, but not
be limited to, audit provisions as follows:

(1) A provision that the service provider's records pertaining to the
service program and/or the provision of services to persons with develop-
mental disabilities shall be open for audit by the Department, regional
center, and any authorized agency representative for a minimum period
of three years from the date of the final payment for the State fiscal year.

(2) A provision indicating that the service provider shall agree to uti-
lize and be bound by Title 17, California Code of Regulations, Sections
50700, et seq. should the service provider elect to appeal any audit find-
ings and/or recommendations.

(3) A provision indicating that the service provider shall accept finan-
cial liability for any audit findings and/or recommendations disclosed by
audit and promptly repay amounts owed unless appealed and liquidation
is stayed pursuant to Title 1 7, California Code of Regulations, Section
50705.

NOTE: Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions
Code and Section 1 1 152, Government Code. Reference: Sections 4629(f), 4631
and 4648.1, Welfare and Institutions Code.

History
1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

§ 5061 1 . Contract Termination.

(a) The regional center/service provider contract shall contain the re-
quirements for the termination of the contract.

(b) The provision for contract termination by the regional center shall
include:

( 1 ) The methods by which termination will be effected;

(2) The basis for settlement; and

(3) A description of the conditions which shall constitute possible
grounds for termination of the contract and/or payment. Such conditions
shall include, but not be limited to, those in which it is determined that:

(A) The service provider has not complied with provisions of its con-
tract, the terms of the purchase of service authorization, applicable Fed-

eral and State regulations, or statutes governing the service program and/
or the provision of services to persons with developmental disabilities.
(4) The Department, regional center, or any authorized representali\ e
shall determine whether the conditions, specified in Section 5061 1(b)(3)
above, exist to constitute possible grounds for contract termination. Such
determination shall be:

(A) Conveyed to the service provider 30 days in advance of payment
and/or contract terminafion, pursuant to Welfare and Institutions Code,
Section 4710.

(B) In the form of a notice containing the provisions for contract termi-
nafion specified in subsections (b)(1) through (3).

( 1 ) A requirement that nofice be given to the regional center in writing;
and

(2) A requirement that notice be given at least 30 days prior to contract
termination.

(d) In no event, shall a regional center or service provider terminate a
contract without complying with the requirements set forth in statute and
regulation including, but not limited to. Welfare and Institutions Code,
Sections 4502, 4646, 4646.3, 4648, 4710, and 4741.

Note: Authority cited; Chapter 722, Statutes of 1 992, Section 147; Sections 4405,
463 1 , 4648.2 and 479 1 (i). Welfare and Institutions Code; and Section 1 ] 1 52, Gov-
ernment Code. Reference: Sections 4502, 4629(f), 463 1 , 4646.5, 4648. 1 and 4741 ,
WelfcU-e and Institutions Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Regfster 93, No. 26).

3 . Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 5061 2. Regional Center Purchase of Service
Requirements.

(a) A purchase of service authorization shall be obtained from the re-
gional center for all services purchased out of center funds.

(b) The authorization shall be in advance of the provision of service,
except as follows:

( 1) A retroactive authorization shall be allowed for emergency ser-
vices if services are rendered by a vendored service provider:

[The next page is 267.]

Page 266.1

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§ 50701

(A) At a time when authorized personnel of the regional center cannot
be reached by the service provider either by telephone or in person (e.g.,
during the night or on weekends or holidays);

(B) Where the service provider, consumer, or the consumer's parent,
guardian or conservator, notifies the regional center within five working
days following the provision of service; and

( 1 ) The authorization shall be in writing, except as follows:
(A) A verbal authorization by the regional center director or his autho-
rized agency representative shall be allowed to provide emergency ser-
vices utilizing the following procedures:

1 . An immediate notation is made in the case record showing the date
and nature of such authorization; and

2. The verbal authorization is confirmed with a written authorization
from the regional center as soon as possible, but no later than the regional
center's next cyclical production of purchase of service authorization
documents.

(d) All authorizations which are not self-limiting in nature shall be
cancelled in writing at the time a consumer case is closed by the regional
center.

(e) The regional center purchase of service authorization shall contain
the requirements for terminating payments to service providers. The pro-
vision for termination shall be consistent with the requirements set forth
in Sections 4710, 4715, and 4741, Welfare and Institutions Code.

( 1 ) The circumstances for terminating payments by the regional center
shall include:

(A) The relocation of the consumer as a result of consumer or, where
appropriate, the parent, guardian or conservator dissatisfaction;

(B) The relocation of a facility resident as a result of the determination
of immediate danger or reasonable cause as defined in Title 1 7, Califor-
nia Code of Regulations, Section 56551(j) and (p); or

(2) In no event, shall a regional center terminate payments to service
providers without complying with the requirements set forth in statute
and regulation including, but not limited to. Welfare and Institutions
Code, Sections 4648, 4710 and 4715.

(f) A copy of the purchase of service authorization shall be retained by
the regional center.

NOTE: Authority cited: Sections 4405, 4631 and 4648.2, Welfare and Institutions
Code; and Section 1 1 1 52, Government Code. Reference: Sections 4629(0. 463 1
and 4648.1, Welfare and Institutions Code.

History

1. New section filed 9-22-89; operative 10-22-89 (Register 89, No. 40).

2. Change without regulatory effect amending subsections (b)(1)(B), (d),
(e)(1)(A) and (e)(1)(C) filed 1-17-97 pursuant to section 100, title 1, California
Code of Regulations (Register 97, No. 3).

Subchapter 7. Fiscal Audit Appeals

Article 1. General

§ 50700. Purpose and Scope.

The procedures described in this subchapter shall be applicable to and
govern all appeals from audit reports. Letters of Findings and formal de-
cisions issued by the Department of Development Services or regional
centers which result from fiscal audits of regional centers and/or their
contractors conducted pursuant to Welfare and Institutions Code, Sec-
tions 4648.2 and 4780.5. Additionally, the procedures described herein
may be used to appeal other fiscal audits conducted by the Department
if provided for by way of regulation or agreement.

NOTE: Authority cited: Section 1 1 152, Government Code; and Sections 4648.2
and 4780.5. Welfare and Institutions Code. Reference: Sections 4629, 463 1 , 4635.
4648.1 and 4780.5, Welfare and Institutions Code.

History

1 . New Chapter 4, Subchapter 6 (Articles 1-3, Sections 50600-50667. not consec-
utive) filed 6-26-80: effective thirtieth day thereafter (Register 80, No. 26).

2. Editorial redesignation of former Chapter 4 (Subchapters 5 and 6, Sections
50500-50667, not consecutive) to Chapter 1 (Subchapters 5 and 6, Sections
50500-50667. not consecutive) filed 9-28-83 (Register 83, No. 40)

3. Renumbering of former Subchapter 6 to Subchapter 7, and renumbering and
amendment of former Section 50600 to Section 50700 filed 7-5-88; operative
8-4-88 (Register 88, No. 29).

§50701. Definitions.

The following definitions govern the construction of sections within
this subchapter unless the context otherwise requires:

Words shall have their usual meaning unless the context or a definition
clearly indicates a different meaning. "May" means permissive. "Shall"
means mandatory. "Should" means suggested or recommended.

(a) "Administrative review" means the preliminary investigation of
the "Statement of Disputed Issues" submitted by an appellant as a part of
its initial appeal. The investigation shall be conducted by an appeals re-
view officer of the Department and may include, but not be limited to, the
following:

(1) A review of all documents submitted by the parties;

(2) An interview of the parties and any prospective witnesses;

(3) An on-site inspection of records;

(4) An informal conference.

(b) "Appellant" means any individual, entity or organization which is
in the process or has properly filed an appeal in accordance with the pro-
visions of this subchapter. An appellant may act through any duly autho-
rized agent or legal counsel designated pursuant to subsection (c) of Sec-
tion 50730.

(c) "Appeal" means a written notification to the Department by any in-
dividual, entity or organization audited by the Department or regional
center which disputes or protests a written report, finding or decision is-
sued by the Department or regional center relating to such audit.

(d) "Appeals review officer" means an individual designated by the
Department to conduct the administrative review.

(e) An "audit adjustment" means a finding contained in an audit report
that either the fiscal requirements governing the individual, entity or or-
ganization audited have not been complied with to a specified extent or
that a previously reported or claimed amount does not agree with an au-
dited amount.

(f) An "audit exception" means a type of audit adjustment or manage-
ment comment which is against the interests of the individual, entity or
organization audited.

(g) An "audit report" means a document issued by the Department or
regional center which results from a fiscal examination of the accounts,
records and transactions of any individual, entity or organization subject
to audit by the Department or regional center. The audit report may con-
tain findings, such as audit exceptions, audit adjustments or management
comments, as well as management recommendations, schedules and any
other items of explanation necessary to provide an analysis of the fiscal
activities for the period covered by the audit.

(h) "Date of mailing" means the date postmarked on the envelope if
postage was prepaid and the envelope was properly addressed.

(i) "Days" means calendar days.

(j) "Department" means the State Department of Development Ser-
vices unless otherwise specified. The Department shall act through its au-
thorized representatives.

(k) "Director" means the Director of the State Department of Develop-
ment Services.

(/) "Duplicate" means a facsimile of the original produced by the same
impression or from the same matrix as the original or by some other tech-
nique of accurate reproduction.

(m) A "finding" means a relevant, written conclusion arrived at as a
result of an audit, an administrative review or hearing and is contained

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

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in the audit workpapers, audit report. Letter of Findings, or decision re-
lated to tiie audit in question.

(n) "Formal hearing" means an administrative hearing conducted by
a hearing officer pursuant to Welfare and Institutions Code Section
4648.2, 4780.5 and the provisions of this subchapter.

(0) "Hearing officer" means a person appointed by the Director pur-
suant to Welfare and Institutions Code Sections 4648.2 and 4780.5 to
conduct formal hearings under this subchapter.

(p) "Informal conference" means a meeting conducted by an appeals
review officer as a part of the administrative review to clarify or resolve
facts and issues in dispute.

(q) A "management comment" means a finding contained in an audit
report describing management practices of the individual, entity or orga-
nization audited as such practices relate to its fiscal activities.

(r) A "management recommendation" means a corrective action pro-
posed by the Department or regional center to enable the individual, enti-
ty or organization audited to better comply with appropriate fiscal re-
quirements.

(s) "Party" means an appellant, regional center or the Department.
"Party also means an individual, entity, or organization joined to an ap-
peal as an additional party pursuant to subsection (b) of Section 50708."
The term "party" does not include the appeals review officer, the hearing
officer, the Director, or any witnesses.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfaie and Institutions Code.

History

1. Renumbering and amendment of former Section 50601 to Section 50701 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of Note (Register 2002, No. 46).

§ 50702. Revised Audit Report.

(a) A revised audit report may be issued by or on behalf of the Depart-
ment or regional center for the fiscal period or periods for which proceed-
ings are pending under this subchapter.

(b) The appeals review officer or hearing officer may suspend their re-
spective proceedings until identification of any additional disputes that
may result from a revised audit report.

report may be included in the proceedings at the request of the appellant

in accordance with Section 50730.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 463 1 , 4635,
4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181,
and 1 11 82, Government Code.

History

1 . Renumbering and amendment of former Section 50602 to Section 50702 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of of subsection (c) (Register 2002, No. 46).

§ 50703. Department IVIailings.

A mailing by the Department shall be deemed to have been properly
executed if addressed and mailed to the last address on record with the
Department.

NoTE: Authority cited: Section 1 1 1 52, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History
1 . Renumbering of former Section 50603 to Section 50703 filed 7-5-88; operadve

8-4-88 (Register 88, No. 29).

§ 50704. Disqualification of Appeals Review Officer or
Hearing Officer.

(a) An appeals review officer or hearing officer shall upon his/her own
motion withdraw from any proceedings in which he/she:

(1) Cannot give a fair or impartial hearing;

(2) Has a personal or pecuniary interest.

(b) A party may request the disqualification of an appeals review offi-
cer or hearing officer by filing an affidavit prior to the taking of evidence
at a hearing, stating with particularity the grounds upon which it is

claimed that a fair and impartial hearing cannot be accorded. The issue
shall be determined by the appeals review officer or the hearing officer.
NOTE: Authority cited: Sections 1 1 152. and 11512, Government Code; and Sec-
tions 4648.2 and 4780.5. Welfare and Institutions Code. Reference: Sections
4648. 1 and 4780.5, Welfare and Institutions Code; and Sections 1 1 1 8 1 and 1 1 1 82,
Government Code.

History
1 . Renumbering and amendment of former Section 50604 to Section 50704 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

§ 50705. Recovery of Overpayments.

(a) Where the Department, as a result of an audit, establishes that an
overpayment has been made to an individual, entity or organization, the
Department shall begin liquidation of the overpayment 30 days after the
issuance of the audit report, except that:

( 1 ) Where the appellant has requested an administrative review pur-
suant to Section 50730 of this subchapter, liquidation of the disputed
overpayments shall be deferred until the Letter of Findings has become
final;

(2) If any overpayments remain in dispute after the administrative re-
view, the appellant may file with the hearing officer, a request for stay
of liquidation pending the outcome of the formal hearing. To be consid-
ered, such request shall be in writing, and shall be submitted with the re-
quest for formal hearing pursuant to Secfion 50750. Such request for stay
must set forth reasons why liquidation should be stayed for the duration
of the formal hearing process. The hearing officer may in his/her discre-
tion, make such orders as he/she deems necessary pursuant to such re-
quest, including, but not limited to, a temporary stay of liquidation.

(b) When the overpayment is due and owing, it shall be recovered by
any of the following methods:

( 1 ) Lump sum payment;

(2) Offset against current payments due;

(3) A repayment agreement of not more than five years duration from
the date the agreement is made;

(4) Any other method of recovery available to and deemed appropriate
by the Director.

(1) The overpayment is recovered;

(2) The Department and/or the regional center enters into a repayment
agreement which satisfies such overpayment;

(3) The Department determines that, as a result of proceedings under
this subchapter, there is no overpayment.

(d) The regional center shall promptly remit all recoveries to the De-
partment along with the information necessary to identify the causal au-
dit report, the applicable fiscal year and the applicable audit adjustment.

(e) Nothing in this secfion shall prohibit an individual, entity or organi-
zafion audited by the Department or regional center from repaying all or
apart of the disputed overpayment without prejudice to its right to a hear-
ing under this subchapter.

(f) Any recovered overpayment that is subsequently determined to
have been erroneously collected shall be promptly refunded to the appel-
lant.

NOTE: Authority cited: SecUons 1 1 152, Government Code; and Secfions 4648.1 ,
4648.2, and 4780.5, Welfare and Institutions Code. Reference: Sections 4629,
4635, 4648.1, and 4780.5, Welfare and Institufions Code.

History
1 . Renumbering and amendment of former Section 50605 to Section 50705 filed
7-5-88; operaUve 8-4-88 (Register 88, No. 29).

§ 50706. Costs and Attorneys Fees.

(a) Except as otherwise expressly provided in this subchapter, the De-
partment:

( 1 ) Shall assume all expenses related to the operation and maintenance
of the appeal process;

(2) Shall not reimburse under the provisions of this subchapter an ap-
pellant's expenses or costs incident to prosecuting an appeal.

(b) No party shall be liable to any other party for attorneys fees which
result from proceedings under this subchapter.

Page 268

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§ 50730

(c) The Department shall not be liable to, nor reimburse, either through
any contraet, entered into after the effeetive date of this section, or by any
other means, for the following expenses which may result from proceed-
ings under this subchapter, except as ordered by the Director in the deci-
sion:

( 1) Attorney fees;

(2) Costs incurred or assessed pursuant to the following sections:

(A) 50753 (g):

(B) 50754 (e);

(D) 50755 (c);

(E) 50758 (m);

(3) Any other special costs duly assessed against a party by the appeals
review officer or hearing officer in accordance with such other powers
as may be granted herein.

NOTE: Authority cited: Sections 1 11 52, Government Code; and Sections 4648.2,
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1, and
4780.5, Welfare and Institutions Code.

History
1 . Renumbering and amendment of former Section 50606 to Section 50706 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

§ 50707. Consolidation of Appeals.

(a) Parties may seek consolidation of two or more requests for admin-
istrative review or formal hearing which are pending on appeal, for the
reduction of effort and expense of separate appeals, where the issues
stated and evidence cover much the same ground and can advantageously
be combined in one appeal. Such request shall be in writing and may be
made if:

(1) An appellant has consecutive or multiple appeals, or two or more
appellants have concurrent appeals;

(2) The appeals involved common questions of law or fact; and

(3) No substantial right of any party will be prejudiced.

(b) Upon such request, the appeals review officer or hearing officer
may order a joint review or hearing of any or all matters in issue in the
appeals, may order all the appeals consolidated, or may make such orders
concerning the proceedings as may tend to avoid unnecessary delay. In
exercising his/her discretion, the appeals review officer or hearing offi-
cer may refer to appropriate principles of California law governing con-
solidations of actions and/or class actions. The appeals review officer or
hearing officer shall provide adequate notice to the parties of any requests
for consolidation or orders resulting therefrom which may affect them.

(d) The appeals review officer or hearing officer may issue a single
Letter of Findings or decision for the matters decided as a result of a con-
solidated admirustrative review or hearing.

(e) The appeals review officer or hearing officer may, for good cause,
sever appeals previously consolidated.

(f) The appeals review officer' s order granting or denying a request for
consolidation is appealable immediately. The grounds for appeal shall be
limited to abuse of discretion.

NOTE: Authority cited: Sections 1 1 152, Government Code; and Sections 4648.2,
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1, and
4780.5, Welfare and Institutions Code.

History

1 . Renumbering and amendment of former Section 50607 to Section 50707 filed
7-5-88: operative 8-4-88 (Register 88, No. 29).

§ 50708. Additional Parties.

(a) Appellants may submit a joint appeal where the issues involve the
same transaction or series of transactions and there is a common question
of law or fact; or where the appellants are each asserting claims to a par-
ticular amount in controversy, which are adverse to the Department or re-
gional center. It is not necessary that each appellant be interested as to
every issue presented in the joint appeal.

(b) The appeals review officer or hearing officer may, on his/her own
motion, or upon the written request of a party, order the joinder of an indi-
vidual, organization, or entity not a party to the appeal whenever it ap-

pears necessary to avoid injury to absent persons, to bring a real party in
interest into the proceedings, or to otherwise obtain a complete settle-
ment of a controversy in one appeal.

(c) The appeals review officer or hearing officer shall furnish adequate
notice to all parties of joint appeals or orders for joinder, and shall provide
for proper service of process on persons to be joined in the proceedings.

(d) The appeals review officer or hearing officer may make such or-
ders concerning additional parties as he/she deems necessary in his/her
discretion, including, but not limited to the following:

( 1 ) Granting continuances and holding additional conferences or hear-
ing to accommodate an additional party;

(2) Finding for one or more of the appellants according to their respec-
tive rights to relief, or resolving conflicting claims between appellants;

(3) Ordering severance of appeals or parties previously joined; or

(4) Issuing a single Letter of Findings or decision for matters decided
as a result of a merged administrative review or hearing.

(e) In exercising his/her discretion, the appeals review officer or hear-
ing officer may utihze appropriate principles of California law governing
third party practice.

(f) The appeals review officer' s order granting or denying a request for
joinder is appealable immediately. The grounds for appeal shall be lim-
ited to abuse of discretion.

NOTE: Authority cited: Sections 1 1 152, Government Code; and Sections 4648.2
and 4780.5, Welfaie and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History

1. Renumbering and amendment of former Section 50608 to Section 50708 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial conection of Note (Register 2002, No. 46).

Article 2. Administrative Review

§ 50730. Request for Administrative Review.

(a) An individual, entity, or organization which disagrees with any
portion or aspect of an audit report issued by the Department or regional
center may request an administrative review. The appellant's written re-
quest shall be submitted to the Department within 30 days after the re-
ceipt of the audit report. The request may be amended at any time during
the 30-day period.

(b) If the appellant does not submit the written request within the
30-day period, the appeals review officer shall deny such request, and all
audit exceptions or findings in the report shall be deemed final unless the
appellant establishes good cause for late filing.

(c) The request shall be known as a "Statement of Disputed Issues."
It shall be in writing, signed by the appellant or his/her authorized agent.
and shall state the address of the appellant and of the agent, if any agent
has been designated. An appellant shall specify the name and address of
the individual authorized on behalf of the appellant to receive any and all
documents, including the final decision of the Director, relating to pro-
ceedings conducted pursuant to this subchapter. The Statement of Dis-
puted Issues need not be formal, but it shall be both complete and specific
as to each audit exception or finding being protested. In addition, it shall
set forth all of the appellant's contentions as to those exceptions or find-
ings, and the estimated dollar amount of each exception or finding being
appealed.

(d) If the appeals review officer determines that a Statement of Dis-
puted Issues fails to state the grounds upon which objections to the audit
report are based, with sufficient completeness and specificity for full res-
olution of the issues presented, he/she shall notify the appellant, in writ-
ing, that it does not comply with the requirements of this subchapter.

(e) The appellant has 15 days after the date of mailing of such notice
within which to file an amended Statement of Disputed Issues. If the ap-
pellant does not amend his/her appeal to correct the stated deficiencies
within the time permitted, all audit exceptions or findings affected shall
be dismissed from the appeal, unless good cause is shown for the non-
compliance.

Page 269

§ 50731

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(0 The appellant shall attach to the Statement of Disputed Issues all
documents which he/she intends to introduce into evidence in support of
stated contentions. An appellant that is unable to locate, prepare, or com-
pile such documents within the appeal period specified in Subsection (a)
above, shall include a statement to this effect in the Statement of Disputed
Issues. The appellant shall have an additional 30 days after the expiration
of the initial 30-day period in which to submit the documents. Docu-
ments that are not submitted within this period shall not be accepted into
evidence at any stage of the appeal process unless good cause is shown
for the failure to present the documents within the prescribed period.
Note-: Authority cited: Sections 1 1 152, Government Code; and Sections 4648.2,
and 4780.5, Welfare and histitutions Code. Reference: Sections 4629, 463 1 , 4635,
4648.1 and 4780.5, Welfare and Institutions Code; and Sections 1 11 80, 1 1 181,
and 1 1 182, Government Code.

History

1 . Renumbering and amendment of former Section 50630 to Section 50730 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

§ 50731 . Informal Conference.

(a) The appeals review officer may schedule and preside at an informal
conference if he/she determines that it is appropriate as part of the admin-
istrative review process. The appeals review officer shall determine the
time and place of an informal conference giving due consideration to the
reasonable request of a party.

(b) Written notice of the time and place of the informal conference
shall be mailed to each party at least 30 days before the date of the infor-
mal conference. This period may be shortened with the consent of all par-
ties. Any party may waive notice.

(c) Efforts shall be made to resolve the facts and issues in dispute in
a fair and reasonable manner, subject to the requirements of state and fed-
eral law. Matters in dispute, raised in the appellant's Statement of Dis-
puted Issues pursuant to Section 50730, which are not discussed or raised
at the informal conference shall not be deemed waived.

(d) The Department shall make an electronic record of the proceed-
ings.

NOTE: Authority cited: Sections 1 1 152, Government Code; and Sections 4648,2,
and 4780.5, Welfare and Institutions Code. References: Sections 4629, 4635,
4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180, 11181,
and 1 1 182, Government Code.

History
1. Renumbering and amendment of former Section 50631 to Section 50731 filed
7-5-88; operative 8^-88 (Register 88, No. 29).

§ 50732. Letter of Findings.

The results of the administrative review shall be submitted to the par-
ties, within 60 days after the close of the administrative review record,
in the form of a written document entitled "Letter of Findings." The Let-
ter of Findings shall be final unless a timely request for a formal hearing
is made. Upon becoming final, the Letter of Findings has the legal effect
of amending the audit report and supersedes it to the extent there are any
inconsistencies.

NOTE: Authority cited: Sections 1 1 152, Government Code; and Sections 4648.2,
and 4780.5, Welfare and Institutions Code. References: Sections 4635, 4648. 1 and
4780.5, Welfare and Institutions Code.

History
1. Renumbering and amendment of former Section 50632 to Section 50732 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

Article 3. Formal Hearing

§ 50750. Request for Formal Hearing.

(a) Upon receipt of the Letter of Findings following the administrative
review, a party may appeal for a formal hearing conducted by a hearing
officer.

(b) The requirements made applicable to requests for administrative
review by Section 50730 shall apply to requests for formal hearing sub-
mitted pursuant to this section.

(c) A party shall have 30 days following the receipt of the Letter of
Findings within which to file a request for formal hearing with the De-

partment representative identified in the Letter of Findings. The party
shall siinultaneously submit a copy of such request to each other party.
The request shall be deemed filed on the date mailed to the Department.

(d) Within 30 days after receipt of the copy of the request for formal
hearing, each such other party shall submit a position statement. The po-
sition statement shall set forth the validity of each audit exception or find-
ing in dispute.

(e) A request for formal hearing filed after the time permitted in sub-
section (c) above, shall be denied by the hearing officer unless the party
shows good cause for late filing.

NOTE: Authority cited: Sections 1 1 152, Government Code; and Sections 4648.2,
and 4780.5, Welfare and Institutions Code. References: Sections 4629, 4631,
4635, 4648.1 and 4780.5, Welfare and Institutions Code; and Sections 11180,
11181, and 11182, Government Code.

History
1 . Renumbering and amendment of former Section 50650 to Section 50750 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

§ 50751 . Time and Place of Formal Hearing.

(a) The hearing officer shall determine the time and place of a formal
hearing. It shall be held in one of the following counties:

( 1 ) San Francisco if the appellant resides within the First Judicial Ap-
pellate District, as defined in California Rules of Court. Appendix — Di-
vision III, Section 3;

(2) Los Angeles if the appellant resides within the Second or Fourth
Judicial Appellate District, as defined in California Rules of Court. Ap-
pendix— Division III, Section 3; or

(3) Sacramento if the appellant resides within the Third or Fifth Judi-
cial Appellate District, as defined in California Rules of Court. Appen-
dix— Division III, Section 3.

(b) The hearing officer may schedule the formal hearing to be held in
a location other than the one described in subsection (a) above, if he/she
determines that it is necessary for the convenience of the parties and in
the interests of justice.

(c) Except as provided in Section 50760, the hearing officer shall give
written notice to the parties of the time and place of the formal hearing
not less than 30 days prior to such date. This period may be shortened
with the consent of all parties. Any party may waive notice.

NOTE: Authority cited: Secdons 1 11 52, Government Code; and Sections 4648.2,
and 4780.5, Welfare and Institutions Code. References: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History
1. Renumbering and amendment of former Section 50651 to Section 50751 filed
7-5-88; operative 8^-88 (Register 88, No. 29).

§ 50752. Severance of Issues.

(a) The hearing officer, upon his/her own motion, or upon the motion
of any party, may hear any particular issue or issues before hearing any
other issue in the proceeding, if the hearing officers finds that the resolu-
tion of the particular issue or issues could abate further proceedings.

(b) A proposed interlocutory decision on a separately heard issue may
be prepared by the hearing officer and adopted by the Director as the final
decision on the specified issued,

(c) Hearing on any remaining issues presented by the appellant's re-
quest for formal hearing may be postponed until the interlocutory deci-
sion has been issued.

NOTE: Authority cited: Sections 1 1 152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. References: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History

1 . Renumbering and amendment of former Section 50652 to Section 50752 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of Note (Register 2002, No. 46).

§ 50753. Discovery.

(a) A party, after filing a request for a formal hearing, may make a writ-
ten demand for information to an opposing party. The party receiving
such demand must comply within 30 days after its mailing, provided that
the 30th day precedes the hearing date and the demand is entitled to:

Page 270

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Health and Welfare Agency — Department of Developmental Services

§ 50755

( 1 ) Obtain the names and addresses of witnesses to the extent known
to the other party, including, but not limited to, those intended to be called
to testify at the formal hearing;

(2) Inspect and make a copy of any of the following in the possession
or custody or under the control of the other party:

(A) Statements pertaining to the subject matter of the proceeding made
by any party to another party or person;

(B) Statements of witnesses then proposed to be called by the party and
of other persons having personal knowledge of the acts, omissions or
events which are the basis for disputed audit findings, not included in
Subsection (2) (A) above;

(C) All writings, including, but not limited to, audit work papers, client
records, medical records, and invoices or things which the party then pro-
poses to offer into evidence;

(D) Other real or documentary evidence which is relevant and ordi-
narily admissible in administrative proceedings.

(b) Any records received pursuant to a demand for information under
this section which contains client identifying information shall be main-
tained as confidential information.

(c) For the purpose of this section, "statements" includes written state-
ments by persons, signed or otherwise authenticated by such persons,
stenographic, mechanical, electrical or other recordings, or transcripts
thereof, or oral statements by persons, and written reports of summaries
of such oral statements.

(d) Nothing in this section shall authorize the inspection or copying of
any writing or thing which is privileged from disclosure by law or other-
wise made confidential or protected as the attorney's work product.

(e) Any denial of discovery shall be in writing and shall be accompa-
nied by a written statement describing the specific reasons for denial as
to each item of discovery denied. Such a denial shall be mailed within 30
days after the date of filing the request for discovery.

(f) Any party claiming his/her demand for discovery, pursuant to this
section, has not been complied with, may serve upon the nonresponsive
party and file with the hearing officer a verified petition to compel dis-
covery. The petition shall set forth the facts showing that the nonrespon-
sive party failed or refused to comply, a description of matter sought to
be discovered, the reason or reasons why such matter is discoverable un-
der this section, and ground or grounds of the nonresponsive party's re-
fusal so far as known to the petitioner.

(g) The petition shall be served and filed within 15 days after the non-
responsive party first evidenced his/her failure or refusal to comply with
this section, or within 30 days after the demand was made and the party
has failed to reply to the demand whichever period is longer. If, from a
reading of the petition, the hearing officer is satisfied that the petition sets
forth good cause for relief, the hearing officer shall issue a subpoena
duces tecum directed at the nonresponsive party requiring him/her to
comply within 15 days after the issuance of the subpoena; otherwise, the
hearing officer shall issue a written denial. The subpoena duces tecum
shall be served upon the nonresponsive party by personal delivery or cer-
tified mail. Further proceedings shall be in accordance with Subsection
50754.

(h) Parties requesting discovery pursuant to this section shall be liable
for all actual and reasonable costs arising therefrom, except that where
a demand is contested, the losing party shall be responsible for all actual
and reasonable costs arising from such contest.

(i) The provisions of this section provide the exclusive right to and the

method of discovery as to any proceeding governed by this article.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4648.1 and
4780.5, Welfare and Institutions Code; and Sections 1 11 80, 1 11 8 1 , 1 1 1 82, 1 11 84,
and 1 1 189, Government Code.

History

1 . Renumbering and amendment of former Section 50653 to Section 50753 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Change without regulatory effect amending subsection (g) filed 1-14-2003 pur-
suant to section 100, title 1, California Code of Regulations (Register 2003, No.
3).

§ 50754. Subpoenas and Witnesses.

(a) The hearing officer is authorized to issue subpoenas and subpoenas
duces tecum before the formal hearing, for attendance of witnesses or
producUon of documents at the formal hearing, as necessary or at the re-
quest of any party. The hearing officer may also issue subpoenas and sub-
poenas duces tecum after the formal hearing has commenced. Com-
pliance with the provisions of Section 1985, California Code of Civil
Procedure shall be a condition precedent to the issuance of a subpoena
duces tecum.

(b) The process issued pursuant to subsection (a) above, shall be ex-
tended to all parts of the State and shall be served in accordance with the
provisions of Secfions 1987 and 1988, California Code of Civil Proce-
dure. No witness shall be obligated to attend at a place out of the county
in which he/she resides unless the distance be less than 50 miles from his/
her place of residence.

(c) Any person receiving a subpoena duces tecum issued by the hear-
ing officer pursuant to this ardcle shall comply within the time stated, by:

(1 ) Producing the evidence required; or

(2) Filing an affidavit setting forth reasons why such evidence should
not be produced.

(d) Where the person receiving the subpoena duces tecum files an affi-
davit pursuant to Subsecfion (2) above, the hearing officer shall, based
upon a reading of both the affidavit and the petition, either deny the peti-
tion and withdraw the subpoena duces tecum, or order the affiant to pro-
duce the evidence as required by the subpoena. If a person fails to com-
ply, the hearing officer may refer the matter to the Chief Counsel of the
Department for insfitution of court proceedings pursuant to Government
Code Section 1 1 1 87, to compel producfion of the evidence; or, in the case
of a party, the hearing officer may decide the appeal against the nonre-
sponsive party.

(e) All witnesses appearing pursuant to subpoena, other than the par-
ties or officers or employees of the state or any political subdivision
thereof, shall receive fees and all witnesses appearing pursuant to sub-
poena, except the parfies, shall receive mileage reimbursement from the
party which requested the subpoena, in the same amount and under the
same circumstances as prescribed by law for witnesses in civil actions in
a superior court.

(f) Witnesses appearing pursuant to subpoena, except the parties, who
attend formal hearings at points so far removed from their residences as
to prohibit return thereto from day to day shall be entitled, in addition to
fees and mileage, to a per diem compensation of $3.00 for expenses of
subsistence for each day of actual attendance and for each day necessari-
ly occupied in traveling to and from the hearing. Fees, mileage and ex-
penses of subsistence shall be paid by the party at whose request the wit-
ness is subpoenaed.

NOTE: Authority cited: Section 1 11 52, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4631,
4648.1 and 4780.5, Welfare and Institutions Code; Sections 1985, 1987. and 1988,
Code of Civil Procedure; and Sections 11180, 11181, 11182, 11184, 11185,
11186, 11187, 11188, 11189, 11190, and 1 1191, Government Code.

History
1 . Renumbering and amendment of former Section 50654 to Section 50754 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

§ 50755. Depositions.

(a) On verified pefition of any party, the hearing officer may order that
the tesUmony of any material witness residing within or without the state
be taken by deposition in the manner prescribed by law for depositions
in civil actions. The petifion shall set forth:

(1) The nature of the pending proceeding;

(2) The name and address of the witness whose tesdmony is desired;

(3) A showing of the materiality of his/her testimony;

(4) A showing that the witness will be unable or cannot be compelled
to attend; and

(5) A request for an order requiring the witness to appear and testify
before an officer named in the petition for that purpose.

(b) The hearing officer's order for taking of testimony by deposition
from a witness residing out-of-state shall be supported by a court order.

Page 271

§ 50756

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

The court order shall be obtained by filing a petition in the Superior Court
of Sacramento County, in accordance with Section 1 11 89 of the Govern-
ment Code.

(c) Parties requesting depositions pursuant to this section, shall be li-
able for actual and reasonable costs arising therefrom.
NOTIi: Authority cited: Section 1 1 152, Government Code: and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4629, 4648.1 and
4780.5, Welfare and Institutions Code; and Sections 11 1 80, 1 1 1 8 1 , 1 11 82, 1 1 1 84,
11189, 11190, and 11 191, Government Code.

History
1. Renumbering and amendment of former Section 50655 to Section 50755 filed

7-5-88: operative 8-4-88 (Register 88, No. 29).

§ 50756. Affidavits.

(a) Any party shall mail or deliver to all other parties, at least 20 days
prior to a formal hearing or a continued hearing, a copy of any affidavit
to be introduced in evidence, together with a notice as provided in Sub-
section (b) below. Unless an opposing party, within ten days after such
mailing or delivery, mails or delivers to the proponent a request to cross-
examine an affiant, the right to cross-examine such affiant is waived and
the affidavit, if introduced in evidence, shall be given the same effect as
if the affiant had testified orally. If an opportunity to cross-examine an
affiant is not offered after request therefor is made as herein provided, the
affidavit may be introduced in evidence, but shall be given only the same
effect as other hearsay evidence.

(b) The notice referred to in Subsection (a) above, shall be in a form
prescribed by the Department.

(c) "Affidavit" as used in this subchapter means either an affidavit un-
der oath or an unsworn, written declaration under penalty of perjury.
NOTE: Authority cited: Section 11152, Government Code: and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code; and Sections 1 1 181 and 1 1 182, Govern-
ment Code.

History
1 . Renumbering of former Section 50656 to Section 50756 filed 7-5-88; operafive
8-4-88 (Register 88, No. 29).

§ 50757. Preparation for Formal Hearing.

A party appearing at a formal hearing shall have necessary evidence
and witnesses present and be ready to proceed. Two copies of any docu-
ments to be introduced in evidence shall be made available. The hearing
officer, if necessary and following reasonable notice, may require the
parties to submit, prior to a formal hearing, a written statement of conten-
tions and reasons, together with any requested documents. A copy of
such written statement and documents shall be provided to the parties.
NOTE: Authority cited: Section 1 1 152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code; and Sections 11180, 11181, and 11182.
Government Code.

History
1 . Renumbering of former Section 50657 to Section 50757 filed 7-5-88; operative

8-4-88 (Register 88, No. 29).

§ 50758. Conduct of Formal Hearing.

(a) Testimony shall be taken only on oath, affirmation or penalty of
perjury.

(b) The proceedings at the formal hearing shall be electronically re-
corded or reported by phonographic reporter.

(1) Call and examine parties and witnesses;

(2) Introduce exhibits;

(3) Question opposing witnesses and parties on any matter relevant to
the issue even though the matter was not covered in the direct examina-
tion;

(4) Impeach any witness regardless of which party first called the wit-
ness to testify;

(5) Rebut the evidence against him/her.

(d) The appellant shall not be called to testify during presentation of
the Department's prima facie case pursuant to subsection (k) of this sec-
tion. An appellant who declines to testify or present his/her case may be
called and examined by the Department as if under cross-examination.

(e) The formal hearing need not be conducted according to technical
iTjles relating to evidence and witnesses.

(f) Irrelevant repetitious evidence shall be excluded.

(g) Relevant evidence, including hearsay, shall be admitted if it is the
sort of evidence on which responsible persons are accustomed to rely in
the conduct of serious affairs, regardless of the existence of any common
law or statutory rule which might make improper the admission of such
evidence over objection in civil actions, provided:

( 1 ) Hearsay evidence shall not be sufficient in itself to support a find-
ing unless it would be admissible over objection in civil actions;

(2) The rules of privilege shall be effective to the same extent that they
are now or hereafter may be recognized in civil actions;

(3) The evidence shall be excluded if its probative value is outweighed
by excessive consumption of time, undue repetition, or its prejudicial ef-
fect.

(h) The "best evidence" rule (Evidence Code Section 1500) does not
apply unless:

(1 ) A genuine question is raised as to the authenticity of the original
or the duplicate; or

(2) It would be unfair to admit the duplicate in lieu of the original,
(i) A hearing officer may question any party or witness.

(j) The hearing officer shall control the taking of evidence in a manner
best suited to ascertain the facts and safeguard the rights of the parties.
Prior to taking evidence, the hearing officer shall set forth the order in
which evidence will be received.

(k) The Department or regional center shall present its findings and ev-
idence first at the hearing. The Department or regional center has the bur-
den of proof of demonstrating, by a preponderance of the evidence, that
the findings were correctly made. Once the Department or regional cen-
ter has presented such a prima facie case, the burden of proof shifts to the
appellant to demonstrate, by a preponderance of the evidence, that the ap-
pellant's position regarding disputed issues is correct.

(/) The burden of producing evidence is the obhgation of introducing
sufficient testamentary or demonstrative evidence to establish the exis-
tence of an alleged fact. A party who, in support of his/her position, al-
leges a fact which is specifically or generally disputed by the opposing
party, as the burden of producing evidence as to that fact. If the party hav-
ing the burden of producing evidence fails to introduce sufficient evi-
dence, the hearing officer shall find against such party as to the existence
of the particular fact alleged.

(m) The hearing shall be conducted in the English language. The pro-
ponent of any testimony to be offered by a witness who does not speak
the English language proficiently shall provide an interpreter, approved
by the hearing officer as proficient in the English language and the lan-
guage in which the witness will testify, to serve as interpreter during the
hearing. The cost of the interpreter shall be paid by the party providing
the interpreter.

NOTE; Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and InstituUons Code. Reference: Sections 4629, 4635,
4648.1 and 4780.5, Welfare and InstituUons Code; and Sections 11180, 11181,
and 1 1 182, Government Code.

History

1. Renumbering and amendment of former Section 50658 to Section 50758 filed
7-5-88; operative 8-4-88 (Register 88, No. 29).

2. Editorial correction of subsecfion (k) (Register 2002, No. 46).

§ 50759. Official Notice.

(a) The hearing officer shall take official notice of those matters which
must be judicially noticed by a court under Section 45 1 of the Evidence
Code. The hearing officer may take official notice of those matters set
forth in Section 452 of the Evidence Code.

(b) Parties present at the fonnal hearing shall be informed of the mat-
ters to be noticed, and those matters shall be noted in the record, referred
to therein, or appended thereto.

(c) If the hearing officer has been requested to take, or has taken, or
proposes to take official notice of such matters, the hearing officer shall
afford each party reasonable opportunity before closing the record, to
present to the hearing officer information relevant to:

Page 272

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 50765

( 1 ) The propriety of taking official notice of the matter; or

(2) The probative value to be accorded to the matter to be noticed.

(d) If the hearing officer resorts to any source of information not re-
ceived at the formal hearing, including the advice of persons learned in
the subject matter, such information and its source, shall be made a part
of the record in the appeal and the hearing officer shall afford each party
reasonable opportunity to rebut such information before official notice
of the matter may be taken.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History
1 . Renumberina of former Section 50659 to Section 50759 filed 7-5-88; operative
8-4-88 (Register 88, No. 29).

§ 50760. Continued or Further Hearings.

(a) Upon the hearing officer's own motion or upon the request of a
party, the hearing officer may. for good cause, continue a formal hearing
to another time or place. Oral notice of the time and place of the continued
formal hearing may be given to each party present at the formal hearing.
Such oral nofice shall be confirmed in writing by the hearing officer with-
in five days unless waived by the parties.

(b) Upon the hearing officer's own motion or upon a written request
by a party, the hearing officer may, for good cause, order a further formal
hearing prior to his/her issuance of notice of dismissal or adoption of his/
her proposed decision by the Director. Notice of the further formal hear-
ing shall be mailed to the parties not less than 30 days prior to such hear-
ing. This period may be shortened with the consent of all parties. Any
party may waive notice.

NoTti; Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History
1 . Renumbering of former Section 50660 to Section 50760 filed 7-5-88; operative
8-4-88 (Register 88, No. 29).

§ 50761 . Introduction of New Evidence.

The hearing officer upon a showing of good cause consistent with Sub-
section 50730(f), in order to obtain new evidence necessary for the prop-
er determination of the case, may:

(a) Continue the formal hearing and hold the record open in order to
permit any party to produce additional evidence;

(b) Close the hearing and hold the record open in order to permit the
introduction of additional documentary evidence. Any material sub-
mitted after the close of the formal hearing shall be served upon all parties
and each party shall have reasonable opportunity for rebuttal;

(c) Order a further formal hearing if the nature of the additional evi-
dence or the refutafion thereof make a further hearing desirable.
Note: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History
1 . Renumbering of former Section 50661 to Section 50761 filed 7-5-88; operative
8-4-88 (Register 88, No. 29).

§ 50762. Representation at a Formal Hearing.

A hearing officer may refuse to allow any person to represent a party
in any hearing when the person:

(a) Engages in unethical, disruptive or contemptuous conduct which
impairs the appeals process; or

(b) Either intenfionally and repeatedly or willfully fails to comply with
the proper instructions or orders of the hearing officer or the provisions
of this subchapter.

Note: Authority cited: Secfion 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Insfitutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History
1 . Renumbering of former Section 50662 to Section 50762 filed 7-5-88; operative
8-4-88 (Register 88, No. 29).

§ 50763. Oral Arguments and Briefs.

(a) The formal hearing shall be an evidentiary hearing. However, the
hearing officer may, in his/her discretion, permit the submission of oral
or written arguments, if requested to do so by a party prior to the close
of the formal hearing. The parties shall be advised as to the time and man-
ner in which arguments are to be submitted.

(b) The hearing officer may require any party to submit memoranda
or affidavits pertaining to any or all issues raised in the formal hearing.
NoTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5 Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5. Welfare and Institutions Code.

History
1 . Renumbering of former Section 5066.^ to Section 50763 filed 7-5-88; operative
8-4-88 (Register 88, No. 29).

§ 50764. Decision.

(a) The hearing officer shall take the matter under submission at the
conclusion of the hearing. A proposed decision, in a form that may be
adopted as the decision of the Director, shall be submitted within 60 days
after the close of the formal hearing record. The proposed decision shall
be in writing and shall contain findings of fact, a determinadon of the is-
sues presented, and an order.

(b) The Director may adopt the proposed decision in its entirety or may
revise the amount due and adopt the balance of the proposed decision.

(c) If the proposed decision is not adopted under Subsection (b) above,
the Director may decide the case upon his/her review of the record, in-
cluding the transcript, without taking addiUonal evidence, or may re-
mand the matter to the same hearing officer to take additional evidence.
Upon remand, the hearing officer shall prepare a proposed decision, as
provided in Subsection (a) above, upon the additional evidence and the
transcript and other papers, which are part of the record of the prior hear-
ing.

(d) The decision shall be final upon adopfion by the Director. Copies
of the decision of the Director shall be provided to the parfies; the appel-
lant's copy shall be delivered by certified mail.

(e) If a party to a formal hearing other than the appellant fails to appear
at a hearing and the hearing officer issues a decision on the merits adverse
to that party's interests, the decision shall be accompanied by a statement
of the party's right to make appUcation to vacate the decision. The appli-
cation shall be in writing and shall be mailed within 1 0 days after personal
service or mailing of the decision. Upon a showing of good cause for fail-
ure to appear at the hearing, the Director may issue an order to vacate his/
her decision and the matter may be set for further hearing. Lack of good
cause will be inferred when a confinuance of the hearing was not prompt-
ly requested by the applicant upon discovery of the reasons for failure to
appear at the hearing as scheduled.

(f) The parties shall be given written notice of an order granting or de-
nying any application to vacate a decision.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4635, 4648.1 and
4780.5, Welfare and Institutions Code.

History

1. Renumbering and amendment of former Section 50664 to Section 50764 filed
7-5-88; operafive 8-4-88 (Register 88, No. 29).

2. Editorial correcdon of subsection (b) (Register 2002, No. 46).

§ 50765. Dismissal.

(a) A dismissal may be issued by the hearing officer if an appellant
fails to appear at a formal hearing. A copy of such dismissal shall be
mailed to each party together with a statement of the appellant's right to
reopen the hearing.

(b) The Director may vacate any dismissal if the appellant makes
application in writing, within 10 days after personal service or receipt of
such dismissal, showing good cause for failure to appear at the hearing.
Lack of good cause will be presumed when a continuance of the formal
hearing was not promptly requested by the appellant upon discovery of
the reasons for his/her inability to appear at the hearing as scheduled. If
a dismissal has been vacated by the Director, the hearing officer shall re-
schedule the hearing. Notice of the time and place of the hearing shall be

Page 273

§ 50766

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

sent to the parties not less than 30 days prior to the scheduled hearing
date. This period may be shortened with the consent of all parties. Any
party may waive notice.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History

1 . Renumberine of former Section 50665 to Section 50765 filed 7-5-88: operative
8-4-88 (Register 88, No. 29).

§ 50766. Reconsideration.

(a) The Director may order a reconsideration of all or part of the deci-
sion on his/her own motion or on petition of any party. The power to order
a reconsideration shall expire 30 days after delivery or mailing of a deci-
sion to the appellant. The petition of a party shall be deemed denied if the
Director takes no action within the time allowed for ordering reconsider-
ation.

(b) If a reconsideration is ordered, the Director may:

( 1 ) Issue a revised decision based upon a review of all the pertinent
parts of the records and such additional evidence and arguments as he/she
may permit; or

(2) Assign the case to a hearing officer for preparation of a revised de-
cision based upon the records and such additional oral or written evi-
dence as may be necessary. Preparation and adoption of the revised deci-
sion shall be in accordance with the procedures provided for in Section
50764.

NOTE: Authority cited: Section 111 52, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4648.1 and
4780.5, Welfare and Institutions Code.

History

1 . Renumbering of former Section 50666 to Section 50766 filed 7-5-88; operaUve
8-4-88 (Register 88, No. 29).

2. Change without regulatory effect amending subsecdon (b)(2) filed 1-14-2003
pursuant to section 100, title 1, California Code of Regulafions (Register 2003,

No. 3).

§ 50767. Judicial Review.

The final decision of the Director shall be subject to judicial review in
accordance with the provisions of Section 1094.5 of the Code of Civil
Procedure within six months after the date of mailing of the Director's
final decision.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648.2
and 4780.5, Welfare and Institutions Code. Reference: Sections 4635, 4648.1 and
4780.5, Welfare and Institutions Code.

History
1 . Renumbering of former Section 50667 to Section 50767 filed 7-5-88; operative

8-4-88 (Register 88, No. 29).

Subchapter 8. Peer Review of Behavior
Modification Interventions That Cause Pain
or Trauma, and Electroconvulsive Therapy

Article 1. General Provisions

§ 50800. Meaning of Words.

Words shall have their usual meaning unless the context or a definition
clearly indicates a different meaning. Words used in their present tense
include the future tense and words in the singular form include the plural
form. Use of the word "shall" denotes mandatory conduct; "may" de-
notes permissive conduct; and "should" denotes recommended conduct.
NOTE: Authority cited: Section 4505, Welfare and Institufions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New Subchapter 8 (Articles 1-4, Sections 50800-50835, not consecutive) filed

9-29-89; operative 10-29-89 (Register 89, No. 40).

§50801. Definitions.

The following definitions govern the construction of sections within
this subchapter unless the context requires otherwise:

(a) "Behavior modification" means an occurrence under which any
person subjects a client at any time or place to stimuli, events, acts, activi-
ties, or responses that are intended to cause that client to change, adapt,
or alter the occurrence or performance of his or her behavior, provided
that it shall not be construed to prohibit conduct which is otherwise privi-
leged pursuant to the provisions of Section 692 through 694 of the Cali-
fornia Penal Code.

(b) "Behavior Modification Review Committee" means the group of
persons within the developmental center or regional center appointed to
review and consider for approval or denial behavior modification inter-
vendons that cause pain or trauma, in accordance with Article 3. For the
purposes of these regulations, the Behavior Modification Review Com-
mittee is intended to serve as the Peer Review Committee required in
Welfare and Institufions Code, Secfion 4505.

(c) "Behavior Modification Interventions that Cause Pain or Trauma"
means every form of behavior modificafion, as defined in these regula-
fions, that a Behavior Modification Review Committee determines will
result in or cause the recipient to experience either pain or trauma as those
terms are defined in these regulafions.

(d) "Care provider" means any person, corporafion, partnership,
agency or other enfity which directly or indirectly owns, administers, or
operates a developmental center, a community care facihty as defined in
Secfions 1502 and 1504 of the Health and Safety Code, or a health facility
as defined in Secfion 1250 of the Health and Safety Code. Unless other-
wise stated, this term also includes all agents, employees, and contractors
of the care provider involved with or responsible for the provision of care
to clients.

(e) "Client" means any person who is eligible for regional center ser-
vices pursuant to Chapter 3. Subchapter 1 (beginning with Secfion
54000), and who resides in a developmental center, a licensed communi-
ty care facility, or a licensed health facility, or receives services in a pro-
gram described in Health and Safety Code, Secfion 1502.

(f) "Consent" means that the client or the client' s parent/guardian/con-
servator has had the proposed procedure explained in terms understand-
able to the consentor, including prior unsuccessful intervenfions. the ex-
pected side effects and/or risks of the proposed procedure, and the client
or the client' s parent/guardian/conservator agrees in writing to the proce-
dure. Consent may be withdrawn at any time.

(g) "Department" means the Department of Developmental Services,
(h) "Developmental Center" means a center which is operated by the

State and serves persons with developmental disabilifies.

(i) "Director" means the Director of the Department of Developmental
Services.

(j) "Electroconvulsive Therapy" (ECT) means a treatment procedure
for mental disorders in which a convulsive reaction is inducted by pass-
ing an electric current through the cerebral cortex by means of electrodes
placed bilaterally or unilaterally on the pafient' s head. ECT is a treatment
of last resort.

(k) "Electroconvulsive Therapy (ECT) Review Committee" means
the group of persons appointed to review and consider for approval or de-
nial requests to conduct ECT. For the purpose of these regulations the
ECT Review Committee is intended to serve as the Peer Review Com-
mittee required in Welfare and Insfitutions Code, Section 4505.

(/) "Pain" means a subjecfively experienced, substantially unpleasant
bodily sensafion; it ordinarily results from, oris induced by physiological
sfimuli which may include, but not be limited to injury, bodily contact,
situational stress, heat, cold, noise, physical exertion, or immobilization.
Typical observable responses may include, but not be limited to, evasive
action, verbal exclamafion or protest, escape, resistance, stiffening, gri-
macing, and reflexive avoidance or fainfing. Some individuals may not
exhibit any perceivable response.

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•

(m) "Program" means a planned, organized approach to habilitative
treatment of clients that is developed and implementated in accordance
with the provisions of Article 2 (commencing with Section 4640) of
Chapter 5 of Part 2 of Division 4. 1 of the Welfare and Institutions Code,
or with developmental center procedures subject to approval by the De-
partment.

(n) "Qualified Professional" means a person designated to review pro-
posed treatment plans in accordance with Article 2 of these regulations.

(0) "Regional Center" means a private nonprofit community agency
that provides services for persons with developmental disabilities and
their families under contract to the Department pursuant to Welfare and
Institutions Code, Section 4620 et seq.

(p) "Trauma" means an occurrence under which the client experiences
either:

(1) Tissue damage: or

(2) Severe and long-lasting emotional distress.

(q) "Treatment Plan" means the written description of a program con-
taining ECT or behavior modification interventions that may cause pain
or trauma, that is prepared for review and approval in accordance with
this subchapter.

NOTIi: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4503, 4505. Welfare and Institutions Code.

History
1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50802. Limitations on Use of Behavior Modification

Interventions That IVIay Cause Pain or Trauma.

All care providers shall be prohibited from using any form of behavior
modification intervention that may cause pain or trauma upon the client
unless this behavior modification has been developed into a program that
is fully described in a treatment plan proposed by the Interdisciplinary
Team and either endorsed for implementation by a qualified professional
pursuant to Article 2, or approved by a Behavior Modification Review
Committee pursuant to Article 3.

NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

Article 2. Review by Qualified Professional

§ 50810. Designation of Qualified Professionals.

(a) Each regional center and developmental center shall designate in
writing one or more persons to serve as qualified professionals to be re-
sponsible for reviewing proposed treatment plans that may cause pain or
trauma in accordance with this article. Only physicians or psychologists
licensed by the State Department of Consumer Affairs to practice in the
State of California or other professionals whose California licensure per-
mits the practice of behavior modification programs may be so desig-
nated. The regional center or developmental center, as appropriate, shall
designate a sufficient number of qualified professionals to review all pro-
posed treatment plans that may cause pain or trauma within a reasonable
period of time following the date of the plans' submission for review.

(b) Each qualified professional designated in (a) shall possess the fol-
lowing minimum qualifications:

( 1 ) One year of experience designing behavior modification programs
for persons with developmental disabilities; or

(2) Two years of experience teaching behavior modification at the col-
lege level or above.

NOTK: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History

1. New section fded 9-29-89; operative 10-29-89 (Register 89, No. 40).

2. Change without regulatory effect amending subsections (a) and (b)(1) filed
1-14-2003 pursuant to section 100, title 1, California Code of Regulations
(Register2003, No. 3).

§ 5081 1 . Procedures for Review of Proposed Treatment
Plans.

(a) Interdisciplinary Teams intending to apply or institute any form of
behavior modification interventions that may cause pain or trauma shall,
prior to its implementation:

(1) Incorporate or develop the behavior modification into a complete
program that is described in a proposed treatment plan as described in
Secdon 50822;

(2) Obtain consent for the implementation of the proposed treatment
plan; and

(3) Except as specified in (f), forward the proposed treatment plan and
documentation of consent for review by the qualified professional desig-
nated for the client pursuant to Section 508 10.

(b) The qualified professional shall:

(1) Review all treatment plans forwarded for review pursuant to this
article within a reasonable time; and

(2) Enter into the client's treatment record a notation of the scope of
the review that was conducted, along with the determination made con-
cerning whether the treatment plan involves pain or trauma.

(c) Under no instance shall a qualified professional approve a treat-
ment plan that has the potential to cause pain or trauma.

(d) Upon his/her determination that the proposed treatment plan can
be approved for implementation, the qualified professional shall:

(1) Place his/her original signature and California professional license
number on the treatment plan to indicate approval;

(2) Make the proper entries in the client's treatment record in accor-
dance with subsection (b) (2); and

(3) Forward the approved plan to the client's case manager for imple-
mentation through the Individual Program Plan process. The approval
shall be effective for a period not to exceed one year.

(e) Upon his/her determination that the proposed treatment plan may
cause pain or trauma, the qualified professional shall:

( 1 ) Forward the plan and a copy of the written results of his/her review
to the Behavior Modification Review Committee designated by the cli-
ent's regional center or developmental center, providing consent to the
proposed treatment plan has been documented; or

(2) Disapprove the plan and return it to the Interdisciplinary Team
which proposed the plan when consent has not been documented.

(f) When a qualified professional is a member of an Interdisciplinary
Team that develops a proposed treatment plan pursuant to (a) ( I ), the pro-
visions of (a) (3) and (b) shall not apply. Such qualified professional shall
comply with the provisions of paragraph (C) through (e) of this section.
NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Secdon 4505, Welfare and Institutions Code.

History

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

Article 3.

Review of Behavior Modification
Treatment Plans

§ 50820. Establishment of Behavior Modification Review
Committees.

0 Each regional center and developmental center shall establish one
or more committees to be known as Behavior Modification Review
Committees, which shall be responsible for the review and consideration
for approval or denial of behavior modification interventions that may
cause pain or trauma in the manner specified in this article.

(b) Each Behavior Modification Review Committee shall consist of
not less than three persons. The committee shall include at least one Cali-
fornia licensed psychologist or other professional whose California li-
censure permits the practice of behavior modification programs, one Cal-
ifornia licensed physician, and one Clients' Rights Advocate. The person
responsible for the development or implementation, or for review under
Section 50811, of the treatment plan that is before the committee for ap-

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proval shall not sit on the committee for any portion of the review and
approval of the treatment plan.

(c) either the physician or psychologist or other professional specified
in (b) shall have at least three years experience in:

(1) The supervision of the implementation of behavior modification
programs;

(2) Teaching behavior modification at the college level or above; or

(3) A combination of (1) and (2).

NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50821 . Procedures for Review by Behavior Modification
Review Committee.

(a) The Behavior Modification Review Committee shall:

(1) Complete a review, within a reasonable time, of each proposed
treatment plan which has been referred to the committee pursuant to Sec-
tion 50811.

(2) Upon completion of its review, send written notification to the In-
terdisciplinary Team which prepared the proposed treatment plan of its
decision to approve or disapprove the plan.

(b) Approval of a treatment plan shall be by consensus, and docu-
mented pursuant to Section 50822.

(c) Disapproval of a treatment plan shall include the reasons for the ac-
tion along with any suggested changes to the plan which could lead to
subsequent approval.

NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50822. Criteria for Approval of Behavior Modification
Programs Involving Pain or Trauma.

(a) All proposed treatment plans for behavior modification which may
cause pain or trauma shall:

( 1 ) Describe the program which is proposed for implementation.

(2) Prescribe procedures for the monitoring and implementation of the
behavior modification program by the Interdisciplinary Team.

(3) Identify those staff members authorized to use the approved inter-
ventions.

(4) Be accompanied by all of the following:

(A) Documentation that consent has been given for the program de-
scribed in the treatment plan.

(B) A functional analysis of the target behavior(s).

(D) Evidence of a prior review for the proposed treatment plan by the
client's physician, including a statement that:

1 . Medical intervention to remediate the target behaviors is not an ap-
propriate course of action; and

2. There are no medical contraindications to the proposed treatment
plans.

(b) A Behavior Modification Review Committee shall approve a pro-
posed treatment plan only after making a finding that all of the following
conditions exists:

(1) All of the information specified in subsection (a) is present.

(2) The treatment Plan:

(A) Conforms to the requirements of the license of the facility in which
it is to be performed.

(B) Is designed solely for the purpose of achieving the goal of enabling
the client to lead a more independent, productive, and normal life as ex-
pressed in the Lanterman Developmental Disabilities Services Act (Wel-
fare and Institutions Code, Sections 4500 et seq.)

(3) The history of prior interventions demonstrates that all less restric-
tive alternative methods have been tried without success.

(4) The procedures prescribed in the plan for the monitoring and im-
plementation of the program are adequate.

(5) Each element of the behavior modification program described in
the plan is technically adequate and appropriate in light of prevailing be-
havior modification standards within the psychological treatment profes-
sion.

(6) The potential harm from not providing each element of the pro-
gram outweighs the potential harm created by implementing each ele-
ment.

(7) The program will not cause irreparable harm to the client.

(c) No treatment plan shall be deemed approved by the Behavior Mod-
ification Review Committee until the committee has completed and
transmitted a written notice of approval to the initiating Interdisciplinary
Team that includes an express finding concerning each of the elements
listed above, along with a statement of the supporting facts and reasons
for each finding.

(d) Approval by the Behavior Modification Review Committee shall
be effective for a period not to exceed one year.

NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50823. Behavior Modification Reporting Requirements.

(a) Each regional center director and developmental center executive
director shall prepare and submit to the Director by February 15 of each
year the following annual reports from their respective Behavior Modifi-
cation Review Committees:

( 1 ) The number and type of behavior modification treatment plans ap-
proved by the Behavior Modification Review Committee during the re-
porting period; and

(2) The source and type of hcense held by each facility in which ap-
proved treatment plans were implemented during the reporting period.
NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History

1. New section filed 9-29-89; operafive 10-29-89 (Register 89, No. 40).

Article 4. Electroconvulsive Therapy (ECT)

§ 50830. Limitations on the Use of ECT.

Physicians shall be prohibited from using ECT on a regional center cli-
ent unless the use of ECT has been developed into a program that is fully
described in a proposed treatment plan that has been approved by the
ECT Review Committee pursuant to section 50833.
NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50831 . Procedure for Seeking Approval to Use ECT.

(a) All proposals to use ECT shall be developed into a program that is
fully described in a treatment plan. The proposed treatment plan shall in-
clude at a minimum:

( 1 ) A description of:

(A) The reasons for proposing the use of ECT which shall include:

(1) A list of the client behaviors, symptoms, and diagnoses leading to
the decision to propose the use of ECT.

(2) The results of other, less restrictive alternative treatments used to
modify these behaviors or alleviate the described symptoms.

(B) The anticipated benefits to the client of using ECT, with a state-
ment of the probable consequences of denying the use of ECT.

(C) The number and frequency of proposed treatments, their methods
of administration, and the medical support to be used during the course
of treatments.

(2) The methods to be used to determine and document the results of
the treatments.

(3) Consent that shall be:

(A) Limited to a specified maximum number of treatments over a max-
imum period of time not to exceed 30 days. Additional treatments in

Page 276

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§ 50902

number or time, not to exceed 30 days, shall require a renewed written
consent.

(B) Revocable at any time before or between treatments. Withdrawals
of consent may be either oral or written and shall be given effect immedi-
ately.

(b) The proposed treatment plan shall be submitted in writing to the
ECT Review Committee.

NOTIi: Authority cited: Section 4505. Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50832, Electroconvulsive Therapy (ECT) Review
Committee.

(a) The ECT Review Committee shall be established and shall consist
of at least four persons, including:

(1) Two board certified psychiatrists and/or neurologists, licensed in
California with experience in electroconvulsive treatment; one of whom
shall be appointed by the facility and one of whom shall be appointed by
the local mental health director. Neither of these physicians shall be the
client's treating physicians.

(2) A representative from the Department of Developmental Services
appointed by the Director who will function as a Clients Rights Advo-
cate; and

(3) A representative from the Area Board serving the area in which the
client resides, appointed by the Chairperson of the Area Board.
NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History

1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

2. Editorial correction amending subsection (a)(2) and restoring inadvertently
omitted subsection (a)(3) (Register 2006, No. 20).

§ 50833. Criteria for Approval of ECT.

(a) The following criteria are required, at a minimum, for approval of
ECT:

( 1 ) The ECT Review Committee shall consider for approval or denial
only those proposed treatment plans which have met the requirements
specified in Section 5083 1 .

Approval is predicated upon the unanimous agreement of the ECT Re-
view Committee with the treating physician's determinations.

(3) If the ECT Review Committee approves the proposed treatment
plan, their approval shall be limited to 30 days, effective upon written no-
tification of the committee's approval shall be limited to 30 days, effec-
tive upon written notification of the committee's approval. Further, the
approval of the ECT Review Committee shall be nullified if the treatment
plan is not followed exactly as written when approved.

(4) Approval of the proposed plan by the ECT Peer Review Committee
shall not supersede or replace the review requirements necessary under
Section 5325 et seq. of the Welfare and Institutions Code. The review of
a proposal to use ECT with a person with both developmental disabilities
and a mental illness that might justify the use of ECT shall be completed
separately and independently by both the ECT Peer Review Committee
pursuant to these regulations and the reviewing entity required by Sec-
tions 5325 et seq. of the Welfare and Institutions Code.

NOTE: Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50834. Procedures for Review of Proposed ECT.

(a) The ECT Review Committee shall complete its review of all treat-
ment plans submitted pursuant to Section 5083 1 within 30 calendar days
of receipt of the plans. The chairperson of the ECT Review Committee
shall telephone the requesting physician and relay the committee's ap-
proval or denial of the proposed treatment plan on the day the review is
completed.

(b) Written notice of the approval or denial shall:

(1) Be mailed within five working days of the telephone notice pur-
suant to paragraph (a).

(2 ) Include express findings of conformity or nonconformity to the cri-
teria in Section 50833 with statements of reasons for each finding.

(3) Be documented in the client's treatment record.

(4) Be signed by all members of the ECT Review Committee.

(5) Be permanently attached to the treatment plan as proposed.
NOTI;; Authority cited: Section 4505, Welfare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New section filed 9-29-89; operative 10-29-89 (Register 89, No. 40).

§ 50835. Reporting Requirements.

The physician conducting the ECT shall submit a narrative progress
report within 30 days of completion of the treatment to the ECT Review
Committee. The report shall include, but not be limited to, the number of
treatments given and the benefits derived. This regulation shall also ap-
ply to physicians who are small businesses.

NOTH: Authority cited: Section 4505. Wellare and Institutions Code. Reference:
Section 4505, Welfare and Institutions Code.

History
1. New section filed 9-29-89: operative 10-29-89 (Register 89, No. 40).

Subchapter 9. Fair Hearings

Article 1. General Provisions and
Definitions

§ 50900. Intent and Purpose.

The intent and purpose of this subchapter is to implement, interpret,
and make specific, and this subchapter shall be read in conjunction with,
the statutory provisions of the Lantennan Developmental Disabilities
Services Act (Division 4.5 of the Welfare and Institutions Code, com-
mencing with Section 4700) relative to the fair hearing procedures and
fair hearing rights of persons applying for or receiving services pursuant
to said Act. It is the intent of this subchapter:

(a) To implement the fair hearing procedures such that resolutions of
disagreements may be accomplished at the earliest opportunity.

(b) To interpret the fair hearing procedures in a manner which protects
the claimant's fair hearing rights and promotes the rights of claimants to
dignity, privacy, and humane care as established by the Lanterman De-
velopmental Disabilities Services Act.

(c) To make specific the responsibilities of the claimant, service
agency, and state department to conduct full and impartial fair hearings
to resolve differences between service agencies and persons applying for
or receiving services pursuant to the Lanterman Developmental Disabili-
ties Services Act.

Note: Authority cited: Section 4705, Weffare and Institutions Code. Reference:
Sections 4501, 4502 and 4705, Welfare and Institutions Code.

History
1. New subchapter 9 (Articles 1-4, Sections 50900-50964, not consecutive) filed
7-15-85; effective thirtieth day thereafter (Register 85, No. 29).

§ 50902. Definitions.

Whenever the following terms are used in Chapter 7 of Division 4.5
of the Welfare and Institutions Code (commencing with Section 4700)
and in this subchapter, the following definition shall apply:

(a) "Authorized Representative" means those persons described in
Section 4701 .6 of the Welfare and Institutions Code, and a representative
appointed by the Area Board pursuant to subsection (e) of Section 4705
of the Welfare and Institutions Code.

(b) "Business Day" or "Working Day" means any day that is ncU a Sat-
urday, Sunday, or holiday as specified in Sections 6700 and 6701 of the
Government Code.

(c) "CUents' Rights Advocate" means the person assigned by a service
agency to be responsible for rights assurance for applicants, recipients,
and persons with developmental disabilities.

(d) "Immediately" or "Immediate" means within two (2) business
days.

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(e) "Recipient" means those persons described in Section 4703.5 of
the Welfare and Institutions Code and persons receiving services for pre-
vention of a developmental disability.

Note-. Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4701. 4702, 4702.6, 4703, 4703.5, 4703.7, 4705, 4710. 4710.5, 4710.6,
4710.7. 4710.9, 471 1 , 4712, 4712.2, 4715, 4726, 4727 and 4728, Welfare and In-
stitutions Code.

History
1 . Change without regulatory effect amending subsection (a) filed 4-21-99 pur-
suant to section 100, title 1, Cahfornia Code of Regulations (Register 99, No.
17).

§ 50904. Computation of Time for Performance of Act.

If the last date of the performance of any act required within a specified
period of time by these regulations or the provisions of Chapter 7 of Divi-
sion 4.5 of the Welfare and Institutions Code (commencing with Section
4700) is not a business day, then such period shall be extended to the next
business day.

NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4701. 4710, 4710.5, 4710.6, 4710.7, 4710.8. 4710.9, 4712, 4712.2,
4712.5, 4713 and 4715, Welfare and Institutions Code.

Article 2. Adequate Notice

§ 50920. Appeal to Be Filed with Service Agency.

The portion of the adequate notice describing the fair hearing appeal
procedure shall emphasize the requirement of filing a request for fair
hearing with the service agency, and shall explain to the applicant, recipi-
ent, and authorized representative, if any, that the service agency will for-
ward the request to the responsible state agency. The requirement of sub-
section (e) of Section 4701 of the Welfare and Institutions Code to give
notice of the name and address of the responsible state agency with whom
an appeal may be filed is intended solely to require the provision of infor-
mation to the applicant, recipient, or authorized representative, and does
not supplant the procedure described in subsections (a) and (b) of Section
4710.9 of the Welfare and Institutions Code.

NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4701(e) and (g) and 4710.9, Welfare and Institutions Code.

§ 50922. Notice to Clients' Rights Advocate Regarding
Adult Without Conservator.

If a client entitled to adequate notice is an adult, without a court-ap-
pointed conservator, the service agency shall also provide the adequate
notice to the service agency's clients' rights advocate.
NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4710(a) and 4710.8(b), Welfare and Institutions Code.

§ 50924. Notice to Regional Center Director for

Conservatee of Director of Developmental
Services.

When the Director of Developmental Services is the conservator of the
person, or person and estate, of an applicant or recipient entitled to ade-
quate notice, the conservator's notice shall be given to the director of the
regional center which is delegated the responsibility and authority for
serving as that applicant or recipient' s conservator of the person pursuant
to Section 416.19 of the Health and Safety Code and to the service
agency's Client's Rights Advocate.

NOTE; Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Section 4710(a), Welfare and Institutions Code.

Article 3. Procedures for Fair Hearings

§ 50930. Notice of Right to Request Consolidation.

The written decision of the service agency director resulting from the
informal meeting shall include in its explanation of procedures for ap-
peal, notice of the right to request consolidation of appeals involving a
common question of law or fact.

NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4710.7(b) and 4712.2, Welfare and Institutions Code.

§ 50932. Notice of and Consent to Consolidation.

(a) The hearing officer shall notify a party and the authorized represen-
tative, if any, in writing that a request for consolidation of his or her ap-
peal with another appeal has been received, and such notification shall
include an explanation that consolidation may necessitate disclosure of
confidential information about each claimant to other claimants and their
authorized representatives.

(b) Whether or not written consent or objections to consolidation are
received by the hearing officer at the time of the fair hearing, the hearing
officer in all cases shall explain the claimants' rights to confidentiality
pursuant to subsection (a) and obtain consent to consolidation from each
claimant or authorized representative on the record prior to the taking of
testimony. If a claimant, authorized representative, or service agency ob-
jects to consolidation on the record, the hearing officer shall decide
whether to consolidate that case as if written objections had been sub-
mitted prior to the hearing.

hearing officer to continue a hearing beyond 30 days but no longer than

45 days from the receipt of the request for fair hearing.

NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4712 and 4712.2, Welfare and Institutions Code.

§ 50934. Claimant Objection to Authorized Representative.

When the claimant objects to a person appointed by the Area Board to
serve as an authorized representative, that person shall not serve as the
authorized representative. The Area Board shall consult with the claim-
ant and may appoint another person to serve as authorized representative
if the claimant consents and does not personally appoint an authorized
representative.

NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4701.6 and 4710.8(b), Welfare and Institutions Code.

§ 50936. Notice of Documents Provided to Hearing Officer.

NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Sections 4710.9 and 4712(d), Welfare and Institutions Code.

History
1. Change without regulatory effect repealing section filed 4-21-99 pursuant to
section 100, title 1, California Code of Regulations (Register 99, No. 17).

§ 50938. Submission of Written Argument.

(a) When the hearing officer determines that there are complex issues
of law or fact or novel interpretations of difficult questions of law, the
hearing officer may cause the record of the fair hearing to be held open
for submission of written argument by either or both parties. New or addi-
tional evidence, not already entered into evidence on the record, may not
be included with the written argument unless the hearing officer grants
permission on the record to the belated admission of the evidence.

(b) Whenever written argument or new or additional evidence is sub-
mitted to the hearing officer pursuant to subsection (a), the submitting
party shall mail or deliver a copy to the other party.

NOTE: Authority cited: Section 4705, Welfare and Institudons Code. Reference:
Sections 4710.6, 4712 and 4712.5, Welfare and Institutions Code.

Article 4. Miscellaneous Provisions

§ 50960. Internal Grievance Procedure.

The written internal grievance procedure mandated by subsection (a)
of Section 4705 of the Welfare and Institutions Code shall include, but
not be limited to, the rights specified in subsection (a) of Section 47106
of the Welfare and Institutions Code.

NOTE: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Section 4705(a), Welfare and Institutions Code.

§ 50962. Hearing Procedure in Nontechnical Language.

Service agencies shall write their fair hearing procedures mandated by
subsection (a) of Section 4705 of the Welfare and Institutions Code in
clear and nontechnical language.

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•

NOTi:: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Section 47()5(a) and (c). Welfare and Institutions Code.

§ 50964. Regulations to Be Posted.

The service agency shall prominently display a copy of these regula-
tion.s on the premises of the service agency with the service agency's fair
hearing procedure and the provisions of Chapter 7 of Division 4.5 of the
Welfare and Institutions Code (commencing with Section 4700).
NOTt-;: Authority cited: Section 4705, Welfare and Institutions Code. Reference:
Section 4705(c). Welfare and Institutions Code.

§ 50966. Receipt of Fair Hearing Request by Office of
Administrative Hearings.

(a) Upon receipt of a fair hearing request from a claimant, service
agencies shall not have the discretion to determine the appropriateness
or timeliness of the fair hearing request. All fair hearing requests received
by a service agency shall be immediately forwarded to the agency desig-
nated for conducting fair hearings and, if applicable, the agency desig-
nated for conducting mediations.

(b) If a service agency believes that a fair hearing request raises issues
that are not appropriately addressed through a fair hearing pursuant to
Section 4700 et seq. of the Welfare and Institutions Code, or for other rea-
sons does not comply with statutory requirements, the service agency
may file a request to have the matter dismissed with the agency responsi-
ble for conducting hearings. Such dismissal requests shall state the rea-
sons for the request.

NOTE; Authority cited: Section 4707, Welfare and Institutions Code. Reference:
Sections 4710.5 and 47 11. 5, Welfare and Institutions Code.

History
1. New section filed 8-4-2000; operative 9-3-2000 (Register 2000, No. 31).

Article 5. Mediation

§ 50980. Confidentiality of Mediation.

Confidentiality of mediation shall be governed by Chapter 2, Division
9 of the Evidence Code, commencing with § 1115.

NOTE: Authority cited: Section 4707, Welfare and Institutions Code. Reference:
Section 47 11. 5, Welfare and Institutions Code.

History
1 . New article 5 (sections 50980-50992) and section filed 8-4-2000; operative
9-3-2000 (Register 2000, No. 31).

§ 50984. Continuances in Mediation.

(a) The standard for granting a continuance request in mediation shall
be good cause, as defined in Section 47 1 2, Welfare and Institutions Code.

(b) A continuance granted to a claimant in mediation shall extend the
timeline for rendering a final decision, should the matter proceed to hear-
ing.

(c) The extension of time for the final decision resulting from the con-
tinuance shall only be as long as the time period of the continuance.
NOTE: Authority cited: Secdon 4707, Welfare and Institutions Code. Reference:
Sections 4710.6(c), 471 1.5 and 4712, Welfare and Institutions Code.

History

1. New section filed 8-4-2000; operative 9-3-2000 (Register 2000, No. 31).

§ 50988. Mediation Request Made Subsequent to Fair
Hearing Request.

(a) A claiinant may request mediation at any time prior to five days be-
fore the first day of the fair hearing.

(b) A claimant requesting mediation after the fair hearing request has
been submitted must do so in writing. Such request may be made by sub-
mitting an amended fair hearing request form.

(c) The written request for mediation shall be submitted to the service
agency. The service agency shall immediately forward a copy of the writ-
ten request for mediafion to the agency responsible for conducting medi-
ations, the Department, and the agency responsible for conducting fair
hearings. The service agency shall have five days from the date of the
written request for mediation to accept or reject mediation. Such decision

shall be cominunicated immediately to the claimant and the agency re-
sponsible for conducting mediations.

(d) Upon receipt of the written request for mediation, tlie agency re-
sponsible for conducting mediations shall schedule the mediation to take
place within 20 days of the date of the written request. The agency shall
provide notice to the claimant and service agency regarding the time, date
and location of the mediafion and notice to the claimant in compliance
with Secfion 471 1 of the Welfare and Insfitutions Code.

(e) A mediafion request made subsequent to a fair hearing request and
agreed to by the service agency shall constitute good cause for continuing
the fair hearing. In such instances, the timeline for scheduling the fair
hearing and rendering a final decision shall be extended 20 days.
NoTE: Authority cited: Section 4707, Welfare and Institutions Code. Reference:
Sections 4702.6, 47 1 0.5, 47 10.6, 47 11 and 47 11. 5, Welfare and Institutions Code.

History
1. New section filed 8^1-2000; operative 9-3-2000 (Register 2000. No. 31).

§ 50992. Time and Place of Mediation; Nonadversarial.

(a) The mediation shall be held at a fime and place reasonably conve-
nient to the claimant.

(b) Mediation shall be conducted in a nonadversarial manner. Wit-
nesses and other forms of evidence, other than to explain one party's
position to the other, shall not be presented in mediation.

NOTE: Authority cited: Section 4707, Welfare and Insfitutions Code. Reference:
Section 471 1.5, Welfare and Institutions Code.

History
1. New section filed 8-4-2000; operafive 9-3-2000 (Register 2000, No. 31).

Chapter 2. Early Intervention Services

Subchapter 1 . General Provisions

Article 1. Definitions

§ 52000. Meaning of Words.

(a) Words shall have their usual meaning unless the context of a defini-
fion clearly indicates a different meaning. Words used in their present
tense include the future tense; words in the singular form include the plu-
ral form. Use of the word "shall" denotes mandatory conduct; "may" de-
notes permissive conduct.

(b) The following definifions shall apply to the words used in this sub-
chapter:

(1) Acidemia means an excessive acidity of the blood wherein the
acid-base balance of the body is disturbed.

(2) Adaptive development means the acquisition of skills that are re-
quired to meet environmental demands. Adaptive development includes,
but is not limited to, activities of self-care, such as dressing, eating, toi-
leting, self-direction, environmental problem-solving and attention/a-
rousal.

(3) Asphyxia neonatorum means a condition caused by insufficient
oxygen at or near the time of birth.

(4) Assessment means the ongoing procedures used by qualified per-
sonnel throughout the period of an infant' s or toddler' s eligibility for ear-
ly intervention services to identify the infant's or toddler's unique
strengths and needs and the services appropriate to meet those needs.
Assessment also includes the identification of the family's resources,
priorities, and concerns regarding the development of the infant or
toddler and the supports and services necessary to enhance the family's
capacity to meet the developmental needs of the eligible infant or toddler.

(5) Authorized representative means the parent or guardian of a nn'nor,
or person who is legally entitied to act on behalf of the infant, toddler or
family.

(6) Biomedical insult is a general term referring to those biological or
medical conditions such as infection or brain injury which may result in
developmental delay or disability.

Page 278.1

§ 52000

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(7) Cognitive development means the acquisition of learning through
ongoing interactions with the environment. Cognitive development in-
volves perceiving, thinking, problem solving and remembering informa-
tion.

(8) Communication development means the acquisition of expressive
and/or receptive language skills which include understanding and/or us-
ing any of the following: gestures, facial expressions, speech reading,
sign language, body postures and vocal and visual contacts with another
person.

(9) Complainant means any individual or organization filing a written
complaint pursuant to the provisions of Subchapter 5, Article 3.

(10) Concerns means areas that family members identify as needs, is-
sues or problems they want to address as part of the individualized family
service plan (IFSP) or the evaluation and assessment process which are
related to meeting the developmental needs of the infant or toddler.

(11) Day means calendar day unless otherwise stated.

( 1 2) Early intervention services means those services designed to meet
the developmental needs of each eligible infant or toddler and the needs
of the family related to the infant's or toddler's development. The ser-
vices include but are not limited to assistive technology; audiology; fami-
ly training; counseling and home visits; health services; medical services
only for diagnostic or evaluation purposes; nursing services; nutrition
services, occupational therapy; physical therapy; psychological services;
service coordination; social work services; special instruction; speech
and language services; transportation and related costs; and vision ser-
vices. Early intervention services may include such services as respite
and other family support services.

(13) Evaluation means procedures used by qualified personnel to de-
termine an infant's or toddler's present level of development.

(14) Exception circumstances means events beyond the control of the
regional center or local education agency (LEA). These include but are
not limited to the infant's or toddler's or parent's illness, the infant's or
toddler's and parent's absence from the geographical area, inability to lo-
cate the parent, or a natural disaster. Delays caused by the failure to obtain
copies of existing records or other administrative events do not constitute
exceptional circumstances.

(15) Family means the primary caregivers and others who assume ma-
jor long-term roles in an infant's or toddler's daily life.

(16) Fine motor means the use of muscles that control small and de-
tailed movements of the body, as an example, in the hand related to man-
ual dexterity and coordination.

(17) Funded Capacity means the number of eligible infants, between
12 and 16 students per instructional unit, that the California Department
of Education requires LEAs to serve to maintain funding for their classes/
programs/services in a given year pursuant to Education Code section
56728.8 as it read on November 1, 1993.

(18) Gross motor means the use of large muscle groups of the body,
arms, or legs, as in sitting up, walking, or balancing.

(19) Health status means a description of the physical and mental con-
dition of an infant or toddler. Health status may include current diag-
noses, medications, required regular medical procedures, current medi-
cal supplies and technological devices, primary and specially care
providers, and immunization status, nutrition and oral health.

(20) Hearing impairment means a condition, whether permanent or
fluctuating, which impairs the processing of linguistic information
through hearing, even with amplification, and which adversely affects an
infant's or toddler's development. Processing linguistic information in-
cludes speech and language reception and speech and language discrimi-
nation.

(21) Hyperbilirubinemia means a condition in which an excessive
amount of bilirubin, a bile pigment released from the breakdown of red
blood cells, is in the blood.

(22) Hypertonia means a condition of excessive tone or tension in the
skeletal muscles.

(23) Hypotonia means a condition of diminished tone of the skeletal
muscles.

(24) Hypoglycemia means a condition in which the blood sugar is ab-
normally low.

(25) Immediate need means a situation in which an infant or toddler
requires early intervention services without delay pursuant to a physi-
cian' s order or written determination by the multidisciplinary team speci-
fying consequences of a delay in the provision of services.

(26) Individual program plan (IP?) means a plan developed for per-
sons with developmental disabihties to describe the provisions of ser-
vices and supports to meet the written goals and objectives pursuant to
Welfare and Institutions Code sections 4646-4648.

(27) Individualized education program (lEP) means a written state-
ment that is developed and implemented pursuant to Title 20 United
States Code Section 1401(b)(20).

(28) Individualized family service plan (IFSP) means a written plan
for providing early intervention services to infants or toddlers and their
families who have been determined eligible for early intervention ser-
vices. The plan must: (A) Be developed in accordance with Sections
52100 through 521 10; and, (B) Be based on the evaluation and assess-
ment processes described in Sections 52082 though 52086 of these regu-
lations.

(29) Informed clinical opinion means the judgment of a qualified pro-
fessional who is a member of the multidisciplinary team. Informed clini-
cal opinion is based on but is not limited to opinions derived from: a re-
view of records, parental and professional observation of the infant or
toddler, and professional knowledge.

(30) Language of the parent's choice means a primary written or oral
language or mode of communication that the family chooses as a means
of communication. Language of the parent's choice may be the native
language. If the parent is deaf or blind or has no written language, the
mode of communication shall be that normally used by the parent such
as sign language, braille, or oral communication.

(3 1 ) Local education agency (LEA) means the school district in which
the infant or toddler resides or the county office of education or the spe-
cial education local plan area (SELPA) that is responsible for providing
early intervention services to infants and toddlers with disabilities.

(32) Low incidence disability means a severe disabling condition with
an expected incidence rate of less than one percent of the total statewide
enrollment in kindergarten through grade 12. For purposes of this defini-
tion, severe disabling conditions are hearing impairments, vision impair-
ments, and severe orthopedic impairments, or any combination thereof.

(33) Mediation means a voluntary resolution process in which an im-
partial third party may assist the disagreeing parties to resolve issues
prior to a due process hearing.

(34) Multidisciplinary team means two or more individuals of various
disciplines or professions, and the parent, who participate in the provi-
sion of integrated and coordinated services, including evaluation, assess-
ment, and IFSP development.

(35) Natural environments means settings that are natural or typical for
the infant or toddler's age peers who have no disability including the
home and community settings in which children without disabilities par-
ticipate.

(36) Parent means:

(A) A natural or adoptive parent of a child;

(B) A guardian;

(C) A person acting in place of a parent (such as a grandparent or step-
parent with whom the child lives, or a person who is legally responsible
for the child's welfare);

(D) A surrogate parent who has been assigned in accordance with 34
CFR 303.406 and 17 CCR 52175 of these regulations; or

(E) A foster parent, when:

1 . The foster parent has no interest that would conflict with the inter-
ests of the child,

2. The natural parents' authority to make the decisions required of par-
ents has been limited or relinquished under State law, and

3. The foster parent is willing to make the decisions required of par-
ents.

•

Page 278.2

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 52022

•

(37) Payor of last resort means the regional center or LEA that is re-
quired to pay for early intervention services listed on the IFSP when third
party payers or other agencies do not have an obligation to pay as re-
quired by 34 CFR 303.527.

(38) Personally identifiable means information thai includes:

(A) The full name of the infant or toddler, infant's or toddler's parent.
or other family member;

(B) The address of the infant or toddler;

(D) A list of personal characteristics or other information that would
make it possible to identify the infant or toddler with reasonable certain-
ty-

(39) Physical development means the acquisition of fine and gross mo-
tor skills involved in functional movement. Physical development in-
cludes vision, hearing and health status.

(40) Priorities means a family's choice for the focus of early interven-
tion services as well as for the ways in which early intervention services
will be incorporated into the family's day-to-day organization, routine
and planning.

(41) Qualified means that a person meets state certification, licensing,
credentialing, registration, or other comparable requirements for the area
in which he or she is providing early intervention services, or, in the ab-
sence of such approved or recognized requirements, meets the Depart-
ment of Developmental Services or California Department of Education
requirements.

(42) Record means the documentation in the infant's or toddler's re-
gional center client file and/or the LEA's cumulative file.

(43) Regional center means a diagnostic, counseling and service coor-
dination center for persons with developmental disabilities and their fam-
ilies which is established and operated pursuant to Chapter 5 of Division
4.5 of the Welfare and Institutions Code, Sections 4620 through 4669, by
a private nonprofit community agency/corporation acting as a contractor
for the Department of Developmental Services.

(44) Referral means the receipt of oral or written information that
causes a record to be opened for an infant or toddler who may be eligible
for early intervention services.

(45) Resources means the strengths, abilities, formal and informal
supports of the family available to meet the developmental needs of the
infant or toddler.

(46) Severe orthopedic impairment means a condition which adverse-
ly affects an infant's or toddler's development. Such orthopedic impair-
ments include impairments caused by congenital anomaly, impairments
caused by disease and impairments from other causes which may affect
functional movement and/or growth.

(47) Social or emotional development means the acquisition of capaci-
ties for human relationships, emotional expression, communication and
learning. Social or emotional development is based on the motivation to
engage in positive interaction and to sustain personal relationships and
precedes the development of effective coping skills, self esteem and the
ability to take advantage of opportunities for learning. Differences in
temperament, self regulation, range and intensity of affect and modulat-
ing one's response to the environment are additional factors influencing
social or emotional development.

(48) Solely lovj incidence disability means one or a combination of
low incidence disabilities which are vision impairment, severe orthope-
dic impairment, and hearing impairment which is the primary disability
and has a significant impact on learning and development of the infant
or toddler as determined by the IFSP team of the LEA. The infant or
toddler who has a solely low incidence disability shall not be eligible for
services from a regional center.

(49) Teratogen means an agent or factor that causes the production of
physical defects in the developing embryo.

(50) Vision impairment means a visual condition which, even with
correction, adversely affects the infant's or toddler's development.

NOTE; Authority cited: Sections 95009 and 95028. Government Code. Reference:
Sections 95014 and 95028. Government Code; Sections 300 l(y) and 3()3(). Title
5 California Code of Regulations; Sections 1432, 1436 and 1440. Title 20 I'nited
States Code; Sections 303.12, 303.16, 303.17, 303.18. 303.19, 303.21. 303.321.
303.322. 303.340, 303. .M2, 303.343, 303.344, 303.345, 303.401. 303.402.
303.403, 303.406, 303.420, 303.51 1 and 303.527 Title 34 Code ofFederal Regu-
lations.

History

1 . New subchapter 1 , article 1 (section 52000) and section filed 8-4-97 as an emer-
gency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code
section 95028(c), a Certificate of Compliance must be transmitted to OAL by
1-3 1-98, or emergency language will he repealed by operation of law on the
following day.

2. Change without regulatory effect adding chapter 2 heading filed 8-7-97 pur-
suant to section 100, title 1, California Code of Regulations (Register 97, No.
32).

3. Editorial correction of subsections (b)(24). (b)(27) and (b)(47) (Register 98. No.
5).

4. New chapter 2, subsection 1, article 1 (section 52000) and section, including
amendment of subsection (b)(27) and Noth, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98. No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

5. New chapter 2. subchapter 1. article 1 (section 52000) and section refiled
6-1-98 as an emergency; operative 6-1-98 (Register98. No. 23). A Certificate
of Compliance must be transmitted to OAL by 9-29-98 or emergency language
will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 6-1-98 order, including amendment of section
and NOTI-:, transmitted to OAL 6-16-98 and filed 7-2^8-98 (Register 98. No.
31).

7. Amendment of subsection (b)(36). new subsections (b)(36)(A)-(b)(36)(H)3.,
and amendment of Note filed 1-14-2003; operative 2-13-2003 (Register
2003, No. 3).

Article 2.

Eligibility for California's Early
Start Program

§ 52020. General.

An infant or toddler shall be eligible for early intervention services if
he or she is between birth up to thirty-six months of age and meets one
of the criteria specified in Section 52022 as determined by means of eval-
uation pursuant to Secfion 52082 of these regulafions and needs early in-
tervention services.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1432(5), Title 20 United States Code; Sections 95014(a) and 95016, Gov-
ernment Code; and Section 303.16, Title 34 Code ofFederal Regulafions.

History

1. New article 2 (sections 52020-52022) and secfion filed 8^4-97 as an emergen-
cy; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code sec-
tion 95028(c). a Certificate of Compliance must be transmitted to OAL by
1-31-98, or emergency language will be repealed by operation of law on the
following day.

2. New article 2 (sections 52020-52022) and section, including amendment of
Note, refiled 1-30-98 as an emergency: operative 1-31-98 (Register 98, No.
5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emer-
gency language will be repealed by operation of law on the following day.

3. New article 2 (sections 52020-52022) and section refiled 6-1-98 as an emer-
gency; operafive 6-1-98 (Register 98, No. 23). A Certificate of Compliance
must be transmitted to OAL by 9-29-98 or emergency language will be re-
pealed by operation of law on the following day.

4. Certificate of Comphance as to 6-1-98 order, including amendment of NoTi-;,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31 ).

§ 52022. Eligibility Criteria.

(a) Developmental Delay

A developmental delay exists if there is a significant difference pur-
suant to 52082 between the infant's or toddler's current level of function-
ing and the expected level of development for his or her age in one or
more of the following developmental areas:

(1) Cognidve;

(2) Physical: including fine and gross motor, vision, and hearing;

(3) Communication;

(4) Social or emoUonal;

(5) AdapUve.

Page 278.3

§ 52040

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(b) Established Risk

(1) An established risk condition exists when an infant or toddler has
a condition of known etiology which has a high probability of resulting
in developmental delay; or

(2) An established risk condition exists when an infant or toddler has
a solely low incidence disability.

( 1 ) High risk for a developmental disability exists when a multidisci-
plinary team determines that an infant or toddler has a combination of
two or more of the following factors that requires eariy intervention ser-
vices based on evaluation and assessment pursuant to section 52082 and
section 52084:

(A) Prematurity of less than 32 weeks gestation and/or low birth
weight of less than 1500 grams.

(B) Assisted ventilation for 48 hours or longer during the first 28 days
of life.

(D) Asphyxia neonatorum associated with a five minute Apgar score
of 0 to 5.

(E) Severe and persistent metabolic abnormality, including but not
limited to hypoglycemia, acidemia, and hyperbilirubinemia in excess of
the usual exchange transfusion level.

(F) Neonatal seizures or nonfebrile seizures during the first three years
of life.

(G) Central nervous system lesion or abnormality.
(H) Central nervous system infection.

(1) Biomedical insult including, but not limited to, injury, accident or
illness which may seriously or permanently affect developmental out-
come.

(J) Multiple congenital anomalies or genetic disorders which may af-
fect developmental outcome.

(K) Prenatal exposure to known teratogens.

(L) Prenatal substance exposure, positive infant neonatal toxicology
screen or symptomatic neonatal toxicity or withdrawal.

(M) Clinically significant failure to thrive, including, but not limited
to, weight persistently below the third percentile for age on standard
growth charts or less than 85% of the ideal weight for age and/or acute
weight loss or failure to gain weight with the loss of two or more major
percentiles on the growth curve.

(N) Persistent hypotonia or hypertonia, beyond that otherwise asso-
ciated with a known diagnostic condition.

(2) High risk for a developmental disability also exists when a multi-
disciplinary team determines that the parent of the infant or toddler is a
person with a developmental disability and the infant or toddler requires
early intervention services based on evaluation and assessment as speci-
fied in section 52082 and section 52084.

(d) A developmental delay shall not be determined based on:

(1) Temporary physical disability;

(2) Cultural or economic factors;

(3) The normal process of second language acquisition; or

(4) Manifestation of dialect and sociolinguistic variance.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1432(5), 1432(3) and 1435(a)(1), Title 20 United States Code; Sections
303.10, 303.16 and 303.300, Title 34 Code of Federal Regulations; Sections
95014 and 95028(b)(2), Government Code; and Section 4642, Welfare and Insti-
tutions Code.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-3 1-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of Note, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

3. New section refiled 6-1-98 as an emergency; operative (>-l-98 (Register 98,
No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98

or emergency language will be repealed by operation of law on the following
day.
4. Certificate of Compliance as to 6-1-98 order, including amendment of section
and NoTH, transmtted to OAL 6-16-98 and filed 7-28-98 (Register 98. No.
31).

•

Subchapter 2. Program and Service
Components

Article 1. Child Find & Referral

§ 52040. Child Find.

(a) Regional centers and LEAs shall conduct child find activities to lo-
cate all infants and toddlers who may be eligible for early intervention
services.

(b) Child find activities may include:

( 1 ) Assigning liaisons to local hospitals and hospitals with neonatal in-
tensive care units;

(2) Contacting local parent organizations and support groups;

(3) Distributing early intervention materials to agencies and individu-
als providing medical, social and educational services in the community;

(4) Community-wide health and developmental screening;

(5) Producing and distributing public service announcements;

(6) Producing pamphlets, brochures and other written communica-
tion; and,

(7) Making presentations to local professional groups, philanthropic
organizations and other organizations established to inform and/or to
serve culturally diverse populations.

(d) Primary referral sources include but are not limited to hospitals, in-
cluding prenatal and postnatal care facilities, physicians, parents, child
care programs, LEAs, public health facilities, other social services agen-
cies and other health care providers.

(e) Regional centers and LEAs shall inform primary referral sources
of the:

(1) Eligibility criteria for early intervention services;

(2) Types of early intervention services available through the Early
Start Program;

(3) Contact persons and telephone numbers for regional centers and
LEAs; and,

(4) Federal requirement that a referral shall be made to the regional
center or LEA within two (2) working days of identification of an infant
or toddler who is in need of early intervention services.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1435(a)(5), Title 20, United States Code; Section 303. 32L Title 34 Code
of Federal Regulations; and Section 95022(b) and (e). Government Code.

History

1 . New subchapter 2, article 1 (sections 52040-52060) and section filed 8-4-97
as an emergency; operative 8^t-97 (Register 97, No. 32). Pursuant to Govern-
ment Code section 95028(c), a Certificate of Compliance must be transmitted
to OAL by 1-31-98. or emergency language will be repealed by operation of
law on the following day.

2. Editorial correction of subsecdon (b) (Register 98, No. 5).

3. New subchapter 2, article 1 (sections 52040-52060) and section, including
amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98
(Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL
by 6-1-98 or emergency language will be repealed by operation of law on the
following day.

4. New subchapter 2, article 1 (sections 52040-52060) and section refiled 6-1-98
as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Com-
pliance must be transmitted to OAL by 9-29-98 or emergency language will be
repealed by operation of law on the I'oUowing day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (d) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98,
No. 31).

§ 52060. ReferraL

The regional center or LEA that receives an oral or written referral for
early intervention services shall ensure that:

•

Page 278.4

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 52084

(a) The date of the referral is documented in the infant's or toddler's
rect)rd;

(b) A service coordinator is assigned pursuant to Section 52120 of
these regulations; and,

NOTH: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 303.321(d), Title 34 Code of Federal Regulations.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of NoTF-:, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 oremergency language will be repealed by oper-
ation of law on the following day.

3. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 2. Evaluation and Assessment

§ 52082. Procedures for Evaluation to Determine
Eligibility.

(a) The determination of eligibility for an infant or toddler shall be
made by qualified personnel of the regional center or LEA. The determi-
nation shall be made with the participation of the multidisciplinary team
including the parent.

(b) Evaluation to determine eligibility shall be based on informed clin-
ical opinion and include:

(1) A review of pertinent records related to the infant or toddler's
health status and medical history provided by qualified health profes-
sionals who have evaluated or assessed the infant or toddler;

(2) Information obtained from parental observation and report; and,

(3) Evaluation by qualified personnel of the infant's or toddler's level
of functioning in each of the following areas;

(A) Cognitive development;

(B) Physical and motor development, including vision and hearing;

(D) Social or emotional development; and,

(E) Adaptive development.

(d) Standardized tests or instruments may be used as part of the evalua-
tion specified in 52082(b) above, and, if used, they shall;

(1) Be selected to ensure that, when admiiristered to an infant or
toddler with impaired sensory, motor or speaking skills, the tests produce
results that accurately reflect the infant's or toddler's aptitude, develop-
mental level, or any other factors the test purports to measure and not the
infant's or toddler's impaired sensory, motor or speaking skills unless
those skills are the factors the test purports to measure;

(2) Be validated for the specific purpose for which they are used.

(e) If standardized, normed or criterion referenced instruments are
used as part of the evaluation specified in 52082(b) above, a significant
difference between an infant's or toddler's current level of functioning
and the expected level of development for his or her age shall be estab-
lished when an infant's or toddler's age equivalent score falls one third
below age expectation.

(0 Procedures and materials for evaluation and assessment of infants
and toddlers shall be selected and administered so as not to be racially or
culturally discriminatory.

(g) Infants or toddlers with solely low incidence disabilities shall be
evaluated and assessed by qualified personnel of the LEA whose profes-

sional preparation, license or credential authorization are specific to the
suspected disability.

(h) Regional centers, LEAs and multidisciplinary teams shall not pre-
sume or determine eligibility, including eligibility for medical ser\ ices
provided through the Department of Health Services, for any otlier state
or local government program or service when conducting evaluations or
assessments of an infant or toddler or their family.

(i) Evaluations for eligibility shall be conducted in natural environ-
ments whenever possible.

NOTE; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 303.300(b) and (c), .303.322, 303.344 and 303.323(b) and (c). Title 34
Code of Federal Regulations; and Sections 95014(a)(1) and 95016, Government
Code.

History

1. New article 2 (sections 52082-52086) and section filed 8-^1-97 as an emergen-
cy; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code sec-
tion 95028(c), a Certificate of Compliance must be transmitted to OAL by
1-31-98, or emergency language will be repealed by operation of law on the
following day.

2. Editorial correction of subsections (b) and (d)(2)(B) (Register 98, No. 5).

3. New article 2 (sections 52082-52086) and section, including amendment of
NoTi-:. refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No.
5). A Certificate of Compliance must be transmiued to OAL by 6-1-98 oremer-
gency language will be repealed by operation of law on the following day.

4. New article 2 (sections 52082-52086) and .section refiled 6-1-98 as an emer-
gency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance
must be transmitted to OAL by 9-29-98 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of section
and NoTi^, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No.
31).

6. Ainendment of section heading and subsection (b) and new subsection (i) filed
1-14-2003; operative 2-13-2003 (Register 2003, No. 3).

§ 52084. Assessment for Service Planning.

(a) Assessment for service planning for eligible infants or toddlers
shall identify all of the following;

(1) The infant or toddler's unique strengths and needs in each of the
five areas specified in Section 52082(b)(3);

(2) Early intervention and other services appropriate to meet the needs
identified in (a)(1) of this subsection; and

(3) If the family consents to a family assessment, the resources, priori-
ties and concerns of the family and the supports and services necessary
to enhance the family's capacity to meet the developmental needs of an
infant or toddler with a disability.

(b) For purposes of service planning, regional centers and LEAs may
use existing evaluation materials if the multidisciplinary team agrees that
the existing materials adequately describe the levels of development and
service needs for the infant or toddler.

(c) Assessment for service planning shall be based on age appropriate
methods and procedures which may include any of the following;

(1) A review of information related to the infant's or toddler's health
status and medical history provided by qualified health professionals
who have evaluated or assessed the infant or toddler;

(2) Developmental observations by qualified personnel and the parent;

(3) Other procedures used by qualified personnel to determine the
presence of a developmental delay, established risk condition, or high
risk for a developmental disability; and

(4) Standardized tests or instruments.

(d) Assessments of family resources, priorities and concerns related to
enhancing the development of the infant or toddler shall be voluntary on
the part of the family. The family assessment shall;

(1) Be conducted by qualified personnel trained to utilize appropriate
methods and procedures;

(2) Be based on information provided by the family through a personal
interview;

(3) Incorporate the family's description of its resources, priorities and
concerns related to enhancing the development of the infant or toddler;
and,

(4) Be conducted in the language of the family's choice or other mode
of communication unless it is not feasible to do so.

Page 278.5

§ 52086

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(e) Assessments for service planning shall be conducted in natural en-
vironments whenever possible.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections Sections 1435(a)(3) and 1436(a)( 1 ). Title 20 United States Code: Section
303.322, Title 34 Code of Federal Regulations; and Sections 95014 and 95016,
Goveninicnt Code.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c). a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of NoTH, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (a)(3), repealer and new subsection (b), and amendment of Noth, trans-
mitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

5. Amendment of subsection (e) filed 1-14-2003; operative 2-13-2003 (Register
2003, No. 3).

§ 52086. Time Lines for Completion of Evaluation and
Assessment.

(a) Except as provided in subsection (b), the initial evaluation and
assessment for eligibility for each infant or toddler shall be completed
within 45 days of the date that the regional center or LEA received the
referral.

(b) In the event of exceptional circumstances which make it impossi-
ble to complete the initial evaluation and assessment for eligibility within
45 days of receiving a referral, the service coordinator shall:

(1) Document the exceptional circumstances in the infant's or
toddler's record;

(2) Inform the parent of the reasons for the delay;

(3) Inform the parent of an alternative time line which includes a spe-
cific date for completing the evaluation as soon as possible; and,

(4) Document that the parent has been informed and is in agreement
with the reasons documented for the extension beyond 45 days.

(c) If an infant or toddler has been determined eligible but the assess-
ment required in Section 52082 has not been completed within 45 days
of receiving a referral because of exceptional circumstances, the service
coordinator shall:

(1) Document the exceptional circumstances in the infant's or
toddler's record;

(2) Inform the parent of the reasons for the delay;

(3) Develop an interim IFSP pursuant to Section 52107 of these regu-
lations; and,

(4) Provide the services agreed upon in the interim IFSP.

(d) At the parent's signed request, regional centers or LEAs may ex-
tend the 45 day time Hne for completion of evaluation and assessment.
The request for an extension shall be documented in the infant's or
toddler's record.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1435(a)(3), Title 20 United States Code; Sections 303.322(d), 303.322(e)
and 303.345(b), Title 34 Code of Federal Regulations; and Sections 95016(b) and
95020(b), Government Code.

History

1 . New section filed 8-4-97 as an emergency; operafive 8^-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. Editorial correcfion of subsection (b)(3) (Register 98, No. 5).

3. New section, including amendment of Note, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

4. New section refiled 6-1-98 as an emergency; operafive 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tions (a) and (b)(4) and amendment of Note, transmitted to OAL 6-16-98 and
filed 7-28-98 (Register 98, No. 31).

Subchapter 3. Individualized Family
Service Plan

Article 1 . General

§ 52100. Individualized Family Service Plan (IFSP).

Regional centers and/or LEAs shall ensure that a written IFSP is devel-
oped for providing early intervention services. The IFSP shall address the
infant's or toddler's developinental needs and the needs of the family re-
lated to meeting the developmental needs of the infant or toddler. An
IFSP shall be developed and implemented for each infant or toddler who
has been evaluated, assessed and determined to be eligible for early inter-
vention services.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1435(a)(4) and 1436(a)(2), Title 20 United States Code; Sections 303. 14,
303.340 and 303.342, Title 34 Code of Federal Regulations; and Section 95020,
Government Code.

History

1 . New subchapter 3, article 1 (section 52100) and section filed 8-4-97 as an emer-
gency; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code
secfion 95028(c), a Certificate of Compliance must be transmitted to OAL by
1-31-98, or emergency language will be repealed by operation of law on the
following day.

2. New subchapter 3, article 1 (secfion 52100) and section, including amendment
of Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98,
No. 5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or
emergency language will be repealed by operation of law on the following day.

3. New subchapter 3, article 1 (section 52100) and secfion refiled 6-1-98 as an
emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Com-
pliance must be transmitted to OAL by 9-29-98 or emergency language will be
repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 2.

Content and Procedures for the
IFSP

§ 52102. Procedures for IFSP Development, Review and
Evaluation.

(a) An initial IFSP shall be developed by the regional center and/or
LEA for each eligible infant or toddler, who has been evaluated and as-
sessed, within 45 days of the receipt , by either the regional center or
LEA, of the oral or written referral except as provided for in Section
52107 of these regulations.

(b) A periodic review of the IFSP for an infant or toddler and the in-
fant's or toddler's family shall be conducted every six months, or more
frequently if service needs change, or if the parent requests such a review.

( 1 ) The degree to which progress toward achieving the outcomes is be-
ing made; and

(2) All modifications or revisions of the outcomes or services as neces-
sary.

(d) The periodic review of the IFSP may be carried out by a meeting
or by another means that is acceptable to the parent and other participants.

(e) An annual meeting to review the IFSP shall be conducted to docu-
ment the infant's or toddler's progress and revise its provisions and shall
include team members as specified in Section 52104 of these regulations.

(f) Information obtained from ongoing assessment shall be used in re-
viewing and revising outcomes and determining the appropriate services
that will be provided or continued.

(g) All IFSP meetings shall be conducted:

(1) In settings and at times or by means that are reasonably convenient
to the parent; and

Page 278.6

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Health and Welfare Agency — Department of Developmental Services

§ 52106

(2) In the language of parent's choice unless it is clearly not feasible
to do so.

(h) Meeting arrangements shall be made with, and written notice pro-
vided to. the parent and other members of the multidisciplinary team in
a timely manner to ensure attendance at the IFSP meeting pursuant to the
general notice requirements contained in Section 52161 of these regula-
tions.

(i ) The contents of the initial and annual IFSP and changes to the IFSP
resulting from the periodic review shall be fully explained and a legible
copy of the document given to the parent. Written consent from the parent
shall be obtained prior to the provision of early intervention services de-
scribed in the IFSP as required in Section 52162(a) of these regulations.

(j) If the parent does not provide consent with respect to a particular
early intervention service listed in the IFSP or withdraws consent after
first providing it, that service shall not be provided. The early interven-
tion services to which parental consent is obtained shall be provided.
Note; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1435(a)(4) and 1436, Title 20 United States Code; Sections 303.340,
303.342. 303.343, 303.344 and 303.403, Title 34 Code of Federal Regulations;
and Section 95020(b), Government Code.

History

1 . New article 2 (sections 52102-521 10) and section filed 8-4-97 as an emergen-
cy; operative 8-^-97 (Register 97, No. 32). Pursuant to Government Code sec-
tion 95028(c), a Certificate of Compliance must be transmitted to OAL by
1-31-98, or emergency language will be repealed by operation of law on the
following day.

2. New article 2 (sections 52102-521 10) and section, including amendment of
NoTH, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No.
5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emer-
gency language will be repealed by operation of law on the following day.

3. New article 2 (sections 52102-521 10) and section refiled 6-1-98 as an emer-
gency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance
must be transmitted to OAL by 9-29-98 or emergency language will be re-
pealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tions (a), (h) and (i) and amendment of Note, transmitted to OAL 6-16-98 and
filed 7-28-98 (Register 98, No. 31).

§ 52104. Participants in Initial and Annual IFSP Meetings
and Periodic Reviews.

(a) Each initial IFSP meeting and each annual IFSP meeting shall in-
clude the following participants:

( 1 ) The parent of the infant or toddler;

(2) The service coordinator who has been working with the family
since the initial referral of the infant or toddler for evaluation and assess-
ment or who has been designated by the regional center or LEA to be re-
sponsible for implementation of the IFSP; and,

(3) The person(s) who conducted the evaluations or assessments.

(b) If requested by the parent, each initial IFSP meeting and each annu-
al IFSP meeting shall include the following participants:

(1) Other family members; and

(2) An advocate or person outside of the family.

(c) Each IFSP meeting shall include persons who will be providing
services to the infant or toddler and family, as appropriate.

(d) Each periodic review of the IFSP shall include:

( 1 ) The parent;

(2) The service coordinator;

(3) Service providers as appropriate; and,

(4) Other family members, an advocate or person outside of the family
upon parent request.

(e) If either the evaluators or assessors are unable to attend an initial,
or annual IFSP meeting, arrangements shall be made for the person's in-
volvement through other means, including:

(1) Participating in a telephone conference call;

(2) Having a knowledgeable representative attend an IFSP meeting;
and

(3) Making pertinent records available at the IFSP meeting.

Note; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1435(b)(4) and 1436(b), Title 20 United States Code; Section 95020(e),
Government Code; and Section 303.343, Title 34 Code of Federal Regulations.

History

1 . New section filed 8-4-97 as an emergency; operative 8-^1-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of Note, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
tiansinitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

3. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98.
No. 23). A Certificate of Compliance must be transmitted to OAL by 9 29 98
or emergency language will be repealed by operation of law on the follow ing
day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (e) and amendment of Note, transmitted lo OAL 6-16-98 and filed
7-28-98 (Register 98, No. 31 ).

§52106. Content of IFSP.

(a) For purposes of this Section:

(1 ) Duration means the period between the initiation date of services
and the ending date of services in the IFSP.

(2) Frequency means the number of days or sessions that a service will
be provided during a specified period of time, such as, two times each
week or four times each month.

(3) Initiation means the beginning date of the service.

(4) Intensity means the length of time the service is provided during
each session, and whether the service is provided in a group or individual
setting.

(5) Location means the environment where early intervention services
are provided.

(6) Method means how a service is provided by qualified persons to
accomplish a specified outcome.

(b) The IFSP shall include the following:

(1) With the agreement of the parent, a statement of the family's re-
sources, priorities, and concerns related to enliancing the development of
the infant or toddler;

(2) A statement, based on evaluation and assessment information, of
the infant's or toddler's present levels of:

(A) Physical development including fme and gross motor develop-
ment, vision, hearing, and health status;

(B) Cognitive development;

(D) Social or emotional development; and,

(E) Adaptive development;

(3) The statement of present levels of development required in subsec-
tion (b)(2) of this section shall be based on evidence that can be measured
or observed by a quaUfied professional;

(4) A statement of the developmental outcomes expected for the infant
or toddler and the criteria, procedures, and time lines used to determine
the degree to which progress toward achieving outcomes is being made.
Such outcomes shall be based on the identified needs of the infant or
toddler and family pursuant to assessment;

(5) A statement about the outcomes for the family when services for
the family are related to meeting the special developmental needs of the
infant or toddler;

(6) Statements of the specific early intervention services necessary to
meet the unique needs of the infant or toddler and the family to achieve
the outcomes including:

(A) The frequency, intensity, and method of delivering the services;

(B) The location where the services will be delivered;

1. The statements of location shall specify the natural environments
such as home, child care, school program, or private program where early
intervention services shall be provided; and

2. The statement shall include a justification of the extent, if any, to
which the services will not be provided in a natural environment.

(D) The anticipated duration of the services;

(E) The scheduled days when services/programs will not be available
when the service provider operates a program v/hich has a fixed schedule

Page 278.7

§ 52107

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

which includes breaks in service for periods such as holidays or vaca-
tions; and

(F) The name of the regional center, LEA or service provider provid-
ing each early intervention service;

(7) The funding source for other or non-required services provided by
any entity other than regional centers or LEAs including the procedures
that will be followed to obtain such funding;

(8) The name of the service coordinator; and.

(9) A statement of the transition steps, which are initiated when the
toddler is two years nine months, or at the discretion of all parties, up to
six months before the toddler turns three years old, that are necessary to
ensure the transition of the toddler to:

(A) Preschool services under Part B of the Individuals with DisabiH-
ties Education Act, Title 20 United States Code Sections 1400-1420, if
the toddler with a disability is eligible; or

(B) Other public and private services that may be needed by the toddler
pursuant to Section 521 12 of these regulations.

(c) Regional centers and LEAs shall not place an infant or toddler on
a waiting list for early intervention services required by the IFSP.

(d) Regional centers and LEAs shall arrange, provide or purchase ear-
ly intervention services required by the IFSP as soon as possible.
NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1400-1420 and 1436(d), Title 20 United States Code; Sections 303.12
and 303.344, Title 34 Code of Federal Regulations; and Section 95020, Govern-
ment Code.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97. No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. Change without regulatory effect amending subsections (a)(4) and (b)(9) filed
8-7-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 32).

3. Editorial correction of subsections (b)(6)(C) and (b)(6)(E) (Register 98, No. 5).

4. New section, including amendment of Note, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

5. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transinitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

6. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tions (a)(2), (a)(5), (a)(6), (b)(6)(E) and (b)(9), new subsections (b)(6)(B) 1. and
2., and amendment of Note, transmitted to OAL 6-16-98 and filed 7-28-98
(Register98, No. 31).

§52107. Interim IFSP.

(a) An interim IFSP may be developed for an infant or toddler, who has
been determined eligible for early intervention services. The early inter-
vention services may begin before the completion of the assessment if
there is an immediate need to provide services and the infant's or
toddler's parent has given written consent.

(b) The interim IFSP shall include:

(1) Time lines for completing assessments;

(2) The name of the service coordinator responsible for completion of
evaluation and assessment within the 45 day timeline and implementa-
tion of the interim IFSP;

(3) The services agreed upon at the interim IFSP meeting as necessary
for the infant or toddler.

(c) An interim IFSP meeting shall provide for the participation of the
parent and the service coordinator and the persons responsible for the
assessment at a minimum pursuant to Section 52104(a) of these regula-
tions. Provisions shall be made for the participation of other family mem-
bers, an advocate or person outside of the family at the parent's request.

(d) The immediate need, the early intervention services needed and the
name of the service coordinator must be documented in the infant's or
toddler's interim IFSP.

(e) The existence of an interim IFSP does not absolve the regional cen-
ter or LEA from complying with the 45 day time period to complete the
initial assessment in all five areas of development.

(f) An interim IFSP developed to meet an immediate need shall be fol-
lowed by an IFSP meeting within the 45-day period that commenced
with the referral except as provided for in Section 52086(d) of these regu-
lations.

(g) An interim IFSP may be developed for an infant or toddler who has
been determined eligible when exceptional circumstances prevent the
completion of assessment within 45 days.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 303.322(e)(2)(ii) and 303.345, Title 34 Code of Federal Regulations.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

3. New section refiled 6-1-98 as an emergency; operafive 6-1-98 (Register 98,
No. 23). A Certificate of CompHance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (b)(2) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register
98, No. 31).

§ 52108. Designation of Services on the IFSP.

(a) Each service on the IFSP shall be designated as one of the follow-
ing:

(1) A required early intervention service. These services shall be pro-
vided, purchased or arranged by a regional center or LEA; or

(2) Other public programs providing services that may benefit the in-
fant, toddler and/or family which the eligible infant or toddler or his or
her family may be eligible to receive, subject to the statutory, regulatory
and other program criteria of those programs or agencies. These services
may include but not be limited to: residential care; family reunification
services. Head Start, Supplemental Security Income; Supplemental Se-
curity Programs; Temporary Assistance to Needy Families and food
stamps; Medi-Cal; or

(3) A referral to a community service that may be provided to an eligi-
ble infant or toddler or his or her family but is not required under the Cali-
fornia Early Intervention Services Act, Government Code Sections
95000-95030.

(A) A non required service includes but is not limited to: employment;
child care; housing; medical services such as surgery, or medication, hos-
pitalization, medical devices necessary to control or treat a medical con-
dition, or immunizations, well-baby care, income support, family or
marital counseling unrelated to the infant or toddler' s development, and
substance abuse counseling.

(B) The IFSP shall, to the extent appropriate, include the steps and time
lines for the service coordinator to assist the parent to secure those ser-
vices through public or private sources.

(b) The receipt of required early intervention services listed on the
IFSP, pursuant to Section 52108(a)(1) of these regulations, from other
state or federal agencies such as California Children Services, is depen-
dent on the infant or toddler and the infant's or toddler's parent meeting
the statutory, regulatory, and other program criteria of the agency and/or
program that provides those services. These criteria may include finan-
cial eligibility and medical condition eUgibility as diagnosed by program
certified personnel, and on the availability of funding for the program.

( 1 ) In the event that the infant or toddler or infant' s or toddler' s parent
is not eligible to receive those agency services, or funding for the pro-
gram is unavailable, the required early intervention services shall be pro-
vided by the regional center or the LEA.

Page 278.8

Title 17

Health and Welfare Agency — Department of Developmental Services

§52111

•

(2) The parent shall be informed in writing of this provision during the
initial 45 day evaluation and assessment period and/or during the IFSP

meeting.

NOTIi: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1435(a)(4). Title 20 United States Code; Sections 303.12, 303.522 and
303.527(c), Title 34 Code of Federal Regulations; and Section 95020(d), Govern-
ment Code.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of NoTi-:, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6^1-98 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (a)(2) and Noth, transmitted to OAL 6-16-98 and filed 7-28-98 (Register
98, No. 31).

§ 521 09. Basis for the Provision of and Payment for
Services Through Regional Centers.

(a) Regional centers shall provide, arrange, or purchase early interven-
tion services, as required by the infant's or toddler's IFSP, and be payor
of last resort for infants and toddlers determined eligible for early inter-
vention services as:

(1) Developmentally delayed pursuant to 52022(a);

(2) Established risk pursuant to 52022(b)(1); or

(3) High risk for developmental disability pursuant to 52022(c).

(b) Regional centers shall be the payor of last resort after all other pub-
lic sources for payment have been reviewed to determine if a referral
shall be made by the service coordinator and/or the parent. Referrals may
include but not be limited to California Children Services, Medi-Cal, or
other public agencies that may have responsibihty for payment. This re-
view shall not delay the provision of early intervention services specified
on the IFSP. Early Intervention services specified on the IFSP shall begin
as soon as possible.

(c) The use of the family's private insurance to pay for evaluation, as-
sessment, and required early intervention services specified on the infant
or toddler's IFSP, shall be voluntary.

For purposes of this subsection, voluntary means there is documenta-
tion in the child's record that parents have been informed of their right
to receive evaluation, assessment and required early intervention ser-
vices at no cost to the family and that the use of private insurance is volun-
tary.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1435(a)(10) and (c) and 1440. Title 20 United States Code; Sections
303.12, 303.520 and 303.527, Title 34 Code of Federal Regulations; and Sections
95004 and 95014(b), Government Code.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of Note, refiled 1-30-98 as an emergency;
operafive 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

3. New section refiled 6-1-98 as an emergency; operafive 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (b) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98,
No. 31).

5. Amendment of secfion heading and subsection (b), new subsection (c) and
amendment of Note filed 1-14-2003; operative 2-13-2003 (Register 2003,
No. 3).

§ 521 1 0. Basis for the Provision of Services Through
LEAs.

(a) LEAs shall provide, arrange, or purchase early intervention ser-
vices, as required by the infant's or toddler's IFSP, and be payor of last
resort for infants and toddlers with solely low incidence disabilities deter-
mined eligible for early intervention services under the category of estab-
lished risk as specified in Section 52022(b)(2) of these regulations and
who are not eligible for regional center services.

(b) LEAs, pursuant to Education Code Section 56425, shall provide
services for infants and toddlers who are also eligible for regional center
services when the infant or toddler is identified as an individual with ex-
ceptional needs pursuant to Education Code Section 56026 and Title 5
California Code of Regulations Section 3030 and who requires intensive
special education services and:

( 1 ) The infant or toddler is functioning at or below 50% of his or her
chronological age level in any one of the following skill areas:

(A) Gross or fine motor development;

(B) Receptive or expressive language development;

(D) Cognitive development;

(E) Visual development; or.

(2) The infant or toddler is functioning between 51% and 75% of his
or her age level in any two of the skill areas identified in (b)(1)(A)
through (b)(1)(E) of this section; or,

(3) Has a condiUon of known etiology which has a high probability of
resulting in developmental delay as specified in section 52022(b)(1);
and,

(4) The LEA is operating below the funded capacity as required by
Government Code section 95014(c).

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Secfion 1440, Title 20 United States Code; Sections 303.520 and 303.527, Title
34 Code of Federal Regulations; and Sections 95014(b) and (c), Government
Code.

History

1 . New section filed 8-4-97 as an emergency; operafive 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New secfion, including amendment of Note, refiled 1-30-98 as an emergency;
operafive 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 oremergency language will be repealed by oper-
ation of law on the following day.

3. New secfion refiled 6-1-98 as an emergency; operafive 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of section
and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No.
31).

Article 3.

Transfer and Transition
Procedures

§52111. Transfer.

(a) Regional centers and LEAs shall use existing information whenev-
er possible to determine continued eligibility and to mininuze delay in the
provision of appropriate early intervention services when an eligible in-
fant's or toddler's residence changes to another regional center or LEA.

(b) The procedures contained in Welfare and Institutions Code section
4643.5, pertaining to transfers between regional centers, shall apply for
an infant or toddler with an existing IFSP who moves from an area where
he or she received early intervention services from a regional center into
another regional center area.

(c) The procedures contained in Edtication Code section 56325, per-
taining to an lEP, shall apply instead for an infant or toddler with an exist-
ing IFSP who moves from an area where he or she received early inter-
vention services from an LEA into another LEA that provides early
intervention services and the LEA is operating below the funded capac-
ity, or for an infant or toddler with a solely low incidence disability.

Page 278.9

§ 52112

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(d) For an infant or toddler, with an existing IFSP, wiio is receiving
early intervention services from an LEA:

( 1 ) Who has not been determined eligible for regional center services;
and,

(2) Who moves from an area where an LEA provides early interven-
tion services to an area where there are no services available for the infant
or toddler through the LEA.

(A) With parent consent, the sending LEA. if informed about the move
by the family, shall notify the receiving regional center as soon as possi-
ble of a move to the new area and transmit the infant or toddler's record
to expedite service delivery in the new area; or

(B) With parent consent, the LEA shall transmit the infant or toddler's
record upon request of the receiving regional center if the LEA was not
previously informed of the move by the family.

1. Assign a service coordinator as specified in section 52060; and,

2. Arrange, purchase or provide early intervention services to the ex-
tent possible within existing resources as specified on the infant's or
toddler's current IFSP as soon as possible; and,

3. Within 30 days of receipt of evaluation and assessment materials
from the LEA determine eligibility and conduct a periodic review of the
IFSP.

NOTE; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 4643.5. Welfaie and Institutions Code; and Section 56325, Education
Code.

History
1. Amendment of article 3 heading and new section filed 7-28-98; operative
8-27-98 (Register 98, No. 31).

§ 52112. Transition from Early Intervention Services.

(a) LEAs shall provide special education and related services to eligi-
ble children at age three. Pursuant to the requirements contained in Title
34 Code of Federal Regulations, Section 303.344, each LEA shall partic-
ipate in the transition planning for toddlers served under the Early Inter-
vention Services Act, Government Code Sections 95000-95030, who
may be eligible for preschool programs under Part B of the Individuals
with Disabilities Education Act, Title 20 United States Code Sections
1400-1420, before the toddler is two years nine months, or at the discre-
tion of all parties up to six months before the child turns three to ensure
that an lEP has been developed and is implemented by the toddler's third
birthday.

(b) The service coordinator, six months before the third birthday of the
toddler receiving early intervention services, shall;

( 1 ) Notify the parent of a toddler who may be eligible for special edu-
cation and related services under Part B of the Individuals with Disabili-
ties Education Act that transition planning will occur within the next
three to six months;

(2) Notify the LEA where the toddler resides that there will be an IFSP
meeting requiring the attendance of an LEA representative pursuant to
34 CFR 300.132, before the toddler is two years nine months, or at the
discretion of all parties, up to six months before the toddler turns three
years old to specify the transition steps necessary for movement into ser-
vices under Part B of the Individuals with Disabilities Education Act;
and,

(3) Within thirty days following notification of the parent and the
LEA, the family, service coordinator, and LEA shall agree on the date for
the IFSP to specify the transition steps necessary for movement into ser-
vices under Part B.

(c) For all toddlers with an IFSP, the transition steps contained in the
IFSP at two years nine months or earlier shall include all of the following:

(I) Discussions with and providing information to parents regarding:

(A) The toddler's transition to special education for a toddler with a
disability who may be eligible for special education and related services
under Part B of the Individuals with Disabilities Education Act, Title 20
United States Code Sections 1400-1420; and,

(B) Steps to prepare the toddler for changes in service deUvery, includ-
ing steps to help the toddler adjust to, and function in, a new setting;

(2) Provide information about community resources such as Head
Start, Child Development Preschools, private or public preschool, for a
toddler who will not be eligible for special education services after thirty
six months of age; and,

(3) A projected dale for conducting a final review of the IFSP to review
the early intervention services and the transition outcomes by age three.

(d) For toddlers who may be eligible for preschool services from the
LEA under Part B of The Individuals with Disabilities Education Act,
Title 20 United States Code Section 1400-1420, the transition steps nec-
essary for movement into services under Part B or other appropriate pro-
gram, written at the IFSP meeting before the toddler is two years nine
months, or, at the discretion of all parties, up to six months before the
toddler's third birthday, shall include all of the following:

(1) With parental consent, the transmission of information about the
toddler to the LEA including evaluation and assessment information and
copies of IFSPs that have been developed and implemented;

(2) Identifying needed assessments to determine regional center and
special education eligibility and determining the regional center or LEA
responsible and time lines for completing the needed assessments;

(3) Statements of the steps necessary to ensure that the referral to an
LEA is received by the LEA in a timely manner to ensure that asses-
sments required under the provisions of Part B of the Individuals with
Disabilities Education Act are completed and an lEP is implemented by
the toddler's third birthday;

(4) A referral for evaluation and assessment for services under Part B
of the Individuals with Disabilities Education Act, Title 20 United States
Code Sections 1400-1420, no later than the time that the toddler is two
years nine months of age or before the LEA's break in school services if
the toddler will become three years of age during a break in school ser-
vices. The transition IFSP shall contain steps necessary to satisfy the re-
ferral and lEP development requirements contained in Education Code
Sections 56321 and 56344;

(5) Identification of the people responsible for convening an lEP and
final IFSP meeting, and the person responsible for convening an IPP
meeting, if necessary, for a toddler by age three to:

(A) Review the progress toward meeting the early intervention ser-
vices outcomes identified in the IFSP;

(B) Determine the eligibility for special education and develop the
lEP; and,

(C) Develop an IPP if the toddler is also eligible for services under the
Lanterman Developmental Disabilities Services Act as required in Wel-
fare and Institutions Code Section 4646.

(e) If a toddler is older than two years and six months on the date of
the initial IFSP, the IFSP shall include steps to ensure transition to Spe-
cial Education Services under Part B of the Individuals with Disabilities
Education Act or other services that may be appropriate.

(f) Regional centers may continue providing or purchasing services
for a preschooler who has been determined eligible for regional center
services:

(1 ) Until the beginning of the next school term after the toddler's third
birthday during a period when the LEA special education preschool pro-
gram is not in session; and,

(2) When the multidisciplinary team determines that services are nec-
essary until the LEA special education program resumes.

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1436(d)(8), Title 20 United States Code; Sections 303.148, 303.322,
303.340, 303.342, 303.343, 303.344(h) and 303.346, Title 34 Code of Federal
Regulations; and Sections 56321, 56343 and 56344, Education Code.

History

1. New article 3 (section 521 12) and section filed 8-4-97 as an emergency; opera-
tive 8-4-97 (Register 97, No. 32). Pursuant to Government Code section
95028(c), a Certificate of Compliance must be transmitted to OAL by 1-3 1-98,
or emergency language will be repealed by operation of law on the following
day.

2. Editorial correction of subsection (b)(1) (Register 98, No. 5).

3. New article 3 (section 521 12) and section, including amendment of Note, re-
filed 1-30-98 as an emergency; operative 1-3 1-98 (Register 98, No. 5). A Cer-
tificate of Compliance must be transntiitted to OAL by 6-1-98 or emergency
language will be repealed by operation of law on the following day.

Page 278.10

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 52140

•

4. New article 3 (section 521 12) and section refiled 6-1-98 as an emergency; op-
erative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be
transmitted to OAL by 9-29-98 or emergency language will be repealed by op-
eration of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of section
and NoTi:, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No.
31).

Subchapter 4. Service Coordination and
Interagency Agreements

Article 1. Service Coordination

§52120. General.

(a) Regional centers or LEAs shall assign a service coordinator under
the following circumstances:

( 1 ) At the time that infants or toddlers are referred for evaluation and
assessment; and,

(2) When infants or toddlers are determined eligible for early interven-
tion services from regional centers and/or LEAs.

(b) A parent may perform service coordination activities for his or her
ovv'n infant or toddler in collaboration with the service coordinator as-
signed by the regional center or LEA.

NOTH: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 303.22 and 303.344(g), Title 34 Code of Federal Regulations; and Sec-
tion 95018, Government Code.

History

1 . New subchapter 4, aiticle 1 (sections 52120-52122) and section filed 8-4-97
as an emergency; operative 8-4-97 (Register 97, No. 32). Pursuant to Govern-
ment Code section 95028(c), a Certificate of Compliance must be transmitted
to OAL by 1-31-98, or emergency language will be repealed by operafion of
law on the following day.

2. Editorial correction of subsection (a)( 1 ) and History 1 (Register 98, No. 5).

3. New subchapter 4, article 1 (sections 52120-52122) and secfion, including
amendment of NoTi;, refiled 1-30-98 as an emergency; operative 1-31-98
(Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL
by 6-1-98 or emergency language will be repealed by operation of law on the
following day.

4. New subchapter 4, article 1 (sections 52120-52122) and section refiled 6-1-98
as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Com-
pliance must be transmitted to OAL by 9-29-98 or emergency language will be
repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§ 521 21 . Service Coordination Responsibilities.

(a) The service coordinator shall:

(1) Provide the initial notice to the parent pursuant to Section 52160
of these regulations;

(2) Obtain consent pursuant to Section 52162 of these regulations and
provide written notice pursuant to Section 52161;

(3) Serve as the primary point of contact for coordinating services and
assistance for the infant's or toddler's parent, service providers and re-
gional center and/or public agencies;

(4) Inform the parent of the availability of additional non-required ser-
vices as specified in Section 52108(a)(3)(A) of these regulations which
may provide assistance to the family;

(5) Facilitate the delivery of services on the initiation date identified
in the IFSP;

(6) Continuously seek the appropriate services and service providers
necessary to enhance the development of each infant or toddler being
served for the duration of the infant's or toddler's eligibility;

(7) Coordinate the performance of initial and subsequent evaluations
and assessments;

(8) Participate in the development and review of the IFSP;

(9) Monitor the delivery of services and the degree to which progress
toward achieving outcomes is being made through the periodic review
of the IFSP;

( 1 0) Inform the parent of advocacy services and procedural safeguards
contained in these regulations;

(11) Facilitate the exchange of information between service prcniders
including health providers, medical case managers, regional centers and
LEAs; and

(12) Facilitate the development of transition steps in the IFSP.

(b) Service Coordination may include medical case management ser-
vices provided by another agency such as High Risk Infant Follow-up
Program, California Children Services or Medi-Cal Managed Care.
NOTE; Authority cited: Sections 95009 and 95028. Government Code. Reference:
Section 1436(d)(8), Title 20 United States Code; Sections 303.22 and 3()3.344( g ).
Title 34 Code of Federal Regulations; and Section 95018, Government Code.

History

1. New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97. No.
32). Pursuant to Government Code section 95028(c), a Certificate of CA)m-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of NoTi;, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (b) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98,
No. 31).

§ 52122. Service Coordinator Qualifications.

Service coordinators shall have demonstrated knowledge about:

(a) Infants and toddlers who are referred for evaluation and assessment
or who are eligible for early intervention services;

(b) Working with families and community resources; and

(1) Parent rights and responsibilities;

(2) Due process;

(3) Confidentiality;

(4) Required components of the IFSP;

(5) Time lines specified within these regulations beginning with sec-
tion 52000 et seq.; in Sections 52086(a), 521 12(b), 52164(b), 52168(c),
52171(a) and 52174(c) of these regulations;

(6) Transition processes from the early intervention service system
specified in section 521 12 of these regulations; and,

(7) The system of payments for services identified in the IFSP.
NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1436(d)(8), Title 20 United States Code; Sections 303.22(d) and
303.344(g), Title 34 Code of Federal Regulations; and Section 95018, Govern-
ment Code.

History

1. New section filed 8-4-97 as an emergency; operative 8-^4—97 (Register 97. No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (c)(5) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register
98, No. 31).

Article 2. Interagency Agreements

§ 52140. Local Interagency Agreements.

(a) Regional centers and LEAs shall develop and maintain local inter-
agency agreements.

(b) Local interagency agreements shall include, but not be limited to.
the following:

Page 278.11

§ 52160

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1) The responsibilities of each LEA and regional center for meeting
the terms of the agreement;

(2) Procedures for coordination of child find activities with local pub-
lic agencies and regional centers to identify infants and toddlers who may
be eligible for early intervention services;

(3 ) Specific procedures for coordination of referrals for evaluation and
assessment;

(4) Procedures for the assignment of a service coordinator;

(5) Interagency procedures for identifying the responsibilities of the
regional center and LEA for completing the evaluation and assessment
and determining eligibility within the time requirements contained in
Section 52086 of these regulations, when an infant or toddler may receive
services from both the regional center and LEA;

(6) Procedures for the timely exchange of information between re-
gional centers and LEAs;

(7) Mechanisms for ensuring the availability of contacts at regional
centers and LEAs at all times during the year;

(8) Procedures for interagency IFSP development when infants and
toddlers may be eligible for early intervention services from the regional
center and the LEA or other state or local programs or services;

(9) Procedures to ensure the provision of services during periods of
school vacations when services are required on the IFSP;

(10) Transition planning procedures which begin at least six months
prior to a toddler' s third birthday pursuant to Section 52 1 1 2 of these regu-
lations;

(11) Procedures for resolving disputes between regional centers and
LEAs;

(12) Procedures for the training and assignment of surrogate parents;
and

(13) Procedures for accepting transfers of infants or toddlers with ex-
isting IFSPs.

(d) Interagency agreements shall be reviewed by both parties annual-
ly, revised as necessary, dated, and signed by both parties.

Note: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1435{a)(10, Title 20 United States Code; Sections 303.1, 303.174,
303.523 and 303.524. Title 34 Code of Federal Regulations.

History

1 . New article 2 (section 52140) and section filed 8-4-97 as an emergency; opera-
tive 8-4-97 (Register 97, No. 32). Pursuant to Government Code section
95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98,
or emergency language will be repealed by operation of law on the following
day.

2. New article 2 (section 52140) and section, including amendment of Note, re-
filed 1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). ACer-
tificate of Compliance must be transmitted to OAL by 6-1-98 or emergency
language will be repealed by operation of law on the following day.

3. New article 2 (section 52140) and section refiled 6-1-98 as an emergency; op-
erative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be
transmitted to OAL by 9-29-98 or emergency language will be repealed by op-
eration of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (c), new subsection (d), and amendment of Note, transmitted to OAL
6-16-98 and filed 7-28-98 (Register 98, No. 31).

Subchapter 5. Procedural Safeguards

Article 1. Notice and Consent

§52160. Initial and Annual Notice.

Prior to the initial evaluation and assessment to determine eligibility
required in Section 52082 of these regulations and annually thereafter,
service coordinators shall give written notice to the parent, which shall
include:

(a) The personally identifiable information maintained by the regional
center or LEA;

(b) The types of information used in the evaluation, assessment and
IFSP development; and,

(c) The methods that regional centers and LEAs use to protect the con-
fidentiality of personally identifiable information including:

(1) The sources from whom personally identifiable information is
gathered;

(2) The uses to be made of the personally identifiable information;

(3) The policies and procedures which regional centers and LEAs fol-
low regarding storage, disclosure to third parties, retention, and destruc-
tion of personally identifiable information as required in Title 34 Code
of Federal Regulations, Sections 300.572 through 300.573; and,

(4) The rights of parents and infants and toddlers regarding access to
information, including the rights accorded to fainilies in these regula-
tions and the rights under the Family Education Rights and Privacy Act
of 1 974, Title 20, United States Code, Section 1232(g) and implementing
regulations in Title 34 Code of Federal Regulations, Section 99.
NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 99.7. 300.561(a)(4) and 303.460. Title 34 Code of Federal Regulations;
and Sections 1232(g), 1476(b)(12) and 1480(2) and (3), Title 20 United States
Code; and Section 95007(g), Government Code.

History

1. New subchapter 5, article 1 (sections 52160-52162) and section filed 8-4-97
as an emergency; operative 8^-97 (Register 97, No. 32). Pursuant to Govern-
ment Code section 95028(c), a Certificate of Compliance must be transmiued
to OAL by 1-31-98, or emergency language will be repealed by operaUon of
law on the following day.

2. Editorial correcfion of Note (Register 98, No. 5).

3. New subchapter 5, article 1 (sections 52160-52162) and section, including
amendment of Note, refiled 1-30-98 as an emergency; operative 1-31-98
(Register 98, No. 5). A Certificate of Compliance must be transmitted to OAL
by 6-1-98 or emergency language will be repealed by operation of law on the
following day.

4. New subchapter 5, article 1 (sections 52160-52162) and section refiled 6-1-98
as an emergency; operative 6-1-98 (Register 98, No. 23). A Certificate of Com-
pliance must be transmitted to OAL by 9-29-98 or emergency language will be
repealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§ 52161. General Notice Requirements.

(a) Written notice shall be given to the parent of an infant or toddler,
eligible or suspected to be eligible to receive early intervention services,
a reasonable time before a regional center or LEA proposes, or refuses,
to initiate or change:

(1) The identification, evaluation, assessment or placement of the in-
fant or toddler; or

(2) Early intervention services to the infant or toddler and the infant's
or toddler's family.

(b) The notice shall be in sufficient detail to inform the parent about:

(1) The action that is being proposed or refused;

(2) The reasons for taking the action; and

(3) All procedural safeguards that are available under Title 34 Code
of Federal Regulations, Sections 303.400 through 303.460.

(1) Written using words that are understandable to the general public;
and

(2) Provided in the language of the parent's choice, unless it is clearly
not feasible to do so. The regional center or LEA shall take steps to ensure
that:

(A) The notice is translated;

(B) The parent understands the notice; and

NOTE: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Secuon 95007(2), Government Code; Sections 1435(a)( 1 3) and 1439(6)-(7), Title
20 United States Code; and Sections 303.403(a), 303.403(b) and
303.403(c)(l)-(2), Title 34 Code of Federal Regulafions.

History
1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

Page 278.12

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 52166

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note:,
transinitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§52162. Consent.

(a) The service coordinator shall obtain written parental consent be-
fore:

( 1 ) The initial evaluation and assessment of an infant or toddler is con-
ducted; and

(2) Early intervention services are initiated.

(b) The infant's or toddler's record shall contain written evidence that
the parent has been informed:

( 1 ) Of information relevant to the evaluation, assessment, early inter-
vention service, or exchange of records for which consent is sought, in
the language of the parent's choice, and agrees to the completion of the
evaluation or assessment and the provision of early intervention services;

(2) That consent is voluntary and may be revoked at any time;

(3) That he/she may accept or decline any early intervention service
and may decline such service after first accepting it, and continue to re-
ceive other early intervention services; and,

(4) About who will receive the records and a listing of the records to
be exchanged.

( 1 ) That the parent has been informed of the nature of the evaluation
and assessment or the early intervention services that would have been
provided;

(2) That the parent has been informed that the infant or toddler will not
receive the evaluation and assessment or early intervention services un-
less consent is given; and,

(3) That the infant' s or toddler' s record contains documentation of the

attempts to obtain consent.

NOTE; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1480, Title 20 United States Code; Sections 303.401(a)(l)-(3),
303.403(c)(2)(iii), 303.404(a), 303.404(b) and 303.405, Title 34 Code of Federal
Regulations.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

3. New secfion refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 2. Access Rights

§ 521 64. Access Rights.

(a) A regional center and/or LEA shall permit the parent or authorized
representative to inspect and review any record relating to their infant or
toddler.

(b) The regional center and/or LEA shall comply with a request for ac-
cess to records before any meeting regarding an IFSP or any hearing re-
lating to the identification, evaluation, assessment, placement, or the pro-
vision of early intervention services to the infant or toddler and in no case
more than 5 working days after the request has been made.

(c) A regional center and/or LEA shall respond to requests for explana-
tions and interpretations of the content of a record from parents with the
requested explanation or interpretation.

(d) A regional center and/or LEA may presume that the parent has au-
thority to inspect and review records relating to their infant or toddler un-
less there is a court order, state statute, or legally binding document relat-
ing to such matters as divorce, separation or custody that specifically
revokes those rights.

(e) Each service coordinator shall provide parents, on request, a list of
the types and locations of records collected or used by the regional center
or LEA.

NOTE; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1435(a)( 1 3) and 1439(4), Title 20 United States Code; Sections 300.562.
300.565, 300.576, 303.402 and 303.460, Title 34 Code of Federal Regulations;
and Section 95007(g), Government Code.

History

1 . New article 2 (sections 52164-52169) and secUon filed 8^1-97 as an emergen-
cy; operative 8-4—97 (Register 97, No. 32). Pursuant to Government Code sec-
tion 95028(c), a Certificate of Compliance must be transmitted to OAL by
1-31-98, or emergency language will be repealed by operation of law on the
following day.

2. New aiticle 2 (sections 52164-52169) and section, including amendment of
NoTi;, refiled 1-30-98 as an emergency: operative 1-31-98 (Register 98, No.
5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emer-
gency language will be repealed by operation of law on the following day.

3. New article 2 (sections 52164-52169) and secfion refilled 6-1-98 as an emer-
gency; operafive 6-1-98 (Register 98, No. 23). A Certificate of Compliance
must be transmitted to OAL by 9-29-98 or emergency language will be re-
pealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (c) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98,
No. 31).

§ 52165, Documentation of Access.

(a) The regional center and/or LEA providing early intervention ser-
vices to the infant or toddler shall maintain documentation specifying to
whom the record was disclosed other than parents and authorized em-
ployees specified by the regional center or LEA. The parent may inspect
the documentation.

(b) Documentation of access shall include:

(1) The name of the person to whom the record was disclosed;

(2) The date the record was disclosed; and

(3) The purpose for which the record was disclosed.

NOTE; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 1435(a)(13) and 1439(4), Title 20 United States Code; Sections 300.402
and 303.460, Title 34 Code of Federal Regulations; and Section 95007(g), Gov-
ernment Code.

History

1. New section filed 8-4-97 as an emergency; operative 8-^1-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New secfion, including amendment of Note, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

3. New secfion refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98,
No. 23). A Certificate of CompUance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 6-1-98 order, including ajnendment of NoTi:,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§ 52166. Records on More Than One Infant or Toddler.

If a record includes information on more than one infant or toddler, the
regional center or LEA shall provide, for the parent's inspection or re-
view, only the information relating to their infant or toddler or inform the
parent of that specific information.

NOTE; Authority cited: Secfions 95009 and 95028, Government Code. Reference:
Section 1439(2) and (3), Title 20 United States Code; and Sections 30().5f)4 and
303.460, Title 34 Code of Federal Regulations.

History
1 . New section filed 8-4-97 as an emergency; operative 8—4-97 (Register 97. No.
32). Pursuant to Government Code secfion 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

Page 278.13

§ 52167

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. New section, including amendment of Nori;, rcfiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98. No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Noth,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§ 521 67. Fees for Copies of Records.

(a) A regional center or LEA may charge a reasonable fee for copies
of records in an amount not to exceed the actual cost of reproducing re-
cords.

(b) The amount of the fee shall not prevent the parents from exercising
their right to inspect and review those records.

(c) A regional center or LEA may not charge a fee to search for or re-
trieve records requested by parents or an authorized representative.
NOTE; Authority cited: Sections 95009 and 95028, Govemment Code. Reference:
Section 1439(3), Title 20 United States Code; Sections 300.566 and 303.460, Title
34 Code of Federal Regulations; and Section 49065, Education Code.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Govemment Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of NoTt;. refiled 1-30-98 as an emergency;
operafive 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transmitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§ 52168. Amendment of Records at Parental Request.

(a) A parent, who believes that information in a regional center's or
LEA' s records is inaccurate or misleading or violates the privacy or other
rights of an infant or toddler or family, may request that the director of
the regional center or the Superintendent of the LEA amend or remove
the information over which the regional center or LEA has authority.

(b) The service coordinator, upon request, shall assist a parent in com-
municating with those persons who created information contained in the
record, when the regional center or LEA did not originate the information
which the parent believes is inaccurate, misleading, or violates the priva-
cy or other rights of an infant or toddler or family.

(c) No later than 14 days after receipt of the request for amendment or
removal of information from a record, the regional center or LEA shah
notify the parent if the request has been denied and advise the parent of
the right to a meeting with the Director of the regional center or the Super-
intendent of the LEA pursuant to Title 34 Code of Federal Regulations,
Section 99.20(c).

(d) If the result of the meeting is that the record will not be amended,
the regional center or LEA shall inform the parent of the right to place,
in the record maintained on the infant or toddler, a statement commenting
on the information contained in the record or setting forth any reasons for
disagreeing with the contents of any document in the child's records, re-
gardless of whether the document was created by the regional center or
LEA or by any other agency or individual.

(e) Any statement placed in the record of the infant or toddler pursuant
to subsection (d) above shall:

( 1 ) Be kept by the regional center or LEA as part of the record of the
infant or toddler as long as the contested portion of the record is main-
tained by the regional center or LEA; and,

(2) Accompany the record of the infant or toddler if the contested por-
tion is disclosed by the regional center or LEA.

NOTE: Authority cited: Sections 95009 and 95028, Govemment Code. Reference:
Sections 300.566, 300.567, 300.569 and 303.460, Title 34 Code of Federal Regu-
lations.

History

1 . New section filed 8-4-97 as an emergency; operative 8^1—97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. Editorial correction of subsection (b) (Register 98, No. 5).

3. New section, including amendment of subsecfion (e) and Note, refiled 1-30-98
as an emergency; operative 1-31-98 (Register 98. No. 5). A Certificate of Com-
pliance must be transmitted to OAL by 6-1-98 or emergency language will be
repealed by operation of law on the following day.

4. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transinitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tions (c)-(e) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Regis-
ter 98. No. 31).

§ 52169. Consent for Release of Information.

Written parental consent shall be obtained before personally identifi-
able information is disclosed in writing or orally to anyone other than au-
thorized employees specified by the regional center or LEA.
NOTE: Authority cited: Sections 95009 and 95028, Govemment Code. Reference:
Sections 1435(a)(13) and 1439(2), Title 20 United States Code; and Sections
300.571 and 303.460, Title 34 Code of Federal Regulations.

History

1 . New section filed 8-4-97 as an emergency; operafive 8-4-97 (Register 97, No.
32). Pursuant to Govemment Code secfion 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

•

Article 3. Complaint Process

§52170. Complaint Procedures.

(a) A complaint shall be a written and signed statement alleging that
a regional center, LEA or any private service provider receiving funds
under Part C of the Individuals with Disabilities Education Act, Title 20
United States Code, Sections 1431-1445, has violated a federal or state
law or regulation governing the provision of early intervention services
provided through Part C of the Individuals with Disabilities Education
Act, Title 20 United States Code Sections 1431-1445, for infants or
toddlers and their families.

(b) Any individual or organization may file a complaint.

(1) Not more than one year before the date that the complaint is re-
ceived by the Department of Developmental Services unless a longer pe-
riod is reasonable because the alleged violation continues for that child
or other children; or

(2) Not more than three years before the date on which the complaint
is received by the Department of Developmental Services, if the com-
plainant is requesting reimbursement or corrective action as remediation
of the complaint.

(d) The procedures under Chapter 1 , commencing with Section 4500
of Division 4.5 of the Welfare and Institutions Code or Part 30, com-
mencing with Section 56500 of the Education Code, or Title 5 California
Code of Regulations Section 4600 et seq., shall not be used for resolving
complaints regarding California's Early Start Program.

(e) Each regional center and LEA shall inform the parent and other in-
terested individuals or organizations of the right to file a complaint di-

•

Page 278.14

Title 17

Health and Welfare Agency — Department of Developmental Services

§52171

rectly with the Department of Developmental Services at the following
address:

l)i;!'ARTMf:NT C)I- DHVHI.OPMHNTAI. SHRVICHS
Ot-FlCi; OI' HUMAN RICiHTS

aiti;ntk)N: harly start complaint unit

1600 ninth STRI-;E-;T, room 240. M.S. 2-I5
SACRAMUNTO. CA y.S814

( f) If the complainant is unable to provide the complaint in writing, the
service coordinator shall directly assist the complainant or provide assis-
tance to identify resources which can aid the complainant in completing
the written complaint.

(g) The complaint shall include the following:

( 1 ) The name, address and phone number of the complainant;

(2) A statement that a regional center, LEA or any private service pro-
vider receiving funds under Part C of the Individuals with Disabilities
Education Act, Title 20 United States Code Sections 1431-1445, has vio-
lated a federal or state law or regulation governing the provision of early
intervention services for infants or toddlers and their families in Califor-
nia;

(3) A statement of facts upon which the alleged violation is based;

(4) The party allegedly responsible; and

(5) A description of the voluntary steps taken at the local level to re-
solve the complaint, if any.

NOTE; Authority cited: Sections 95009 and 95028, Government Code. Reference:
Sections 303.22 and 303.510-303.512, Title 34 Code of Federal Regulations; and
Section 95007(f), Government Code.

History

1. New article 3 (sections 52170-52171) and section filed 8-4-97 as an emergen-
cy; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code sec-
tion 95028(c), a Certificate of Compliance must be transmitted to OAL by
1-31-98. or emergency language will be repealed by operation of law on the
following day.

2. Editorial correction of Note (Register 98, No. 5).

3. New article 3 (sections 52170-52171) and section, including amendment of
Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No.
5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emer-
gency language will be repealed by operafion of law on the following day.

4. New article 3 (sections 52170-52171) and secfion refiled 6-1-98 as an emer-
gency; operative 6-1-98 (Register 98, No. 23). A Certificate of Compliance
must be transmitted to OAL by 9-29-98 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of section
and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No.
31).

6. New subsections (c)-(c)(2), subsecfion relettering, amendment of newly desig-
nated subsection (e) and amendment of Note filed 1-14-2003; operative
2-13-2003 (Register 2003, No. 3).

§ 521 71 . Complaint Investigation.

(a) Within 60 days of receipt of the complaint the Department of De-
velopmental Services shall:

(1) Assign the investigation of the complaint to a state interagency
team or to the appropriate state agency that is responsible for the adminis-
tration of the regional center, LEA or any private service provider receiv-
ing funds under Part C of the Individuals with Disabilities Education Act,
Title 20 United States Code Sections 1431-1445, named in the com-
plaint, which shall:

(A) Conduct an investigation, on-site if necessary; and

(B) Give the complainant the opportunity to submit additional infor-
mation, either orally or in writing, about the allegations in the complaint;

(2) Review all relevant information and make a determination as to
whether there has been a violation of a statutory or regulatory require-
ment contained in:

(A) Part C of the Individuals with Disabilities Education Act, Title 20
United States Code Sections 1431-1445;

(B) The Federal regulations pertaining to Part C of the Individuals with
Disabilities Education Act;

(D) Regulations contained in this chapter;

(E) Welfare and Institutions Code, Division 4.5, Chapter 5, beginning
with Section 4500; or,

(F) Education Code beginning with Sections 56425 through 5643 1 .

(3) Provide a written decision to all parties vv'hich addresses each alle-
gation and includes:

(A) Findings and conclusions;

(B) The reasons for the final decision;

(D) Time lines for completion of the corrective actions; and,

(E) Provisions for technical assistance.

(4) If the decision of the Department of Developmental Services in-
cludes remedies for denial of appropriate services, the reinedies may in-
clude:

(A) Actions to remediate denial of those services, including as ap-
propriate, the awarding of monetary reimbursement or other corrective
action appropriate to the needs of the child and the child's family, and

(B ) Actions to assure that services are provided appropriately in the fu-
ture for infants and toddlers with disabilities and their families

(b) An extension of the time limit under paragraph (a) of this Section
shall be made by the Department of Developmental Services when
events beyond the control of the Department of Developmental Services
occur including but not limited to the complainant's illness, the com-
plainant's absence from the geographical area, inability to locate the
complainant, or a natural disaster.

(c) If a written complaint is received that is also the subject of a due
process hearing pursuant to 34 CFR 303.420 and 17 CCR 52172 and
52174, or contains multiple issues, of which one or more are part of that
hearing, the Department of Developmental Services shall set aside any
part of the complaint that is being addressed in the due process hearing,
until the conclusion of the hearing. Any issue in the complaint that is not
part of the due process action will be resolved by the Department of De-
velopmental Services within the 60 calendar-day time line using the
complaint procedures described in this section.

(d) If an issue is raised in a complaint filed under this section that has
previously been decided in a due process hearing involving the same par-
ties, the hearing decision is binding, and the Department of Developmen-
tal Services shall inform the complainant to that effect.

(e) The Department of Developmental Services shall resolve any com-
plaint alleging the failure of a public agency or private service provider
to implement a due process decision.

NOTE: Authority cited: Secdons 95009 and 95028, Government Code. Reference:
Section 303.510-303.512, Title 34 Code of Federal Regulations; and Section
52007(g), Government Code.

History

1. New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. Editorial correction of section heading (Register 98, No. 5).

4. New section refiled 6-1-98 as an emergency; operative 6-1-98 (Register 98,
No. 23). A Certificate of Compliance must be transmitted to OAL by 9-29-98
or emergency language will be repealed by operation of law on the following
day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tions (a)(1), (a)(2)(A) and (B) and Note, transmitted to OAL 6-1 6-98 and filed
7-28-98 (Register 98, No. 31).

6. Repealer and new subsection (a)(4), nevv/ subsections (a)(4)(A), (a)(4)(B) and
(c)-(e) and amendment of Note filed 1-14-2003; operadve 2-1 3-2003 (Regis-
ter 2003, No. 3).

Page 278.15

§ 52172

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Article 4. Mediation and Due Process
Procedures

§ 52172. Procedures That Apply to Both Mediation and
Due Process.

(a) A parent may request a mediation conference and/or a due process
hearing under any of the following circumstances:

( 1) A regional center or LEA proposes to initiate or change the identifi-
cation, evaluation, assessment, placement or provision of appropriate
early intervention services;

(2) A regional center or LEA refuses to initiate or change the identifi-
cation, evaluation, assessment, placement or provision of appropriate
early intervention services; or,

(h) A regional center or LEA may request a mediation conference and/
or a due process hearing when the parent refuses to consent to all or any
part of an evaluation and assessment of the infant or toddler.

(c) All requests for a mediation conference and/or due process hearing
shall be in writing and filed with the contractor that the Department of De-
velopmental Services uses for mediation and due process hearings. If a
parent is unable to make a request for mediation or a due process hearing
in writing, the service coordinator shall assist the parent in filing the re-
quest.

(d) The duration for both mediation and due process hearing shall not
exceed a total thirty day period from the receipt of the mediation or due
process request to the mailing of the decision.

(e) The location of the mediation and/or due process hearing shall be
at a time and place reasonably convenient to the parent.

(f) During the pendency of mediation and/or due process hearing pro-
cedures, the infant or toddler shall continue to receive the early interven-
tion services listed on the IFSP they are currently receiving. If mediation
and/or due process hearing involves the initiation of a service(s) the in-
fant or toddler shall receive those services that are not in dispute.

(g) Mediation and due process hearings shall be conducted in English
and interpreted in the language of the family's choice or other mode of
communication.

NOTE: Authority cited: Sections 95009 and 95028, Government Code; and Sec-
tion 4712(k), Welfare and Institutions Code. Reference: Sections I435(a)(13) and
1439(/), Tide 20 United States Code; Sections 303.420 and accompanying notes,
303.421, 303.423 and 303.425, Title 34 Code of Federal Regulations; and Section
95007(g), Government Code.

History

1 . New article 4 (sections 521 72-521 74) and section filed 8^-97 as an emergen-
cy; operative 8-4-97 (Register 97, No. 32). Pursuant to Government Code sec-
tion 95028(c), a Certificate of Compliance must be transmitted to OAL by
1-31-98, or emergency language will be repealed by operafion of law on the
following day.

2. Editorial correction of Note (Register 98, No. 5).

3. New article 4 (sections 52172-52174) and section, including amendment of
Note, refiled 1-30-98 as an emergency; operative 1-31-98 (Register 98, No.
5). A Certificate of Compliance must be transmitted to OAL by 6-1-98 or emer-
gency language will be repealed by operation of law on the following day.

4. New article 4 (sections 52172-52174) and section refiled 6-1-98 as an emer-
gency; operadve 6-1-98 (Register 98, No. 23). A Certificate of Compliance
must be transmitted to OAL by 9-29-98 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 6-1-98 order, including amendment of Note,
transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98, No. 31).

§ 52173. Mediation Procedures.

(a) Mediation shall be voluntary.

(b) The matter being mediated shall proceed to a scheduled due pro-
cess hearing if either party waives mediation or if mediation fails in
whole or in part. The mediator may assist the parties in specifying any
unresolved issue(s) to be included in the hearing request.

(c) The mediation conference shall be conducted by a mediator who
is an impartial, third party with no personal or professional interest that
would conflict with his or her objectivity in mediating a disagreement.

(d) The due process hearing officer shall be a different person than the
mediator when mediation does not resolve the disagreeinent.

(e) The mediator shall be trained in communication, mediation and
problem solving and shall be knowledgeable about early intervention
programs and the federal and state laws and regulations applicable to Part
C of the Individuals with Disabilities Education Act, Title 20 United
States Code Sections 143 1-1445, and the California Early Intervention
Services Act. Government Code Sections 95000-95030.

(f) The mediator shall be under contract with the Department of Devel-
opmental Services.

(g) A person who otherwise qualifies under Subsection (c) and (d) of
this Section as a mediator is not an employee of the Department of Devel-
opmental Services solely because the person is paid by the Department
of Developmental Services to conduct the mediation process.

(h) A parent may be accompanied by any representative at the medi-
ation.

(i) The mediator shall ensure that written agreements from the medi-
ation conference are signed and provided to all participants at the conclu-
sion of the mediation conference.

(j) Discussions during mediation must be confidential and may not be
used as evidence in any subsequent due process or civil proceedings.
Note: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1439( 1), Title 20 United States Code; Secdons 303.420(a)-(b) and accom-
panying notes, 303.42 l(a)-(b) and 303.422, Title 34 Code of Federal Regulations.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of Note, refiled 1-30-98 as an emergency;
operative 1-31-98 (Register 98, No. 5). A Certificate of Compliance must be
transinitted to OAL by 6-1-98 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
don (e) and Note, transmitted to OAL 6-16-98 and filed 7-28-98 (Register 98,
No. 31).

5. New subsection (j) filed 1-14-2003; operadve 2-13-2003 (Register 2003, No.
3).

§ 52174. Due Process Hearing Procedures.

(a) The hearing shall be conducted by a due process hearing officer
who is an impartial, third party with no personal or professional interest
that would conflict with his or her objectivity in conducting the hearing.

(b) The due process hearing officer shall be knowledgeable about the
federal and state laws and regulations applicable to Part C of the Individ-
uals with Disabilities Education Act, Title 20 United States Code Sec-
tions 1431-1445, and the California Early Intervention Services Act,
Government Code Sections 95000-95030, the Lanterman Developmen-
tal Disabilities Services Act, Welfare and Institutions Code sections 4500
et seq.; and Part 30 of the California Education Code, commencing with
Section 56500 et seq.

( 1 ) Listen to the presentation of relevant viewpoints about the issue of
disagreement;

(2) Examine the evidence presented during the hearing;

(3) Issue a decision that is in compliance with federal and state law;

(4) Provide documentation of the proceedings, including findings of
fact and a written decision; and

(5) Ensure that the decision is mailed to each party after completion
of the hearing and within 30 days of receipt of the due process hearing
request.

(d) A parent involved in a due process hearing shall have the right to:
(1) Be accompanied and advised by counsel and/or by an individual

with special knowledge and training with respect to early intervention
services;

Page 278.16

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Health and Welfare Agency — Department of Developmental Services

§ 54000

(2) Present evidence and confront, cross-examine, and compel the at-
tendance of witnesses;

(3) Prohibit the introduction of any evidence at the proceeding that has
not been disclosed to the parent or the other party at least five days before
the proceeding;

(4) Obtain a written or electronic, verbatim transcription of the pro-
ceeding;

(5) Obtain written findings of fact and decision.

(e) The hearing officer shall be under contract with the Department of
Developmental Services. A person who otherwise qualifies under Sub-
section (a) or (b) of this Section is not an employee of a regional center
or LEA solely because the person is paid by the agency to conduct the due
process hearing.

(f) Disputes which occur related to an lEP meeting which may occur
prior to the child's third birthday and which pertain to proposed Part B
preschool placements or services shall be filed with and processed by the
agent or division of the Department of Education which is responsible for
administering due process mediations and hearings pursuant to Part B of
the Individuals with Disabilities Education Act and Part 30 of the Califor-
nia Education Code, commencing with section 56500 et seq.

NOTK: Authority cited: Sections 95009 and 95028. Government Code. Reference:
Section 1439(/), Title 20 United States Code; Sections 303.421(aHb), 303.422(b)
and 303.423(b), Title 34 Code of Federal Regulations; and Section 95007(g), Gov-
ernment Code.

History

1 . New section filed 8-4-97 as an emergency; operative 8-4-97 (Register 97, No.
32). Pursuant to Government Code section 95028(c), a Certificate of Com-
pliance must be transmitted to OAL by 1-31-98, or emergency language will
be repealed by operation of law on the following day.

2. New section, including amendment of subsection (d)(1) and Note, refiled
1-30-98 as an emergency; operative 1-31-98 (Register 98, No. 5). A Certifi-
cate of Compliance must be transmitted to OAL by 6-1-98 or emergency lan-
guage will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
tion (b), new subsection (0 and amendment of Note, transmitted to OAL
6-16-98 and filed 7-28-98 (Register 98, No. 31).

Article 5. Surrogate Parents

§ 52175. Surrogate Parents.

(a) Regional centers or LEAs shall assign an individual to act as a sur-
rogate parent if:

(1) No parent can be identified;

(2) The infant or toddler is a dependent of the juvenile court and the
parental rights of the parent have been limited by the court or relin-
quished; or

(3) The parent cannot be located, after reasonable efforts by the re-
gional center or LEA.

(b) Interagency agreements as required in Section 52140(b)(12) shall
include procedures for:

( 1 ) Determining whether an infant or toddler needs a surrogate parent;

(2) Assigning a surrogate parent to the infant or toddler consistent with
the provisions of this Article and Government Code section 7579.5;

(3) Ensuring that surrogates have no interest that conflicts with the in-
terests of the infant or toddler he or she represents;

(4) Ensuring that surrogates have knowledge and skills that ensure ad-
equate representation of the infant or toddler;

(5) Ensuring that the surrogate parent is not an employee of any state
agency, regional center, LEA or service provider involved in the provi-
sion of early intervention services to the infant or toddler. A person who
otherwise qualifies as a surrogate parent is not an employee solely be-
cause he or she is paid by a state agency, regional center or LEA to serve
as a surrogate parent.

( 1 ) The evaluation and assessment of the infant or toddler;

(2) Development and implementation of the infant's or toddler's IFSP
including annual evaluations, assessments and periodic reviews;

(3) The ongoing provision of early intervention services to the infant
or toddler;

(4) Requesting mediation or due process hearings; and,

(5) Any other early intervention service established under Part C of the
Individuals with Disabilities Education Act, Title 20 United States Code
Sections 1431-1445.

(d) A surrogate parent may not provide consent for medical services
for which consent by a parent or legal guardian is required.
Note: Authority cited: Sections 95009 and 95028, Government Code. Reference:
Section 1439(5), Title 20 United States Code; Sections 303.18 and 303.406(a-e),
Title 34 Code of Federal Regulations; and Section 95022(f), Government Code.

History

1 . New article 5 (section 52 175) and section filed 8-4-97 as an emergency; opera-
tive 8-4-97 (Register 97, No. 32). Pursuant to Government Code section
95028(c), a Certificate of Compliance must be transmitted to OAL by 1-31-98,
or emergency language will be repealed by operation of law on the following
day.

2. New article 5 (section 52175) and section, including amendment of NoTi;, re-
filed 1-30-98 as an emergency; operative 1-31-98 (Register98, No. 5). A Cer-
tificate of Compliance must be transmitted to OAL by 6-1-98 or emergency
language will be repealed by operation of law on the following day.

3. New article 5 (secfion 52175) and section refiled 6-1-98 as an emergency: op-
erative 6-1-98 (Register 98, No. 23). A Certificate of Compliance must be
transmitted to OAL by 9-29-98 or emergency language will be repealed by op-
eration of law on the following day.

4. Certificate of Compliance as to 6-1-98 order, including amendment of subsec-
dons (b), (b)(2), (b)(5) and (c)(5) and amendment of Note, transmitted to OAL
6-16-98 and filed 7-28-98 (Register 98, No. 31).

5. Amendment of subsection (b)(5) filed 1-14-2003; operative 2-13-2003 (Reg-
ister 2003, No. 3).

Chapter 3. Community Services

Subchapter 1. General

Article 1. Definitions

§ 54000. Developmental Disability.

(a) "Developmental Disability" means a disability that is attributable
to mental retardation, cerebral palsy, epilepsy, autism, or disabling
conditions found to be closely related to mental retardation or to require
treatment similar to that required for individuals with mental retardation.

(b) The Developmental Disability shall:

(1) Originate before age eighteen;

(2) Be likely to continue indefinitely;

(3) Constitute a substantial disabihty for the individual as defined in
the article.

(1 ) Solely psychiatric disorders where there is impaired intellectual or
social functioning which originated as a result of the psychiatric disorder
or treatment given for such a disorder. Such psychiatric disorders include
psycho-social deprivation and/or psychosis, severe neurosis or personal-
ity disorders even where social and intellectual functioning have become
seriously impaired as an integral manifestation of the disorder.

(2) Solely learning disabilities. A learning disability is a condition
which manifests as a significant discrepancy between estimated cogni-
tive potential and actual level of educational performance and which is
not a result of generalized mental retardation, educational or psycho-so-
cial deprivation, psychiatric disorder, or sensory loss.

(3) Solely physical in nature. These conditions include congenital
anomalies or conditions acquired through disease, accident, or faulty de-
velopment which are not associated with a neurological impairment that
results in a need for treatment similar to that required for mental retarda-
tion.

Page 278.17

§ 54001

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Title 17

NOTE: Authority cited: Section 4312. Welfare and Institutions Code. Reference:
Sections 4.300 et seq.. Welfare and Institutions Code.

History

1. New section filed 6-24-80; effective thirtieth day thereafter (Register 80. No.
26).

2. Editorial redesienation of former Chapter 3 (Subchapter 1, Sections
34000-34010) to^Chapter 3, (Subchapter 1, Sections .34000-34010) filed
9-28-8.3 (Register 83, No. 40).

3. Change without regulatory effect amending subsections (a) and (b)(3) filed
10-29-2002 pursuant to section 100, title f, California Code of Regulations
(Register 2002, No. 44).

§54001. Substantial Disability.

(a) "Substantial disability" means:

( 1 ) A condition which results in major impairment of cognitive and/or
social functioning, representing sufficient impairment to require inter-
disciplinary planning and coordination of special or generic services to
assist the individual in achieving maximum potential; and

(2) The existence of significant functional limitations, as determined
by the regional center, in three or more of the following areas of major
life activity, as appropriate to the person's age:

(A) Receptive and expressive language;

(B) Learn i tig;

(D) Mobility;

(E) Self-direction;

(F) Capacity for independent living;

(G) Economic self-sufficiency.

(b) The assessment of substantial disability shall be made by a group
of Regional Center professionals of differing disciplines and shall in-
clude consideration of similar qualification appraisals performed by oth-
er interdisciplinary bodies of the Department serving the potential client.
The group shall include as a minimum a program coordinator, a physi-
cian, and a psychologist.

(c) The Regional Center professional group shall consult the potential
client, parents, guardians/conservators, educators, advocates, and other
client representatives to the extent that they are willing and available to
participate in its deliberations and to the extent that the appropriate con-
sent is obtained.

(d) Any reassessment of substantial disability for purposes of continu-
ing eligibility shall utilize the same criteria under which the individual
was originally made eligible.

NOTE: Authority cited: Section 4512, Welfare and Institutions Code. Reference:
Section 4312, Welfare and Institutions Code.

History

1 . New section filed 6-24-80; effective thirtieth day thereafter (Register 80, No.
26).

2. Amendment of section heading, section and Note filed 9-23-2003 as an emer-
gency; operative 9-25-2003 (Register 2003, No. 39). A Certificate of Com-
pliance must be transmitted to OAL by 1-23-2004 or emergency language will
be repealed by operafion of law on the following day.

3. Amendment of section heading, section and NoTi-; refiled 1-23-2004 as an
emergency; operafive 1-24-2004 (Register 2004, No. 4). A Certificate of Com-
pliance must be transmitted to OAL by 5-24-2004 or emergency language will
be repealed by operafion of law on the following day.

4. Certificate of Compliance as to 1-23-2004 order, including amendment of sub-
section (a)(2)(A), transmitted to OAL 3-3-2004 and filed 4-12-2004 (Register
2004, No. 16).

§ 54002. Cognitive.

"Cognitive" as used in this chapter means the ability of an individual
to solve problems with insight, to adapt to new situations, to think ab-
stractly and to profit from experience.

NOTE: Authority cited: Section 4512, Welfare and Institutions Code. Reference:
Sections 4300 et seq.. Welfare and Institutions Code.

History
] . New section filed 6-24-80; effective thirtieth dav thereafter (Register 80, No.
26).

Article 2. Eligibility

§ 5401 0. Eligibility for Regional Center Services.

(a) Any resident of the State of California believed to have a develop-
mental disability, and any resident of the State of California believed to
be at high risk of parenting an infant with a developmental disability shall
be eligible, upon application to the regional center, for initial intake,
diagnostic and counseling services, and a determination regarding the
need for assessment.

(b) Eligibility for ongoing regional center services shall be contingent
upon the determination, after intake and assessment, that the person has
a developmental disability that constitutes a substantial disability as de-
fined in Article 1 of this subchapter.

(c) Any individual deemed ineligible may appeal the decision in accor-
dance with Welfare and Institutions Code, Sections 4700-471 6. The Di-
rector's decision resulting from a fair hearing appeals process shall be fi-
nal and binding on all parties.

Note: Authority cited: Secfions 4312 and 4640, Welfare and Institutions Code.
Reference: Sections 4312, 4640, 4642, 4643 and 4644, Welfare and Insfitutions
Code.

History

1 . New secfion filed 6-24-80; effecfive thirtieth day thereafter (Register 80, No.
26).

2. Order of Repeal of subsecdon (c) and relettering of subsecfion (d) to subsection
(c) filed 8-26-82 by OAL pursuant to Government Code Section 11349.7(j)
(Register 82, No. 35).

3. Amendment of subsections (b)-(c) and amendment of Note filed 9-25-2003
as an emergency; operative 9-2.3-2003 (Register 2003, No. 39). A Certificate
of Compliance must be transmitted to OAL by 1-23-2004 or emergency lan-
guage will be repealed by operation of law on the following day.

4. Amendment of subsections (b)-(c) and amendment of Note refiled 1-23-2004
as an emergency; operative 1-24-2004 (Register 2004, No. 4). A Certificate of
Compliance must be transmitted to OAL by 5-24-2004 or emergency language
will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 1-23-2004 order transmitted to OAL 3-3-2004
and filed 4-12-2004 (Register 2004. No. 16).

Subchapter 2. Vendorization

Article 1. Definitions

§ 54300. Meaning of Words.

Words shall have their usual meaning unless the context or a definition
clearly indicates a different meaning. Words used in their present tense
include the future tense and words in the singular form include the plural
form. Use of the word "shall" denotes mandatory conduct; "may" de-
notes permissive conduct; and "should" denotes recommended conduct.
NOTE: Authority cited: Sections 4405, and 4648(a), Welfare and Insfitutions
Code; and Section 11 152, Government Code. Reference: Article II, Chapter 5, Di-
vision 4.5, Welfare and Insfitutions Code.

History

1. New secfion filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

[The next page is 279.]

Page 278.18

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Health and Welfare Agency — Department of Developmental Services

§ 54302

3. Amcndmenl of NoTi; filed 8-6-92; operative 8-6-92 (Register 92. No. 3.3).

4. Amendment of .section filed as an emergency 6-17-93: operative 6-17-93.
.Submitted to OAL for printing only pursuant to 8848.^ (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

Article 2. Vendorization Process

§ 54302. Definitions.

(a) The following definitions shall apply to the language contained in
Sections 54310 through 54390 of these regulations:

( 1 ) "Accreditation" means a formal determination and recognition by
CARF that a Work Activity or Supported Employment Program is in
compliance with the service delivery standards CARF has established for
the program.

(2) "Activity Center" means a community-based day program that
serves adults who generally have acquired most basic self-care skills,
have some ability to interact with others, are able to make their needs
known, and respond to instructions. Activity center programs focus on
the development and maintenance of the functional skills required for
self-advocacy, community integration and employment;

(3) "Adult" means a person 18 years of age or older;

(4) "Adult Day Health Care Program" means an Adult Day Health
Care Program as defined in Health and Safety Code Section 1570.7(a);

(5) "Adult Day Programs" means those community-based day pro-
grams defined in (a)(1), above and (a)(6), (11), (13), (31), and (60) be-
low;

(6) "Adult Day Services" means the broad category of nonresidential
services under which adult day programs are categorized;

(7) "Adult Development Center" means a community-based day pro-
gram that serves adults who are in the process of acquiring self-help
skills. Individuals who attend adult development centers generally need
sustained support and direction in developing the ability to interact with
others, to make their needs known, and to respond to instructions. Adult
development center programs focus on the development and mainte-
nance of the functional skills required for self-advocacy, community in-
tegration, employment, and self-care;

(8) "Age Appropriate" means the consideration of the chronological
age of the person in the use of activities, instructional locations, and tech-
niques;

(9) "Applicant" means an individual or entity that desires to be a ven-
dor;

(10) "Authorized Agency Representative" means a person authorized
to act on behalf of either the Department or the regional center, by law,
by court order, or by a written statement signed by the Director of the De-
partment or the regional center director, respectively;

(11) "Authorized Consumer Representative" means the parent or
guardian of a minor, conservator of an adult, or person who is legally en-
titled to act on behalf of the consumer;

(12) "Behavior Management Program" means a community-based
day program that serves adults with severe behavior disorders and/or
dual diagnosis who, because of their behavior problems, are not eligible
for or acceptable in any other community-based day program;

(13) "CARF" means The Rehabilitation Accreditation Commission,
as referenced in Welfare and Institutions Code, Section 4851.

(14) "Certification" means a certification determination completed by
the Department of Rehabilitation.

(15) "Child" means a person under the age of 18 years;

(16) "Community-based Day Programs" means those programs
which provide services to individuals on an hourly or daily basis, but less
than a 24-hour basis in the community rather than at a developmental
center. Only the following types of services are community-based day
programs: activity centers, adult development centers, behavior manage-
ment programs, independent living programs, infant developmental pro-
grams and social recreation programs;

(17) "Community Integration" means presence, participation and in-
teraction in natural environments;

( 1 8) "Congregate Living Health Facility" means a Congregate Living
Health Facility as defined in Health and Safety Code Section 1 250(i)( 1 );

(19) "Consumer" means an individual who has been determined by a
regional center to meet the eligibility criteria of the Welfare and Institu-
tions Code, Section 4512, and of Title 17, Sections 54000, 54001 and
54010, and for whom the regional center has accepted responsibility;

(20) "Controlling Agency" means any agency, department, or com-
mission that by statute requires standards to be met for the issuance of a
license, credential, registration, certificate or permit required for the op-
eration or provision of service;

(21) "Days" means calendar days unless otherwise stated;

(22) "Department" means the Department of Developmental Ser-
vices;

(23) "Developmental Center" means any institution referred to in the
Welfare and Institutions Code. Section 4440. Developmental Center is
synonymous with state hospital;

(24) "DHS" means the Department of Health Services;

(25) "DSS" means the Department of Social Services;

(26) "Direct Care Staff means staff who personally provide direct ser-
vices to consumers. Personnel who arc responsible for other staff func-
tions may be considered direct care staff only during that time when they
are providing direct services to consumers or are involved in program
preparation functions;

(27) "Direct Services" means hands-on training provided by the ven-
dor in accordance with the requirements of the consumer's Individual
Program Plan and the provisions of Section 56720 of these regulations;

(28) "Director" means the Director of the Department of Developmen-
tal Services;

(29) "Family Member" means an individual who: A) Has a develop-
mentally disabled person residing with him or her; B) Is responsible for
the 24-hour care and supervision of the developmentally disabled per-
son; and C) Is not a licensed or certified resident care facility or foster
family home receiving funds from any public agency or regional center
for the care and supervision provided;

(30) "Functional Skills" means those skills which enable an individual
to communicate, interact with others and to perform tasks which have
practical utility and meaning at home, in the community or on the job;

(3 1 ) "Generic Agency" means any agency which has a legal responsi-
bility to serve all members of the general public and which is receiving
public funds for providing such services;

(32) "Generic Support(s)" means voluntary service organizations,
commercial businesses, non-profit organizations, generic agencies, and
similar entities in the community whose services and products are regu-
larly available to those members of the general public needing them.

(33) "Group Practice" means more than one individual which func-
tions as a business entity while providing services to individuals;

(34) "Habihtation Services" means community-based services pur-
chased or provided for adults with developmental disabilities, including
services provided under the Work Activity Program and the Supported
Employment Program, to prepare and maintain these adults at their high-
est level of vocational functioning, or to prepare them for referral to
Vocational Rehabilitation services;

(35) "Independent Living Program" means a community-based day
program that provides to adult consumers the functional skills training
necessary to secure a self-sustaining, independent living situation in the
community and/or may provide the support necessary to maintain those
skills. Independent living programs foctis on functional skills training for
adult consumers who generally have acquired basic self-help skills and
who, because of their physical disabilities, do not possess basic self-help
skills, but who employ and supervise aides to assist them in meeting their
personal needs;

(36) "Individual Program Plan (IPP)" means a written plan that is de-
veloped by a regional center interdisciplinary (ID) team, in accordance

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BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

with the provisions of tiie Welfare and Institutions Code, Sections 4646
and 4646.5;

(37) "Infant Development Program" means a community-based day
program defined in the Welfare and Institutions Code, Section 4693;

(38) "In-home Respite Services" means intermittent or regularly
scheduled temporary non-medical care and supervision provided in the
consumer's own home and designed to do all of the following:

(A) Assist family members in maintaining the consumer at home;

(B) Provide appropriate care and supervision to protect the consum-
er's safety in the absence of family members;

(D) Attend to the consumer's basic self-help needs and other activities
of daily living, including interaction, socialization, and continuation of
usual daily routines which would ordinarily be performed by the family
member;

(39) "Interdisciplinary (ID) Team" means the group of persons con-
vened in accordance with the Welfare and Institutions Code, Section
4646, for the purpose of preparing a consumer's IPP;

(40) "Intermediate Care Facility" means an Intermediate Care Facility
as defined in Health and Safety Code Section 1250(d);

(41) "Intermediate Care Facility /Developmentally Disabled (ICF/
DD)" means a licensed residential health facility which provides care and
support services to developmentally disabled consumers whose primary
need is for developmental services and who have a recurring, but inter-
mittent, need for skilled nursing services;

(42) "Intermediate Care Facility/Developmentally Disabled-Habili-
tative (ICF/DD-H)" means a licensed residential health facility which
has as its primary purpose the furnishing of 24-hour personal care, devel-
opmental training, habilitative, and supportive health services in a facil-
ity with 15 beds or less to residents with developmental disabilities;

(43) "Intermediate Care Facility/Developmentally Disabled-Nursing
(ICF/DD-N)" means a licensed residential health facility which has as
its primary purpose the furnishing of 24-hour nursing supervision, per-
sonal care, and training in habilitative services in a facility with 4-15
beds to medically fragile developmentally disabled consumers, or to con-
sumers who demonstrate a significant developmental delay that may lead
to a developmental disability if not treated. Such consumers must have
been certified by a physician as not requiring skilled nursing care;

(44) "Long-Term Health Care Facility" means an Adult Day Health
Care Program, a Congregate Living Health Facility, a Skilled Nursing
Facility (SNF), an Intermediate Care Facility (ICF), an Intermediate Care
Facility/Developmentally Disabled (ICF/DD), an Intermediate Care Fa-
cility/Developmentally Disabled-Habilitative (ICF/DD-H), or an Inter-
mediate Care Facility/Developmentally Disabled-Nursing (ICF/
DD-N);

(45) "Management Organization" means a separate and distinct cor-
poration or entity which operates two or more services;

(46) "Mobility Training" means individually planned activities and in-
struction which enable adults with developmental disabilities to utilize
the most normalizing independent transportation modes possible;

(47) "Natural Environment" means places and social contexts com-
monly used by individuals without developmental disabilities;

(48) "Natural Supports" means, pursuant to Welfare and Institutions
Code, Section 4512(e), personal associations and relationships typically
developed in the family and community that enhance or maintain the
quality and security of life for people;

(49) "Nonresidential Services" means all services provided by any
vendor other than a residential facility;

(50) "Nursing Facility" means a licensed health facility or a distinct
part of a hospital which provides continuous skilled nursing and support-
ive care to patients whose primary need is for availability of skilled nurs-
ing care on an extended basis. It provides 24— hour inpatient care and, as
a minimum, includes physician, skilled nursing, dietary and pharmaceu-
tical services, and an activity program;

(51) "Program Preparation Functions" means secondary activities
performed by non-residential direct care staff, such as preparation of les-
son plans, completion of the necessary documentation required by these
regulations, preparation and clean-up of the area where the direct service
is provided to consumers, or involvement in other duties such as staff
meetings and parent conferences;

(52) "Purchase of Service Funds" means those funds identified in the
Budget Act for the purpose of purchasing services, provided by vendors,
for consumers;

(53) "Reasonably suspected" means an objectively reasonable suspi-
cion that a person would entertain, based upon facts that could cause a
reasonable person in a like position, drawing, when appropriate, on his
or her training and experience, to suspect abuse.

(54) "Regional Center" means a diagnostic, counseling, and service
coordination center for developmentally disabled persons and their fami-
lies which is established and operated pursuant to the Welfare and Institu-
tions Code, Sections 4620 through 4669, by a private nonprofit commu-
nity agency or corporation acting as a contracting agency. As used in
these regulations, any reference to the regional center shall, by reference,
be applicable to those agencies or persons with which the regional center
contracts to provide service coordination to consumers under the provi-
sions of the Welfare and institutions Code, Section 4648;

(55) "Residential Facility" means any licensed community care facil-
ity as defined in Health and Safety Code Section 1502(a)(1), (4), (5) or
(6), or a licensed residential care facility for the elderly as defined in
Health and Safety Code Section 1569.2;

(56) "Self-Advocacy" means the awareness, motivation and ability of
an individual to represent and communicate his or her own interests, to
exercise personal choice, to exert control over his or her environment,
and to avoid exploitation and abuse;

(57) "Self-Care" means meeting one's physical and personal needs,
such as dressing, grooming and hygiene without dependence on others
or having the ability to direct others to meet those needs;

(58) "Service Catchment Area" means the geographical area within
which a regional center provides services specified in its contract with the
Department as required by the Welfare and Institutions Code, Section
4640;

(59) "Service Code" means a number which is assigned by the vendor-
ing regional center to a vendor which indicates the type of authorized ser-
vice to be provided;

(60) "Service Contract" means an agreement entered into between a
regional center and a non-residential vendor which specifies the level of
payment and units of service to be used by the vendor to charge and in-
voice the regional center for services provided to consumers;

(61 ) "Service Design" means a written description of the service deliv-
ery capabilities and orientation developed, maintained, and implemented
by a SLS vendor;

(62) "Services" means assistance provided, and duties performed, by
a vendor for a consumer;

(63) "Skilled Nursing Facihty (SNF)" means a Skilled Nursing Facil-
ity as defined in Health and Safety Code Section 1250(c);

(64) "Social Recreation Program" means a community-based day
program which provides community integration and self-advocacy
training as they relate to recreation and leisure pursuits;

(65) "Special Incident Report" is the documentation prepared by ven-
dor staff or long-term health care facility staff detailing a special incident
and provided to the regional center;

(66) "Staffing Ratio" or "Staff-to-Consumer Ratio" means the nu-
merical relation of the number of direct care staff to the number of con-
sumers;

(67) "Statewide Vendor Panel" means the statewide listing of all ven-
dors which contains information specified in Section 54334 of these reg-
ulations;

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•

(68) "Subcode" means a series of a maximum of five numbers and/or
letters which is assigned by the vendoring regional center to a vendor for
billing purposes;

(69) "Supported Employment" means services that are provided by a
job coach in order to support and maintain an individual with develop-
mental disabilities in employment;

(70) "Supported Employment Program" means a program that meets
the requirements of the term supported employment , as defined in this
section, and of the terms, integrated work, supported employment place-
ment, allowable supported employment services, group services, and in-
dividualized services as defined in Section 58801.

(71) "Supported Living Service(s) (SLS)" means those services and
supports referenced in Section 54349(a) through (e), and specified as
SLS service and support components in Title 17, Section 58614, which
are provided by a SLS vendor, paid for by the regional center, and support
consumers" efforts to:

(A) Live in their own homes, as defined in Title 17, Section
58601(a)(3);

(B) Participate in community activities to the extent appropriate to
each consumer's interests and capacity; and

(72) "Unit of Service" means the increment of service provided to con-
sumers which is used to charge and invoice the regional center for ser-
vices provided. The increment of service is specified as hours, days,
transportation mileage or any other increment of service agreed to by the
Department, regional center and the vendor;

(73) "User Regional Center" or "Utilizing Regional Center" means
any regional center which utilizes a service within the vendoring regional
center's catchment area;

(74) "Vendor" means an applicant which has been given a vendor
identification number and has completed the vendorization process, and
includes those specified in Section 54310(d) and (e);

(75) "Vendor Application" means the form, DS 1890 (12/92), which
contains the information specified in Section 54310(a)(1) through (10)
of these regulations;

(76) "Vendor Identificafion Number" means the unique number which
is assigned to each vendor in order to estabhsh a recordkeeping and track-
ing system for regional centers' billing purposes;

(77) "Vendoring Regional Center" means the regional center in whose
service catchment area the vendor is located;

(78) "Vendorization" means the process used to:

(A) Verify that an applicant meets all of the requirements and stan-
dards pursuant to Section 54320(b) of these regulafions prior to the provi-
sion of services to consumers; and

(B) Assign vendor identification numbers, service codes and sub-
codes, for the purpose of identifying vendor expenditures;

(79) "Voucher" means a written authorization issued by a regional
center to a family member or consumer to procure the service for which
the voucher was issued and which specifies the maximum reimburse-
ment authorized by the regional center.

(80) "Work Activity Program" includes, but is not limited to. Work
Activity centers or settings that provide support to consumers engaged
in paid work and have demonstrated that the program is in compliance
with Department of Rehabilitation certification standards or are accred-
ited by CARP;

NOTE; Authority cited: Sections 4405, 4648(a). 4689.7(c) and 4866, Welfare and
Institutions Code; and Section 11152, Government Code. Reference: Sections
1 250 and 1 502, Health and Safety Code; Sections 240, 242, 243.4, 245, 26 1 , 264. 1 ,
273d, 285, 286, 288, 288a, 289, 311.2, 3H.3, 311.4, 647a, 11165.1, 11165.2,
11165.3 and 11165.6, Penal Code; Sections 4504, 4512(i), 4646.5, 4648(a),
4689.7(c), 4691, 4693, 4791, 4851, 15610.57 and 15610.63; and Article II, Chap-
ter 5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9 28 90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92.
No. 21). A Certificate of Compliance must be transmitted to OAL 3-+ 92 or
emergency language will be repealed by operation of law on the follow ing day.

4. Amendment refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92.
No. 25). A Certificate of Compliance must be transmitted to OAL 1- 2 92 or
emergency language will be repealed by operation of law on the follow ing day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections
(a)( 14) and (a)(46) and subsection renumbering and amendments transmitted to
OAL 6-25-92 and filed 8-6-92 (Register 92. No. 33).

6. Kditorial coiTection of printing error restoring article heading (Register 92. No.
34}.

7. Amendment of section filed as an emergency 6-17-93: operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

8. Amendment of subsection (a)(57) filed 4-22-94; operative 4-22-94. Sub-
mitted to OAL for printing only (Register 94, No. 16).

9. Amendment of subsections (a)(2) and (a)(57) filed 6-20-94 as an emergency;
operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter
722, Statutes of 1992, Section 147 (Register 94, No. 25).

10. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94
and filed 8-2-94 (Register 94, No. 31).

11. Amendment of subsections (a)(2) and (a)(10), new subsections (a)(13),
(a)(26), (a)(39), (a)(51), (a)(59)-(a)(59)(C), subsection renumbering and
amendment of Noxr: filed 8-14-95 as an emergency; operative 8-14—95 (Reg-
ister 95, No. 33). A Certificate of Compliance must be transmitted to OAL by
12-12-95 or emergency language will be repealed by operation of law on the
following day.

12. Amendment of subsections (a)(2) and (a)(10), new subsections (a)(13),
(a)(26), (a)(39), (a)(51), (a)(59)-(a)(59)(C), subsection renumbering and
amendment of Note refiled 12-4-95 as an emergency; operative 12-12-95
(Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL
by 4-10-96 or emergency language will be repealed by operation of law on the
following day.

13. Certificate of Comphance as to 6-20-94 order, including amendment of sub-
section (a)(62), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96,
No. 13).

14. Amendment of subsections (a)(2) and (a)(10), new subsections (a)(13),
(a)(26), (a)(39), (a)(51), (a)(59)-(a)(59)(C), subsecfion renumbering and
amendment of NoTi-: refiled 4-8-96 as an emergency; operative 4—10-96 (Reg-
ister 96, No. 15). A Certificate of Compliance must be transmitted to OAL by
8-6-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

15. Certificate of Compliance as to 8-14-95 order, including further amendment
of subsections (a)(13), (a)(39), (a)(5I) and (a)(59)(A), transmitted to OAL
8-8-96 and filed 9-20-96 (Register 96, No. 38).

16. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

17. Amendment of secfion and Note filed 6-29-98 as an emergency; operative
6-29-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted
to OAL by 10-27-98 or emergency language will be repealed by operation of
law on the following day.

18. Amendment of section and Note refiled 10-20-98 as an emergency; operative
10-27-98 (Register 98, No. 43). A Certificate of Compliance must be trans-
mitted to OAL by 2-24-99 or emergency language will be repealed by opera-
tion of law on the following day.

19. Certificate of Comphance as to 10-20-98 order, including further amendment
of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No.
8).

20. Amendment of subsection (a)(16), (a)(34)(D), (a)(53)(A)4., (a)(53)(B)3.,
(a)(62)(B)-(C), (a)(66)-(a)(66)(A), (a)(66)(C), subsecfion renumbering of du-
plicate subsection (a)(71) et seq., amendment of newly designated subsections
(a)(72)-(73) and amendment of Note filed 4-18-2000; operafive 5-18-2000
(Register 2000, No. 16).

21. Repealer of subsections (a)(53)-(a)(53)(B)3. and (a)(62)-(a)(62)(C), subsec-
fion renumbering and amendment of subsection (a)(61) filed 6-27-2001 as an
emergency; operative 7-1-2001 (Register 2001, No. 26). A Certificate of Com-
pliance must be transmitted to OAL by 10-29-2001 or emergency language
will be repealed by operafion of law on the following day.

22. Reinstatement of section as it existed prior to 6-27-2001 emergency amend-
ment by operafion of Government Code section 11346.1(f) (Register 200 1. No.
43).

23. Repealer of subsections (a)(53)-(a)(53)(B)3. and (a)(62)-(C), sub.secdon re-
numbering and amendment of subsecfion (a)(61 ) filed 10-25-2001 as an emer-
gency; operative 10-31-2001 (Register 2001, No. 43). A Certificate of Com-
pliance must be transmitted to OAL by 2-28-2002 or emergency language will
be repealed by operafion of law on the following day.

24. Certificate of Compliance as to 10-25-2001 order, including new subsection
(a)(49) and subsection renumbering, transmitted to OAL 2-28-2002 and filed
4-10-2002 (Register 2002, No. 15).

25. New definifions of "Accreditation," "CARF," "Certification," "Habilitation
Services," "Supported Employment," "Supported Employment Program" and
"Work Acfivity Program" and subsecfion renumbering filed 7-22-2004 as an
emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of

Page 281

§ 54306

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Compliance must be transmitted to OAL by 1 1-19-2004 or emergency lan-
guage will be repealed by operation of law on the following day.

26. Reinstatement of section as it existed prior to 7-22-2004 emergency amend-
ment by operation of Government Code section 1 1 346. 1 ( 1) (Register 2004, No.
49).

27. New definitions of "Accreditation," "CARF," "Certification," "Habililation
Services," "Supported Employment," "Supported Employment Program" and
"Work Activity Program" and subsection renumbering re filed 1 1-29-2004 as
an emergency; operative 1 1-29-2004 (Register 2004, No. 49). A Certificate of
Compliance must be transmitted to OAL by .3-29-2005 or emergency language
will be repealed by operation of law on the following day.

28. New definitions of "Accreditation," "CARF," "Certification," "Habilitation
Services," "Supported Employinent," "Supported Employment Program" and
"Work Activity Program" and subsection renumbering refiled .3-30-2005 as an
emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate of
Compliance must be transmitted to OAL by 7-28-2005 or emergency language
will be repealed by operation of law on the following day.

29. Certificate of Compliance as to 3-30-2005 order, including further amend-
ment of definitions of "Supported Employment" and "Work Activity Progiam,"
transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments operative
8-31-2005 (Register 2005, No. 31).

§ 54306. Service Bank Application.

NOTE: Authority cited: Chapter 93, Statutes of 1991, Section 2(g); Sections 4405
and 4648(b), Welfare and Institutions Code; and Section 11152, Government
Code. Reference: Chapter 93, Statutes of 1991, Section 2(g); and Sections 4502,
4631, 4648(b) and 4691, Welfare and Institutions Code.

History

1 . New section filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3^-92 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 3-4-92 as an emergency; operative 3^-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

3. Repealer filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Editorial correction of printing error moving article heading to section 54302
(Register 92, No. 34).

§ 54308. Determination of Need and Notice Requirements.

NOTE: Authority cited: Chapter 93, Statutes of 1991 , Section 2(g); Sections 4405
and 4648(b), Welfare and Institutions Code; and Section 11152, Government
Code. Reference: Chapter 93, Statutes of 1991, Section 2(g); and Sections 4631
and 4648(b), Welfare and Institudons Code.

History

2. New section refiled 3-4—92 as an emergency; operative 3^-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

3. Repealer filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

§ 54310. Vendor Application Requirements.

(a) An applicant who desires to be vendored shall submit Form DS
1890 (8/04), entitled Vendor Application, and the information specified
in ( I ) through ( 1 0) below, as appUcable, to the vendoring regional center.
Items (1) through (7) specified below must be completed by all appli-
cants.

(1) Applicant's name, including the name of any governing body or
management organization;

(2) Applicant's Social Security Number, Federal Tax ID number, or
a copy of any document accepted by the federal government which esta-
blishes identity of applicant;

(3) Applicant's mailing address;

(4) Address of service, if applicable;

(5) Name of family member, owner or executive director, as applica-
ble;

(6) Types of service to be provided;

(7) Telephone number;

(8) Facility capacity, if applicable;

(9) Identification of the type of consultants, subcontractors and com-
munity resources to be used by the vendor as part of its service.

(10) Copies of:

(A) Any license, credential, registration, certificate or permit required
for the performance or operation of the service, or proof of application
for such document;

(B) Any academic degree required for performance or operation of the
service;

(C) Any waiver from licensure, registration, certification, credential,
or permit from the responsible controlling agency;

(D) The proposed or existing program design as required in Sections
56712 and 56762 of these regulations, if applicable, for applicants seek-
ing vendorization as community-based day programs;

(E) The proposed or existing staff qualifications and duty statements
as required in Sections 56722 and 56724 of these regulations for appli-
cants seeking vendorization as community-based day programs;

(F) The proposed or existing service design as required in Section
56780 of these regulations for applicants seeking vendorization as in-
home respite service agencies;

(G) The proposed or existing program design as required in Section
5881 1 of these regulations for applicants seeking vendorization as habi-
litation service providers;

(H) The proposed or existing staff qualifications and duty statements
as required in Sections 56790 and 56792 of these regulations for appli-
cants seeking vendorization as in-home respite services agencies;

(I) The proposed service design as required in Sections 58630 and
5863 1 of these regulations for applicants seeking vendorization to pro-
vide supported living service;

(J) The signed Home and Community-Based Services Provider
Agreement (6/99) with the Department of Health Services, obtainable
from the regional centers as part of the vendorization packet, for those
applicants whose proposed service is eligible for Medi-Cal reimburse-
ment; and

(K) The proposed program design as required by Subchapter 4. 1 , Sec-
tion 56084 for those applicants seeking vendorization as a family home
agency (FHA).

(b) The applicant shall sign and date Form DS 1890 (8/04), which in-
cludes a certification that the information is true, correct and complies
with Title 17, Section 54310(a).

( 1 ) The name, title, business address and telephone number of each of-
ficer and member of the governing board;

(A) The application shall include copies of the corporation's articles
of incorporation; by-laws, which shall include provisions for control by
a responsible governing board; annual statement filed with the Secretary
of State; corporate charter, if applicable; and evidence certifying the cor-
poration's nonprofit status.

(B) The application shall contain a written resolution from the govern-
ing board stating that the board shall operate the FHA in full conformity
with all applicable statutes and regulations.

(2) Name, address and telephone number of the owner of the facility
premises if the applicant is leasing or renting;

(3) Disclosure of:

(A) Any board member's or officer's prior or present service as an ad-
ministrator, general partner, corporate officer or director of any health fa-
cility certified by the Department of Health Services or community care
facility licensed by the Department of Social Services' Community Care
Licensing Division; and

(B) Any revocation or other action taken, or in the process of being tak-
en, against any community care facility license or health facility certifi-
cation held or previously held by the applicant or any officer or member
of the governing board.

(4) A financial statement and budget which demonstrate the appli-
cant's ability to cover the costs of operating the FHA to provide the level
of services and supports necessary to maintain consumers for whom the
regional center is responsible in family homes;

(5) A written statement that no FHA employee, Board of Directors
member or officer shall be a family home provider of the FHA;

(6) A written statement that no family home shall be approved by the
FHA as a residence for a consumer who is a relative of the family home
provider except when: (1) the residence is consistent with the services

•

Page 282

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54310

and supports referenced in the consumer's IPP; and (2) the relative has
no legal obligation to support the consumer;

(7) Any other information required by the regional center which is per-
tinent to vendori/ation of the FHA.

(d) Habilitalion services providers who, on July 1. 2004. are providing
services to consumers shall be deemed to be an approved vendor. Each
approved vendor shall submit to the vendoring regional center, and a
copy to the Department, a completed Vendor Application, DS 1890
(12/03) and a completed Annual Habilitation Services Provider Profile,
DS 1970 (4/04) by July 31, 2004.

(e) Habilitation Services providers not deemed approved vendors pur-
suant to (d), and approved vendors seeking vendorization as Habilitation
Services providers in a new location, shall, in addition to meeting the
general requirements of this section and of Title 17, Sections 58800
through 58882, meet the following requirements as a condition of vendo-
rization:

(1) The applicant shall:

(A) If currently accredited, supply a copy of its last accreditation report
and indicate the date its next accreditation review is due.

(B) If not currently accredited, supply a copy of certification by the
Department of Rehabilitation and shall become accredited within 3 years
of the date of their certification.

(f) The following applicants shall be required to submit only Form DS
1 890 (8/04) and, if applicable, a copy of any license, credential, registra-
tion, certificate, permit, or academic degree required for the performance
or operation of the service, or any waiver from licensure, registration,
certification, credential, or permit from the responsible controlling
agency. If the proposed service is eligible for Medi-Cal reimbursement,
the applicant shall also sign the Home and Community Based Services
Provider Agreement (6/99), and submit the original of the signed agree-
ment to the vendoring regional center.

( 1 ) Public transit authorities, dial-a-ride, rental car agencies, or taxis;

(2) Out-of-state manufacturers or distributors who are eligible for
vendorization pursuant to Section 54318 of these regulations;

(3) Retail/wholesale stores; and

(4) Generic agencies specified in Section 54316(a)(2) of these regula-
tions.

(g) Family members or consumers who desire to be vendored in the
following categories shall be required to submit to the vendoring regional
center Form DS 1890 (8/04), and, if the vouchered family member or
consumer is also the provider of the vouchered service, a copy of any li-
cense, credential, registration, certificate, permit, or academic degree re-
quired for the performance or operation of the service, or any waiver from
licensure, registration, certification, credential, or permit from the re-
sponsible controlling agency, if applicable. If a proposed service is eligi-
ble for Medi-Cal reimbursement, the applicant shall also sign the Home
and Community-Based Services Provider Agreement (6/99) and submit
it to the vendoring regional center.

( 1 ) Respite service — family member;

(2) Nursing service — family member;

(3) Transportation — family member;

(4) Day care — family member; and

(5) Diaper and nutritional supplements — family member.

NOTE: Authority cited: Chapter 157, Statutes of 2003; Sections 4405, 4648(a) and
4689.1, Welfare and Institutions Code; and Section 11152, Government Code;
Chapter 1095, Statutes of 1994, Section 14. Reference: Sections 4502, 4631,
4648(a), 4690 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Editorial correction of printing error in article 2 heading (Register 91 , No. 30).

4. Amendment of section heading, subsections (a), (a)(5)(b) and Note filed
1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92, No. 21). A Certifi-
cate of Compliance must be transmitted to OAL 3-4-92 or emergency language
will be repealed by operation of law on the following day.

5. Amendment of section heading, subsections (a), (a)(5)(b) and Noit. rcfilcd
3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate
of Compliance must be U-ansmitted to OAL 7-2-92 oremergenc)' language w ill
be repealed by operation of law on the following day.

6. Certificate of Compliance as to 3-4-92 order including amendment of section
heading and text transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92.
No. 33^

7. Amendment of section filed as an emergency 6-17-93; operative 6 17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of subsecfions (a)(10)(H), (c) and (d) filed 4-22-94; operative
4-22-94. Submitted to OAL for printing only (Register 94. No. 16).

9. Amendment of subsections (d)(l)-(5) and new subsections (e)-(e)(8) filed
6-20-94 as an emergency; operafive 6-20-94. Submitted to OAL for printing
only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No".
25).

10. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94
and filed 8-2-94 (Register 94, No. 31).

11. New subsections (a)(10)(I) and (c)-(c)f7), subsection relettering and amend-
ment of Note filed 7-24-95 as an emergency; operative 7-24-95 (Register 95,
No. 30). A Certificate of Compliance must be transmitted to OAL by 1 1-21-95
or emergency language will be repealed by operation of law on the following
day.

12. New subsection (a)(10)(H), subsection relettering and amendment of NoTi-;
filed 8-14-95 as an emergency; operative 8-14-95 (Register 95, No. 33). A
Certificate of Compliance must be transmitted to OAL by 12-12-95 or emer-
gency language will be repealed by operation of law on the following day.

13. New subsections (a)(10)(I) and (c)-(c)i'7), subsecUon relettering and amend-
ment of Note refiled 1 1-14-95 as an emergency; operative 1 1-14-95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by
3-1 3-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

14. New subsection (a)(10)(H), subsection relettering and amendment of NoTi:re-
filed 12-4-95 as an emergency; operative 12-12-95 (Register 95, No. 49). A
Certificate of Compliance must be transmitted to OAL by 4-10-96 oremergen-
cy language will be repealed by operafion of law on the following day.

15. Certificate of Compliance as to 7-24-95 order including new subsection
(a)(10)(H) and subsection relettering transmitted to OAL 1-8-96 and filed
2-22-96 (Register 96, No. 8).

16. Certificate of Compliance as to 6-20-94 order, including amendment of sub-
sections (a)(10)(I), (d) and (e) and repealer of subsections (f)-(f)(8), transmitted
to OAL 2-20-96 and filed 3-29-96 (Register 96. No. 13).

17. Editorial correction of History 12 and History 14 (Register 96, No. 15).

18. New subsection (a)(10)(H), subsection relettering and amendment of Ncm: re-
filed 4-8-96 as an emergency; operative 4-10-96 (Register 96, No. 15). A Cer-
tificate of Compliance must be transmitted to OAL by 8-6-96 or emergency
language will be repealed by operation of law on the following day.

19. Certificate of Compliance as to 8-14-95 order transmitted to OAL 8-8-96 and
filed 9-20-96 (Register 96, No. 38).

20. Change without regulatory effect amending subsecfion (e) filed 1-17-97 pur-
suant to section 100, title 1, California Code of Regulations (Register 97, No.
3).

2 1 . New subsections (a)( 1 0)(G) and (d)-(f), subsection relettering and amendment
of Note filed 7-22-2004 as an emergency; operative 7-22-2004 (Register
2004, No. 30). A Certificate of Comphance must be transmitted to OAL by
1 1-19-2004 or emergency language will be repealed by operation of law on the
following day.

22. Amendment of subsections (a), (a)(5), (a)(10)(J), (b), (g) and (i) and amend-
ment of Note filed 8-27-2004 as an emergency; operative 8-27-2004 (Regis-
ter 2004, No. 35). A Certificate of Compliance must be transmitted to OAL by
1 2-27-2004 or emergency language will be repealed by operation of law on the
following day.

23. Reinstatement of section as it existed prior to 7-22-2004 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f) (Register 2004, No.
49).

24. New subsections (a)(10)(G) and (d)-(f)' subsection relettering and amendment
of Note refiled 1 1-29-2004 as an emergency; operative 1 1-29-2004 (Register

2004, No. 49). A Certificate of Comphance must be transmitted to OAL by
3-29-2005 or emergency language will be repealed by operation of law on the
following day.

25. Refiling of 8-27-2004 order, including relettering of subsection ( i ) to subsec-
tion (h), 12-22-2004 as an emergency; operative 12-22-2004 (Register 2004,
No. 52). A Certificate of Compliance must be transmitted to OAL by
4-21-2005 or emergency language will be repealed by operation of law on the
following day.

26. New subsecfions (a)(10)(G) and (d)-(f), subsection relettering and amendment
of Note refiled 3-30-2005 as an emergency; operative 3-30-2005 (Register

2005, No. 13). A Certificate of Compliance mu.st be transmitted to OAL by
7-28-2005 or emergency language will be repealed by operation of lav\ on the
following day.

27. Certificate of Compliance as to 12-22-2004 order, including further amend-
ment of subsecfions (a)(2) and (h), transmitted to OAL 4-19-2005 and filed
5-18-2005 (Register 2005, No. 20).

Page 282.1

§ 54312

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

28. Certificate of Compliance as to 3-30-200? order, including redesignation of
former subsections (f)-(f)(2) as new (e)( 1 He)( 1 )(B) and subsection relettering,
transmitted to OAL 6-21-2005 and filed 8-1-2005: amendments operative
8-31-2005 (Register 2005, No. 31).

§ 54312. Applicants Exempted from the Application
Process.

NOTE: Authority cited: Chapter 93, Statutes of 1991 , Section 2(g); Sections 4405
and 4648(b), Welfare and Institutions Code; and Section 11152, Government
Code. Reference: Chapter 93, Statutes of 1991, Section 2(g); and Sections 4631
and 4648(b), Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of subsection (a)( 1 ) filed 9-26-91 ; operative 9-26-91 pursuant to
Government Code section 1 1346.2(d) (Register 92, No. 10).

4. Amendment of section heading, subsections (a), (a)(2)-(4), repealer of subsec-
tion (b) and new subsections (b)-(c), and amendment of NoTii filed 11-5-91
as an emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of
Compliance must be transmitted to OAL 3-4-92 or emergency language will
be repealed by operation of law on the following day.

5. Amendment of section heading, subsections (a), (a)(2)-(4), repealer of subsec-
tion (b), and new subsections (b)-(c), and amendment of Notk refiled 3^-92
as an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of Compliance as to 3^-92 order includins amendments trans-
mitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Repeal of section filed as an emergency 6-17-93; operative 6-17-93. Sub-
mitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of
1992) Section 147(a) (Register 93, No. 26).

§ 54314. Ineligibility for Vendorization.

(a) The following applicants shall not be vendored:

(1) Any officer or employee of the State of California;

(2) Any applicant in which an officer or employee of the State of Cali-
fornia has a financial interest, as defined in the Government Code, Sec-
tion 87103, except as permitted by Public Contract Code, Section
10430(g), effective January 1, 1992;

(3) Employees and board members of any regional center with a con-
flict of interest pursuant to Title 17, Sections 54500 through 54525, un-
less the conflict is eliminated or a waiver is obtained pursuant to Title 17,
Sections 54522 through 54525;

(4) Any applicant in which the regional center employee or board
member has a relationship which creates a conflict of interest pursuant
to Title 17, Sections 54500 through 54525, unless the conflict is elimi-
nated or a waiver is obtained pursuant to Title 17, Sections 54522 through
54525;

(5) Consumers, to provide services for, or to, themselves except to:

(A) Provide transportation services to themselves as specified in Sec-
tion 54355(g)(5); and

(B) Serve as their own Supported Living Service vendors as specified
in Title 17, Section 58616.

(6) Except as specified in Section 54318 of these regulations, any
applicant located outside the state.

NOTE: Authority cited: Sections 4405, 4648(a) and 4689, Welfare and Institutions
Code; and Section 11152, Government Code. Reference: Sections 4626, 4627,
4631, 4648(a), 4648.1(d), and 4689(a)(1), Welfare and Institutions Code; and
Section 10430(g), Public Contract Code.

History

1 . New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(5) filed 9-26-91 ; operative 9-26-91 pursuant to
Government Code section 11346.2(d) (Register 92, No. 10).

4. Amendment of subsection (a)(2) and Note filed 11-5-91 as an emergency;
operative 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance must be

transmitted to OAL 3^+-92 or emergency language will be repealed by opera-
tion of law on the following day.

5. Amendment of subsection (a)(2) refiled 3-4-92 as an emergency; operative
3^-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted
to OAL 7-2-92 or emergency language will be repealed by operation of law on
the following day.

6. Certitlcate of Compliance as to 3-4-92 order including amendment of text and
NoTK transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printina only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (RegiW 93. No. 26).

8. Amendment of subsection (a)(5)(A) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printina only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

10. Amendment of subsections (a)(5)-(a)(5)(A), new subsection (a)(5)(B) and
amendment of Note filed 8-14-95 as an emergency; operative 8-14-95 (Reg-
ister 95, No. 33). A Certificate of Compliance must be transmitted to OAL by
12-12-95 or emergency language will be repealed by operation of law on the
following day.

11. Amendment of subsecfions (a)(5)-(a)(5)(A), new subsecdon (a)(5)(B) and
amendment of Note refiled 12-4-95 as an emergency; operative 12-12-95
(Register 95, No. 49). A Certificate of Compliance must be transmitted to OAL
by 4-10-96 or emergency language will be repealed by operation of law on the
following day.

12. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96
and filed 3-29-96 (Register 96, No. 13).

13. Amendment of subsecfions (a)(5)-(a)(5)(A), new subsecdon (a)(5)(B) and
amendment of Noti^ refiled 4-8-96 as an emergency; operative 4—1 0-96 (Reg-
ister 96, No. 15). A Certificate of Compliance must be transmitted to OAL by
8-6-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

14. Certificate of Compliance as to 8-14-95 order, including further amendment
of Note, transmitted to OAL 8-8-96 and filed 9-20-96 (Register 96, No. 38).

§54316. Generic Agencies.

(a) Any service operated by a generic agency shall be:

( 1 ) Ineligible for vendorization if the genetic agency is statutorily
mandated to provide the services to the general public and/or to consum-
ers, except as specified in (a)(2) below;

(2) Eligible for vendorization and subject to the vendorization process
specified in Section 54310(d) and (e) of these regulations, if the generic
agency:

(A) Provides services to the general public; and

(B) Charges a fee; however, the amount charged for consumers is the
same as the amount charged to the general public for the same type of ser-
vice.

(3) Eligible for vendorization and subject to the entire vendorization
process specified in Section 543 10(a) of these regulations, if the generic
agency:

(A) Operates a service which is not mandated to provide to the general
public;

(B) Has designed the service specifically for consumers; and

(b) For purposes of (a) above, fees shall not include:

( 1 ) Shares of cost under the Medi-Cal program pursuant to the Wel-
fare and Institutions Code, Section 14009;

(2) Annual deductibles under the uniform patient fee schedule for
community mental health services pursuant to the Welfare and Institu-
tions Code, Sections 5717 and 5718; or

(3) Repayment obligations under the California Children Services
program pursuant to the Health and Safety Code, Section 255.

(c) Any generic agency meeting the requirements specified in (a)(2)
above may request an exemption from the vendorization process by sub-
mitting a written statement to the vendoring regional center which in-
cludes:

(1) A description of the services to be provided; and

(2) The reasons it believes it qualifies for the exemption.

(d) Upon receipt of the written statement specified in (c) above:

(1) The vendoring regional center shall submit the request to the De-
partment within 15 days of its receipt; and

Page 282.2

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54319

(2) Within 15 days of receipt of the request from the regional center,
the Department shall review the request and notify the vendoring region-
al center and the generic agency, in writing, that the exemption has been:

(A) Approved, along with the service code assigned pursuant to Sec-
tion 54358(b) of these regulations; or

(B) Denied, along with the basis for the denial and an explanation of
the appeal rights pursuant to Sections 54380 through 54390 of these reg-
ulations.

NOTt-;: Authority cited: Chapter 722, Statutes of 1992, Section 1 47; Sections 4405,
4648(a) and 479 l(i). Welfare and Institutions Code; and Section 1 11 52, Govem-
nicnt Code. Reference: Sections 463 1 , 4644, 4648(a) and 479 1 , Welfare and Insti-
tutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(2) and (a)(3) and Ncm-: filed 11-5-91 as an
emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Com-
pliance must be transmitted to OAL 3-4-92 or emergency language will be re-
pealed by operation of law on the following day.

4. Amendment of subsections (a)(2) and (a)(3) and NOTH refiled 3^-92 as an
emergency; operative 3^-92 (Register 92, No. 25). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 3^-92 order including amendment of subsec-
tions (a)(2)-(3) and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Reg-
ister 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsecfions (a)(2) and (3) and (c) filed 4-22-94; operative
4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Amendment of subsecdon (a)(2) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Secdon 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of sub-
secdon (a)(2), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No.
13).

11. Change without regulatory effect amending subsections (a)(1), (a)(2),
(a)(2)(B) and (a)(3)(B) filed 1-17-97 pursuant to section 100, title 1, California
Code of Regulations (Register 97, No. 3).

§ 54318. Vendorization of Out-of-State Appiicants and
Manufacturers or Distributors.

(a) A regional center may approve for vendorization an applicant not
located and licensed, certified, or registered in California if the applicant
meets all of the following requirements:

(1) Meets the requirements in California for the specific type of ser-
vice, or meets the requirements for the specific service as specified by the
appropriate controlling agency in the jurisdiction in which the applicant
is located;

(2) Meets either of the following two criteria:

(A) Is located in a state bordering California and has an office or facil-
ity located within 50 miles of the California border: or

(B) Receives prior approval by the Director of the Department of the
Director's designee pursuant to the Welfare and Institutions Code, Sec-
tions 45 1 9(a) through (c).

(b) Manufacturers and distributors of merchandise which are located
outside of California shall only be vendored if:

( 1 ) The specific item is not available in California; or

(2) It is more economical to purchase the item outside of California.

(1) Submit a vendor application pursuant to Section 54310(d)(2) of
these regulations; and

(2) Receive a service code pursuant to Sections 54342 through 54354
of these regulations, as applicable, providing they meet California re-
quirements for a specific type of service; or

(3) Be vendored through miscellaneous services pursuant to Section
54356 of these regulations, providing they do not meet California re-
quirements for a specific type of service.

Note. Authority cited: Chapter 722, Statutes of 1992. Section 147; Sectic)ns44()5,
4648(a) and 479 l(i). Welfare and Institutions Code; and Section 1 1 152. (lovern-
ment Code. Reference: Sections 4519, 4631. 4648(a) and 479 1 . Welfare and Insti-
tutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (c)(1) and NoTi; filed as an emergency; operative
11-5-91 (Register 92, No. 21 ). A Certificate of Compliance must be transmitted
to OAL 3-4-92 or emergency language will be repealed by operation of law
on the following day.

4. Amendment of subsection (c)(I ) and Nam refiled 3-4-92 as an emergency; op-
erative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
don (c)(1) and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register
92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prindng only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (c)( 1 ) filed 4-22-94; operative 4-22-94. Submitted
to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending subsection (c)(1) filed 1-17-97
pursuant to secdon 1 00, title 1 , California Code of Regulations (Register 97, No.
3).

§ 54319. Group Practices.

(a) Services which shall apply to both individuals and group practices
include:

(1) Adaptive Skills Trainer — Service Code 605;

(2) Art Therapist — Service Code 691 ;

(3) Associate Behavior Analyst — Service Code 613;

(4) Attorney — Service Code 610;

(5) Behavior Analyst — Service Code 612;

(6) Behavior Management Consultant — Service Code 620;

(7) Counseling Services — Service Code 625;

(8) Dance Therapist — Service Code 692;

(9) Developmental Specialist — Service Code 670;

(10) Educational Psychologist — Service Code 672;

(11) Music Therapist — Service Code 693;

(12) Recreational Therapist — Service Code 694;

(13) Teacher — Service Code 674;

(14) Teacher of Special Education — Service Code 678;

(15) Tutor — Service Code 680;

(16) Dentistry — Service Code 715;

(17) Dietary Services (Dietitian only) — Service Code 720;

(18) Laboratory and Radiologic Services — Service Code 735;

(19) Occupational Therapy — Service Code 773;

(20) Orthoptic Services — Service Code 745;

(21) Orthotic and Prosthetic Services — Service Code 750;

(22) Other Medical Equipment or Supplies — Service Code 750;

(23) Other Medical Services — Service Code 760;

(24) Pharmaceutical Services — Service Code 765;

(25) Physical Therapy — Service Code 772;

(26) Physicians or Surgeons — Service Code 775;

(27) Psychiatrist — Service Code 780;

(28) Clinical Psychologist — Service Code 785; and

(29) Genetic Counselor — Service Code 800.

(b) Group practices which provide more than one service shall be ven-
dored separately for each service.

(c) The name of the group practice shall appear on the statewide ven-
dor panel if all persons providing services as a group practice:

(1) Require no license, registration, and/or certificate; or

Page 282.3

§ 54320

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) Have the appropriate license, registration, and/or certificate.

(d) If some of tlie persons providing services within a group practice
are assistants or trained aides who are not licensed, registered, or certified
as appropriate to the service, the name of the group practice and the licen-
sed/registered/certified applicant shall both appear on the statewide ven-
dor panel.

(e) Except as specified in (f)(-^) below, the following person shall sign
the vendor application pursuant to Section 543 1 0(b) of these regulations:

{ I ) Any person in the group practice for those services that do not re-
quire licensing, registration or certification; or

(2) A licensed/registered/certified person in the group practice for
those services that require licensing, registration or certification.

(f) Any group practice which is incorporated shall:

( 1 ) Possess corporation papers issued by the Secretary of State or other
appropriate agency;

(2) Possess the appropriate license, certificate, and/or registration for
all persons providing services as a group practice, if applicable; and

(3) Ensure that the coiporation president sign the vendor application
pursuant to Section 54310(b) of these regulations.

(g) The name of the corporation shall appear on the vendor panel for
any group practice which is incorporated.

NOTE: Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code;
and Section 11152. Government Code. References: Sections 4631 and 4648(a),
Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(1) and (a)(9) and subsection renumbering, amendment of
subsections (c) and (f) and Note and repealer and new subsection (e) filed
1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92, No. 21). A Certifi-
cate of Compliance must be transmitted to OAL 3^-92 or emergency language
will be repealed by operation of law on the following day.

4. New subsections (a)(1) and (a)(9) and subsecfion renumbering, amendment of
subsections (c) and (f) and Note, repealer of subsection (e) and new subsecfion
(e) refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25).
A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency
language will be repealed by operafion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tions (e) and (f)(3) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92,
No. 33).

6. Amendment of section filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Repealer of subsecfion (a)( 14) and subsecfion renumbering filed 6-20-94 as an
emergency; operative 6-20-94. Submitted to OAL for printing only pursuant
to Chapter 722, Statutes of 1992, Secfion 147 (Register 94, No. 25).

8. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

10. Change without regulatory effect amending subsecfions (a)(l)-(a)(27) filed
1 - 1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

1 1 . New subsection (a)(4) and subsecfion renumbering filed 5-3-2001 ; operative
6-2-2001 (Register 2001, No. 18).

12. New sub.secfion (a)(3) and subsecfion renumbering filed 7-11-2005; opera-
five 8-10-2005 (Register 2005, No. 28).

§ 54320. Regional Center Review of Vendor Application.

(a) The vendoring regional center shall review the vendor application
identified in Section 543 10(a) and, as applicable, (d) or (e) within 45 days
after receipt from the applicant, to ensure all of the following:

(1) The application is complete;

(2) The applicant has complied with provisions of Sections 54342
through 54355 of these regulations, as applicable;

(3) Any required license, credential, registration, accreditation, certif-
icate or permit:

(A) Is current;

(B) Has been issued for the service to be vendored; and

(4) Staffing ratios and qualifications as specified in Section 56724, and
56770, if applicable, and Section 56756 or 56772 of these regulations are
consistent with the program design as required in Section 567 1 2 and Sec-
tion 56762 of these regulations, if applicable, for applicants seeking ven-
dorization as community-based day programs.

(5) The applicant has signed the Home and Community Based Ser-
vices Provider AgreeiTient (6/99), if applicable pursuant to Section
54310(a)(10)(I), (d)and(e).

(b) If an applicant submits an incomplete vendor application, the re-
gional center shall provide written notification to the applicant of the
missing items within 45 days of receipt of the application. The regional
center shall take no further action until all required information is re-
ceived. At that ti me, the vendoring regional center shall consider the ven-
dor application completed.

(c) No provision of this section shall preclude the regional center from
completing the vendorization process, up to the point of approval for
those applicants which have applied for the appropriate license, creden-
tial, registration, certificate, or permit. However, the regional center shall
not approve vendorization, nor refer consumers, until the appropriate li-
cense, credential, registration, certificate or permit is received.

Note: Authority cited: Chapter 157, Statutes of 2003; Sections 4405 and 4648(a),
Welfare and Insfitutions Code; and Section 1 1 152, Government Code. Reference:
Secfions 4502, 4631, 4648(a) and 4691, Welfare and Insfitutions Code.

History

1. New secfion filed 6-26-90 as an emergency; operafive 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operafion of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of secfion heading and text filed 1 1-5-91 as an emergency; opera-
five 1 1-5-91 (Register 92, No. 2 1 ). A Certificate of Comphance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of secfion heading and text refiled 3-4-92 as an emergency; opera-
tive 3^1—92 (Register 92, No. 25). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3^1-92 order including repealer of subsections
(a) and (d) and subsection relettering and amendments transmitted to OAL
6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for prinfing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsecfion (a)(5) filed 4-22-94; operafive 4-22-94. Submitted
to printing only (Register 94, No. 16).

8. Amendment of subsecfions (a)(2) and (5) filed 6-20-94 as an emergency; op-
erative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722,
Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of sub-
secfion (a)(5), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No.
13).

1 1 . Change without regulatory effect amending subsections (a)(5) and (c) filed
1-1 7-97 pursuant to section 100. fitle 1 , California Code of Regulations (Regis-
ter 97, No. 3).

12. Amendment of subsection (a) filed 7-22-2004 as an emergency; operative
7-22-2004 (Register 2004, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-19-2004 or emergency language will be repealed by op-
eration of law on the following day.

13. Amendment of subsecfion (a)(5) and amendment of Note filed 8-27-2004 as
an emergency; operative 8-27-2004 (Register 2004, No. 35). A Certificate of
Compliance must be transmitted to OAL by 12-27-2004 or emergency lan-
guage will be repealed by operation of law on the following day.

14. Reinstatement of section as it existed prior to 7-22-2004 emergency amend-
ment by operafion of Government Code secfion 1 1346.1(f) (Re sister 2004, No.
49).

1 5. Amendment of subsection (a) refiled 1 1 -29-2004 as an emergency; operative
1 1-29-2004 (Register 2004, No. 49). A Certificate of Compliance must be
transinitted to OAL by 3-29-2005 or emergency language will be repealed by
operation of law on the following day.

16. Amendment of subsecfion (a)(5) and amendment of Note refiled 12-22-2004
as an emergency; operative 12-22-2004 (Register 2004, No. 52). A Certificate
of Compliance must be transmitted to OAL by 4-21-2005 or emergency lan-
guage will be repealed by operation of law on the following day.

Page 282.4

Title 17 Health and Welfare Agency — Department of Developmental Services § 54320

1 7. Amendment of subseetion (a) refiled 3-30-2005 as an emergency; operative 4-1 9-2005 and filed 5-1 8-2005 (Register 2005. No. 20).

.3-30-2005 (Register 2005, No. 13). A Certificate of Compliance must be trans- ]g Certificate of Compliance as to 3-30-2005 order, including amendment of

mitted to OALby 7-28-2005 or emergency language will be repealed by opera- subsection (a)(3). transmitted to OAL 6-21-2005 and filed 8-1-2005: amcnd-

tion ol law on the foliowmg day. ments operative 8-3 1-2005 (Register 2005, No. 3 1 ).

18. Certificate of Compliance as to 12-22-2004 order transmitted to OAL

[The next page is 282.5.]

Page 282.4(a) Register 2005, No. 31; 8-5-2005

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54324

§ 54322. Regional Center Approval/Denial of
Vendorization.

(a) The vendoring regional center shall approve vendorization within
45 days of receipt of all information which specifies that the applicant is
in compliance with Section 54320(a).

(b) The vendoring regional center shall select criteria to apply in ven-
doring family home agencies (FHAs), including but not limited to, the
following:

( 1 ) The FHA's potential for providing cost-effective quality services
and supports;

(2) The degree to which consumer choice regarding the provision of
services and supports is identified as a factor in the FHA's program de-
sign;

(3) The experience of the FHA or key agency personnel in providing
the same or comparable services;

(4) The reasonableness of the FHA's overhead;

(5) The capability of the regional center to monitor and evaluate the
FHA; and

(6) The need for service.

(c) The regional center shall not approve vendorization of the FHA un-
til completion of the criminal record review required by Title 17, Section
56085(a) and (b).

(d) The vendoring regional center shall issue an approval letter pur-
suant to (a) above to the vendor specifying all of the following:

( 1 ) That the vendor is approved to provide the specified vendored ser-
vices to consumers;

(2) That the statewide vendor panel reflects ( I ) above;

(3) The vendor identification number pursuant to Section 54340 of
these regulations;

(4) The approved service code pursuant to Sections 54342 through
54358 of these regulations;

(5) The subcode, if applicable, pursuant to Section 54340 of these reg-
ulations;

(6) The approved staffing ratio for community-based day programs
pursuant to Section 56756 or 56772 of these regulations;

(7) The approved facility service type and/or service level for residen-
tial services, as applicable;

(8) The process by which consumers are referred to the vendor and au-
thorized to receive services;

(9) That vendorization is valid during the effective period of any li-
cense, credential, registration, certificate or permit required, and that
vendorization shall not continue if the required document is suspended
or revoked; and

(10) That vendorization does not guarantee that any consumers will be
placed or referred to the vendor by the regional center.

(e) A vendoring regional center shall deny an application for vendori-
zation within 45 days of receipt of a completed vendor application if the
applicant fails to comply with the requirements of Section 54320(a) of
these regulations, as applicable.

(0 The vendoring regional center shall notify the applicant, in writing,
of the denial pursuant to (e) above and the reason for such denial. The no-
tification shall also include:

( 1 ) A statement that the applicant may appeal the action pursuant to
Section 54380(a) of these regulations;

(2) A statement that failure to file an appeal within 30 days shall result
in denial of the appeal pursuant to Sections 54380(b) and (d) of these reg-
ulations; and

(3) An explanation of the appropriate appeal procedures pursuant to
Sections 54380 through 54390 of these regulations.

Note; Authority cited: Chapter 722, Statutes of 1 992, Section 147; Sections 4405,
4648(a). 4689.1 and 4791(i), Welfare and Institutions Code; and Section 11152,
Government Code; Chapter 1095, Statutes of 1994, Section 14. Reference: Sec-
tions 4631, 4648(a), 4689.1 and 4791, Welfare and Institutions Code.

History
1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 35). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 l-.'i-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7 2- 92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections
(a), (bHb)(5) and (d)(1) and subsecfion reletterina and amendments trans-
mitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Editorial correction of subsections (b)(3)-(4) (Register 95, No. 30).

9. New subsections (b)-(c), subsection relettering, amendment of newly desig-
nated subsection (f) and amendment of Note filed 7-24-95 as an emergency;
operative 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be
transmitted to OAL by 1 1-21-95 or emergency language will be repealed by
operation of law on the following day.

10. New subsecfions (b)-(c). subsection relettering, amendment of newly desig-
nated subsection (f) and amendment of NoTi- refiled 1 1-14-95 as an emergen-
cy; operative 1 1-14-95 (Register 95, No. 46). A Certificate of Compliance must
be transmitted to OAL by 3-13-96 or emergency language will be repealed by
operation of law on the following day.

11. Certificate of Compliance as to 7-24-95 order including amendment of sub-
section (b)(4)-(5), new subsection (b)(6) and amendment of subsection (c)
transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

12. Change without regulatory effect amending subsections (d)(1), (d)(8) and
(d)( 10) filed 1-17-97 pursuant to section 100, title I, California Code of Regu-
lations (Register 97, No. 3).

§ 54324. Emergency Vendorization.

(a) The regional center is authorized to approve emergency vendoriza-
tion for an applicant prior to the receipt of a completed vendor application
if the regional center determines that the health or safety of a consumer
is in jeopardy and no current vendor is available to provide the needed
service.

(b) If emergency vendorization is approved, the appUcant may provide
services for no more than 45 days.

(c) The applicant shall meet all applicable requirements pursuant to
Section 54320(b)(2) through (5) of these regulations.

(d) The applicant shall submit a completed vendor application pur-
suant to Section 54310(a), (d) or (e) of these regulations within 30 days
of the authorization by the vendoring regional center to provide the ser-
vice.

(e) Within 15 days after receipt of the vendor application, the regional
center shall:

(1) Review the vendor application as required in Section 54320(a) of
these reguladons; and

(2) Notify the vendor of vendorization approval pursuant to Section
54322(d) of these regulations; or

(3) Nodfy the applicant of vendorizadon denial pursuant to Section
54322(f) of these regulations.

(0 The emergency vendorization shall lapse if the vendor application
is not properly submitted or if the regional center does not approve the
application within 45 days of the initial authorization.

(g) If a lapse of emergency vendorization occurs pursuant to (0 above,
in no case shall the regional center allow the vendor to reapply for emer-
gency vendorization.

NOTE; Authority cited: Chapter 722, Statutes of 1 992, Secfion 1 47; Sections 4405,
4648(a) and 479 l(i), Welfare and Institutions Code; and Section 1 1 152. Govern-
ment Code. Reference: Sections 4502, 463 1 , 4648(a) and 479 1 , Welfare and Insti-
tutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transnutted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a) and (c)-(f) and Notk filed 1 1-5-91 as an emer-
gency; operafive 11-5-91 (Register 91, No. 21). A Certificate of Compliance

Page 282.5

§ 54326

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

must be transmitted to OAL 3-4-92 or emergency language will be repealed by
operation of law on the following day.

4. Amendment of subsections (a) and (cHO and NoTti refiled 3-4-92 as an emer-
gency; operative 3^-92 (Register 92, No. 25). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (a), (c)-(d) and {e){lH2) transmitted to OAL 6-25-92 and filed 8-6-92
(Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93: operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Regfster 93, No. 26).

7. Amendment of subsection (d) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

8. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Editorial correction of History 3 (Register 95, No. 18).

10. Certificate of Compliance as to 6-20-94 order, including amendment of sub-
section (d), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96. No.
L3).

11. Change without regulatory effect amending subsections (a), (d), (e)(2) and
(e)(3) filed 1-17-97 pursuant to secUon 100, title 1, California Code of Regula-
tions (Register 97, No. 3).

§ 54326. General Requirements for Vendors and Regional
Centers.

(a) All vendors shall:

( 1 ) Be prohibited from transferring vendorization of their service to
another person or entity;

(2) Provide access to regional center and/or Department staff, on an
announced or unannounced basis, for the purposes specified in the Wel-
fare and Institutions Code, Section 4648.1;

(3) Maintain records of services provided to consumers in sufficient
detail to verify delivery of the units of service billed:

(A) Such records shall be maintained for a minimum of five years from
the date of final payment for the State fiscal year in which services were
rendered or until audit findings have been resolved, whichever is longer;

(B) Records must include for each consumer the information specified
in Section 50604(d)(3)(A), (B), (C), (D), (E) or (F), as apphcable.

(C) Data, as specified in Section 50604(d)(3)(A), (B), (C). (D), (E) or
(F), as applicable, for the billing period shall be submitted to the regional
center with the billings/invoices.

(4) Make available any books and records pertaining to the vendored
service, including those of the management organization, if apphcable,
for audit, inspection or authorized agency representatives. This shall also
include only those portions of any personnel records that are necessary
to ensure staff qualifications comply with the requirements contained in
Section 56724, and Section 56770 or 56792 of these regulations, if apph-
cable, in order to comply with the monitoring of program standards pur-
suant to the Welfare and Institutions Code, Section 4691(f);

(5) Utilize and be bound by Title 17, Sections 50700 through 50767,
and the Welfare and Institutions Code, Section 4648.2, should the vendor
elect to appeal any audit findings;

(6) Comply with the provisions contained in the Fair Labor Standards
Act (29 U.S.C, Sections 201 through 219);

(7) Not discriminate in the provision of services to consumers on the
basis of race, religion, age, disability, sex, or national origin of the con-
sumer, or his/her parents, guardian, or conservator;

(8) Be vendored separately for each type of service provided, as speci-
fied in Sections 54342 through 54356 of these regulations unless the re-
gional center waives separate vendorization pursuant to Section
54342(a)(37) or 54342(a)(78)(A);

(9) Provide certification consistent with the Public Contract Code,
Sections 10410 and 1041 1, that the vendor and the agents or employees
of the vendor, in the performance of the contracts, are independent con-
tractors and are not officers or employees of the State of California;

(10) Bill only for services which are actually provided to consumers
and which have been authorized by the referring regional center. When
the vendor is receiving payment for a consumer from the Department of

Rehabilitation and/or the Department of Health Services for a portion of
the program day, and the vendor's rate of reimbursement is based on
costs reported pursuant to Section 57422(c)(2), the vendor shall only bill
the prorate share of the daily rate.

(11) Not bill for consumer absences for nonresidential services. The
Department shall authorize payment for absences which are the direct re-
sult of situations and/or occurrences for which a State of Emergency has
been declared by the Governor. If payment for absences due to a State of
Emergency is authorized by the Department, the vendor shall bill only
for absences in excess of the average number of absences experienced by
the vendor during the 1 2-month period prior to the month in which the
disaster occurred;

( 1 2) Agree to accept the rate established, revised or adjusted by the De-
partment as payment in full for all authorized services provided to con-
sumers and not bill the consumer nor the consumer's family, conservator,
guardian or authorized consumer representative for a supplemental
amount regardless of the cost of providing the authorized service. This
shall not preclude the vendor from billing the consumer or consumer's
family for services provided wliich were authorized by the consumer or
family and which were not authorized by the regional center;

(13) Comply with all applicable staffing ratio requirements;

(14) Be prohibited from being vendored by more than one regional
center for the same service at the same location; and

(15) Comply with conflict of interest requirements as determined by
the criteria established by Title 17, Sections 54500 through 54525 and the
Welfare and Institutions Code, Sections 4626 through 4628.

(16) Sign the Home and Community-Based Services Provider Agree-
ment (6/99), if applicable pursuant to Section 54310(a)(10)(I), (d) and
(e). If the Home and Community-Based Services Provider Agreement
(6/99) is required and has not been signed, the regional center shall:

(A) For new appUcants requesting vendorization, deny vendorization
pursuant to Section 54322(c); or

(B) For existing vendors, notify in writing, the vendor and utilizing re-
gional center(s), if any, that the signed Home and Community-Based
Services Provider Agreement (6/99) is required and that payment of the
vendor's rate will be suspended, the effective date of the suspension, and
that payment shall remain suspended until the signed Home and Commu-
nity-Based Services Provider Agreement (6/99), is received.

(1) The effective date for suspension of payment of the vendor's rate
shall be 15 days from the date of the letter notifying the vendor that pay-
ment will be suspended.

(2) If the signed Home and Community-Based Services Provider
Agreement (6/99), is submitted within the time specified, no further ac-
tion will be taken.

(3) If the Home and Community-Based Services Provider Agreement
(6/99), is submitted after the date when payment of the vendor's rate has
been suspended, the vendoring regional center shall notify the vendor
and utilizing regional center(s) that payment of the vendor's rate is rein-
stated as of the date payment was suspended.

(b) The vendor shall maintain a written description of its organization-
al structure and operations at the vendor's business office in accordance
with the following:

(1) All descriptions shall include:

(A) An identification of the legal entity serving as the governing body
or board of directors;

(B) The policies of operation that are established by the governing
body or board of directors; and

(2) In addition to the information specified in (b)(1) above, if the ven-
dor:

(A) Operates more than one service, the description shall also include:

1 . The names, addresses and vendor numbers of the other services; and

2. Whether any of the services share staff or facility space.

(B) Has a management organization, the description shall also include
a diagram depicting the relationships among the management organiza-

Page 282.6

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54327

tion, the vendor, and any other services under the management organiza-
tion.

(c) Regional centers shall submit the information specified in subsec-
tion (a)(3)(C) above to the Department on a monthly basis, and no later
than 30 days after the end of the previous month.

(d) Regional centers shall not:

( 1 ) Use purchase of service funds to purchase services for a minor
child without first taking into account, when identifying the minor child's
service needs, the family's responsibility for providing similar services
to a minor child without disabilities. In such instances, the regional center
must provide for exceptions, based on family need or hardship.

(2) Use purchase of service funds to purchase services for those execu-
tive/management services, legal services for the benefit of the regional
center, service coordination, and administrative service and support
functions that are funded through the regional center operations budget.
Funding of specialized clinical and diagnostic assessment services and
other services for the benefit of a consumer through purchase of service
funds is permissible.

(3) Charge vendors or consumers for providing representative payee
services.

(4) Except as specified in Section 54324 of these regulations:

(A) Refer any consumer to an applicant until the vendor application
is approved; or

(B) Reimburse a vendor for services provided before vendorization.

(e) Compliance with the standards and requirements specified in these
regulations does not exempt a vendor from compliance with existing stat-
utes and regulations or with any other applicable standards or require-
ments promulgated by the controlling agencies for the service provided
by the vendor.

Note. Authority cited: Chapter 1 57, Statutes of 2003; and Section 1 11 52, Gov-
ernment Code. Reference: Sections 4500, 4501, 4502, 4648, 4648.1 and 4742,
Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(9) and (d)(1)(A) and Note filed 11-5-91 as an
emergency; operative 11-5-91 (Register 92, No. 21). A Certificate of Com-
pliance must be transmitted to OAL 3^^-92 or emergency language will be re-
pealed by operation of law on the following day.

4. Amendment of subsections (a)(9) and (d)( 1 )( A) and Note re filed 3-4-92 as an
emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 3^-92 order including amendment of subsec-
tion (a)(9) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of secdon filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prindng only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsecUons (a)(17), (a)(17)(B) and (a)(17)(B)2-3 filed
4-22-94; operative 4-22-94. Submitted to OAL for printing only (Register 94,
No. 16).

8. Amendment of subsections (a)( 12) and (17) filed 6-20-94 as an emergency; op-
erative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722,
Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of sub-
sections (a)(9), (a)(12), (a)(17), (a)(17)(B) and (a)(17)(B)(2)-(3), transmitted to
OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

1 1 . Change without regulatory effect amending section filed 1-17-97 pursuant to
secdon 100, dtle 1, California Code of Reguladons (Register 97, No. 3).

12. Repealer of subsection (a)(2), subsecdon renumbering, and amendment of
Note filed 6-29-98 as an emergency; operadve 6-29-98 (Register 98, No. 27).
A Certificate of Compliance must be d-ansmitted to OAL by 10-27-98 or emer-
gency language will be repealed by operation of law on the following day.

13. Repealer of subsection (a)(2), subsecdon renumbering, and amendment of
Note refiled 1 0-20-98 as an emergency; operadve 1 0-27-98 (Register 98, No.
43). A Certificate of Compliance must be transmitted to OAL by 2-24-99 or
emergency language will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 1 0-20-98 order transmitted to OAL 12 31 'JS
and filed 2-17-99 (Register 99, No. 8).

15. Amendment of subsecdon (a)(3)(B), new subsections (a)(3)(C) and (c). sub-
secdon relettering and amendment of Note filed 1 0-9-2003 as an emergency;
operative 10-9-2003 (Register 2003, No. 41). A Certificate of Compliance
must be transmitted to OAL by 2-6-2004 or emergency language will be re-
pealed by operation of law on the following day.

16. Amendment of subsection (a)(3)(B), new subsections (a)(3)(C) and (c), sub-
secdon relettering and amendment of NcrrE refiled 2-3-2004 as an emergency;
operadve 2-3-2()04 (Register 2004, No. 6). A Certificate of Compliance must
be transmitted to OAL by 6-2-2004 or emergency language will be repealed by
operation of law on the following day.

17. Amendment of subsecdon (a)(3)(B), new subsections (a)(3)(C) and (c), sub-
section relettering and amendment of Note; refiled 6-1-2004 as an emergency;
operative 6-l-2(T04 (Register 2004, No. 23). A Certificate of Compliance must
be transmitted to OAL by 9-29-2004 or emergency language will be repealed
by operation of law on the following day.

18. Amendment of subsections (a)(3)(A), (a)(16), (a)(16)(B) and
(a)( 16)(B)(2)-(3) and amendment of Note; filed 8-27-2004 as an emergency;
operative 8-27-2004 (Register 2004, No. 35). A Certificate of Compliance
must be transmitted to OAL by 12-27-2004 or emergency language will be re-
pealed by operation of law on the following day.

19. Certificate of Compliance as to 6-1-2004 order, including amendment of sub-
sections (a)(3)(B)-(C), transmitted to OAL 9-13-2004 and filed 10-28-2004
(Register 2004, No. 44).

20. Amendment of subsections (a)(3)(A), (a)(16), (a)(I6)(B) and
(a)( 16)(B)(2)-(3) and amendment of Note refiled 12-22-2004 as an emergen-
cy: operadve 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance
must be transmitted to OAL by 4-21-2005 or emergency language will be re-
pealed by operadon of law on the followmg day.

21. Certificate of Compliance as to 12-22-2004 order, including further amend-
ment of subsection (a)(16), transmitted to OAL 4-19-2005 and filed
5-18-2005 (Register 2005, No. 20).

§ 54327. Requirements for Special Incident Reporting by
Vendors and Long-Term Health Care Facilities.

(a) Parent vendors, and consumers vendored to provide services to
themselves, are exempt from the special incident reporting requirements
set forth in this Article.

(b) All vendors and long-term health care facilities shall report to the
regional center:

( 1 ) The following special incidents if they occurred during the time the
consumer was receiving services and supports from any vendor or long-
termi health care facility:

(A) The consumer is missing and the vendor or long-term health care
facility has filed a missing persons report with a law enforcement agency;

(B) Reasonably suspected abuse/exploitation including:

1 . Physical;

2. Sexual;

3. Fiduciary;

4. Emotional/mental; or

5. Physical and/or chemical restraint.

1. Provide medical care for physical and mental health needs;

2. Prevent malnutrition or dehydration;

3. Protect from health and safety hazards;

4. Assist in personal hygiene or the provision of food, clothing or shel-
ter or

5. Exercise the degree of care that a reasonable person would exercise
in the position of having the care and custody of an elder or a dependent
adult.

(D) A serious injury/accident including:

1 . Lacerations requiring sutures or staples;

2. Puncture wounds requiring medical treatment beyond first aid;

3. Fractures;

4. Dislocations;

5. Bites that break the skin and require medical treatment beyond first
aid;

6. Internal bleeding requiring medical treatment beyond first aid;

7. Any medication errors;

8. Medication reactions that require medical treatment beyond first
aid; or

9. Bums that require medical treatment beyond first aid.

Page 282.7

§ 54327.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(E) Any unplanned or unscheduled hospitalization due to the follow-
ing conditions:

1 . Respiratory illness, including but not limited, to asthma; tuberculo-
sis; and chronic obstructive pulmonary disease;

2. Seizure-related;

3. Cardiac-related, including but not limited to, congestive heart fail-
ure; hypertension; and angina;

4. Internal infections, including but not limited to, ear, nose and throat;
gastrointestinal; kidney; dental; pelvic; or urinary tract;

5. Diabetes, including diabetes-related complications;

6. Wound/skin care, including but not limited to, cellulitis and decubu-
tus;

7. Nutritional deficiencies, including but not limited to, anemia and
dehydration; or

8. Involuntary psychiatric admission;

(2) The following special incidents regardless of when or where they
occurred:

(A) The death of any consumer, regardless of cause;

(B) The consumer is the victim of a crime including the following:

1 . Robbery, including theft using a firearm, knife, or cutting instru-
ment or other dangerous weapons or methods which force or threaten a
victim;

2. Aggravated assault, including a physical attack on a victim using
hands, fist, feet or a firearm, knife or cutting instrument or other danger-
ous weapon;

3. Larceny, including the unlawful taking, carrying, leading, or riding
away of property, except for motor vehicles, from the possession or
constructive possession of another person;

4. Burglary, including forcible entry; unlawful non-forcible entry;
and, attempted forcible entry of a structure to commit a felony or theft
therein;

5. Rape, including rape and attempts to commit rape.

(c) The report pursuant to subsection (b) shall be submitted to the re-
gional center having case management responsibility for the consumer.

(d) When the regional center with case management responsibility is
not the vendoring regional center, the vendor or long-term health care
facility shall submit the report pursuant to subsection (b) to both the re-
gional center having case management responsibility and the vendoring
regional center.

(e) The vendor's or long-term health care facility's report to the re-
gional center pursuant to subsection (b) shall include, but not be limited
to:

(1) The vendor or long-term health care facility's name, address and
telephone number;

(2) The date, time and location of the special incident;

(3) The name(s) and date(s) of birth of the consumer(s) involved in the
special incident;

(4) A description of the special incident;

(5) A description (e.g., age, height, weight, occupation, relationship to
consumer) of the alleged perpetrator(s) of the special incident, if applica-
ble;

(6) The treatment provided to the consumer(s), if any;

(7) The name(s) and address(es) of any witness(es) to the special inci-
dent;

(8) The action(s) taken by the vendor, the consumer or any other
agency(ies) or individual(s) in response to the special incident;

(9) The law enforcement, licensing, protective services and/or other
agencies or individuals notified of the special incident or involved in the
special incident; and

(10) The family member(s), if applicable, and/or the consumer's au-
thorized representative, if applicable, who have been contacted and in-
formed of the special incident.

(f) The report pursuant to subsection (b) shall be submitted to the re-
gional center by telephone, electronic mail or FAX immediately, but not
more than 24 hours after learning of the occurrence of the special inci-
dent.

(g) The vendor or long-term health care facility shall submit a written
report of the special incident to the regional center within 48 hours after
the occurrence of the special incident, unless a written report was other-
wise provided pursuant to subsection (e). The report pursuant to this sub-
section may be made by FAX or electronic mail.

(h) When a vendor makes a report of an event to the Department of So-
cial Services' Community Care Licensing Division pursuant to Title 22,
California Code of Regulations, Section 80061(b) the vendor shall si-
multaneously report the event to the regional center by telephone, FAX
or electronic mail.

(1 ) The vendor shall concurrently submit to the regional center a copy
of any subsequent written report regarding the event that is submitted to
the Department of Social Services' Community Care Licensing Divi-
sion.

(i) When a long-term health care facility reports an unusual occur-
rence to the Department of Health Services' Licensing and Certification
Division pursuant to Title 22, California Code of Regulations, Sections
72541, 75339, 76551 or 76923, the long-term health care facility shall
simultaneously report the unusual occurrence to the regional center im-
mediately by telephone, FAX or electronic mail.

(1) The long-term health care facility shall concurrently submit to the
regional center a copy of any subsequent report, or any written confirma-
tion of the unusual occurrence, that is submitted to the Department of
Health Services' Licensing and Certification Division.

(j) The vendor or long-term health care facility may submit to the re-
gional center a copy of the report submitted to a hcensing agency when
the report to the licensing agency contains all the information specified
in subsection (d)(1) through (10).

(k) These regulations shall not remove or change any reporting obliga-
tions under the Elder and Dependent Adult Abuse Reporting Act com-
mencing with Welfare and Institutions Code Section 15600 or the Child
Abuse and Neglect Reporting Act commencing with Penal Code Section
11164.

NOTE: Authority cited: Section 11152, Government Code. Reference: Sections
4500, 4501, 4502, 4648, 4648.1 and 4742, Welfare and Institutions Code.

History

1. New section filed 6-29-98 as an emergency; operative 6-29-98 (Register 98,
No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-20-98 as an emergency; operative 10-27-98 (Register
98, No. 43). A Certificate of Compliance must be transmitted to OAL by
2-24-99 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-20-98 order, including further amendment
of secfion, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No.
8).

4. Amendment filed 6-27-2001 as an emergency; operative 7-1-2001 (Register

2001, No. 26). A Certificate of Compliance must be transmitted to OAL by
1 0-29-200 1 or emergency language will be repealed by operation of law on the
following day.

5. Reinstatement of section as it existed prior to 6-27-2001 emergency amend-
mentby operation of Government Code section 11346.1(f) (Register 2001, No.
43).

6. Amendment filed 10-25-2001 as an emergency; operative 10-31-2001 (Regis-
ter 2001, No. 43). A Certificate of Comptiance must be transmitted to OAL by
2-28-2002 or emergency language will be repealed by operation of law on the
following day.

7. Certificate of Compliance as to 10-25-2001 order, including further amend-
ment of section, transmitted to OAL 2-28-2002 and filed 4-1 0-2002 (Register

2002, No. 15).

8. Change without regulatory effect amending subsection (b)(2)(B)5. filed
5-27-2003 pursuant to section 100, title 1, California Code of Regulations
(Register 2003, No. 22).

§ 54327.1. Requirements for Special Incident Reporting by
Regional Centers.

(a) The regional center shall submit an initial report to the Department
of any special incident, as defined in Section 54327(b), within two work-
ing days following receipt of the report pursuant to Section 54327(b).

(b) When a regional center has knowledge of a special incident for
which the vendor or long-term health care facility is responsible for re-
porting but has not submitted a report to the regional center within the re-

Page 282.8

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54330

quired time period, the regional center shall submit an initial report to the
Department within two working days of learning of the occurrence.

(c) The initial report shall include the following information, to the ex-
tent the information is available at the time of the initial report:

( 1 ) The consumer(s) name and date of birth;

(2) The vendor or long-term health care facility's name, address and
telephone number;

(3 ) The name and telephone number of the regional center contact per-
son regarding the special incident;

(4) The consumer(s) Unique Consumer Identifier (UCI);

(5) Name of the consumer's conservator or guardian, if applicable;

(6) Date, time and location of the incident;

(7) Date the incident was reported to the regional center;

(8) Name of the person preparing the report;

(9) Date the report was prepared;

(10) Type of incident;

(11) Any medical care or treatment required as a result of the special
incident;

(12) Relationship of the alleged perpetrator to the consumer;

(13) Identification of any persons or entities notified about the incident
and the date they were notified;

(14) A description of the special incident;

( 1 5) If the special incident was a death, indication if the death was dis-
ease related; non-disease related; or, unknown;

( 1 6) A description of any actions/outcomes taken by any of the follow-
ing persons or entities in response to the special incident:

(A) Regional center(s);

(B) Vendor(s);

(D) Department of Social Services Community Care Licensing;

(E) Child Protective Services;

(F) Adult Protective Services;

(G) Long Term Care Ombudsman;
(H) Law enforcement; and/or

(I) Coroner.

(17) Any additional information that the regional center determines is
necessary to explain or describe the special incident.

(d) Any required information that is not submitted with the initial re-
port in (c) shall be submitted within 30 working days following receipt
of the report of the special incident pursuant to Section 54327(b).

(e) The regional center shall comply with all Department requests for
initial and follow-up information pertaining to a special incident.

(f) The report shall be considered complete when the regional center
has submitted all the information required by this section.

(g) Effective January 1 , 2002, all reports of special incidents prepared
by the regional center shall be transmitted to the Department utilizing the
Department's Electronic Data Reporting System.

NOTE: Authority cited: Section 11152, Government Code. Reference: Sections
4434, 4500, 4501, 4502, 4629, 4648, 4648.1 and 4742, Welfare and Institutions
Code.

History

3. Certificate of Compliance as to 10-20-98 order, including further amendment
of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No.
8).

4. Amendment filed 6-27-2001 as an emergency; operative 7-1-2001 (Register
2001, No. 26). A Certificate of Compliance must be transmitted to OAL by
1 0-29-2001 or emergency language will be repealed by operation of law on the
following day.

5. Reinstatement of section as it existed prior to 6-27-2001 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f) (Register 2001 , No.
43).

6. Amendment filed 10-25-2001 as an emergency; operative 10-31-2001 (Regis-
ter 2001 , No. 43). A Certificate of Compliance must be transmitted to OAL by

2-28-2002 or emergency language will be repealed by operation of law on the
following day.

7. Certificate of Compliance as to 10-25-2001 order, including further amend-
ment of section, transmitted to OAL 2-28-2002 and filed 4-1 0-2002 ( Re^'istcr
2002, No. 15).

8. Change without regulatory effect relettering subsections and the internal cross-
references thereto filed 5-27-2003 pursuant to section 100, title 1, California
Code of Regulations (Register 2003, No. 22).

§ 54327.2. Regional Center Risk Management, Assessment
and Planning Committee and Risk
Management and Mitigation Plans.

(a) Each regional center shall establish a Risk Management, Assess-
ment and Planning Committee that, at a minimum, includes a representa-
tive from the regional center's clinical, quality assurance and training
staff.

(b) The Risk Management, Assessment and Planning Committee shall
develop the regional center's Risk Management and Mitigation Plan
which shall address, at a minimum:

( 1 ) The process and procedures for ensuring accurate and timely han-
dling and reporting of special incidents by regional center staff, vendors,
and long-term health care facilities;

(2) The provision of training and technical assistance to regional cen-
ter stafL vendors and long-term health care facility staff and others on
the legal obligations of abuse reporting, special incident reporting, risk
assessment, developing and implementing an incident prevention plan
and proactive accident/safety planning through the individualized pro-
gram planning process;

(3) Coordination and communication with local licensing, protective
service and law enforcement agencies relative to investigative actions
and findings;

(4) A process for reviewing individual and aggregate special incident
report data to identify trends and unusual patterns which may require re-
gional center action, and;

(5) A process for reviewing medical records and coroner reports, as
appropriate, associated with special incidents to ensure that appropriate
medical attention was sought and/or given.

(1) Monitor the regional center's Risk Management and Mitigation
Plan to ensure it is being implemented;

(2) Annually review the regional center's internal special incident re-
porting and risk management systems; and

(3) Update the Risk Management and Mitigation Plan as necessary.

(d) The Risk Management, Assessment and Planning Committee shall
meet at least semi-annually.

NOTE: Authority cited: Section 11152, Government Code. Reference: Sections
4434, 4500, 4501, 4502, 4629, 4648, 4648.1 and 4742, Welfare and Institutions
Code.

History

1. New section filed 6-27-2001 as an emergency; operative 7-1-2001 (Register
2001, No. 26). A Certificate of Compliance must be transmitted to OAL by
1 0-29-200 1 or emergency language will be repealed by operation of law on the
following day.

2 . Repealed by operation of Government Code section 1 1 346. 1 (g) (Register 200 1 ,

No. 43).

3. New section filed 10-25-2001 as an emergency; operative 10-31-2001 (Regis-
ter 2001, No. 43). A Certificate of Compliance must be transmitted to OAL by
2-28-2002 or emergency language will be repealed by operation of law on the
following day.

4. Certificate of Compliance as to 10-25-2001 order, including amendment of
subsection (b)(2), transmitted to OAL 2-28-2002 and filed 4^10-2002 (Regis-
ter 2002, No. 15).

§ 54330. Changes in Vendor Ownership, Location, or
Program/Service Design.

(a) The vendor shall notify the vendoring regional center 30 days prior
to any change in any of the following:

(1) Ownership. A new vendor application shall be completed by the
new owners and be approved by the vendoring regional center prior to
provision of services to consumers. If necessary, a new license shall be

Page 282.8(a)

§ 54332

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

obtained prior to approval of the vendor application and the provision of
services to consumers;

(2) Location. If a license is applicable, the new location shall be li-
censed prior to the provision of services to regional center consumers;
and

(3) The vendor's required license, certificate, registration, credential
or permit.

(b) The vendor shall notify the vendoring regional center and all user
regional centers:

( 1 ) In writing at least 60 days before it discontinues providing services.
The regional center shall delete the vendor from the vendor panel; or

(2) Of any modification to the program design or service design pur-
suant to Section 56712(b). 56762(c) or 56780(b) of these regulations, if
applicable.

NOTE: Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code;
and Section 11152, Government Code. Reference: Sections 4631, 4648(a) and
4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3 . Repealer of subsections (a)( 1 ) and new subsections (a)( 1 )-(B) and amendment
of Note filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92, No.
21 ). A Certificate of Compliance must be transmitted to OAL 3-4-92 or emer-
gency language will be repealed by operafion of law on the following day.

4. Repealer of subsection (a)(1) and new subsections (a)(l)-(B) and amendment
of Note refiled 3^-92 as an emergency; operative 3-4-92 (Register 92, No.
25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or emer-
gency language will be repealed by operation of law on the following day.

5. Editorial cortection of printing error in History 3 (Register 92, No. 25).

6. Certificate of Compliance as to 3^-92 order including amendment of subsec-
tion (a)(1) and Note transmitted to OAL 6-25-92 and filed 8-6-92 (Register
92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

8. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending subsecfions (a)(l)-(a)(3) filed
1 - 1 7-97 pursuant to section 1 00, tide 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 54332. Regional Center Files.

(a) The vendoring regional center shall maintain a file for each vendor
which includes copies of:

(1) Tlie vendor application as described in Section 54310(a) of these
regulations;

(2) Any required certificate, credential, license, degree, permit or reg-
istration;

(3) Statement of current vendor status;

(4) The regional center approval letter;

(5) The program design or service design as described in Sections
56712, 56762 and 56780 of these regulations, if applicable;

(6) The staff qualifications and duty statements as described in Sec-
tions 56722, 56724, 56752, 56754, 56770, 56790 and 56792 of these reg-
ulations, if applicable;

(7) Notification of established rate and all documentation submitted
pursuant to Sections 57422, 57433 through 57439, 58020, and 58033
through 58039 of these regulations, for a rate determination, if applica-
ble;

(8) The signed Home and Community Based Services Provider Agree-
ment, (6/99) if applicable.

(9) Agreements negotiated pursuant to Section 57300(d) or (e), if
applicable;

(10) Service contracts negotiated pursuant to Section 57540, if appli-
cable;

(11) Agreements negotiated pursuant to Section 58140, if applicable.

(b) Regional centers may review, at least annually, all vendor files
maintained by the regional center to determine that:

( 1 ) The information required for vendorization is completed and accu-
rate;

(2) At least one consumer has been provided services by the vendor
within the last 24 months;

(3) The service currently provided by the vendor is the same service
approved for vendorization; and

(4) Vendors meet the minimum program standards as specified in Sec-
tions 56710 through 56802 of these regulations, if applicable; and

(5) The vendor has signed the Home and Community Based Services
Provider Agreement (6/99), if applicable.

(c) If, after a review of the vendor files, the vendoring regional center
determines that the vendored service has not been provided to any con-
sumer within the last 24 months, the vendoring regional center shall:

(1) Send the vendor a written notice stating that vendorization will be
terminated in 30 days unless the vendoring regional center receives noti-
fication from the vendor expressing an interest to continue as a vendor;
and

(2) Make the changes to the statewide vendor panel required by Sec-
tion 54334(d) of these regulations if the vendor does not respond in ac-
cordance with (c)(1) above.

NOTE: Authority cited: Chapter 157, Statutes of 2003; Sections 4405 and 4648(a),
Welfare and Institutions Code; and Secdon 1 1 152, Government Code. Reference:
Sections 4631, 4648(a), 4691 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operafive 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operafion of law on the following day.

4. Amendment refiled 3-4—92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsection
(a) and subsection relettering and amendments transmitted to OAL 6-25-92
and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for prinfing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsecfions (a)(8) and (b)(5) filed 4-22-94; operafive 4-22-94.
Submitted to OAL for prinfing only (Register 94, No. 16).

8. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending subsections (b)(2) and (c) filed
1-17-97 pursuant to section 100. title 1, California Code of Regulations (Regis-
ter 97, No. 3).

10. Amendment of subsecfion (a)(9) filed 4-25-2000; operafive 5-25-2000 (Reg-
ister 2000, No. 17).

11. Amendment of subsecfions (a)(8) and (b)(5) and amendment of Note filed
8-27-2004 as an emergency; operative 8-27-2004 (Register 2004. No. 35). A
Certificate of Compliance must be transmitted to OAL by 1 2-27-2004 or emer-
gency language will be repealed by operation of law on the following day.

12. Amendment of subsecfions (a)(8) and (b)(5) and amendment of Note refiled
12-22-2004 as an emergency; operafive 12-22-2004 (Register 2004, No. 52).
A Certificate of Compliance must be transmitted to OAL by 4-21-2005 or
emergency language will be repealed by operation of law on the following day.

13. Certificate of Compliance as to 12-22-2004 order transmitted to OAL
4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

§ 54334. Statewide Vendor Panel.

(a) The statewide vendor panel shall include the following information
for all vendors:

(1) Vendor's name and telephone number;

(2) Vendor's Social Security Number or Federal tax ID number;

(3) Vendor's mailing address, including the county;

(4) Location of vendor's facility;

(5) The vendor identification number, service code, and subcode;

(6) The vendor's area of specialty, if any;

(7) A description of the service provided;

(8) Licensed capacity, if applicable;

(9) The effective date of vendorization;

Page 282.8(b)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54334

(10) The vendoring and all user regional centers; and

(11) The name of the management organization, if any.

(b) Any regional center utilizing a service within the vendoring region-
al center's catchment area shall notify the vendoring regional enter, in
writing, within 1 3 days from the day the vendor begins to serve, or ceases
to serve, the utilizing regional center's consumers.

( 1 ) Input all applicable information for each vendor into the statewide
vendor panel;

(2) Transmit this information to the Department via the centralized au-
tomated regional center accounting system. This information shall be
maintained on a master file by the Department; and

(3) Ensure that all the information contained in the statewide vendor
panel is current by updating the panel any time a change to any of the
items specified in (a) above, is reported by a vendor or a regional center
utilizing the service.

(d) The vendoring regional center shall delete a vendor's name I'rom
the vendor panel and shall send the vendor written notification, along
with an explanation of the appeal rights pursuant to Sections 54380
through 54390 of these regulations, that vendorization has been termi-
nated, if any of the following conditions exist:

( 1 ) The vendor notifies the vendoring regional center of its intent to
discontinue providing services;

(2) The vendor has not responded to the 30-day notice pursuant to Sec-
tion 54332(c)(1) of these regulations; or

(3) Vendorization is being terminated for noncompliance pursuant to

Sections 54370 or 54372.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4405, 4648(a) and 4791(i). Welfare and Institutions Code; and Section 1 1 L52,
Government Code. Reference: Sections 4631, 4648(a), 4691 and 4791, Welfare
and Institutions Code.

[The next page is 282.9.

Page 282.8(c)

•

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54342

History

1. New section filed 6-26-90 as an emergency; operalive 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21 ). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 3^-92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections
(b)-(b)(6) and (e) and subsection relettering and amendments transmitted to
OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

8. Change without regulatory effect amending subsection (b) filed 1-17-97 pur-
suant to secfion 100, title 1, California Code of Regulations (Register 97, No.

3).

Article 3.

Vendor Numbers and Service
Codes

§ 54340. Vendor Identification Numbers, Service Codes,
and Subcodes.

(a) The Department shall issue a block of numbers to each regional
center to use in assigning vendor identification numbers. The vendoring
regional center shall assign a vendor identification number to each ven-
dor in accordance with this section. The vendor identification number
shall be used by all regional centers purchasing the vendored service
from that specific vendor. Vendors shall be assigned vendor identifica-
tion numbers as follows:

(1) Vendor identification numbers beginning with the letter "H" shall
be assigned to adult day programs, mobility training services agencies,
acute care hospitals, day treatment centers, infant development pro-
grams, camping services vendors, day care vendors, home health agen-
cies, homemaker services, in-home respite services agencies, out-of-
home respite services vendors, supported employment programs —
group, supported employment programs — individual, work activity
programs, transportation companies, transportation/additional compo-
nent vendors, residential facilities, intermediate care facilities and nurs-
ing facilities:

(A) A separate vendor identification number shall be assigned for each
location at which the vendor provides the service, with the exception of
in-home respite services agency vendors which have received a waiver
pursuant to Section 54342(a)(37) of these regulations;

(B) If a single vendor has more than one service of the same type at the
same location, the regional center shall assign each service a separate
vendor identification number; and

(C) Location, pursuant to paragraphs (a)( 1 )(A) and (B) above, shall be
the business address for those vendors who offer services solely in the
community and have no specific facility or building site.

(2) Vendor identification numbers beginning with the letter "P" shall
be assigned to all vendors not listed in (a)(1) above, or (a)(3) , (a)(4) or
(a)(5) below;

(3) A vendor identification number beginning with the letter "Z" shall
be assigned to:

(A) The following vendors when the rate charged for consumers is the
same charged to the general public for the same service:

1. Out-of-state manufacturers or distributors;

2. Retail/wholesale stores;

3. Public transit authorities;

4. Dial-a-ride;

5. Rental care agencies;

6. Taxis; and

7. Generic agencies.

(4) A vendor identification number beginning with the letter "V" shall
be assigned to:

(A) Respite service - family member, nursing service - family mem-
ber, day care - family member, transportation - family member, diaper
and nutritional supplements - family member.

(B) Vendors who provide vouchered and non-vouchered services
shall be assigned two vendor identification numbers:

1. a vendor identification number beginning with the letter "V" shall
be assigned for vouchered services; and

2. A vendor idenfification number shall be assigned pursuant to (a)( 1 )
through (3) above, as applicable, for non-vouchered services.

3. Regional centers may issue only one number to a vendor which shall
be preceded by the letter "V" for vouchered services and the letter "H",
"P", or "Z", as appropriate pursuant to (a)( 1 ) through (3) above, for non-
vouchered services.

(5) A vendor identification number beginning with the letter "S" shall
be assigned to vendors with whom the regional center negotiates and en-
ters into a service contract pursuant to Section 57540.

(b) The Department shall assign vendor identification numbers to:

(1) Regional centers:

(A) When an emergency arises which affects the health or safety of a
consumer and requires the regional center to provide services; and

(B) To facilitate payment for services pursuant to agreements between
regional centers.

(2) Developmental centers to provide a mechanism for a regional cen-
ter to pay a developmental center when the developmental center is pro-
viding services to a consumer residing in the community.

(c) The vendoring regional center shall assign a service code to the
vendor based upon the program design and/or the services provided.
NOTE; Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4405, 4648(a) and 4791(i), Welfare and In.stitutions Code; and Section 11152,
Government Code. Reference: Secfions 463 1 , 4648(a) and 479 1 , Welfare and In-
stitutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)-(a)(6) and NoTi: filed 1 1-5-91 as an emergency;
operative 1 1-5-91 (Register 92, No. 21 ). A Certificate of Compliance must be
transmitted to OAL 3-4-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment of subsections (a)-(a)(6) and Note refiled 3-4-92 as an emergen-
cy; operafive 3-4-92 (Register 92, No. 25). A Certificate of Compliance must
be transmitted to OAL 7-2-92 or emergency language will be repealed by oper-
ation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections
(a)(1) and (a)(5)-(6) and subsecdon reletterina and amendments transmitted to
OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of secfion filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for prinfing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

7. Amendment filed 6-20-94 as an emergency; operative 6-20-94. Submitted to
OAL for prinfing only pursuant to Chapter 722, Statutes of 1992, Secfion 147
(Register 94, No. 25).

8. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order, including amendment of subsec-
fions (a)(1)(A) and (a)(4)(A), transmitted to OAL 2-20-96 and filed 3-29-96
(Register 96, No. 13).

1 0. Change without regulatory effect amending section filed 1 - 1 7-97 pursuant to
secfion 100, title L California Code of Regulations (Register 97, No. 3).

1 1 . Amendment of subsection (a)(1) filed 8-1-2005; operative 8-3 1 -2005 (Ree-
ister2005,No. 31).

§ 54342. Types of Services.

(a) The following service codes shall be assigned to the following
types of services:

Page 282.9

§ 54342

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1) Activity Center - Service Code 505. Activity Centers shall meet
the requirements in Sections 56710 through 56756 of these regulations
for the specific service being vendored.

(2) Acute Care Hospitals - Service Code 700. A regional center shall
classify a vendor as an acute care hospital if the vendor is either:

(A) An acute care hospital which is validly licensed as such by DHS,
and which provides inpatient care 24-hours per day; or

(B) An acute psychiatric hospital which is validly licensed as such by
DHS, and which provides care for the mentally disordered, incompetent
persons referred to in Welfare and Institutions Code, Sections 5000 to
5550.

(3) Adaptive Skills Trainer- Service Code 605. A regional center shall
classify a vendor as an adaptive skills trainer if the vendor possesses the
skills, training and education necessary to enhance existing consumer
skills. An adaptive skills trainer may also remedy consumer skill deficits
in communication, social function or other related skill areas and shall
meet the following requirements:

(A) Possess a Master's Degree in one of the following: education, psy-
chology, counseling, nursing, social work, applied behavior analysis, be-
havioral medicine, speech and language, or rehabilitation; and

(B) Have at least one year of experience in the design and implementa-
tion of adaptive skills training plans.

(4) Aduh Day Care - Service Code 855.

(A) A regional center shall classify a vendor as an adult day care facil-
ity if the vendor:

1. Possesses a valid day care license for adults issued by DSS or an
agency authorized by DSS to assume specific licensing responsibilities;
and

2. Provides nonmedical care and supervision to adults 18 years of age
or older on less than a 24-hour per day basis.

(B) Adult day care does not include adult day programs as identified
in(a)(l), (6), (12), (33), and(72).

(5) Adult Day Health Center - Service Code 702. A regional center
shall classify a vendor as an adult day health center if the vendor has a
signed adult day health care provider agreement with the Department of
Health Services to provide the services described in Title 22, Chapter 5
to Medi-Cal beneficiaries who are eligible for and voluntarily elect to
participate in an adult day health care program.

(6) Adult Development Center - Service Code 510. Adult Develop-
ment Centers shall meet the requirements in Sections 56710 through
56756 of these regulations for the specific service being vendored.

(7) Art Therapist - Service Code 691. A regional center shall classify
a vendor as an art therapist if the vendor possesses a current registration
issued by the American Art Therapy Association and works with an indi-
vidual using art media as a means of expression and communication to
promote the individual's perceptive, intuitive, affective, and expressive
experiences which lead to the individual' s personal growth or personality
reintegration.

(8) Associate Behavior Analyst - Service Code 61 3. A regional center
shall classify a vendor as an Associate Behavior Analyst if the vendor as-
sesses the function of a behavior of a consumer and designs, implements,
and evaluates instructional and environmental modifications to produce
socially significant improvements in the consumer's behavior through
skill acquisition and the reduction of behavior, under direct supervision
of a Behavior Analyst or Behavior Management Consultant. Associate
Behavior Analysts engage in descriptive functional assessments to iden-
tify environmental factors of which behavior is a function. Associate Be-
havior Analysts shall not practice psychology, as defined in Business and
Professions Code Section 2903. A regional center shall classify a vendor
as an Associate Behavior Analyst if an individual is recognized by the
National Behavior Analyst Certification Board as a Board Certified
Associate Behavior Analyst.

(9) Attorney - Service Code 610. A regional center shall classify a
vendor as an attorney if the vendor:

(A) Is an active member in good standing of the State Bar of Califor-
nia;

(B) Advises individuals of their legal rights; and

(10) Audiology - Service Code 706.

(A) A regional center shall classify a vendor as a provider of audiology
services if the vendor is:

1. An audiologist who is validly licensed as an audiologist by the
Speech Pathology and Audiology Examining Committee of the Medical
Board of California; and

2. Uses techniques to identify and evaluate hearing disorders and to
develop methods of improving hearing disorders involving speech, lan-
guage, auditory behavior, and other aberrant behavior related to hearing
loss.

(B) A vendored audiologist shall not dispense hearing aids to consum-
ers, or be additionally vendored as an audiology center or hearing aid dis-
penser.

(11) Behavior Analyst - Service Code 612. Behavior Analyst means
an individual who assesses the function of a behavior of a consumer and
designs, implements, and evaluates instructional and environmental
modifications to produce socially significant improvements in the con-
sumer's behavior through skill acquisition and the reduction of behavior.
Behavior Analysts engage in functional assessments or functional analy-
ses to identify environmental factors of which behavior is a function. A
Behavior Analyst shall not practice psychology, as defined in Business
and Professions Code section 2903. A regional center shall classify a
vendor as a Behavior Analyst if an individual is recognized by the nation-
al Behavior Analyst Certification Board as a Board Certified Behavior
Analyst.

(12) Behavior Management Assistant - Service Code 615. A regional
center shall classify a vendor as a behavior management assistant if the
vendor designs and/or implements behavior modification intervention
services under the direct supervision of a behavior management consul-
tant; or if the vendor assesses the function of a behavior of a consumer
and designs, implements, and evaluates instructional and environmental
modifications to produce socially significant improvements in the con-
sumer's behavior through skill acquisition and the reduction of behavior,
under direct supervision of a Behavior Analyst or Behavior Management
Consultant, and meets either of the following requirements:

(A) Possesses a Bachelor of Arts or Science Degree and has either:

1 . Twelve semester units in applied behavior analysis and one year of
experience in designing and/or implementing behavior modification in-
tervention services; or

2. Two years of experience in designing and/or implementing behav-
ior modification intervention services.

(B) Is registered as either:

1 . A psychological assistant of a psychologist by the Medical Board
of California or Psychology Examining Board; or

2. An Associate Licensed Clinical Social Worker pursuant to Business
and Professions Code, Section 4996. 1 8.

(13) Behavior Management Consultant - Service Code 620.

(A) A regional center shall classify a vendor as a behavior manage-
ment consultant if the vendor designs and/or implements behavior modi-
fication intervention services and meets the following requirements:

1 . Individuals vendored as a behavior management consultant prior to,
or as of, December 3 1 , 2006, that have not previously completed twelve
semester units in applied behavior analysis, shall have until December
3 1 , 2008 to complete twelve semester units in applied behavior analysis
and possess a license and experience as specified in 3. through 7. below.

2. Individuals vendored as a behavior management consultant on, or
after, January 1, 2007, shall, prior to being vendored, have completed
twelve semester units in applied behavior analysis and possess a license
and experience as specified in 3. through 7. below.

3. Possesses a valid license as a psychologist from the Medical Board
of Cahfornia or Psychology Examining Board; or

4. Is a Licensed Clinical Social Worker pursuant to Business and Pro-
fessions Code, Sections 4996 through 4998.7; or

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5. Is a Licensed Marriage and Family Therapist pursuant to Business
and Professions Code, Sections 4980 ttirough 4984.7; or

6. Is any other licensed professional whose California licensure per-
mits the design and/or implementation of behavior modification inter-
vention services.

7. Have two years experience designing and implementing behavior
modification intervention services.

(B) Behavior management consultants shall follow the requirements
of Title 1 7, Sections 50800 through 50823, when using planned behavior
modiiication interventions that cause pain or trauma.

(14) Behavior Management Program - Service Code 515. Behavior
Management Programs shall meet the requirements in Sections 56710
through 56756 of these regulations for the specific service being ven-
dored.

(15) Camping Services - Service Code 850. A regional center shall
classify a vendor as a provider of camping services if the vendor has staff
that possesses demonstrated competence to supervise safety of camp ac-
tivities and is:

(A) A day camp which:

1 . Provides a creative experience in outdoor living for a limited period
of hours per day and days per year; and

2. Contributes to the individuars mental, physical, and social growth
by using the resources of the natural surroundings;

(B) A residential camp which:

1 . Possesses a valid fire clearance issued by the California State Fire
Marshal, city t"ire department, or local fire district;

2. Complies with the requirements of Title 17, Sections 30700 through
30753;

3. Has a registered nurse on staff at all hours of operation; or

4. Has received a waiver issued by the appropriate agency if any of the
requirements specified in 1. through 3. above are not met; and

5. Provides:

a. A creative experience in outdoor living on a 24-hour per day basis
for a limited period of time;

b. Services which use the resources of the natural surroundings to con-
tribute to the individual's mental, physical, and social growth; and

c. Other consistent services; or

(C) A traveling camp which provides camping or vacation experiences
by traveling to various campgrounds or other tourist areas.

( 1 6) Child Day Care - Service Code 85 1 . A regional center shall clas-
sify a vendor as child day care if the vendor:

(A) Possesses a valid family day care license issued by DSS or by an
agency authorized by DSS to assume specified licensing responsibilities,
and provides nonmedical care and supervision to children under 18 years
of age on a less than 24-hour per day basis in the vendor's own home;
or

(B) Possesses a valid day care license for children issued by DSS or
by an agency authorized by DSS to assume specific licensing responsibi-
lities, and provides personal care, protection, supervision and assistance
to children under 1 8 years of age with special developmental needs in a
nonresidential facility; or

(C) Possesses a preschool license issued by the Department of Educa-
tion or a valid child care center license issued by DSS or an agency autho-
rized by DSS to assume specified licensing responsibiUties, and aids chil-
dren in developing pre-academic skills, group training, and social skills
in a nonresidential facility.

(17) Clinical Psychologist - Service Code 785. A regional center shall
classify a vendor as a clinical psychologist if the vendor:

(A) Is validly licensed as a clinical psychologist by the Psychology Ex-
amining Committee of the Medical Board of California; and

(B) Provides:

1. Diagnosis and psychotherapy of mental and emotional disorders; or

2. Individual and group testing and counseling in order to assist indi-
viduals achieve more effective personal, social, educational, and voca-
tional development and adjustment.

(18) Counseling Services - Service Code 625. The services included
within this service code shall be provided by the following persons:

(A) Family Counselor- A regional center shall classify a vendor as a
family counselor if the vendor possesses a valid Marriage and Family
Therapist license issued by the California Board of Behavioral Science
Examiners, and provides support and counseling to help the individual
maintain and maximize the use of his or her current functioning patterns;
and

(B) Social Worker- A regional center shall classify a vendor as a so-
cial worker if the vendor possesses a valid Clinical Social Worker's li-
cense issued by the California State Board of Behavioral Science Ex-
aminers, and provides the following services:

1. Social assessments;

2. Counseling; and

3. Other case work functions for the benefit of the individual.

( 1 9) Dance Therapist - Service Code 692. A regional center shall clas-
sify a vendor as a dance therapist if the vendor is validly registered as a
dance therapist by the American Dance Therapy Association, and pro-
vides the following services:

(A) Teaches the individual to use body movement and dance as the
process in therapeutic intervention directed toward gaining insight into
the consumer's problematic behavior, and expanding the consumer's
freedom of movement, flexibility, and coordination;

(B) Provides opportunities for the individual to express and communi-
cate feelings, needs, and conflicts; and

(20) Day Treatment Centers - Service Code 710. A regional center
shall classify a vendor as a day treatment center if the vendor provides
services to outpatients at an acute care hospital or acute psychiatric hospi-
tal.

(21) Dentistry - Service Code 715. A regional center shall classify a
vendor as a dentist if the vendor is validly licensed by the California
Board of Dental Examiners and practices the branch of medicine which
specializes in the diagnosis, prevention, and treatment of diseases of the
teeth and their associated stmctures.

(22) Developmental Specialist - Service Code 670. A regional center
shall classify a vendor as a developmental specialist if the vendor pos-
sesses valid certification by an accredited hospital as having successfully
completed a one-year developmental specialist training program, or if
the vendor possesses a Master's Degree in Developmental Therapy from
an accredited college or university.

(23) Diaper Service - Service Code 627. A regional center shall classi-
fy a vendor as a provider of diaper service if the vendor:

(A) SuppHes cloth diapers for the consumer; and

(B) Provides pick-up, laundering, and delivery of the diapers to the
consumer's home.

(24) Dietary Services - Service Code 720. A regional center shall clas-
sify a vendor as a provider of dietary services if the vendor is:

(A) A dietitian who is validly registered as a member of the American
Dietetic Association and who prescribes or modifies a person's diet to
meet the person's nutritional needs; or

(B) a nutritionist who evaluates an individual's nutritional needs and
meets one of the following requirements:

1. Possesses a Master's Degree in one of the following:

a. Food and Nutrition;

b. Dietetics; or

c. Public Health Nutrition; or

2. Is employed as a nutritionist by a county health department.

(25) Driver Trainer - Service Code 630. A regional center shall classi-
fy a vendor as a driver trainer if the vendor possesses the skills and train-
ing necessary to teach other individuals to drive automobiles and meets
the following requirements:

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(A) Possesses a current certification by the California Department of
Motor Vehicles as a driver instmctor; and

(B) Possesses a current and valid California driver's license.

(26) Durable Medical Equipment Dealer - Service Code 725. A re-
gional center shall classify a vendor as a durable medical equipment deal-
er if the vendor possesses a valid business license, and operates a busi-
ness which manufactures, individually tailors, or sells durable medical
equipment as defined in Title 22, California Code of Regulations, Sec-
tion 5 1 1 60.

(27) Educational Psychologist - Service Code 672. A regional center
shall classify a vendor as an educational psychologist if the vendor pos-
sesses a vaUd educational psychologist's license issued by the California
Board of Behavioral Science Examiners, and provides evaluation and
counseling to assist individuals in achieving more effective educational
development.

(28) Family Home Agency (FHA) - Service Code 904. A regional cen-
ter shall classify a vendor as a family home agency (FHA) if the agency:

(A) Recruits, approves, trains, and monitors family home and family
teaching home providers;

(B) Provides services and supports to family home and family teaching
home providers; and

(29) Genetic Counselor - Service Code 800. A regional center shall
classify a vendor as a genetic counselor if the vendor:

(A) Has successfully completed training in an accredited genetic
counseling program at the master or doctoral level;

(B) Is eligible for certification, or is certified by the National Board of
Human Genetics; and

(C) Advises and counsels persons and families concerning a genetic
and medical diagnosis and the probability that they carry and may trans-
mit genetically determined characteristics to their offspring.

(30) Hearing and Audiology Facilities - Service Code 730. A regional
center shall classify a vendor as a hearing or audiology facility if the ven-
dor is:

(A) A hearing facility which provides the following services:

1. Diagnosis of the individual's hearing loss; and

2. Treatment for individuals whose hearing loss does not require mul-
ti-disciplined diagnostic services; or

(B) An audiology facility which:

1 . Treats the individual whose hearing loss requires multi-disciplined
diagnostic services;

2. Provides a diagnosis of the individual's hearing loss;

3. Provides services intended to help the individual compensate for the
hearing loss;

4. Does not dispense hearing aids to the individual;

5. Employs at least one audiologist who is licensed by the Speech Pa-
thology and Audiology Examining Committee of the Medical Board of
California; and

6. Employs individuals, other than (B)5. above, who perform services,
all of whom shall be:

a. Licensed audiologists; or

b. Obtaining required professional experience, and whose required
professional experience application has been approved by the Speech Pa-
thology and Audiology Examining Committee of the Medical Board of
California.

(3 1 ) Home Health Agency - Service Code 854. A regional center shall
classify a vendor as a home health agency if the vendor possesses a valid
home health agency license issued by DHS, or meets the requirements
established by DHS for providing home health services, and is primarily
engaged in providing skilled nursing services and at least one of the fol-
lowing:

(A) Physical therapy;

(B) Occupational therapy;

(D) Medical social work; or

(E) Home health aide services.

(32) Home Health Aide - Service Code 856. A regional center shall
classify a vendor as a home health aide if the vendor possesses a valid
home health aide license issued by DHS or meets the requirements estab-
lished by DHS for providing home health services, and who:

(A) Provides services to the individual in order to maintain a safe and
healthful home environment;

(B) Performs personal services directed toward adequate nutrition and
personal cleanliness;

(D) Other services consistent with the duties specified in (a)(31)(A)
through (C) above.

(33) Homemaker - Service Code 858. A regional center shall classify
a vendor as a homemaker if the vendor maintains, strengthens, or safe-
guards the care of individuals in their homes.

(34) Homemaker Service - Service Code 860. A regional center shall
classify a vendor as a homemaker service if the vendor employs, trains,
and assigns personnel who maintain, strengthen, or safeguard the care of
individuals in their homes.

(35) Independent Living Program - Service Code 520. Independent
Living Programs shall meet the requirements in Sections 56710 through
56756 of these regulations for the specific service being vendored.

(36) Independent Living Specialist - Service Code 635. A regional
center shall classify a vendor as an independent living specialist if the
vendor possesses the skill, training, or education necessary to teach con-
sumers to live independently and/or provide the supports necessary for
the consumer to maintain a self-sustaining, independent-living situation
in the community.

(37) Infant Development Program - Service Code 805. Infant devel-
opment programs shall meet the appropriate requirements in Sections
56710 through 56734 and 56760 through 56774 of these regulations.

(38) Infant Development Specialist - Service Code 810. A regional
center shall classify a vendor as an infant development specialist if the
vendor has at least one year of experience working with parents and chil-
dren with disabihties and possesses either of the following:

(A) A valid license or certification in one of the following disciplines:

1 . Occupational therapy;

2. Physical therapy;

3. Special education;

4. Psychology;

5. Nursing; or

6. Speech and language therapy; or

(B) A Masters degree in child development/early childhood education
which includes a minimum of 1 5 units of formal instruction in at least one
of the following areas:

1 . Typical and atypical infant development;

2. Infant assessment;

3. Infant intervention techniques; or

4. Family involvement in infant treatment.

(39) In-home Respite Services Agency - Service Code 862. A region-
al center shall classify a vendor as an in-home respite services agency if
the vendor meets the appropriate requirements in Sections 56780 through
56802 of these regulations. Separate vendorization may be waived at the
vendor's request for existing in-home respite services agency vendors
requesting to provide new in-home respite services at an additional busi-
ness address.

(40) In-home Respite Worker - Service Code 864. A regional center
shall classify a vendor as a provider of in-home respite worker services
if the vendor is an individual who:

(A) Has received Cardiopulmonary Resuscitation (CPR) and First Aid
training from agencies offering such training, including, but not limited
to, the American Red Cross;

(B) Has the skill, training, or education necessary to perform the re-
quired services; and

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(41) Intermediale Care Facility/Developmentally Disabled (ICF/DD)
- Service Code 925. A regional center shall classify a vendor as an inter-
mediate care facility/developmentally disabled if the vendor possesses a
valid ICF/DD health facility license issued by the Department of Health
Services.

(42) Intermediate Care Facility/Developmentally Disabled-Habilita-
tive (ICF/DD-H) - Service Code 930. A regional center shall classify a
vendor as an intermediate care facility/developmentally disabled-habili-
lative if the vendor possesses a valid ICF/DD-H health facility license
issued by the Department of Health Services.

(43) Intermediate Care Facility/Developmentally Disabled-Nursing
(ICF/DD-N) - Service Code 935. A regional center shall classify a ven-
dor as an intermediate care facility/developmentally disabled-nursing if
the vendor possesses a valid ICF/DD-N health facility license issued by
the Department of Health Services.

(44) Interpreter - Service Code 642. A regional center shall classify
a vendor as an interpreter if the vendor demonstrates:

(A) Fluency in both English and in sign language; and

(B) Proficiency in facilitating communication between hearing-imp-
aired and hearing persons using American sign language and spoken lan-
guage.

(45) Laboratory and Radiologic Services - Service Code 735. The fol-
lowing types of services are included within this service code:

(A) A regional center shall classify a vendor as a clinical laboratory if
the vendor:

1. Is validly licensed by DHS as a clinical laboratory, and examines
and tests specimens.

(B) A regional center shall classify a vendor as a provider of radiolog-
ical services if the vendor:

1 . Possesses a valid license as a technologist or radiologist issued by
DHS;

2. Uses x-ray equipment which is validly registered with DHS; and

3. Provides services which involve the use of x-rays or radioactive
materials for medical, diagnostic, or treatment procedures.

(46) Licensed Vocational Nurse - Service Code 742. A regional center
shall classify a vendor as a licensed vocational nurse if the vendor:

(A) Is validly licensed as a licensed vocational nurse by the California
State Board of Vocational Nurse and Psychiatric Technician Examiners;
or

(B) Is a nurse registry from whom the services of a licensed vocational
nurse are obtained; and

(47) Mobility Training Services Agency - Service Code 645. A re-
gional center shall classify a vendor as a provider of mobility training ser-
vices if the vendor is an agency which employs staff who possess the
skill, training, or education necessary to teach individuals how to use
public transportation or other modes of transportation which will enable
them to move about the community independently.

(48) Mobility Training Services Specialist - Service Code 650. A re-
gional center shall classify an individual as a vendor of mobility training
services if the vendor possesses the skill, training, or education necessary
to teach individuals how to use public transportation or other modes of
transportation which will enable them to move about the community in-
dependently.

(49) Music Therapist - Service Code 693. A regional center shall clas-
sify a vendor as a music therapist if the vendor possesses a valid registra-
tion issued by the National Association for Music Therapy, and uses mu-
sic media and activities to effect change or growth in the individual's:

(A) Self-awareness;

(B) Gross motor development;

(D) Eye-hand coordination and visual tracking;

(E) Visual, auditory, and tactile awareness and perception;

(F) Language development and communication skills;

(G) Emotional expression;

(H) Self-esteem and body image;

(I) Socialization and community awareness; and

(J) Sterotypical behaviors.

(50) Nurse Anesthetist - Service Code 741. A regional center shall
classify a vendor as a nurse anesthetist if the vendor:

(A) Is a nurse anesthetist who is validly licensed by the California State
Board of Registered Nurses and certified by the American Association
of Nurse Anesthetists; or

(B) Is a nurse registry from whom the services of a nurse anesthetist
are obtained.

(5 1 ) Nurse's Aide or Assistant - Service Code 743. A regional center
shall classify a vendor as a nurse's aide or assistant if the vendor:

(A) Is certified as a nurse's aide or a home health aide by DHS; or

(B) Is a nurse registry from whom the services of a nurse's aide or as-
sistant are obtained; and

(52) Nursing Facility - Service Code 940. A regional center shall clas-
sify a vendor as a nursing facility if the vendor possesses a valid nursing
facility license issued by the Department of Health Services.

(53) Occupational Therapy - Service Code 773. A regional center
shall classify a vendor as a provider of occupational therapy if the vendor
is:

(A) An occupational therapist validly licensed by the California Board
of Occupational Therapy and who, based on the written prescription of
a physician, dentist or podiatrist, provides occupational therapy evalua-
tion, treatment planning, treatment, instruction and consultative ser-
vices; or

(B) An occupational therapist assistant validly certified by the Califor-
nia Board of Occupational Therapy and who provides occupational ther-
apy evaluation, treatment planning, treatment, instruction and consulta-
tive services while under the direct supervision of a registered
occupational therapist.

(54) Orthoptic Services - Service Code 745. A regional center shall
classify a vendor as a provider of orthoptic services if the vendor is:

(A) An orthoptic technician who is validly certified by the American
Orthoptic Council and provides the following services:

1. Treats an individual's defective visual habits.

2. Treats defects of binocular vision and muscle imbalance by exercise
and visual training, and re-educating the individual's visual habits.

(B) An optometrist who is validly licensed as an optometrist by the
California State Board of Optometry and provides the following ser-
vices:

1. Examines the eye for defects and faults of refraction; and

2. Prescribes correctional lenses or exercises.

(55) Orthotic and Prosthetic Services - Service Code 750. A regional
center shall classify a vendor as a provider of orthotic and prosthetic ser-
vices if the vendor is:

(A) An orthotist who makes or fits orthopedic braces and who is either:

1. Validly certified by any of the following:

a. American Board for Certification in Orthotics and Prosthetics;

b. Academy of Orthotics and Prosthetics;

c. American Orthotics and Prosthetics Association;

d. California Children's Services Association; or

e. Veteran's Administration; or

2. A member of the California Orthotic and Prosthetic Association
which employs only those orthotists who are eligible for certification.

(B) A prosthetist who makes or fits artificial limbs or other parts of the
body, and who is either:

1 . Validly certified by any of the following:

a. American Board for Certification in Orthotics and Prosthetics;

b. Academy of Orthotics and Prosthetics;

c. California Children's Services Association; or

d. Veteran's Administration; or

2. A member of the California Orthotic and Prosthetic Association
which employs only those prosthetists who are eligible for certification.

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(C) An individual who is validly licensed as a pharmacist by the Cali-
fornia State Board of Pharmacy and who fits orthotic or prosthetic de-
vices.

(56) Other Medical Equipment or Supplies - Service Code 755. A re-
gional center shall classify a vendor as a provider of other medical equip-
ment or supplies if the vendor is:

(A) A dispensing optician who is validly registered as a dispensing op-
tician by the Division of Allied Health Professions of the Medical Board
of California, and who:

1. Fills prescriptions of physicians or optometrists for prescription
lenses and related products;

2. Fits and adjusts such lenses and spectacle frames; and

3. Fits contact lenses under the advice, direction, and responsibility of
a physician or optometrist;

(B) A hearing aid dispenser who is validly licensed as a hearing aid dis-
penser by the Hearing Aid Dispensers' Examining Committee of the
Medical Board of California, and who:

1. Performs audiometric pure tone and speech testing;

2. Tests hearing in order to fit, dispense, or repair hearing aids; and

3. Is not vendored separately as an audiology center or individually as
an audiologist; or

(C) A prosthetic and orthotic appliance factory which fits and sells
orthotic and prosthetic appliances necessary for the restoration of func-
tion or replacement of body parts.

(57) Other Medical Services - Service Code 760. A regional center
shall classify a vendor as a provider of other medical services if the ven-
dor provides any medical services not included otherwise in this section,
and services provided by clinics or other medical facilities which are not
included in another service code.

(58) Out-of-home Respite Services - Service Code 868. A regional
center shall classify a vendor as a provider of out-of-home respite ser-
vices if the vendor:

(A) Is licensed by DSS or by an agency authorized by DSS or is li-
censed by DHS to provide out-of-home care to persons with develop-
mental disabilities; and

(B) Is vendored by the regional center and provides services under the
following service codes:

1 . Service Code 855 - Adult Day Care; or

2. Service Code 851 - Child Day Care; or

3. Service Code 905 or 915 - Residential Facility Serving Adults; or

4. Service Code 910 or 920 - Residential Facility Serving Children;
or

5. Service Code 930 - Intermediate Care Facility /Developmentally
Disabled - Habilitative (ICF/DD-H); or

6. Service Code 935 - Intermediate Care Facility/Developmentally
Disabled - Nursing (ICF/DD-N).

(C) Has staff who have received Cardiopulmonary Resuscitation
(CPR) and First Aid training from agencies offering such training, in-
cluding, but not limited to, the American Red Cross;

(D) Has the training, education, and skill to perform the required ser-
vices; and

(E) Provides out-of-home respite services which consist of intermit-
tent or regularly scheduled temporary care to individuals in a licensed fa-
cility and which:

1 . Are designed to relieve families of the constant responsibility of car-
ing for a member of that family who is a consumer;

2. Meet planned or emergency needs;

3. Are used to allow parents or the individual the opportunity for vaca-
tions and other necessities or activities of family life; and

4. Are provided to individuals away from their residence.

(59) Out-of-state Manufacturer or Distributor - Service Code 655. A
regional center shall classify a vendor as an out-of-state manufacturer
or distributor of merchandise if the vendor provides a specific item that
is not available in California, or it is more economical to purchase the
item outside of California.

(60) Pharmaceutical Services - Service Code 765. A regional center
shall classify a vendor as a provider of pharmaceutical services if the ven-
dor is:

(A) A person who is validly licensed as a pharmacist by the California
State Board of Pharmacy, and who identifies, prepares, or preserves com-
pounds and dispenses drugs; or

(B) A pharmacy which is validly licensed as a pharmacy by the Cali-
fornia State Board of Pharmacy, and which is a facility where medicines
are compounded or dispensed.

(61) Physical Therapy - Service Code 772. A regional center shall
classify a vendor as a provider of physical therapy services if the vendor
is:

(A) A physical therapist who is validly licensed by the Physical Thera-
py Examining Committee of the Medical Board of Cahfomia and who,
under medical supervision, treats individuals to relieve pain, develop or
restore motor function, and maintain performance by using a variety of
physical means; or

(B) A physical therapist assistant who is registered as a physical thera-
pist assistant by the Physical Therapy Examining Committee of the Med-
ical Board of California and who provides physical therapy while under
the direct supervision of the licensed physical therapist.

(62) Physicians or Surgeons - Service Code 775. A regional center
shall classify a vendor as a physician or surgeon if the vendor provides
professional services to individuals and is validly licensed by the Medi-
cal Board of California as a physician or surgeon.

(63) Psychiatric Technician - Service Code 790. A regional center
shall classify a vendor as a psychiatric technician if the vendor:

(A) Under medical direction, provides psychotherapeutical services;
and

(B) Possesses a vahd psychiatric technician's license issued by the
California State Board of Vocational Nurse and Psychiatric Technician
Examiners.

(64) Psychiatrist - Service Code 780. A regional center shall classify
a vendor as a psychiatrist if the vendor:

(A) Is validly licensed as a physician and surgeon by the Medical
Board of California;

(B) Is validly certified by the American Board of Psychiatry and Neu-
rology; and

(65) Recreational Therapist - Service Code 694. A regional center
shall classify a vendor as a recreational therapist if the vendor possesses
a valid registration issued by either the National Council for Therapeutic
Recreation Certification or the California Board of Recreation and Park
Certification and provides the following services:

(A) Uses self-modvafing recreational activities to develop the indi-
vidual's motor skills, social skills, sensory functioning, or acceptable be-
havior;

(B) Counsels the individual in recreation and leisure pursuits; and

(66) Registered Nurse - Service Code 744. A regional center shall
classify a vendor as a registered nurse if the vendor:

(A) Is an individual who is validly licensed as a registered nurse by the
California State Board of Registered Nurses; or

(B) Is a nurse registry from whom the services of a registered nurse are
obtained.

(67) Residential FaciUty Serving Adults - Owner Operated - Service
Code 905. A regional center shall classify a vendor as an owner-operated
residential facility serving adults if:

(A) The facility serves adults;

(B) The vendor possesses a valid community care facility license as
required by Health and Safety Code, Sections 1500 through 1569.87; and

(C) The facility is the residence of the licensee or a member of the cor-
porate board (board of directors). The licensee may perform all of the ac-

•

Page 282.14

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54342

tivities necessary to operate the facility, or he/she may employ staff,
which may include members of his/her family, to assist.

(68) Residential Facility Serving Children - Owner Operated - Ser-
vice Code 9 1 0. A regional center shall classify a vendor as an owner-op-
erated residential facility serving children if:

(A) The facility serves children;

(B) The vendor possesses a valid community care facility license as
required by Health and Safety Code, Sections 1500 through 1569.87; and

(C) The facility is the residence of the licensee or a member of the cor-
porate board (board of directors). The licensee may perform all of the ac-
tivities necessary to operate the facility, or he/she may employ staff
which may include members of his/her family, to assist.

(69) Residential Facility Serving Adults - Staff Operated - Service
Code 915. A regional center shall classify a vendor as a staff-operated
residential facility serving adults if:

(A) The facility serves adults;

(B) The vendor possesses a valid community care facility license as
required by Health and Safety Code, Sections 1 500 through 1 569.87; and

(C) The facility is not the residence of the licensee or a member of the
corporate board (board of directors) and the licensee employs personnel
to provide direct care and training to individuals.

(70) Residential Facility Serving Children - Staff Operated - Service
Code 920. A regional center shall classify a vendor as a staff-operated
residential faciUty serving children if:

(A) The facility serves children;

(B) The vendor possesses a valid community care facility license as
required in the Health and Safety Code, Section 1500 through 1569.87;
and

(C) The facihty is not the residence of the licensee or a member of the
corporate board (board of directors) and the licensee employs personnel
to provide direct care and training to individuals.

(71) Respiratory Therapist- Service Code 793. A regional center shall
classify a vendor as a respiratory therapist if the vendor:

(A) Provides respiratory therapy services; and

(B) Possesses a valid respiratory care practitioner certificate issued by
the Respiratory Care Board of California of the Department of Consumer
Affairs.

(72) Respite FaciUty - Service Code 869. A regional center shall clas-
sify a vendor as a respite facility if the vendor:

(A) Is licensed as a residential facility by DSS or by an agency autho-
rized by DSS;

(B) Provides only out-of-home respite services in accordance with
(a)(58)(E)l. through 4. above.

(D) Is not vendored by the regional center to provide services under
the following service codes:

1. Service Code 905 or 915 - Residential Facility Serving Adults; or

2. Service Code 910 or 920 - Residential Facility Serving Children.

(73) RetailAVholesale Stores - Service Code 660. A regional center
shall classify a vendor as a retail/wholesale store if the facility provides
goods for purchase and possesses a valid business license to operate that
facility.

(74) Social Recreation Program - Service Code 525. Social Recre-
ation Programs shall meet the requirements in Sections 56710 through
56756 of these regulations for the specific service being vendored.

(75) Speech Pathology - Service Code 707. A regional center shall
classify a vendor as a provider of speech pathology services if the vendor
is:

(A) A speech pathologist who is validly licensed as a speech patholo-
gist by the Speech Pathology and Audiology Examining Committee of
the Medical Board of California; and provides:

1 . Diagnostic screening; and

2. Preventative and corrective therapy for persons with speech or lan-
guage disorders.

(76) Teacher - Service Code 674. A regional center shall classify a
vendor as a teacher if the vendor possesses a valid California teaching

credential issued by the Cahfomia Commission on Teacher Credential-
ing or an instruction credential such as a "Life Diploma" or "California
Community Colleges Certificate" issued by the California Commission
on Teacher Credentialing. A teacher provides the following services:

(A) Conducts lessons;

(B) Prepares instructional materials;

(D) Provides other services consistent with the duties specified in (A)
through (C) above.

(77) Teacher' s Aide - Service Code 676. A regional center shall classi-
fy a vendor as a teacher's aide if the vendor works under the supervision
of a teacher and possesses the training, education, and/or skill to perform
the services specified in (a)(76)(A) through (D) above.

(78) Teacher of Special Education - Service Code 678. A regional cen-
ter shall classify a vendor as a teacher of special education if the vendor
possesses a valid California teaching credential in Special Education is-
sued by the California Commission on Teacher Credentialing and pro-
vides the services specified in (a)(76)(A) through (D) above.

(79) Translator - Service Code 643. A regional center shall classify a
vendor as a translator if the vendor demonstrates:

(A) Fluency in both English and a language other than English; and

(B) The ability to read and write accurately in both English and a lan-
guage other than English.

(80) Transportation - Additional Component - Service Code 880. A
regional center shall classify a vendor as a provider of transportation ser-
vices - additional component if the vendor:

(A) Is vendored separately from the primary service. The vendoring
regional center may waive separate vendorization as a transportation ser-
vices-additional component if the vendor is a community-based day
program vendor, who conducts its curriculum solely in natural environ-
ments, and the regional center determines that it would be more cost ef-
fective to include the cost of transportating consumers, which occurs be-
tween the first and last training site as specified in Section
57434(a)(3)(N). The cost of transporting consumers shall be considered
more cost effective if the cost of including the transportation service in
determining the rate of reimbursement for the community-based day
program is less than the cost of providing the transportation service pur-
suant to separate vendorization as a provider of transportation services
- additional component;

(B) Provides services by employees of the primary service agency; and

(C) Provides the regional center with proof of adequate insurance as
designated by the vendoring regional center in accordance with the Wel-
fare and Institutions Code, Section 4648.3.

(8 1 ) Transportation Assistant - Service Code 882. A regional center
shall classify a vendor as a provider of transportation assistant services
if the vendor:

(A) Is vendored separately from the transportation service vendor;

(B) Assists and monitors regional center consumers while the consum-
ers are being transported; and

(82) Transportation Auto Driver - Service Code 890. A regional cen-
ter shall classify a vendor as transportation auto driver if the vendor pro-
vides the transportation to authorized services identified in the consum-
er's IPP and the vendor:

(A) Is an individual who is actually providing the transportation ser-
vice;

(B) Possesses a valid California driver's license; and

(83) Transportation Broker - Service Code 883. A regional center
shall classify a vendor as a transportation broker if the vendor:

(A) Is not the transportation service provider; and

(B) Develops routing and time schedules for the transport of consum-
ers to and from their day program;

Page 282.15

§ 54344

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

1. Conduct monitoring and quality assurance activities; and/or

2. Perform safety reviews; and/or

3. Assist the regional center in implementing contracted transportation
services.

(84) Transportation Companies - Service Code 875. A regional center
shall classify a vendor as a transportation company if the vendor pos-
sesses a current business license as a transportation company and:

(A) Provides the regional center with proof of adequate insurance as
designated by the vendoring regional center in accordance with the Wel-
fare and Institutions Code, Section 4648.3; and

(B) Will be employed to transport individuals to and from their com-
munity-based day programs or other vendored services for the regional
center.

(85) Transportation - Medical - Service Code 885. A regional center
shall classify a vendor as a provider of medical transportation if the ven-
dor:

(A) Provides medical transportation services; and

(B) Meets the standards specified in Title 22, California Code of Regu-
lations, Sections 5 1 23 1 , 5 1 23 1 . 1 or 5 1 23 1 .2, for Litter Vans, Wheelchair
Vans, or Medical Transportation Services.

(86) Transportation - Public Transit Authority, Dial-A-Ride, Rental
Car Agency or Taxi - Service Code 895. A regional center shall classify
a vendor as a public transit authority, dial-a-ride rental car agency or taxi
provider if the vendor is licensed to perform such services, and if the rate
charged in the use of these services to consumers is the same as that
charged to the general public for the same service.

(87) Tutor - Service Code 680. A regional center shall classify a ven-
dor as a tutor if the vendor possesses the training, educadon, and/or skill
necessary to provide the in-home individualized instmcdon to the indi-
vidual which is supplementary to, or independent of, instruction pro-
vided by the classroom teacher.

NOTE; Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code;
and Section 1 1152, Government Code. Reference: Sections 4631, 4648(a) and
4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section, including incorporation
and amendment of former section 54344, filed 1-17-97 pursuant to section 100,
title 1, California Code of Regulations (Register 97, No. 3).

6. Amendment of subsection (a)(37), (a)(52)(B)2., (a)(54)(A)l., (a)(54)(B),
(a)(58)(A),(a)(72).(a)(75)and(a)(81)(B),newsubsections(a)(81)(C)l.-3.and
amendment of (a)(83)(B) filed 4-25-2000; operative 5-25-2000 (Register
2000, No. 17).

7. New subsection (a)(10) and subsection renumbering filed 5-3-2001 ; operative
6-2-2001 (Register 2001, No. 18).

8. Change without regulatory effect amending subsections (a)(52)(A)-(B) filed
6-12-2003 pursuant to section 100, title 1, California Code of Regulations
(Register 2003, No. 24).

9. New subsection (a)(8), subsecfion renumbering, amendment of newly desig-
nated subsections (a)(12) and (a)(13)(A), new subsection (a)(13)(A)l. and
amendment of newly designated subsections (a)(I3)2.-4., (a)(18)(A),
(a)(32)(D), (a)(72)(B)-(C), (a)(76) and (a)(77) filed 4-29-2004; operafive
5-29-2004 (Register 2004, No. 18).

10. Amendment of subsecfions (a)(28)(A)-(C) filed 11-7-2006; operafive
12-7-2006 (Register 2006, No. 45).

11. Repealer and new subsection (a)(13)(A)l., new subsection (a)(I3)(A)2., sub-
section renumbering and new subsection (a)(13)(A)7. filed 6-27-2007; opera-
five 7-27-2007 (Register 2007, No. 26).

§ 54344. Other Services: Nonmedical Services.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Secfion 147; Secfions 4405,
4648(a) and 479 l(i). Welfare and Institutions Code; and Section 1 1 152, Govern-

ment Code. Reference: Sections 463 1 , 4648(a) and 479 1 , Welfare and Institutions
Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order including editorial conection to
subsection (n)(4) transmitted to OAL 9-28-90 and filed 1 0-29-90 (Register 90,
No. 46).

3. Amendment of subsection (g) and NOTH filed 11-5-91 as an emergency; opera-
tive 1 1-5-91 (Register 92, No. 21). A Certificate of Coinpliance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (g) and NoTiirefiled 3-4-92 as an emergency; opera-
tive 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Editorial correction of History 3 (Register 92, No. 25).

6. Certificate of Compliance as to 3^-92 order including amendment of subsec-
tion (e)( 1 ) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33 ).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of section and Note filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992. Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96
and filed 3-29-96 (Register 96, No. 13).

1 1 . Change without regulatory effect incorporating former section 54344 into sec-
tion 54342, including amendments, and repealing former section 54344, filed
1-1 7-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

§ 54346. Other Services: IVIedical Services.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405,
4648(a) and 479I(i), Welfare and Institutions Code; and Section 1 1 152, Govern-
ment Code. Reference: Sections 463 1 , 4648(a) and 479 1 , Welfare and Institutions
Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (h)-(h)(2) and subsection relettering and amendment of Note
filed 11-5-91 as an emergency; operative 11-5-91 (Register 92, No. 21). A
Certificate of Compliance must be tiansmitted to OAL 3-4-92 or emergency
language will be repealed by operation of law on the following day.

4. New subsections (h)-(h)(2) and subsection relettering and amendment of Note
refiled 3^1—92 as an emergency; operative 3-4-92 (Register 92, No. 25). A
Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency
language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3^-92 order including repealer of subsection
(h)(1)(B) and subsection relettering, adoption of new subsections (h)(2) and (n)
and subsection renumberine and amendments transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of section and Note filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94. No. 25).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Certificate of Compliance as to 6-20-94 order, including amendment of subsec-
tion (s)(2), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No.
13).

10. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title I. CaHfornia Code of Regulations (Register 97, No. 3).

§ 54348. Prevention Services/Infant Development
Services.

NOTE: Authority cited: Sections 4405 and 4648 (a). Welfare and Instimtions Code

and Section 11152, Government Code. Reference: Sections 4631, 4648 (a) and

4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

Page 282.16

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54349

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of .section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

.'S. Change without regulatory effect repealing section filed 1-17-97 pursuant to
•section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 54349. Supported Living Service.

The following service codes are included within "Supported Living
Service," and shall be accessed only by providers who are vendored as
Supported Living Service vendors, pursuant to Title 17, Section 58612.

(a) Personal Support Service — Service Code: 891. A regional center
shall classify a vendor as a provider of Personal Support Service for any
services the vendor provides prior to July 1, 2000, pursuant to Title 17,
Section 58614(b) to meet the consumer's need for assistance with com-
mon daily living and routine household activities, accessing medical ser-
vices, and animal companions. Personal Support Service must be tailored
to meet those specific needs of an individual consumer which can not be
met by the unassisted consumer because of the nature or severity of the

consumer's physical or developmental challenges. Personal Support
Service differs from Training and Habilitation Service as defined in (h).
in that the immediate result of the service (e.g., successful preparation of
a meal) is the primary objective of the service, while any training or habil-
itation that may result is an incidental and unanticipated consequence.
Beginning July 1, 2000, all services previously provided under Service
Code 891 shall be provided only in accordance with (d).

(b) Training and Habilitation Service — Service Code: 892. A region-
al center shall classify a vendor as a provider of Training and Habilitation
Service for any services the vendor provides prior to July 1, 2()()(), pur-
suant to Title 17, Section 58614(b) to meet the training and habilitation
needs of the consumer. Training and Habilitation Service must be tai-
lored to the specific training and habilitation needs and capacities of an
individual consumer, and is intended to result in an increased ability on
the part of the consumer to establish and maintain constructive human
relationships, assume and exercise membership in the community, and
meet his/her needs without assistance. Training and Habilitation Service
is accessed only in accordance with the determination made through the
consumer's IPP process of its appropriateness in consideration of the
consumer's cognitive or physical challenges, and only when any corre-

•

[The next page is 282.17.]

Page 282.16(a)

•

Title 17

Health and Welfare Agency — Department of Developmental Services

5} 54351

•

sponding Personal Support Service alternative, as defined in (a), is deter-
mined to be less appropriate in consideration of tlie consumer's cognitive
or physical challenges. Training and Habilitation differs from any corre-
sponding Personal Support Service in that the immediate result of the ser-
vice (e.g., successful preparation of a meal) is always consequential to,
but never the primary objective of, the training. Beginning July 1 , 2000,
all services previously provided under Service Code 892 shall be pro-
vided only in accordance with (d).

(c) 24-Hour Emergency Assistance — Service Code: 893. A regional
center shall classify a vendor as a provider of 24-Hour Emergency Assis-
tance Service for any services the vendor provides prior to July 1 , 2000,
pursuant to Title 17, Section 58614(b)(16). Beginning July 1, 2000, all
services previously provided under Service Code 893 shall be provided
only in accordance with (d).

(d) Supported Living Service — Service Code: 896. Beginning July
1 , 2000, a regional center shall classify a vendor as a provider of Sup-
ported Living Service if the vendor provides services enumerated in Title
17, Section 58614.

(e) Supported Living Service Vendor Administration — Service
Code: 894. A regional center shall classify a vendor as a provider of Sup-
ported Living Service Vendor Administration if the vendor:

( 1 ) Pursuant to Title 17, Section 58660(b)(2), is paid for any direct ser-
vices referenced in (a); and

(2) Provides administrative services as specified in Section 58614(c),
in support of the delivery of direct services.

(f) Vendors shall bill for services included in (a) through (d) under the
following subcodes:

( 1 ) Subcode "HA" when billing at an hourly rate negotiated pursuant
to Title 17, Section 58660(b)(1);

(2) Subcode "MA" when billing at a monthly rate negotiated pursuant
to Title 17, Section 58660(b)(1);

(3) Subcode "OA" when billing at other than an hourly or monthly rate
negotiated pursuant to Title 17, Section 58660(b)(1);

(4) Subcode "H" when billing at an hourly rate negotiated pursuant to
Title 17, Section 58660(b)(2);

(5) Subcode "M" when billing at a monthly rate negotiated pursuant
to Title 17, Section 58660(b)(2);

(6) Subcode "O" when billing at other than an hourly or monthly rate
negotiated pursuant to Title 17, Section 58660(b)(2).

(g) A regional center shall authorize a SLS vendor to provide a service
only if such service:

(1) Is cost-effective; and

(2) Can not feasibly be provided without cost, or at a lesser cost,
through generic or natural supports available in the community.

NOTE: Authority cited: Section 11152, Government Code; and Sections 4648,
4689, 4689.7(c) and 4690, Welfare and Institutions Code. Reference: Section
4640.7(b), 4648(a)(2), 4689(c) and 4689.7(c), Welfare and Institutions Code.

History

1. New section filed 8-14-95 as an emergency; operative 8-14-95 (Register 95,
No. 33). A Certificate of Compliance must be transmitted to OAL by 12-12-95
or emergency language will be repealed by operation of law on the following
day.

2. New secfion refiled 12-4-95 as an emergency; operative 12-12-95 (Register
95, No. 49). A Certificate of Compliance must be transmitted to OAL by
4-10-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. New section refiled 4-8-96 as an emergency; operative 4-10-96 (Register 96,
No. 15). A Certificate of Compliance must be transmitted to OAL by 8-6-96
or emergency language will be repealed by operation of law on the following
day.

4. Certificate of Compliance as to 8-14-95 order, including further amendment of
subsecfions (b), (d)(2), (e)(3), (e)(5)-(6) and Note, transmitted to OAL 8-8-96
and filed 9-20-96 (Register 96, No. 38).

5. Amendment of section and Note filed 4-18-2000; operafive 5-18-2000 (Reg-
ister 2000, No. 16).

§ 54350. Supportive Services.

Note: Authority cited: Chapter 722, Statutes of 1992, SecUon 147; and Sections
4405, 4648(a) and 479 l(i). Welfare and Institutions Code. Reference: Sections
4631, 4648(a) and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0 29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of sub,section (b)(2), new subsection (b)(4), amendment of subsec-
tions (g) and (i) and Notk filed 1 1-5-91 as an emergency; operative 1 1-5-91
(Register 92. No. 21). A Certificate of Compliance must be transmitted to OAL
3-4-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

4. Amendment of subsecUon (b)(2), new subsection (b)(4), amendment of subsec-
tions (g) and (i) and Note refiled 3^-92 as an emergency; operative 3-4-92
(Register 92, No. 25). A Certificate of Compliance must be transmitted lo OAL
7-2-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

5. Certificate of Compliance as to 3-4-92 order including adoption of subsection
(c) and subsection renumberina and amendments transmitted to OAL 6-25-92
and filed 8-6-92 (Register 92.''No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93. No. 26).

7. Amendment of subsecfions (i)(l), (i)(l)(C) and (k)(3) filed 4-22-94: operative
4-22-94. Submitted to OAL for printing only (Register 94, No. 16).

8. Amendment filed 6-20-94 as an emergency; operative 6-20-94. Submitted to
OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147
(Register 94. No. 25).

9. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96
and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 54351 . Habilitation Services.

The following service codes are included within "Habilitation Ser-
vices":

(a) Supported Employment Program — Group Services — Service
Code 950. A regional center shall classify a vendor as a provider of Sup-
ported Employment — Group Services if the vendor meets all the re-
quirements of the vendorization process, including proof of certification
of nonprofit status and provides supported employment services with a
single job coach to a group of individuals engaged in paid work that is
integrated in the community.

(b) Supported Employment Programi — Individual Services — Ser-
vice Code 952. A regional center shall classify a vendor as a provider of
Supported Employment — Individual Services if the vendor meets all the
requirements of the vendorization process, including proof of certifica-
tion of nonprofit status and provides supported employment services in-
cluding job coaching services to a single individual with developmental
disabilities engaged in paid work in an community setting.

(c) Work Activity Program — Service Code 954. A regional center
shall classify a vendor as a provider of Work Activity Program services
if the vendor provides support to consumers engaged in paid work in a
work activity center or similar setting.

NOTE: Authority cited: Secfion 11152, Government Code; and Section 4866,
Welfare and Insfitufions Code. Reference: Sections 4857 and 4860, Welfare and
Institutions Code.

History

1 . New section filed 7-22-2004 as an emergency; operative 7-22-2004 (Register
2004, No. 30). A Certificate of Compliance must be transmitted to OAL by
] 1-19-2004 or emergency language will be repealed by operation of law on the
following day.

2. Repealed by operation of Government Code section 1 1 346. 1 (g) (Register 2004,
No. 49).

3. New section refiled 1 1-29-2004 as an emergency; operative 1 1-29-2004 (Reg-
ister 2004, No. 49). A Certificate of Compliance must be transmitted to OAL
by 3-29-2005 or emergency language will be repealed by operation of law on
the following day.

4. New section refiled 3-30-2005 as an emergency; operative 3-30-2005 (Regis-
ter 2005, No. 13). A Certificate of Compliance must be transmitted to OAL by
7-28-2005 or emergency language will be repealed by operation of law on the
following day.

5. Certificate of Compliance as to 3-30-2005 order, including amendment of sub-
section (b), transmitted to OAL 6-21-2005 and filed 8-1-2005; amendments
operative 8-31-2005 (Register 2005, No. 31).

Page 282.17

§ 54352

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 54352. Transportation Services.

NOTK: Authority cited: Chapter 722, Statutes of 1992. Section 147; Sections 4405,
4648(a) and 4791(i), Welfare and Institutions Code; and Section 1 1 152, Govern-
ment Code. Reference: Sections 4631, 4648(a), 4690.1 and 4791, Welfare and In-
stitutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsection (c), amendment of former subsection (e) (now subsection (f))
and subsection renumberins filed 9-26-91 pursuant to Government Code sec-
tion 1 1346.2(d) (Register 92, No. 10).

4. Amendment of subsections (b)(1) and (e) and NoTi; filed 11-5-91 as an emer-
gency; operative 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance
must be transmitted to OAL 3-4-92 or emergency language will be repealed by
operation of law on the following day.

5. Amendment of subsections (b)( 1 ) and (e) and NoTt- refiled 3-4-92 as an emer-
gency; operative 3^-92 (Register 92, No. 25). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

6. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (b)( 1 ) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

7. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

8. Amendment of section and NoTii filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96
and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, fitle 1, California Code of Regulations (Register 97, No. 3).

§ 54354. Service Codes for Residential, Intermediate Care
and Nursing Facility Services.

NOTE: Authority cited: Sections 4405, 4648 (a) and 4689.1, Welfare and Insdtu-
tions Code; and Section 11152, Government Code; Chapter 1095, Statutes of
1994, Section 14. Reference: Sections 1500 throuah 1569.87 and 1250 through
1338.3, Health and Safety Code; and Sections 4631, 4648 (a) and 4689.1, Welfare
and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Comphance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. New subsections (a)(l)(A)-(C), subsecfion renumbering, and amendment of
NoTii filed 7-24-95 as an emergency; operative 7-24-95 (Register 95, No. 30).
A Certificate of Compliance must be transmitted to OAL by 1 1 -2 1 -95 or emer-
gency language will be repealed by operation of law on the following day.

6. New subsections (a)(l)(A)-(C), subsection renumbering, and amendment of
Note refiled 1 1-14-95 as an emergency; operadve 1 1-14-95 (Register 95, No.
46). A Certificate of Compliance must be transmitted to OAL by 3-13-96 or
emergency language will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and
filed 2-22-96 (Register 96, No. 8).

8. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, fitle 1, California Code of Regulations (Register 97, No. 3).

§ 54355. Vouchers.

(a) A regional center may offer vouchers to family members or adult
consumers to allow the famihes and consumers to procure their own
diaper/nutritional supplements, day care, nursing, respite, and/or trans-
portation services. When vouchers are issued they shall:

(1) Be used in lieu of, and shall not exceed the cost of services the re-
gional center would otherwise provide; and

(2) Be issued only for services which are unavailable from generic
agencies.

(b) The regional center shall provide prospective voucher recipients
with information to assist them in determining liabilities they may incur
by participating in a voucher program. Information provided shall in-
clude, but need not be limited to:

( 1 ) Identification of the following areas of potential impact:

(A) Impact of vouchers on Supplemental Security Income (SSI) and/
or other benefits;

(B) Voucher recipient's status as an employer and employer responsi-
bilities;

(D) Potential increase in insurance needs; and

(E) Voucher recipient's responsibility for worker's compensation;
and

(F) Voucher recipient's responsibility to withhold and pay the ap-
propriate Federal, State and local taxes; and

(2) Identification of the appropriate agency(ies), including the Internal
Revenue Service and the Employment Development Department, which
the voucher recipient may contact to obtain information and/or technical
assistance regarding the areas of potential impact specified in ( 1 )( A)
through (F) above.

(3) The requirement to maintain records for at least 5 years, pursuant
to Section 50604(d)(3)(A) through (E), as applicable.

(4) The requirement to submit to the regional center on form DS 1811,
Respite Services Billing Form (7/04) data as specified in (A) through (O)
below with billings/invoices for the billing period:

(A) Name and Unique Client Identifier (UCI) number of consumer re-
ceiving respite service;

(B) Vendored family member name;

(D) Vendor address;

(E) Vendor phone number;

(F) Date of service;

(G) Address where respite services were provided;
(H) Start and end times of service provided;

(I) Number of hours respite worker worked;
(J) Amount billed to the regional center;
(K) Name of respite worker, agency or facility used;
(L) Respite worker's social security number or any document pursuant
to Section 50604(d)(3), if individual worker is used;

(M) Respite worker's address, if individual worker is used;

(N) Respite worker's phone number, if individual worker is used; and

(O) Respite worker's signature, if individual worker is used.

(5) The requirement of the vendored family member to sign, with orig-
inal signature, and date Form DS 1 8 1 1 (8/04), which includes a certifica-
tion that the information provided on the form is true and correct, and that
the person signing the form is the only person who employed, supervised,
and assigned duties to the respite worker(s) listed on the form, in addition
to having read and followed all respite service program requirements and
the terms and conditions pursuant to Title 17, Sections 50604(a),
50604(d), 54326(a)(10), 54355(b)(1) through (3), 54355(g)(4)(B),
54355(g)(4)(C) 1. and 54355(g)(4)(C)2.

(c) If a family member or adult consumer accepts a voucher to procure
their own service, the regional center shall assist the consumer or family
member, as appropriate, in identifying providers of services and sup-
ports.

(d) Voucher recipients shall be legally responsible for the selection
and supervision of the services provided under any voucher issued pur-
suant to this section. It is the responsibility of the voucher recipient to
ensure that the requirements specified in (g)(1) through (5) below for the
actual provider of the vouchered service are met by the individual/entity
selected to provide the service.

•

Page 282.18

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54355

•

(e) If a family member or adult consumer accepts a voucher to procure
their own service, as listed in (a) above, the regional center shall vendor
either:

( 1 ) The vouchered family member or adult consumer pursuant to (g)
below; or

(2) The provider of the vouchered service pursuant to Section 54342.
The regional center shall not vendor the voucher recipient and the

voucher service provider for the same service.

(f) Family members or adult consumers to whom the voucher is issued
shall only be vendored as the provider of the service for which the vouch-
er is issued if specifically authorized pursuant to (g)(1) through (5) be-
low.

(g) If the vouchered family member or adult consumer is to be ven-
dored to procure their own service, the family member or adult consumer
shall meet the specified criteria and be vendored pursuant to the follow-
ing:

(1) Day Care — Family Member — Service Code 405.

(A) A regional center shall classify a vendor as day care - family mem-
ber if the vendor:

1. Is a family member;

2. Is not the direct provider of the day care service; and

3. Selects the day care service for the consumer from:

a. An individual who possesses the skill, training, or education neces-
sary to provide the day care service; or

b. An agency that meets the criteria specified in Section
54342(a)(4)(A) 1. and 2., or (a)(15)(A), (B), or (C).

(B) Vouchers for day care for children shall only be issued by regional
centers for day care costs and/or hours exceeding the cost of providing
day care services provided to a child without disabilities. The regional
center may pay in excess of this amount when a family can demonstrate
a financial need and when doing so will enable the children to remain in
the family home.

(2) Diaper and Nutritional Supplements — Family Member — Service
Code 410.

(A) A regional center shall classify a vendor as diaper and nutritional
supplements — family member if the vendor is a family member who is
authorized by the regional center to directly purchase diapers and/or nu-
tritional supplements for a consumer in the family member's home.

(B) Vouchers for diapers shall only be issued for the procurement of
diapers for children three years of age or older. A regional center may
purchase diapers for children under three years of age when a family can
demonstrate a financial need and when doing so will enable the child to
remain in the family home.

(3) Nursing Service — Family Member — Service Code 415.

(A) A regional center shall classify a vendor as nursing service - fami-
ly member if the vendor:

Lisa family member; and

2. Selects, assigns, and monitors an individual who provides nursing
services for a consumer.

(B) The family member may be the direct provider of the nursing ser-
vice if the service is not intended to provide respite to the family member.

(C) The individual or family member who provides the nursing service
shall possess the qualifications specified in Section 54342(a)(46), (51),
or (66).

(4) Respite Service — Family Member — Service Code 420. A re-
gional center shall classify a vendor as respite service - family member
if the vendor:

(A) Is a family member;

(B) Is not the direct provider of the respite service; and

a. Is at least 18 years of age. Individuals currently providing in-home
respite service shall have 90 days from the effective date of these regula-
tions to comply; and

b. Possesses the skill, training, or education necessary to provide the
respite service. The vendored family member shall be responsible for en-

suring that the individual selected to provide the respite service will pos-
sess the skill, training, or education necessary to provide the respite ser-
vice. In addition, the vendored family member is responsible for ensuring
that the person providing respite care is familiar with the consumer' s dai-
ly routines and needs, and is trained in any specialized supports necessary
for the consumer. To the extent that these specialized support needs re-
quire additional training or certification in such things as First Aid. Car-
diopulmonary Resuscitation (CPR). etc., these needs and requirements
will be included as part of the description of respite care needs in the con-
sumer's Individual Program Plan (IPP) or Indisidualized Family Service
Plan (IFSP); or

2. An agency that meets the criteria specified in Section 54342(a)(38);
or

3. For out-of-home respite services, a facility which meets the stan-
dards specified in Secfion 54342(a)(58) or (72). A relative who provides
out-of-home respite in the relative's own house is exempt from licensure
pursuant to Title 22, California Code of Regulations, Section 80007.

(5) Transportation — Family Member — Service Code 425.

(A) A regional center shall classify a vendor as transportation - family
member if the vendor secures the transportafion to and/or from autho-
rized services identified in the consumer's IPP and the vendor:

1 . Is a family member or adult consumer. The family member or adult
consumer may either provide the transportation service or secure an indi-
vidual to provide the transportafion services idenfified in the consumer's
IPP;

(B) The individual who is actually providing the transportation service
shall:

1. Possess a driver's license which is valid in California; and

2. Have evidence of maintenance of adequate insurance coverage pur-
suant to Welfare and Insfitutions Code, Secfion 4648.3.

(C) Vouchers for transportafion shall only be issued by regional cen-
ters to cover transportafion costs which exceed the transportafion costs
that the family member would incur for a minor child without disabilities.
The regional center may pay in excess of this amount when a family can
demonstrate a financial need and when doing so will enable the consumer
to remain in the family home.

(h) The voucher recipient shall maintain records of services provided
to the consumer pursuant to Secfion 54326(a)(4).

NOTE: Authority cited: Chapter 157, Statutes of 2003; Sections 4405 and 4648(a),
Welfare and Institutions Code; and Section 11 152, Govemmenl Code. Reference:
Sections 4631 and 4648(a), Welfare and Institutions Code.

History

1. New section filed 6-20-94 as an emergency; operative 6-20-94. Submitted to
OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147
(Register 94, No. 25).

2. Certificate of Compliance as to 6-20-94 order, including amendment of section,
transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Reguladons (Register 97, No. 3).

4. Redesignation of subsections (b)l.-2. to (b)(l)-(2) and amendment of newly
designated subsecfion (b)(2) and subsections (e) and (e)(2) filed 4—25-2000;
operative 5-25-2000 (Register 2000, No. 17).

5. Change without regulatory effect amending subsections (g)( l)(A)3.b.,
(g)(3)(C) and (g)(4)(C)l.-3. filed 1-14-2003 pursuant to section 100, dtle 1,
California Code of Regulafions (Register 2003, No. 3).

6. Amendment of section and Note filed 8-27-2004 as an emergency; operative
8-27-2004 (Register 2004, No. 35). A Certificate of Compliance must be trans-
mitted to OAL by 12-27-2004 or emergency language will be repealed by op-
eration of law on the following day.

7. Amendment of section and Note refiled 12-22-2004 as an emergencv; opera-
tive 12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be
transmitted to OAL by 4-21-2005 or emergency language will be repealed by
operation of law on the following day.

8. Certificate of Compliance as to 12-22-2004 order, including further amend-
ment of subsections (b)(4) and (b)(4)(L), transmitted to OAl! 4-19-2005 and
filed 5-18-2005 (Register 2005, No. 20).

9. Change without regulatory effect amending subsection (g)(4)(C)3. filed
ll-l()-2005 pursuant to section 100, title 1, California Code of Regulations
(Register 2005, No. 45).

10. Change without regulatory effect amending subsection (g)(3)(C) filed
4-21-2008 pursuant to section 100, title 1, California Code of Reeulations
(Register 2008, No. 17).

Page 282.19

§ 54356

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 54356. Miscellaneous Services.

(a) A regional center shall classify a vendor as a miscellaneous service
provider only if the vendor does not provide goods or services which are
similar to any of the descriptions of goods or services contained within
sections 54342 through 54355 of these regulations.

(b) The regional center shall obtain a service code from the Depart-
ment for the vendors specified in (a) above.

NOTE; Authority cited: Chapter 722, Statutes of 1992, Section 147: Sections 4405,
4648(a) and 479 l(i). Welfare and Institutions Code; and Section 1 11. 52, Govem-
menl Code. Reference: Sections 4631 , 4648(a) and 4791, Welfare and Institutions
Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for prinfing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Regi^ster 93, No. 26).

4. Amendment of subsection (a) and Note filed 6-20-94 as an emergency; opera-
live 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722,
Statutes of 1992, Section 147 (Register 94, No. 25).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

6. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

§ 54358. Exempted Services.

(a) For all vendors identified in Section 54310(d)(1) through (3) and
(e) of these regulations, the vendoring regional center shall issue a service
code consistent with the service codes identified in Sections 54342
through 54355 of these regulations.

(b) For generic agencies specified in Section 54310(d)(4) of these reg-
ulations, the vendoring regional center shall obtain a service code from
the Department.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4405,
4648(a) and 4791(i), Welfare and Institutions Code; and Secfion 1 1 152, Govern-
ment Code. Reference: Sections 463 1 , 4648(a) and 479 1 , Welfare and Insfitutions
Code.

History

1. New section filed 6-26-90 as an emergency; operafive 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3^-92 or
emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (a) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (b) filed 4-22-94; operative 4-22-94. Submitted to
OAL for printing only (Register 94, No. 16).

8. Amendment of subsection (a) and Note filed 6-20-94 as an emergency; opera-
tive 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722,
Statutes of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order, including amendment of sub-
section (a)(3), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No.
13).

1 1 . Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Vendor Compliance and
Prohibitions

§ 54370. Termination of Vendorization for Noncompliance.

(a) The vendoring regional center shall be responsible for ensuring that
vendors within its service catchment area comply with the vendorization
requirements. Except as specified in section 54372 of these regulations,
the regional center shall take the actions as appropriate for the violations
specified in (b) and (c) below.

(b) Vendorization shall be terminated at the end of the first working
day after written notification is received from the vendoring regional
center if any of the following conditions exist:

( 1 ) The vendor is serving consumers without a current license, creden-
tial, registration, accreditation, certificate, degree or permit that is re-
quired for the performance or operation of the service;

(2) Vendorization has been transferred to another person or entity;

(3) The vendor has refused to make available any books and records
pertaining to the vendored service, including those of the management
organization, for audit, inspection or reproduction by regional center.
Department or authorized agency representative staff;

(4) The service currently provided is not the same service that was ap-
proved for vendorization;

(5) The vendor is using planned behavior modification interventions
that cause pain or trauma without meeting the conditions specified in title
17, sections 50800 through 58023; or

(6) The vendor is transporting consumers using a driver who does not
possess a valid driver's license appropriate for the vehicle being driven.

(7) The regional center has determined that continued utilization of the
vendor threatens the health and safety of the consumer(s).

(c) If a vendor is not in compliance with any requirement, other than
those specified in (b) above, vendorization shall be terminated 30 days
after written notification from the vendoring regional center.

(d) The written notification pursuant to (b) or (c) above shall:

(1) Be sent by registered return receipt requested mail; and

(2) Include all of the following:

(A) A description of the specific violation(s);

(B) A reference to the statute(s) or regulation(s) with which the vendor
is not complying; and

(C) The date on which vendorization will be terminated unless action
pursuant to (e) or (f) below is taken by the vendor.

(e) Termination pursuant to (b) above shall not occur if the vendor no-
tifies the vendoring regional center, in writing, prior to the expiration of
the period specified in the notice, of the vendor's intent to take either of
the following actions:

(1) Correct the violation(s) and provide documentation of the correc-
tion to the vendoring regional center within 30 days from receipt of the
notice; or

(2) File an appeal within 30 days from receipt of the notice in accor-
dance with section 54380 of these regulations.

(3) If, within the 30-day period, the vendor fails to correct the violation
and provide documentation pursuant to ( 1 ) above or to file an appeal pur-
suant to (2) above, vendorization will be terminated effective immediate-

ly-

(f) Termination pursuant to (c) above shall not occur if the vendor
takes either of the following actions prior to the expiration of the period
specified in the notice:

(1) Corrects the violation(s) and provides documentation of the cor-
rection to the vendoring regional center; or

(2) Files an appeal in accordance with section 54380 of these regula-
tions.

(g) Action taken by the vendor pursuant to (e) or (f) above shall not
preclude the vendoring regional center nor any user regional center from
withdrawing purchase of service authorizations if necessary to protect
the health, safety and welfare of the consumers.

Page 282.20

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54382

(h) Regional Centers may place a moratorium on new referrals during
the appeal process or until such violations have been corrected.

(i) No provision of this section shall be construed to supersede or re-
place the monitoring or corrective action plan provisions for residential
facilities contained in title 17, sections 56550 through 56610.
NOTH: Authority cited: Sections 4405, 4648(a) and 4866, Welfare and Institutions
Code; and Section 1 1 152, Government Code. Reference: Sections 4631, 4648(a)
and 4861(c), Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency: operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printins only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Regfster 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

5. Change without regulatory effect amending subsections (b)( 1 ), (b)(6) and (e)(2)
filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations
(Register97, No. 3).

6. Amendment of subsection (a), new subsection (b)(7) and amendment of Note
filed 10-9-2003 as an emergency; operative 10-9-2003 (Register 2003, No.
41 ). A Certificate of Compliance must be transinitted to OAL by 2-6-2004 or
emergency language will be repealed by operation of law on the following day.

7. Amendment of subsection (a), new subsection (b)(7) and amendment of Note
refiled 2-3-2004 as an emergency; operative 2-3-2004 (Register 2004, No. 6).
A Certificate of Compliance must be transmitted to OAL by 6-2-2004 or emer-
gency language will be repealed by operation of law on the following day.

8. Amendment of subsection (a), new subsection (b)(7) and amendment of Note
refiled 6-1-2004 as an emergency; operative 6-1-2004 (Register 2004, No.
23). A Certificate of Compliance must be transmitted to OAL by 9-29-2004 or
emergency language will be repealed by operation of law on the following day.

9. Amendment of subsection (b)(1) and amendment of Note filed 7-22-2004 as
an emergency; operative 7-22-2004 (Register 2004, No. 30). A Certificate of
Compliance must be transmitted to OAL by 11-19-2004 or emergency lan-
guage will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 6-1-2004 order, including amendment of sub-
section (d)(1)(C), new subsections (e)-(e)(3) and (h), subsection relettering and
amendment of newly designated subsections (f) and (g), transmitted to OAL
9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

1 1 . Reinstatement of section as it existed prior to 7-22-2004 emergency amend-
ment by operation of Government Code section 1 1346. 1(f) (Register 2004, No.
49).

12. Amendment of subsection (b)(1) and amendment of Note refiled 1 1-29-2004
as an emergency; operative 1 1-29-2004 (Register 2004, No. 49). A Certificate
of Compliance must be transmitted to OAL by 3-29-2005 or emergency lan-
guage will be repealed by operation of law on the following day.

13. Amendment of subsection (b)(1) and amendment of Note refiled 3-30-2005
as an emergency; operative 3-30-2005 (Register 2005, No. 13). A Certificate
of Compliance must be transmitted to OAL by 7-28-2005 or emergency lan-
guage will be repealed by operation of law on the following day.

14. Certificate of Compliance as to 3-30-2005 order, including amendment of
subsection (b)(1). transmitted to OAL 6-21-2005 and filed 8-1-2005; amend-
ments operative 8-31-2005 (Register 2005, No. 31).

§ 54372. Review of Existing Vendors.

NOTE: Authority cited: Secfions 4405 and 4648 (b). Welfare and Institutions
Code; and Section 1 1 152, Government Code. Reference: Sections 4631 and 4648
(b), Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Repeal of section filed as an emergency 6-17-93; operative 6-17-93. Sub-
mitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of
1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 54374. Use of Planned Behavior IVIodification

Interventions That Cause Pain or Trauma.

Vendors and regional centers shall follow the requirements of title 17,
sections 50800 through 50823, when using planned behavior modifica-
tion interventions that cause pain or trauma.

Note: Authority cited: Sections 4405 and 4648 (a). Welfare and Institutions
Code; and Section 1 1 1 52, Government Code. Reference: Sections 4502 and 4(S48
(a). Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing onlv pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

Article 5. Vendorization Appeal

§ 54380. Vendorization Appeal.

(a) A vendor or an applicant for vendorization may appeal any of the
following actions to the director of the vendoring regional center:

(1) Denial of a vendorization application;

(2) Failure of the vendoring regional center to comply with the provi-
sions of these regulations; or

(3) Findings of noncompliance as specified in section 54370 of these
regulations.

(b) The vendor shall file an appeal with the director of the vendoringre-
gional center within 30 days after the receipt of written noUfication of the
action of the regional center, or within 30 days after the failure of the ven-
doring regional center to comply with these regulaUons.

(c) Notwithstanding the provisions of (b) above, if a vendor wishes to
have the terminadon of vendorization pursuant to section 54370 (b) of
these regulafions stayed pending appeal, such appeal must be made prior
to the end of the first working day after receipt of written noUfication of
the proposed termination from the vendoring regional center.

(d) If an appeal is not filed within the dme specified, it shall be denied
unless good cause pursuant to section 54388 of these regulations is estab-
lished for the late submission. Good cause shall be determined by the di-
rector of the vendoring regional center or his or her designee in accor-
dance with section 54388 of these regulations. If good cause for late
submission is established, the director or his or her designee shall pro-
ceed to decide the appeal in accordance with section 54382 of these regu-
lations.

NOTE: Authority cited: Sections 4440 and 4648 (a). Welfare and Institutions
Code; and Section 11 152, Government Code. Reference: Section 4648 (a). Wel-
fare and Institutions Code; U.S Constitution, Amendment XIV, Section 1 and Cal-
ifornia Constitution, Article I, Section 7.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of secfion filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 54382. Contents of Appeal and Decision.

(a) The appeal filed pursuant to secfion 54380 of these regulations
shall be in writing and shall include the follov/ing:
(1) The appellant's:
(A) Name, business address, and telephone number; and

Page 282.21

§ 54384

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(B) Vendor identification number, service code, subcode, and type of
service provided as specified in sections 54340 through 54356 of these
regulations, if applicable.

(2) Identification of the action being appealed;

(3) The specific basis for the appeal; and

(4) All supporting documentation and any other information necessary
to substantiate and/or justify the appeal, including the specific regulation
used as the basis for the appeal.

(b) Within 15 days after receipt of the appeal, the director of the ven-
doring regional center or his or her designee shall review the appeal to
determine whether it contains the information required by (a) above.

(1) If all required information has been submitted, the director or his
or her designee shall render a decision pursuant to (c) below.

(2) If all the required information has not been submitted and/or addi-
tional information is needed, the director of the vendoring regional center
or his or her designee shall request the information in writing from the
appellant. The appellant shall submit the information within 1 5 days after
receipt of the request:

(A) If the information is not submitted within the time specified, the
appeal shall be deemed withdrawn and no further action will be taken un-
less the appellant established good cause pursuant to section 54388 of
these regulations for the later submission. Good cause shall be deter-
mined by the director of the vendoring regional center or his or her desig-
nee in accordance with section 54388 of these regulations:

1 . If good cause for late submission is established, the director of the
vendoring regional center or his or her designee shall proceed with the
appeal and render a decision pursuant to (c) below.

(B) If the information is submitted but does not comply with the re-
quest, the appeal shall be deemed withdrawn and no further action will
be taken.

(c) The director of the vendoring regional center or his or her designee
shall render a decision on the appeal within 60 days after receipt of all
required and/or requested information. The decision shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling;

(4) Specify the statutes and regulations upon which each ruling is
based; and

(5) Specify the procedure for appealing the vendoring regional cen-
ter's decision to the Director of the Department.

(d) A written copy of the decision shall be mailed to the appellant with-
in 15 days after the decision is rendered.

(e) If the appellant does not appeal the decision to the Director of the
Department, pursuant to section 54384 of these regulations, it shall be
deemed final, and the vendoring regional center shall send a copy of the
decision to all regional center(s) utilizing the service.

NOTE: Authority cited: Sections 4405 and 4648 (a). Welfare and Institutions
Code; and Section 1 1 152, Government Code. Reference: Section 4648 (a). Wel-
fare and Institutions Code; U.S. Constitution, Amendment XIV, Section 1 and Cal-
ifornia Constitution, Article I, Section 7.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 54384. Appeal of the Regional Center's Decision.

(a) The appellant may appeal the decision of the vendoring regional
center's director to the Director of the Department within 15 days after
receipt of the written decision. The appeal must be filed with the director
of the vendoring regional center who shall forward the appeal to the Di-
rector of the Department in accordance with (c) below.

(b) The appeal shall be in writing and shall include the following:

( 1 ) All information submitted to the vendoring regional center pur-
suant to section 54382 (a) of these regulations;

(2) A copy of the vendoring regional center's decision; and

(3) A statement of the issue(s), facts, documentation, and supporting
authority identifying why the appellant believes the decision of the direc-
tor of the vendoring regional center should be reversed by the Director.

(c) Within 15 days after receipt of the appeal, the director of the ven-
doring regional center or his or her designee shall ensure that the appeal
includes all information required by (b) above, and forward the appeal
to the Director. The vendoring regional center shall not forward an in-
complete appeal or an appeal filed after the time specified unless the ap-
pellant establishes good cause pursuant to section 54388 of these regula-
tions.

(d) Within 30 days after receipt of the appeal, the Director of the De-
partment or the Director s designee shall review the appeal and determine
whether additional information upon which to base a decision is needed
from the appellant, or the vendoring regional center.

(1) If no additional information is needed, the Director of the Depart-
ment or the Director's designee shall render a decision pursuant to (e) be-
low.

(2) If additional information is required, the Director of the Depart-
ment or the Director' s designee shall request the information from the ap-
pellant or the regional center. The appellant or the regional center shall
submit the information within 15 days after receipt of the request.

(A) If the appellant does not submit the information within that time,
the appeal shall be deemed withdrawn and no further action taken unless
the appellant establishes good cause pursuant to section 54388 of these
regulations for the late submission. Good cause shall be determined by
the Director of the Department or the Director's designee pursuant to sec-
tion 54388 of these regulations.

1 . If good cause for late submission is established, the Director of the
Department or the Director's designee shall proceed with the appeal and
render a decision pursuant to (e) below.

(B) If the information is submitted, but does not comply with the re-
quest, the appeal shall be deemed withdrawn and no further action will
be taken.

(C) If the regional center does not submit the requested information,
the Director of the Department or the Director's designee shall proceed
with the appeal and render a decision pursuant to (e) below.

(e) The Director of the Department or the Director's designee shall
render a decision within 60 days after receipt of all required and/or re-
quested information. The decision shall:

(1) Identify the specific issues in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling; and

(4) Identify the statutes and regulations upon which each ruling is
based.

(f) A written copy of the decision shall be sent to the appellant, the ven-
doring regional center and all regional center(s) utilizing the service
within 15 days after the decision is rendered.

(g) The decision of the Director is the final administrative decision.
NOTE: Authority cited: Sections 4405 and 4648 (a), Welfare and InstituUons
Code; and Section 1 1152, Government Code. Reference: Section 4648 (a), Wel-
fare and Institutions Code; U.S. Constitution, Amendment XIV, Section 1 and Cal-
ifornia Constitution, Article 1, Section 7.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of secfion filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

Page 282.22

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54388

§ 54386. Effective Date of Decision.

The effective date of the director of the vendoring regional center's
and the Director of the Department's decisions shall be stated in the deci-
sions.

NOTH: Authority cited: Sections 440,*^ and 4648 (a), Welfai-e and Institutions
Code; and Section 11 152. Government Code. Reference: Section 4648 (a). Wel-
fare and Institutions Code; U.S. Constitution, Amendment XIV, Section 1 and Cal-
ifornia Constitution, Article I, Section 7.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by rO-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing onlv pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 54388. Good Cause.

(a) For the purposes of sections 54380 through 54386 of these regula-
tions, good cause for a failure to act is limited to:

[The next page is 282.23.

Page 282.22(a)

•

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54505

(1) A violent act of nature including but not limited to, flood, earth-
quake, bliz/ard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property by indi-
viduals other than the appellant which preclude the appellant from filing
a timely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days
after the incident giving rise to its claim of good cause, submit to the di-
rector of the regional center or the Director of the Department, whichever
is appropriate, the basis for its claim of good cause and all supporting
documents or other evidence substantiating its claim. The director of the
regional center, the Director of the Department or the Director's desig-
nee, whichever is appropriate, shall, within 30 days of receipt of the claim
and supporting documentation, review the information and render a deci-
sion regarding whether good cause has been established.

(c) The director of the regional center, the Director of the Department
or the Director's designee, whichever is appropriate, shall notify the ap-
pellant in writing of the decision and shall specify what action will be tak-
en, if any, pursuant to sections 54380 through 54386 of these regulations.

NOTE; Authority cited: Chapter 722, Statutes of 1 992, Section 147; Sections 4405,
4648 (a) and 479 l(i). Welfare and Institutions Code; and Section 11 152, Govern-
ment Code. Reference: Sections 4648 (a) and 479 1 , Welfare and Institutions Code;
U.S. Constitution. Amendment XIV, Section 1 and California Constitution, Ar-
ticle I, Section 7.

History

2. Certificate of Compliance as to 6-26-90 order tiansmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 54390. Review of Documents Only.

An appeal made pursuant to sections 54380 through 54386 of these
regulations shall be decided only on the documents submitted. There
shall be no oral testimony or argument; however, the vendoring regional
center and the appellant may hold an informal conference at any time to
discuss or resolve the disputed issues.

NOTE: Authority cited: Sections 4405 and 4648(a), Welfare and Institutions Code;
and Section 1 1 152, Government Code. Reference: Section 4648(a), Welfare and
Institutions Code; U.S. Constitution, Amendment XIV, Section 1 and California
Constitution, Article I, Section 7.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Repealer of Appendix and new Appendices A and B filed 1 1-5-91 as an emer-
gency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance
must be transmitted to OAL 3-4-92 or emergency language will be repealed by
operation of law on the following day.

4. New Appendices A and B refiled 3-4-92 as an emergency; operative 3-4-92
(Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL
7-2-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

5. Certificate of Compliance as to 3-4-92 order including amendment of Appen-
dix A and repealer of Appendix B transmitted to OAL 6-25-92 and filed
8-6-92 (Register 92, No. 33).

6. Amendment of secfion filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prindng only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Certificate of Compliance as to 6-20-94 order, including new form, transmitted
to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 13).

9. Repealer of Appendix A filed 12-22-2004 as an emergency; operative
12-22-2004 (Register 2004, No. 52). A Certificate of Compliance must be
transmitted to OAL by 4-21-2005 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 12-22-2004 order transmitted to OAL
4-19-2005 and filed 5-18-2005 (Register 2005, No. 20).

Subchapter 3. Regional Center
Administrative Practices and Procedures

Article 1. Regional Center Conflict of
Interest Standards and Procedures

§ 54500. Authority and Scope.

These regulations prescribe conflict of interest standards and proce-
dures for all members of the regional center governing boards and em-
ployees of the regional center to ensure that such persons make decisions
relative to the regional center which are in the best interests of the center's
clients and families pursuant to authority provided in Section 4627 of the
Welfare and Institutions Code. Members serving on the governing board
of a regional center on January 1, 1982 are subject to these regulations
to the extent not prohibited by Welfare and Institutions Code, Section
4626.

NOTE: Authority cited: Section 4627, Welfare and Institutions Code. Reference:
Secfions 4626 and 4627, Welfare and Institutions Code.

History

1 . Editorial redesignation and renumbering of former Chapter 3 (Articles 1 -3, Sec-
tions 50301-50327, not consecutive) to Chapter 3 (Subchapter 2, Article 1, Sec-
tions 54500-54529, not consecutive) filed 9-28-83 (Register 83, No. 40). For
prior history, see Register 76, No. 51.

2. Repealer and new secfion filed 12-29-86; effecfive thirtieth day thereafter
(Register 87. No. 1).

§ 54505. Definitions.

As used in this subchapter, the following words and phrases have the
specified meanings:

(a) "Area Board" means the organization of individuals established
and constituted according to Welfare and Institutions Code, Section 4570
et seq.

(b) "Board Member" or "Member of the Governing Board" means an
individual serving on a governing board of a regional center.

(c) "Business Entity, Entity or Provider" means any individual or busi-
ness venture from whom or from which the regional center purchases/ob-
tains goods or services to conduct its operations. These entities or provid-
ers include, but are not limited to, residential facilities, intermediate care
facilities, skilled nursing facilities, hospitals, medical groups, activity
centers, independent living facilities, infant programs, clinics, laborato-
ries, pharmacies, drug stores, ambulance services, furniture stores,
equipment and supply stores, physicians, psychologists, nurses, thera-
pists, teachers, social workers, and contract case managers.

(d) "Client" means the individual described in Section 56551(e),
Chapter 3, Subchapter 4, Article 1, Title 17, California Administrative
Code.

(e) "Decision or Policy-Making Authority" means the authority an in-
dividual possesses whenever the individual:

(1) makes a final decision; or

(2) may compel a decision or may prevent a decision either by reason
of an exclusive power to initiate the decision or by reason of a veto which
may or may not be overridden; or

(3) makes substantive recommendations which are, and over an ex-
tended period of time have been, regularly approved without significant
amendment or modification by another person or entity or provider; or

(4) votes on matters, appoints or hires people, obligates or commits his
or her agency to any course of action, or enters into any contractual agree-
ment on behalf of his or her agency.

This authority does not include actions of the individuals which are
solely secretarial or clerical.

(f) "Department" means the Department of Developmental Services.

(g) "Governing Board" means the board of directors of a private non-
profit corporation which contracts with the State for the purpose of estab-

Page 282.23

§ 54510

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

lishing and operating a regional center and which is constituted in accor-
dance with Section 4622 of the Welfare and Institutions Code.

(h) "Potential Conflict of Interest" means a situation which, based
upon circumstances reasonably expected to occur at a point in the future,
may result in a conflict of interest, as specified in Sections 54520 or
5452 1 of these regulations, at that time.

(i) "Present Conflict of Interest" means a conflict of interest, as speci-
fied in Sections 54520 or 54521 of these regulations, which currently ex-
ists.

(j) "Prospective Client" means any person who has presented himself
or herself, at the regional center, as requiring services for the develop-
mentally disabled but who has not yet gone through the initial intake and
assessment process.

(k) "Regional Center" means a diagnostic, counseling, and service
coordination center for persons with developmental disabilities and their
families which is established and operated pursuant to Chapter 5 of Divi-
sion 4.5 of the Welfare and Institutions Code by a private nonprofit cor-
poration acting as a contracting agency.

(1) "Regional Center Employee" means any person who performs ser-
vices for wages, salary or a fee under a contract of employment, express
or implied, with the regional center. For purposes of these regulations, a
business entity, entity or provider as defined in Section 54505(c) herein,
is not a regional center employee.

(m) "Regional Center Operations" means those activities or services
which regional centers are required by law, regulation, or contract with
the State to provide, obtain, or purchase. Such activities include, but are
not limited to: case finding, outreach, prevention, intake and assessment,
individual program planning, case management, community programs,
program development, and client advocacy and protection.

(n) "State Council" means the organization of individuals established
and constituted pursuant to Welfare and Institutions Code, Section 4520
et seq.

NOTE: Authority cited: Section 4627, Welfare and Institutions Code. Reference:
Sections 4512, 4520 et seq., 4570 et seq., 4620, 4621, 4626, 4627, 4641, 4642,
4643, 4644, 4646, 4647 and 4648, Welfare and Institutions Code.

History

1. New section filed 12-29-86; effective thirtieth day thereafter (Register 87, No.
1).

§ 54510. Regional Center.

History

1 . Repealer filed 12-29-86; effecUve thirtieth day thereafter (Register 87, No. 1).

§ 5451 1 . Contracting Agency.

History

1 . Repealer filed 12-29-86; effecfive thirtieth day thereafter (Register 87, No. 1).

§ 54512. Regional Center Employee.

History

1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§ 54520. Conflict of Interest Standards for Regional Center
Governing Board Members.

(a) The following constitute conflicts of interest for regional center
governing board members:

( 1 ) A conflict of interest exists when a member of the governing board
or a family member of such person is a director, officer, owner, partner,
shareholder, trustee or employee of any business entity or provider, holds
any position of management in any business entity or provider, or has de-
cision or policy-making authority in such an entity or provider, except
to the extent permitted by Welfare and Institutions Code, Section
4626(a)(3) and (b). These conflict of interest provisions are in addition
to those stated in Welfare and Institutions Code, Sections 4622(a)(9) and
4626.

(2) A conflict of interest exists when the advisory committee board
member, appointed pursuant to Welfare and Institutions Code, Section
4622(a)(7), is an employee or member of the governing board of a pro-
vider from which the regional center purchases client services and en-
gages in the activities prescribed in Welfare and Institutions Code Sec-

tion 4622(a)(9). Such member is therefore prohibited from serving as an
officer of the regional center governing board and from voting on the
matters or issues described in Section 4622(a)(9). Furthermore, the mem-
ber is subject to disclosure under Section 54522 of these regulations in
addition to providing a list of his or her financial interests, as defined in
Government Code Section 87103. Fiscal matters, as used in Welfare and
Institutions Code Section 4622(a)(9) include, but are not limited to, set-
ting purchase of service priorities, transferring funds to the purchase of
service budget, and establishing policies and procedures with respect to
payment for services.

(3) A conflict of interest exists when a governing board member is any
individual described in Welfere and Institutions Code Section 4626. A
financial interest in regional center operations, as used in Welfare and In-
sfitudons Code Section 4626(a)(4), exists if it is reasonably foreseeable
that the member's interest, or the member's decision regarding that inter-
est, will have a material financial effect, on the board member's interest
in, or relafionship with, the business entity or provider pursuant to Gov-
ernment Code, Section 87 103. The financial effect is material if the deci-
sion will result in a benefit, detriment, gain, loss or profit to the member,
endty or provider.

(b) The regional center governing board shall not enter or authorize the
regional center to enter into any contract or any other type of agreement
for pecuniary gain with any entity or provider in which a member has a
conflict of interest as set forth in subsection (a)(1) and (a)(3) above, nor
shall the board or board member allow the regional center to refer a client
or prospective client to such an entity or provider.

(c) No regional center governing board member who has a conflict of
interest shall continue to serve as a board member in violation of these
provisions unless the board member has eliminated the conflict of inter-
est or obtained a waiver pursuant to these regulations. This prohibition
does not apply to the extent it is precluded by Welfare and Institutions
Code, Sections 4626(a)(3) and (b).

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4622,
4626, 4627 and 479 1 (i), Welfai'e and Institutions Code. Reference: Sections 4622,
4626, 4627 and 4791, Welfare and Institutions Code and Secfion 87103, Govern-
ment Code.

History

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter
(Register 87, No. 1).

2. Amendment of secdon filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prinfing only pursuant to SB484 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 54521 . Conflict of Interest Standards for Regional Center
Employees.

(a) The following constitute conflicts of interest for regional center
employees:

( 1 ) A conflict of interest exists when a regional center employee or a
family member of such person is a governing board member, director, of-
ficer, owner, partner, shareholder, trustee, or employee of any business
entity or provider, holds any position of management in any business en-
tity or provider, or has decision or policy-making authority in such an en-
tity or provider, or makes a decision regarding regional center operations
involving a business entity or provider in which he or she has a financial
interest.

For the purpose of this section, an employee has a financial interest in
regional center operations if it is reasonably foreseeable that the em-
ployee's interest or the employee's decision regarding that interest will
have a material financial effect, as distinguished from its effect on the re-
gional center's clients and/or their families generally, on:

(A) Any business entity or provider in which the employee has a direct
or indirect investment worth more than one thousand dollars ($1000).

(B) Any real property in wliich the employee has a direct or indirect
interest worth more than one thousand dollars ($1000).

(C) Any source of income, other than loans by a commercial lending
institution in the regular course of business on terms available to the pub-
lic without regard to employee status, aggregating two hundred fifty dol-

Page 282.24

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54522

•

lars ($250) or mare in value provided to, received by or promised to the
employee within 12 months prior to the time when the decision is made.

For purposes of this section, "indirect investment" or "interest" means
any investment or interest owned by the spouse or dependent child of an
employee, by an agent on behalf of an employee, or by a business entity
or provider or trust in which the employee, the employee' s agent, spouse,
or dependent children own directly, indirectly, or beneficially a ten per-
cent interest or greater.

The financial effect is material if it will result in a benefit, detriment,
gain. loss, or profit to the employee, entity, or provider.

(2) A conflict of interest exists when a regional center employee de-
votes less than his or her full-time attention and effort to his or her region-
al center employment for that period for which he or she is being reim-
bursed.

(3) A conflict of interest exists when a regional center employee pro-
vides services for salary, honorarium, or compensation of any kind in
such fashion that the employee is receiving dual compensation for the
same period of time. This subsection does not apply to regional center
employees while officially off duty.

(4) A conflict of interest exists when a regional center employee par-
ticipates in the evaluation of an application for employment at the region-
al center when the applicant is a member of the employee's family, or
when an employee acts as a supervisor of another regional center em-

ployee who is a member of the supervisor's family.

(A) For the purpose of this subsection, supervisors shall include tho.se
individuals who serve as reviewing officer for reports of performance.

(B) For the purpose of this subsection, family members shall include:
spouse, children, stepchildren, parents, stepparents, brothers, sisters.
grandchildren, grandparents, or inlaws.

(b) No regional center employee shall continue employment with the
regional center where the employee has a conflict of interest in violation
of those provisions, unless the employee eliminates the conflict of inter-
est or obtains a waiver pursuant to these regulations.

Note: Authority cited: Section 4627, Welfare and Institutions Code. Reference:
Section 4627, Welfare and Institutions Code.

History
1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter
(Register 87, No. 1).

§ 54522. Conflict of Interest Disclosure— Content of

Statements, Procedures and Actions Required
for Resolution.

(a) Within 60 calendar days of the effective date of this Article, each
regional center employee who has decision or policy-making authority,
as defined in Section 54505(e) herein, and each member of the governing
board, including the board member designated by the regional center
provider advisory committee pursuant to Welfare and Institutions Code,

•

[The next page is 282.25.]

Page 282.24(a)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54524

Section 4622(a)(7), shall prepare and file an initial conflict of interest
statement pursuant to these regulations. Employees shall file their state-
ments with their respective regional center and governing board mem-
bers shall file their statements with their regional center governing board.
Subsequent statements shall be filed thereafter whenever a change in sta-
tus would create a present or potential conflict of interest situation as de-
fined in these regulations. Individuals serving in any capacity under a
waiver granted pursuant to Section 54523 of these regulations shall be
required to file a conflict of interest statement with each waiver renewal
as required pursuant to Section 54524(b)(3) of these regulations. The re-
gional center and governing board shall designate the individual who is
responsible for receiving, processing, and maintaining the initial and
subsequent annual statements for their own respective agency. Such indi-
vidual, however, may not review his or her own filed statement. The ini-
tial conflict of interest statement and all subsequent annual statements
shall be dated, signed, and contain a declaration, under penalty of perju-
ry, that the governing board member or employee has:

( 1 ) No present or potential conflict of interest;

(2) A present conflict of interest; or

(3) A potential conflict of interest pursuant to these regulations.
The individual shall specify the factual basis for that determination

and provide full and complete disclosure relative to any present or poten-
tial conflict of interest, including a description of the nature of the conflict
of interest. For the board member designated by the regional center pro-
vider advisory committee pursuant to Welfare and InsUtutions Code,
Section 4622(a)(7), the disclosure shall include, to the extent not other-
wise disclosed, a list of the member's financial interest as required by
Welfare and Institutions Code, Section 4622(a)(9)(C).

(b) If a present or potential conflict of interest exists, the statements of
regional center employees and governing board members, including the
board member designated by the regional center provider advisory com-
mittee pursuant to Welfare and Institutions Code, Section 4622(a)(7),
shall if desired by the governing board member or regional center em-
ployee, also contain a request for waiver of the prohibitions of any pres-
ent or potential conflict of interest, and a suggested plan of action for res-
olution of the present or potential conflict of interest, including
limitations on the governing board member or regional center employee
which will enable him or her to avoid actions involving the conflict of in-
terest during the period the waiver request is being reviewed pursuant to
Section 54523 of these regulations.

(c) The regional center or regional center governing board shall re-
view, respectively, the waiver requests of all regional center employees
and governing board members, and determine, in its discretion, whether
to submit the request pursuant to the regulations, or require the individual
to eliminate the conflict of interest or resign his or her position as stated
therein.

(d) If a present or potential conflict of interest exists and no waiver is
requested, or if the regional center or regional center governing board
elects not to submit such a request in accordance with these regulations,
the regional center employee or governing board member, and the board
member designated by the regional center provider advisory committee
pursuant to Welfare and Institutions Code, Section 4622(a)(7), shall have
thirty (30) calendar days from the date of filing the conflict of interest
statement or the date of notification by the regional center or its govern-
ing board in which to either take whatever action is necessary to eliminate
the conflict of interest, or resign his or her position as a regional center
employee or governing board member. During the thirty (30) calendar
day period, the employee or board member shall avoid all involvement
with or participation in regional center activities involving the conflict of
interest in question.

(e) If no conflict of interest is declared at the time of filing the initial
statement or subsequent statements, no further action is required by the
governing board member or regional center employee unless or until
such time as that individual's status changes, so that he or she is in a pres-
ent or potential conflict of interest situation. Upon such a change in sta-

tus, a new statement shall be filed immediately with the member's gov-
erning board or the employee's regional center, specifying the factual
basis for that determination and providing full and complete disclosure
relative to the present or potential conflict of interest in accordance with
provisions of subsection (a) above.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147: and Sections
4627 and 4791(i), Welfare and Institutions Code. Reference: Sections 4622, 4626.
4627 and 4791, Welfore and Institutions Code.

History

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter
(Register 87, No. 1).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for piinting only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Certificate of Coinpliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 54523. Requests for Waiver.

(a) If the conflict of interest statement filed by the regional center gov-
erning board member or the regional center employee indicates that a
present or potential conflict of interest exists and a waiver is being re-
quested, then within thirty (30) calendar days of receipt of such a state-
ment, the governing board or regional center shall, unless it has elected
to do otherwise pursuant to Section 54522(c), submit the request for
waiver packet in accordance with the procedures set forth in this section.

(b) All requests for waiver packets must be submitted to the Depart-
ment. In addition, copies of requests for waiver packets involving gov-
erning board members must also be sent to the area board in the area and
to the State Council.

(1) A copy of the board member's or employee's conflict of interest
statements;

(2) The request for waiver;

(3) The plan of action for resolution of his or her conflict of interest and
the time frames for doing so; and

(4) Any limitations proposed by the governing board or regional cen-
ter to be appfied to the board member or employee during the term of the
waiver. Limitations may include, but are not limited to:

(A) Abstention by the person from voting on the conflict of interest sit-
uations;

(B) Nonparticipation by the person, individually or as part of a group,
in the preparation, presentation, formulation or approval of reports,
plans, policies, analyses, opinions or recommendations regarding the
conflict of interest situation, when the exercise of judgement is required
and the purpose is to influence the decision;

(C) Noninvolvement of the person in the negotiation, obligation, or
commitment of the regional center to a course of action involving the
conflict of interest situation;

(D) Reassignment of the person to duties or responsibilities where no
conflict of interest exists; and

(E) Establishment of an independent review and prior approval proce-
dure by supervisors or administrative staff regarding purchase of service
and other decisions made by the person with respect to the conflict of in-
terest situation.

(5) The individual(s) responsible for ensuring that the above plan of
action or limitations are applied and monitored;

(6) Any other information which the employee or board member feels
is pertinent to his or her request.

NOTE: Authority cited: Section 4627, Welfare and Institutions Code. Reference:
Sections 4627 and 4628, Welfare and Institutions Code.

History

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter
(Register 87, No. 1).

§ 54524. Response to Requests for Waiver.

(a) Within twenty (20) calendar days after the area board in the area
and the State Council receive copies of a request for waiver packet re-
garding a regional center governing board member, the area board in the
area and the State Council, respectively, shall provide to the Department

Page 282.25

§ 54525

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

their written approval or disapproval of such request. The Department
may not approve the request for waiver of a regional center governing
board member without the approval of both the area board in the area and
the State Council.

(b) Within sixty (60) calendar days after the Department receives a re-
quest for waiver packet the Department will respond to the request for
waiver in writing:

( 1 ) Explaining the outcome of its review including approval or denial
of the request, where appropriate, and the rationale for the decision;

(2) Specifying the actions, if any, by the governing board or regional
center which the Department deems necessary in order to resolve the con-
flict of interest; and

(3) Stating the duration of the waiver, if approved, according to the fol-
lowing:

(A) For the members of the governing boards who are subject to those
regulations, the duration of the waiver may not exceed one year;

(B) For the regional center employee, the duration of the waiver will
be determined by the Department.

(c) If the request for waiver is denied by the Department and/or the
State Council or area board in the area pursuant to subsections (a) and (b)
herein, the governing board member or regional center employee shall
have thirty (30) calendar days from the date of receipt of the denial in
which to either take whatever action is necessary to eliminate the conflict
of interest or resign his or her position as a governing board member or
regional center employee. During this thirty (30) calendar day period, the
board member or employee shall avoid all involvement with and partici-
pation in the conflict of interest in question.

NOTE: Authority cited: Section 4627, Welfare and Institutions Code. Reference:
Sections 4627 and 4628, Welfare and Institutions Code.

History

1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter
(Register 87. No. 1).

§ 54525. Sanctions.

(a) If the Department finds a governing board, a board member, a re-
gional center or a center employee, in violation of any of the sections set
forth in this Article, the Department shall:

( 1 ) Immediately inform the party or parties in writing of such viola-
tion, including the supporting facts or information upon which determi-
nation of violation was made; and

(2) Require that the party or parties take appropriate action, within
thirty (30) calendar days of the notice of violation, to resolve the conflict
of interest or otherwise eliminate the violation. The Department may ex-
tend this thirty-day period only once and for a period not to exceed thirty
(30) calendar days.

(b) If the violation is not resolved or eliminated within the thirty (30)
calendar days as herein provided, and no extension of time has been
granted by the Department, the Department may take immediate action
to:

( 1 ) Withhold part of the funding for that regional center; or

(2) Commence procedures for termination or nonrenewal of the re-
gional center contract pursuant to Welfare and Institutions Code, Section
4635.

The area board in the area and the State Council shall be notified of the
above action.

NOTE: Authority cited: Section 4627, Welfare and Institutions Code. Reference:
Sections 4627 and 4635, Welfare and Institutions Code.

History
1. Repealer and new section filed 12-29-86; effective thirtieth day thereafter

(Register 87, No. 1).

§ 54526. Purchases.

History
1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§ 54527. Records.

History
1. Repealer filed 12-29-86; effective thirtieth day thereafter (Register 87, No. 1).

§ 54528. Board Meetings.

History
1 . Repealer filed 12-29-86; effecfive thirtieth day thereafter (Register 87. No. 1 ).

§ 54529. Sanctions.

History
1 . Repealer filed 12-29-86; effecfive thirtieth day thereafter (Register 87, No. 1 ).

Subchapter 3.5. Regional Center Budget
Deficit Controls

Article 1. Definitions

§ 54600. Definitions.

Note: Authority cited: Secfion 26, Chapter 1 6, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Sections 4646, 4647, 4648 and 4693, Welfare and Institu-
tions Code.

History

1 . New Subchapter 3 (Secfions 54600-54676, not consecutive) filed 8-24-83 as
an emergency; effective upon filing (Register 83, No. 40). A Certificate of Com-
pliance must be transmitted to OAL within 1 20 days or emergency language
will be repealed on 12-22-83.

2. Certificate of Compliance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5)

3. Order of Repeal of subsections (1) and (m) filed 1-23-84 by OAL pursuant to
Government Code Section 1 1349.6; effecfive thirtieth day thereafter (Register
84, No. 5).

4. Editorial relettering only of subsections (a)-(p) organizing text in alphabetical
order (Register 84, No. 15).

5. Amendment filed 2-22-84 as an emergency; effecfive upon filing. Certificate
of Compliance included (Register 84, No. 15).

6. Order of Repeal of subsecfions (g) and (h) filed 3-23-84 by OAL pursuant to
Government Code Section 1 1349.6; effective thirtieth day thereafter (Register
84. No. 15).

7. Expired by own terms (Register 88, No. 25).

§ 54601 . Expiration.

NOTE: Authority cited: Secfion 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinaiy Session.

History

1. Editorial correction adding new Section filed 1-23-84 (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

Article 2. Service Authorization and Review

§ 54620. Service Purchase Authorizations.

NOTE: Authority cited: Secfion 26, Chapter 1 6, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Secfions 4646, 4647 and 4648(b), Welfare and Insfitu-
fions Code.

History

1 . Certificate of Comphance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (corrected Certificate of Comphance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Order of Repeal of subsections (b)-(c) filed 1-23-84 by OAL pursuant to Gov-
ernment Code Secfion 1 1349.6; effective thirtieth day thereafter (Register 84,
No. 5).

3. Editorial correcfion of HISTORY NOTE No. 2 and reprinfing of subsection (d)
inadvertently deleted in Register 84, No. 5 (Register 84, No. 15).

4. New subsections (b) and (c) filed 2-22-84 as an emergency; effective upon fil-
ing. Certificate of Comphance included (Register 84, No. 15).

5. Order of Repeal of subsections (b) and (c) filed 3-23-84 by OAL pursuant to
Government Code Section 1 1349.6; effective thirtieth day thereafter (Register
84, No. 15).

6. Expired by own terms (Register 88, No. 25).

§ 54621 . Review of Service Authorizations.

NOTE: Authority cited: Secfion 26, Chapter 16, Statutes o 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-

Page 282.26

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54643

traordinary Session; and Sections 4646, 4647 and 4648(b), Welfare and Institu-
tions Code.

History

1 . Certificate of Compliance including new subsection (c) transmitted to OAL
12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed
1-30-84) (Register 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

Article 3. Plans of Action

§ 54640. Projecting Deficits.

NOTE: Authority cited: Section 26. Chapter 1 6, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session.

History

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84
(corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsection (d) filed 1-23-84 by OAL pursuant to Govern-
ment Code Secfion 1 1349.6; effective thirtieth day thereafter (Register 84, No.
5).

3. Editorial con-ection adding HISTORY NOTE Nos. 1 and 2 (Register 84, No.
13).

4. New subsection (d) filed 2-22-84 as an emergency; effecfive upon filing. Cer-
tificate of Compliance included (Register 84, No. 15).

5. Expired by own terms (Register 88, No. 25).

§ 54641 . Content of Plans of Action.

NOTE: Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First I^xtraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 l-'irst Fa-
traordinary Session.

History

1 . Certificate of Compliance including amendment transmitted to OAL 1 2-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Recis-
ter 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§ 54642. Review of Plans of Action.

NOTE: Authority cited: Section 26, Chapter 1 6, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session.

History

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84
(corrected Certificate of Compliance filed 1-30-84) (Register 84. No. 5).

2. Editorial correction adding HISTORY NOTE No. 1 (Register 84. No. 15).

3. Expired by own terms (Register 88, No. 25).

§ 54643. Modification and Implementation of Plans of
Action.

NOTE: Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session.

[The next page is 283.]

Page 282.27

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 54672

History

1. Certificate of Compliance transntitted to OAL 12-22-83 and filed 1-23-84
(corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Kditorial correction adding HISTORY NOTE No. 1 (Register 84, No. 15).

3. Expired by own terms (Register 88, No. 25).

§ 54644. Noncompliance.

NOTE: Authority cited: Section 26, Chapter 1 6, Statutes of 1983-84 Eirst Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session.

History

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84
(coiTccted Certificate of Compliance filed 1-30-84) (Register 84. No. 5).

2. Editorial correction adding HISTORY NOTE No. 1 (Register 84, No. 15).

3. Expired by own terms (Register 88, No. 25).

Article 4. Service Standards

§ 54660. Early Intervention Services.

NOTE; Authority cited: Section 26, Chapter 1 6, Statutes of 1 983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Sections 4642, 4644, 4648 and 4693, Welfare and Institu-
tions Code.

History

1 . Certificate of Compliance including amendment transmitted to OAL 1 2-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§ 54661 . Preschool Services.

NOTE: Authority cited: Section 26, Chapter 1 6, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Sections 4648 and 4693, Welfare and Institutions Code.

History
1 . Expired by own terms (Register 88, No. 25).

§ 54662. Education.

History

1 . Certificate of Compliance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Expired by own terms (Register 88, No. 25).
§ 54663. Day Program Services.

History

1 . Certificate of Compliance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Order of Repeal of subsection (b)(3) filed 1-23-84 by OAL pursuant to Govern-
ment Code Section 1 1349.6; effective thirtieth day thereafter (Register 84, No.
5).

3. Expired by own terms (Register 88, No. 25).

§ 54664. Independent Living Skills Training.

NOTE: Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History

1. Certificate of Compliance transmitted to OAL 12-22-83 and filed 1-23-84
(corrected Certificate of Compliance filed 1-30-84) (Register 84, No. 5).

2. Order of Repeal of subsecfion (c) filed 1-23-84 by OAL pursuant to Govern-
ment Code Section 1 1349.6; effecUve thirtieth day thereafter (Register 84, No.
5).

3. New subsection (c) filed 2-22-84 as an emergency; effective upon filing. Certif-
icate of CompUance included (Register 84, No. 15).

4. Order of Repeal of subsection (c) filed 3-23-84 by OAL pursuant to Govern-
ment Code Section 1 1349.6; effecdve thirtieth day thereafter (Register 84, No.
15).

5. Expired by own terms (Register 88, No. 25).

§ 54665. Extended Day Programs.

NOTE: Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Secdon 4648, Welfare and Institutions Code.

History

1 . Certificate of Compliance including amendment transmitted to OAL 1 2-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Order of Repeal of subsecfion (a) filed 1-23-84 by OAL pursuant to Govern-
ment Code Section 1 1349.6; effective thirtieth day thereafter (Resister 84, No.
5).

3. New subsection (a) filed 2-22-84 as an emergency; effective upon filing. Certif-
icate of Compliance included (Register 84, No. 15).

4. Expired by own terms (Register 88, No. 25).

§ 54666. Social Recreation Services.

NOTE; Authority cited: Section 26. Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16. Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History

1 . Certificate of Compliance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§ 54667. Special Services.

NOTE; Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinai-y Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History

I . Certificate of Compliance including repealer of Section 54667 transmitted to
OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed
1-30-84) (Register 84, No. 5).

§ 54668. Behavior Modification.

NOTE: Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History

1 . Certificate of Compliance including amendment transmitted to OAL 1 2-22-83
and filed 1-23-84 (cortected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Order of Repeal of subsection (a)(2) filed 1-23-84 by OAL pursuant to Govern-
ment Code Secfion 1 1349.6; effective thirtieth day thereafter (Register 84, No.
5).

3. Expired by own terms (Register 88, No. 25).

§ 54669. Sensory Motor Development.

NOTE: Authority cited: Section 26, Chapter 1 6, Statutes of 1983-84 First Extraor-
dinai-y Session. Reference: Secfion 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History

1. Certificate of Compliance including repealer of Section 54669 transmitted to
OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed
1-30-84) (Register 84, No. 5).

§ 54670. Education Training.

NOTE: Authority cited: Secdon 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institudons Code.

History

1. Certificate of Compliance including repealer of Section 54670 transmitted to
OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed
1-30-84) (Register 84, No. 5).

§ 54671 . Independent Living Skills Training.

Note; Authority cited: Section 26, Chapter 1 6, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Insfitutions Code.

History
1. Certificate of Compliance including repealer of Section 54671 transmitted to

OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed

1-30-84) (Register 84, No. 5).

§ 54672. Vocational Training.

NOTE: Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Secdon 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Secdon 4648, Welfare and Institutions Code.

History

1. Certificate of Compliance including repealer of Section 54672 transmitted to
OAL 12-22-83 and filed 1-23-84 (corrected Certificate of Compliance filed
1-30-84) (Register 84, No. 5).

Page 283

§ 54673

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 54673. Work Activity.

Note: Authority cited: Section 26. Chapter 1 6, Statutes of 1 983-84 First Extraor-
dinary Section. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History
1. Certificate of Compliance including repealer of Section 54673 transmitted to

OAL 12-22-83 and filed 1-23-84 "(corrected Ceilificate of Compliance filed

1-30-84) (Register 84, No. 5).

§ 54674. Respite Care.

NOTE: Authority cited: Section 26, Chapter 16, Statutes of 1983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Sections 4648 and 4685, Welfare and Institutions Code.

History

1 . Certificate of Compliance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (coiTccted Certificate of Compliance filed 1-30-84) Register
84, No. 5).

2. Expired by own terms (Register 88, No. 25).

§ 54675. Transportation.

NOTE: Authority cited: Section 26, Chapter 1 6, Statutes of 1 983-84 First Extraor-
dinary Session. Reference: Section 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History

1 . Editorial correction of subsection (b) filed 9-7-83 (Register 83, No. 40).

2. Certificate of Compliance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

3. Order of Repeal of subsections (b) and (d)(3) filed 1-23-84 by OAL pursuant
to Government Code Section 1 1349.6; effective thirtieth day thereafter (Regis-
ter 84, No. 5).

4. Expired by own terms (Register 88, No. 25).

§ 54676. Exceptions.

NOTE: Authority cited: Section 26, Chapter 1 6, Statutes of 1 983-84 First Extraor-
dinary Session. Reference: Secfion 26, Chapter 16, Statutes of 1983-84 First Ex-
traordinary Session; and Section 4648, Welfare and Institutions Code.

History

1 . Certificate of Compliance including amendment transmitted to OAL 12-22-83
and filed 1-23-84 (corrected Certificate of Compliance filed 1-30-84) (Regis-
ter 84, No. 5).

2. Expired by own terms (Register 88, No. 25).

Subchapter 4. Residential Services and
Quality Assurance Regulations

Article 1. Definitions

§ 56001 . Meaning of Words.

Words shall have their usual meaning unless the context or a definition
clearly indicates a different meaning. Words used in their present tense
include the future tense; words in the singular form include the plural
form. Use of the word "shall" denotes mandatory conduct; "may" de-
notes permissive conduct.

NOTE: Authority cited: Sections 4681 .1 and 4748, Welfare and Institutions Code.
Reference: Sections 4681.1 and 4748, Welfare and Institutions Code.

History

1 . Repealer of former subchapter 4 (articles 1-2, sections 56550-56610) and new
subchapter 4 (arficles 1-11, secfions 56001-56067), article 1 (sections
56001-56002) and section filed 1-14-91; operative 2-13-91 (Register 91, No.
14).

2. Editorial correction of HISTORY 1 (Register 98, No. 27).

§ 56002. Definitions.

(a) The following definitions shall apply to the regulations used in this
subchapter:

(1) "Administrator" means the Ucensee, or the adult designated by the
licensee to act in his/her behalf who assumes responsibility for facility
operations.

(2) "Admission Agreement" means the agreement required pursuant
to Title 22, California Code of Regulations, Sections 80068, 85068 and
87568.

(3) "Authorized Consumer Representative" means the parent, or
guardian of a minor, conservator of an adult, or person who is legally en-
titled to act on behalf of the consumer.

(4) "Child With Special Health Care Needs" means a child with a de-
velopmental disability who: 1) is receiving services and service coordi-
nation from a regional center; 2) is placed in a foster family home, small
family home or group home; and 3) has a medical condition that can rap-
idly deteriorate, resulting in permanent injury or death; or who has a med-
ical condition that requires specialized in home health care, including an
internal feeding tube, total parenteral feeding, a cardiorespiratory moni-
tor, intervenous therapy, a ventilator, urinary catheterization, ministra-
tions imposed by tracheostomy, colostomy, ileostoiny, or other medical
or surgical procedures; or special medication regimens, including injec-
tion, areosol treatment, and intravenous or oral medication which re-
quires specialized in-home health care.

(5) "Consumer" means an individual who has been determined by a
regional center to meet the eligibility criteria of the Welfare and Institu-
tions Code Section 45 1 2, and of Title 17, California Code of Regulations,
Sections 54000, 54001 and 54010, and for whom the regional center has
accepted responsibility.

(6) "Consumer Notes" means those ongoing notations made in the in-
dividual consumer file at the facility which are incidental to specific
events in the consumer's life, and which are made at the time of occur-
rence and are not a part of the quarterly or semi-annual report.

(7) "Consumer Services" means those services which the residential
service provider is responsible for implementing as a part of the program
design and the consumer's IPP.

(8) "Consumers' Rights" means the rights of regional center consum-
ers residing in facilities, as specified in Welfare and Institutions Code
Sections 4502, 4502. 1, 4503, 4504, 4705 and 4710.6; and Title 17, Cali-
fornia Code of Regulations, Division 2, Chapter 1, Subchapter 5, Sec-
tions 50510, 50515(a)(2), (b)(2) and (c), 50520(b), 50530, 50532, 50534,
50536, 50540 and 50960.

(9) "Contact" means any communication between two or more per-
sons or entities by means of face-to-face meetings, phone conversations,
or letters.

(10) "Days" means calendar days unless otherwise stated.

(11) "Department" means the State Department of Developmental
Services.

(12) "Direct Care Staff means facility staff, in Service Level 2, 3 and
4 facilities, who personally provide direct supervision and special ser-
vices to consumers and is synonymous with "Direct Support Profession-
als". The term includes the licensee, the administrator, management and
supervisory staff during that time when they are providing direct supervi-
sion and special services to consumers or are involved in performing pro-
gram preparation functions.

( 1 3) "Director" means the Director of the Department of Developmen-
tal Services or his/her designee.

(14) "Direct Supervision" means those activities in which direct care
staff provide care, supervision, training and support to promote the con-
sumer's functioning in the areas of self-care, daily living skills, physical
coordination, mobihty, behavioral self-control, choice-making, com-
munity integration, accessing community resources and participating in
leisure time activities.

(15) "Facility" means a licensed community care facility as defined in
Health and Safety Code Section 1502(a)(1), (4), (5) or (6); or a licensed
residential care facility for the elderly as defined in Health and Safety
Code Section 1 569. 2(k), which has been vendorized as a residential facil-
ity by a regional center pursuant to the requirements of Title 17, Califor-
nia Code of Regulations, Division 2, Chapter 3, Subchapter 2.

(16) "Facility Liaison" means the person, or his or her designee, as-
signed by the regional center as the principal coordinator between the re-
gional center and the facility.

(17) "Facility Staff means the administrator and direct care staff
employed by the facility who provide direct supervision and special ser-

Page 284

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56002

vices to consumers residing in the facility, and consultants employed by
the facility who provide support to direct care staff.

(18) 'immediate Danger" means conditions which constitute an im-
pending threat to the health and safety of a consumer(s) and which re-
quire immediate action by the regional center to safeguard the health and
safety of the consumers in the facility.

(19) "individual Life Quality Outcomes" means desired outcomes for
individual life quality and represent life conditions that people have iden-
tified as being important in their everyday lives.

(20) 'individual Program Plan (IPP)" means a written plan that is de-
veloped by a regional center Interdisciplinary Team, in accordance with
the provisions of Welfare and Institutions Code Sections 4646 and
4646.5.

(21) 'interdisciplinary Team (ID Team)" means the group of persons
convened, in accordance with Welfare and Institutions Code Sections
4646 and 4645.5, for the purpose of preparing a consumer's IPP.

(22) "Licensee" means the person who is identified as the licensee on
the license to operate as a community care facility which is issued to the
facility by the Department of Social Services' Community Care Licens-
ing Division.

(23) "Looking at Service Quality Provider's Handbook" means the
publication so entitled and developed by the Department to help adminis-
trators and direct care staff increase the quality of their services through
a self-assessment of their direct supervision and special services to con-
sumers. The self-assessment is based upon twenty-five individual life
quality outcomes. The publication entitled "Looking at Service Quality
Provider's Handbook," original edition which bears no revision or publi-
cation date, is hereby incorporated by this reference as though fully set
forth herein.

(24) "Medication" means any drug or other agent ordered by a physi-
cian, and over-the-counter medications used to treat symptoms of illness
or injury.

(25) "Natural Environment" means places and social contexts com-
monly used by individuals without developmental disabilities.

(26) "Noncompliance" means failure to comply with any of the re-
quirements of Title 17, California Code of Regulations, Division 2,
Chapter 3, Subchapter 4 or 6.

(27) "Normalization" means life conditions which enable consumers
to lead more independent, productive and normal lives which approxi-
mate the pattern of daily living of non-disabled persons of the same age
and reflect personal choice.

(28) "Personal and Incidental Allowance" means that portion of the
Supplemental Security Income/State Supplemental Program (SSI/SSP)
payment designated for the personal expenses of the consumer.

(29) "Placement" means the process the regional center and the con-
sumer complete to assist the consumer to locate and make an initial move
to a facility.

(30) "Program Design" means the description of consumer services
offered by a facility, the functional characteristics of the consumers the
facility will serve, and the resources available to meet individual service
needs consistent with the facility's service level.

(31) "Program Preparation Functions" means ancillary activities per-
formed by direct care staff or administrators, including, but not limited
to. data collection and analysis, development of training plans, staff
meetings, consumer meetings and parent conferences.

(32) "Quality Assurance (QA) Coordinator" means that person who
is knowledgeable in, and designated by the regional center to be responsi-
ble for, managing all elements of the Quality Assurance Plan.

(33) "Quality Assurance (QA) Evaluation" means the process of as-
sessing a specific facility's ability to provide the minimum acceptable
level of service required by these regulations and the effects of those ser-
vices upon the consumers served.

(34) "Quality Assurance Evaluation Team" means a group of two or
more persons who perform a QA evaluation and have knowledge of resi-
dential services for persons with a developmental disability by virtue of
personal, professional or academic experience or training.

(35) "Quality Assurance (QA) Plan" means the written plan developed
by each regional center to coordinate the QA evaluation process, ongoing
monitoring, and necessary training and technical assistance to assure im-
plementation of these regulations.

(36) "Regional Center" means a diagnostic, counseling and service
coordination center for developmentally disabled persons and their fami-
nes which is established and operated pursuant to Welfare and Institu-
tions Code Sections 4620 through 4669, by a private nonprofit communi-
ty agency or corporation acting as a contracting agency. As used in these
regulations, any reference to the regional center shall, by reference, be
applicable to those agencies or persons with which the regional center
contracts or employs to provide service coordination to consumers under
the provisions of Welfare and Institutions Code Section 4647.

(37) "Regional Center Director" means the Director of the Regional
Center or his/her designee.

(38) "Regional Center Representative" means a person who is
employed or designated by the regional center to represent that agency.

(39) "Relocation" means the process the regional center and the con-
sumer complete to enable a consumer to move from one facility to anoth-
er.

(40) "Residential Service(s)" means the direct supervision and special
services which facility staff provide to a consumer during the process of
implementing the program design and achieving the objectives of the In-
dividual Program Plan (IPP) for which the residential service provider is
responsible.

(41) "Residential Service Provider" means an individual or entity
which has been licensed by the Department of Social Services as a com-
munity care facility pursuant to Health and Safety Code Section
1 502(a)( 1), (4), (5) or (6); or is defined as a licensed facility for the elder-
ly in Health and Safety Code Section 1569.2; has completed the vendori-
zation process pursuant to Title 1 7 , California Code of Regulations , Divi-
sion 2, Subchapter 2; and has been assigned a vendor identification
number beginning with the letter "H" pursuant to Title 17, California
Code of Regulations, Section 54340(a)(1).

(42) "Self Care" means providing for, or meeting, a consumer's own
physical and personal needs in the areas related to eating, dressing, toilet-
ing, bathing and personal hygiene.

(43) "Service Coordinator" means the regional center or designee
agency employee, or his/her designee, who has responsibility for provid-
ing or ensuring service coordination as specified in Welfare and Institu-
tions Code Section 4647.

(44) "Service Level" means one of a series of 4 levels which has been
approved for each facility by a regional center. Service Levels 2, 3 and
4 have a specified set of requirements that a facility must meet wliich ad-
dresses the direct supervision and special services for consumers within
that facility.

(45) "Service Needs" means those consumer needs which require di-
rect supervision and special services, which are identified through the ID
Team assessment process.

(46) "Service Outcomes" means the results, for the consumer, of direct
supervision and special services provided by the facility's program.

(47) "Special Incident Report (SIR)" means a special incident report
as defined in Title 17, California Code of Regulafions, section 54327(b).

(48) "Special Services" means specialized training, treatment, and/or
supervision which are required by the consumer's IPP and provided by
direct care staff in addifion to direct supervision.

(49) "Submit" means the postmarking or hand delivery of the item re-
quired no later than the last day of the timeline allowed.

NOTE: Authority cited: Sections 468 LI, 4695.2(e) and 4748, Welfare and Institu-
tions Code. Reference: Sections 4501, 4502, 4503, 4504, 4646, 4646.5, 4647,
4648, 4681.1, 4695, 4695.2, 4705, 4740 through 4748 and 17710, Welfare and
Institutions Code; Sections 1502(a) and 13131, Health and Safety Code.

History
\. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).
2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992.
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

Page 285

§ 56003

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

3. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

4. Hditorial correction of History 2 (Register 94. No. 47).

5. P^ditorial correction of subsections (a)(2) and (24) and capitalizing "S" of "Sec-
tion" throughout (Register 95, No. 18).

6. Change without regulatory effect amending subsection (a)(21) and NoTt- filed
6-19-95 pursuant to section 100, title 1. California Code of Regulations (Resis-
ter95. No. 25).

7. Repealer of subsection (a)( 1), subsection renumbering, and amendment of new-
ly designated subsections (a)(20), (a)(38), (a)(40), (a)(41) and (a)(45) and
amendment of NoTi; filed 6-29-98 as an emergency; operative 6-29-98 (Reg-
ister 98, No. 27). A Certificate of Compliance must be transmitted to OAL by
10-27-98 or emergency language will be repealed by operation of law on the
following day.

8. New subsections (a)(19) and (a)(22) and subsection relettering filed 6-30-98
as an emergency: operative 6-30-98 (Register 98, No. 27). A Certificate of
Compliance must be transmitted to OAL by 10-28-98 or emergency language
will be repealed by operation of law on the following day.

9. New subsections (a)(19) and (a)(22) refiled 10-20-98 as an emergency; opera-
tive 10-20-98 (Register 98, No. 43). A Certificate of Compliance must be trans-
mitted to OAL by 2-17-99 or emergency language will be repealed by opera-
tion of law on the following day.

10. Repealer of subsection (a)(1), subsecfion renumbering, amendment of newly
designated subsections (a)(20), (a)(38), (a)(40), (a)(41 ) and (a)(45) and amend-
ment of NoTt-, refiled 10-2()-98 as an emergency: operative 10-27-98 (Register
98, No. 43). A Certificate of Compliance must be transmitted to OAL by
2-24-99 or emergency language will be repealed by operation of law on the fol-
lowing day.

1 1 . Certificate of Compliance as to first 10-20-98 order, including further amend-
ment of subsection (a)(22), transmitted to OAL 12-31-98 and filed 2-17-99
(Register 99, No. 8).

12. Certificate of Compliance as to second 10-20-98 order, including further
amendment of section, transmitted to OAL 12-31-98 and filed 2-17-99 (Reg-
ister 99, No. 8).

1 3. Amendment of subsection (a)( 1 2), new subsection (a)( 13). repealer of subsec-
tion (a)( 14), renumbering and amendment of former subsection (a)(13) to sub-
section (a)(14), amendment of subsections (a)(41) and (a)(48) and amendment
of NoTi-: filed 3-13-2000 as an emergency; operative 3-13-2000 (Register
2000, No. 1 1 ). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2000 or emergency language will be repealed by operation of law on the
following day.

14. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code secfion 1 1346.1(f) (Register 2000, No.
30).

15. Amendment of subsection (a)(12), new subsection (a)(13), repealer of subsec-
tion (a)(14), renumbering and amendment of former subsecfion (a)(13) to sub-
section (a)( 14), amendment of subsections (a)(41 ) and (a)(48) and amendment
of Note filed 7-26-2000 as an emergency; operative 7-26-2000 (Register
2000, No. 30). A Certificate of Compliance must be transmitted to OAL by
1 1-27-2000 or emergency language will be repealed by operation of law on the
following day.

16. Refiling of 7-26-2000 order, including further amendment of subsection
(a)(12), new subsection (a)(22), subsection renumbering and amendment of
newly designated subsections (a)(23) and (a)(42), 1 1-27-2000 as an emergen-
cy; operative 1 1-27-2000 (Register 2000, No. 48). A Certificate of Compliance
must be transmitted to OAL by 3-27-2001 or emergency language will be re-
pealed by operation of law on the following day.

17. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

18. Change without regulatory effect amending subsection (a)(48) filed
8-28-2001 pursuant to section 100, title 1, California Code of Regulations
(Register 2001, No. 35).

19. Repealer of subsection (a)(43), subsection renumbering, and amendment of
newly designated subsection (a)(47) filed 10-25-2001 as an emergency; opera-
tive 10-31-2001 (Register 2001, No. 43). A Certificate of Compliance must be
transmitted to OAL by 2-28-2002 or emergency language will be repealed by
operation of law on the following day.

20. Change without regulatory effect amending Note filed 2-28-2002 pursuant
to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

21. Certificate of Compliance as to 10-25-2001 order transmitted to OAL
2-28-2002 and filed 4-10-2002 (Register 2002, No. 15).

22. Change without regulatory effect repealing subsection (a)(42), renumbering
subsections and adopting new subsection (a)(47) filed 5-27-2003 pursuant to
section 100, title 1, California Code of Regulations (Register 2003, No. 22).

23. Change without regulatory effect amending subsection (a)(2) filed
11-10-2005 pursuant to section 100, titie 1, California Code of Regulations
(Register 2005, No. 45).

Article 2. General Requirements

§ 56003. Residential Services Orientation.

(a) The regional center shall provide a residential services orientation
for all persons who wish to become vendorized to provide services pur-
suant to Subchapter 4. The residential services orientation shall occur no

less than every six months and shall include the following information:

( 1 ) An overview of Title 17, California Code of Regulations require-
ments applicable to residential facilities, including:

(A) Record inaintenance requirements pursuant to Title 17, California
Code of Regulations, Section 50604.

(B) Vendorization procedures pursuant to Title 17, California Code of
Regulations, Sections 54310 through 54374;

(D) Regional center evaluation and monitoring processes pursuant to
Sections 56046 through 56052:

(E) Access requirements as specified in Title 17. California Code of
Regulations. Section 50603;

(F) Consumers' Rights as defined in Section 56002(a)(9);

(G) Elements of the program design pursuant to Section 56013.

(2) An overview of the self-assessment process and the individual life
quality outcomes identified in the "Looking at Service Quality Provid-
er's Handbook".

(3) Copies of sections of Title 17, California Code of Regulations
applicable to residential facilities, and "Looking at Service Quality Pro-
vider's Handbook," supplied by the Department.

(b) The administrator shall complete the residential services orienta-
tion:

(1) Before the admission of the first regional center consumer; or

(2) When two or more years have elapsed since he/she last served as
an administrator.

NOTE: Authority cited: Chapter 157, Statutes of 2003; and Sections 4648.1,
4681.1, 4742 and 4748, Welfai-e and Institutions Code. Reference: Sections 4648,
4648.1. 4681.1, 4740, 4742 and 4748, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Change without regulatory effect amending designation of subsection (a) filed
11-1 7-93 pursuant to titie 1 , section 1 00, California Code of Regulations (Reg-
ister 93, No. 47).

4. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

5. Editorial correction of History 2 (Register 94, No. 47).

6. Editorial correction capitahzing "S" of "Section" throughout (Register 95, No.
18).

7. New subsections (a)(2) and (a)(3) filed 6-30-98 as an emergency; operative
6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted
to OAL by 10-28-98 or emergency language will be repealed by operation of
law on the following day.

8. New subsections (a)(2)-(3) refiled 10-20-98 as an emergency; operative
10-20-98 (Register 98, No. 43). A Certificate of Compliance must be trans-
mitted to OAL by 2-17-99 or emergency language will be repealed by opera-
tion of law on the following day.

9. Certificate of Compliance as to 10-20-98 order, including further amendment
of subsections (a)(2) and (a)(3) and amendment of Note, transmitted to OAL
12-31-98 and filed 2-17-99 (Register 99, No. 8).

10. New subsection (a)(1)(A), subsection relettering, amendment of newly desig-
nated subsection (a)(1)(B) and amendment of Note filed 10-9-2003 as an
emergency; operative 10-9-2003 (Register 2003, No. 41). A Certificate of
Compliance must be transmitted to OAL by 2-6-2004 or emergency language
will be repealed by operation of law on the following day.

1 1 . New subsection (a)( 1 )(A), subsection relettering, amendment of newly desig-
nated subsection (a)(1)(B) and amendment of Note refiled 2-3-2004 as an
emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of Com-
pliance must be transmitted to OAL by 6-2-2004 or emergency language will
be repealed by operation of law on the following day.

12. New subsection (a)(1)(A), subsection relettering, amendment of newly desig-
nated subsection (a)(1)(B) and amendment of Note refiled 6-1-2004 as an
emergency; operative 6-1 -2004 (Register 2004, No. 23). A Certificate of Com-
pliance must be transmitted to OAL by 9-29-2004 or emergency language will
be repealed by operation of law on the following day.

13. Certificate of Compliance as to 6-1-2004 order transmitted to OAL
9-15-2004 and filed 10-28-2004 (Register 2004, No. 44).

§ 56004. Facility Service Levels.

(a) Service Level 1 through 4 facilities shall possess a valid Communi-
ty Care Facility license issued by the Department of Social Services'
Community Care Licensing Division pursuant to Health and Safety Code
Sections 1500 et seq., and Title 22, California Code of Regulations, Divi-
sion 6, Sections 80000 et seq.

Page 286

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56004

(b) Service Level 1 through 4 facilities shall be vendorized by a region-
al center pursuant to the requirements of Title 17, Cahfornia Code of
Regulations, Chapter 3, Subchapter 2.

( 1 ) Direct supervision and special services pursuant to Welfare and In-
stitutions Code Sections 4681.1(b)(2) and (b)(3) as needed to provide
services in accordance with, and to meet the requirements of, the ap-
proved program design pursuant to Section 56005 and the consumer's
IPP objectives.

(2) A basic staffing level of no less than one direct care staff person at
all times when consumers are under the supervision of facility staff. This
basic staffing level shall be the total direct supervision and special ser-
vices required of the facility up to a maximum number of consumers as
follows:

(A) For Service Level 2, one direct care staff person for up to six con-
sumers in the facility;

(B) For Service Levels 3, 4A, and 4B. one direct care staff person for
up to three consumers in the facility;

(D) For Service Levels 4F, 4G, 4H, and 4L one direct care staff person
for the first consumer in the facility.

(d) In addition to the basic level of staffing described in subsection
(c)(2)(A) through (D) above, facilities providing residential services to
a greater number of consumers shall provide a cumulative number of ad-
ditional weekly direct care staff hours for consumers based upon the fa-
cility's service level, as specified in the table below:

ADDITIONAL DIRECT CARE STAFF HOURS BY SERVICE

LEVEL

Number of Additional Weekly Hours for

Each Additional Consumer

Service
Level

7 or more*

2
3

Basic

12
19

Staffing

Level

4D
4E

18
30

30
34

*Consumer(s)

( 1 ) A facility with seven or more consumers shall provide the number
of weekly direct care staff hours for each additional consumer as speci-
fied in the table above.

(e) A facility may include within the total number of additional direct
care staff hours required pursuant to subsection (d) above, hours of pro-
gram preparation functions which shall be counted as follows:

(1) Service Level 2 facihties: Up to 2 hours per consumer per week.

(2) Service Level 3 facilities: Up to 2 hours per consumer per week.

(3) Service Level 4A, 4B, 4C facilities: Up to 3 hours per consumer per
week.

(4) Service Level 4D, 4E, 4F, 4G facilities: Up to 4 hours per consumer
per week.

(5) Service Level 4H facilities: Up to 5 hours per consumer per week.

(6) Service Level 41 facilities: Up to 7 hours per consumer per week.
Program preparation function hours shall not be used as a basis for in-
creasing a service level.

Staff schedules which were part of the facility's program design as ap-
proved by the regional center pursuant to Section 56005 prior to Septem-
ber 20, 1993 shall remain in effect.

(f) In addition to the above direct care staff hours requirements, Ser-
vice Level 4 facilities shall provide a cumulative number of consultant
hours consisting of no less than the number of hours indicated below dur-
ing each consecutive six-month period after the effective date of these
regulations based upon the number of consumers in the facility.

Page 287

§ 56005

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

CONSULTANT HOURS BY SERVICE LEVEL

Service

Number of Hours for Each

Level

Consumer

NOTE: Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institu-
tions Code; Chapter 722. Statutes of 1992, Section 147. Reference: Sections 4646,
4646.5, 4648, 4681.1, 4748, 4786 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Change without regulatory effect amending subsection (b) filed 1-18-91 pur-
suant to section 100, title 1 , California Code of Regulations; operative 2-13-91
pursuant to Government Code section 11346.2(d) (Register 91, No. 14).

3. Amendment of Table, new subsection (d) and subsection renumbering, and
amendment of Note filed 1 1-4-91 as an emergency; operative 1 1-4-91 (Reg-
ister 92, No. 8). A Certificate of Compliance must be transmitted to OAL
3-3-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

4. Amendment of Table, new subsection (d) and subsection renumbering and
amendment of Noth refiled 3^1—92 as an emergency; operative 3^-92 (Regis-
ter 92, No. 1 5). A Certificate of Compliance must be transmitted to OAL 7-2-92
or emergency language will be repealed by operation of law on the following
day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8^1-92 (Register 92, No. 32).

6. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

7. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.

47).

8. Editorial correction of History 6 (Register 94, No. 47).

9. Editorial correction of subsection (c)(1) (Register 95, No. 18).

10. Change without regulatory effect amending Note filed 12-2-98 pursuant to
secdonlOO, title 1. California Code of Regulations (Register 98, No. 49).

§ 56005. Facility Service Level Approval Process.

(a) A residential service provider shall submit a written request to the
regional center to establish an approved Service Level 2, 3 or 4. The writ-
ten request shall include the following:

(1) A statement of the administrator's qualifications pursuant to Sec-
tion 56037;

(2) A program design pursuant to Section 56013 which is consistent
with the proposed service level; and

(3) Specification of the proposed facility service level pursuant to the
requirements in Section 56004.

(b) Within 45 days of receipt of a request to establish an approved Ser-
vice Level 2, 3 or 4, the regional center shall review the request and pro-
vide written notification to the applicant of the:

(1) Approval of the requested service level and the effective date for
the approved service level which shall be the date of issuance of written
notification to the applicant; or

(2) Disapproval of the requested service level specifying the reason(s)
for disapproval.

(c) The requirements specified in subsections (a) and (b) above shall
also apply to those facilities which have an approved service level and
are submitting a request to establish another approved service level.

(1) A facility's written request to be established as another approved
service level shall be considered only when there is a change in the facil-
ity's ownership or the ID Teams of a majority of the facility's consumers
have identified, pursuant to Section 56022(a) and (b), that the consumers
need a new service level.

NOTE: Authority cited: Secfions 4681.1 and 4791(i), Welfare and Institutions
Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1 and
4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (c)(1) and amendment of Note filed 1 1-4-91 as an emergency;
operative 11-4—91 (Register 92, No. 8). A Certificate of Compliance must be
transmitted to OAL 3-3-92 or emergency language will be repealed by opera-
tion of law on the following day.

3. New subsection (c)(1) and amendment of Note refiled 3-4-92 as an emergen-
cy; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must
be transmitted to OAL 7-2-92 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-4-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 1 47 (Register 93 , No . 39 ) . These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsection (c)(1) filed 6-19-95
pursuant to section 100, title 1, California Code of Regulations (Register 95, No.
25).

§ 56009. Regional Center Compliance.

NOTE; Authority cited: Sections 4681 . 1 and 4748, Welfare and Institutions Code.
Reference: Sections 4631, 4635, 4648.1. 4681,1 and 4748, Welfare and Institu-
tions Code.

History

1. New section filed 8-4-92; operative 8^-92 (Register 92, No. 32).

2. Repealer filed 9-20-93 as an emergency; operative 9-20-93. Submitted to
OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147
(Register 93, No. 39). These regulations shall not be repealed by the Office of
Administrative Law and shall remain in effect until revised or repealed, as ap-
propriate.

3. Editorial correction of History 2 (Register 94, No. 47).

Article 3. Program Design

§ 56013. Program Design Requirements.

(a) Each facihty applying for Service Level 2, 3 or 4 approval shall
submit a written program design to the regional center pursuant to Sec-
tion 56005 which is based upon the principles of normalization as mea-

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§ 56017

sured by consumer participation in a variety of integrated, age-appropri-
ate activities wliich take place in natural environments, at home, at work,
in the community and during leisure time.

(b) The program design shall include:

( 1 ) An organizational chart for the facility;

(2) A statement of purpose, a description of consumer services to be
provided, and expected service outcomes for consumers to be served;

(3) Facility entrance and exit criteria which identify the characteristics
of the consumer population the facility intends to serve, including age
range, gender, ambulatory status, medical conditions, self-help skills
and behavioral characteristics;

(4) A description of program preparation functions to be performed by
facility staff which is consistent with the requirements specified in Sec-
tion 56004(e)(1) through (6);

(5) A description of staff qualifications and a duty statement for each
staff position in the facility;

(6) A sample staff schedule; and

(7) A staff training plan.

(c) In addition to subsection (b) the program design for each facility
applying for Service Level 3 approval shall include:

( 1 ) A description of services designed to enhance the capabilities of
consumers including those with:

(A) Significant deficits in self-help skills; and/or

(B) Some limitations in physical coordination and mobility; and/or

(d) In addition to subsection (b) the program design for each faciUty
applying for Service Level 4 approval shall include:

(1) A description of services designed to enhance the capabilities of
consumers including those with:

(A) Severe deficits in self-help skills; and/or

(B) Severe impairment in physical coordination and mobility; and/or

(2) A description of consultant qualifications, hours and duties;

(3) A specific description of the instructional methods and techniques
to be utilized to achieve the desired service outcomes; and

(4) A methodology for measurement of consumer progress toward
achievement of IPP objectives which includes:

(A) Types of data to be collected;

(B) Data collection systems;

(D) Methods and intervals for summarizing data and reporting on
progress made toward achieving IPP objectives.

NOTE: Authority cited: Sections 4648(a), 468 1.1, 4748 and 4791(i), Welfare and
Institutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections
4501, 4646, 4648, 4681.1 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsections (a)(1)(A) and (a)(4), and amendment of renumbered subsec-
tions (a)(4)-(7) and Note filed 1 1^-91 as an emergency; operative 1 1-4-91
(Register 92, No. 8). A Certificate of Compliance must be transmitted to OAL
3-3-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. New subsections (a)(1)(A) and (a)(4), and amendment of renumbered subsec-
tions (a)(4)-(7) and Note refiled 3-4-92 as an emergency; operative 3-4-92
(Register 92, No. 15). A Certificate of Compliance must be transmitted to OAL
7-2-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

4. Certificate of Compliance as to 3-^-92 order including repealer of subsections
(a)(1)(A) and (d)(3) and amendment of subsections (a)(4) and (d)(2) transmitted
to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
SecUon 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Editorial correction of subsections (a) and (d)(4)(D) (Register 95, No. 18).

9. Change without regulatory effect amending Note filed 12-2-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 49).

Article 4. Consumer Placement and
Relocation

§ 56016. Placement and Relocation Requirements.

(a) The regional center shall, to the extent feasible, provide opportuni-
ties for each consumer or authorized consumer representative to have a
choice among appropriate, available living arrangements.

(b) The regional center shall provide placement and relocation assis-
tance to each consumer as specified in Welfare and Institutions Code
Sections 4647, 4648 and 4747.

(c) The administrator may refuse to admit a consumer who has been
referred to the facility by a regional center representafive if the facility
cannot meet the identified needs of the consumer.

(d) No consumer shall be placed into or relocated to a facility where
a license revocation action is pending or the license renewal application
has been denied.

(e) When the administrator determines that the facility can no longer
meet the needs of the consumer, the administrator shall immediately
notify the regional center, the consumer and/or the consumer's autho-
rized representative.

( 1 ) The administrator shall put verbal notification in writing and for-
ward to the regional center within 24 hours.

(f) Upon notification as required in subsection (e), the regional center
shall relocate the consumer within 30 days or within a time frame which
has been muhially agreed-upon by the regional center, the administrator
and the consumer and/or the consumer's authorized representative.

(g) Within a reasonable period of time based on the health and safety
considerations for the consumer and no longer than the time frame for re-
location pursuant to subsection (f) the regional center shall convene the
consumer's I.D. Team to assess the consumer's needs and to determine:

( 1 ) The services and supports to be provided to the consumer before,
during and after the relocation; and

(2) Any additional measures necessary to meet the consumer's health
and safety needs until the relocation has been accomplished.

Note: Authority cited: Sections 4681.1 , 4748 and 4791(i), Welfare and Institu-
tions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4647,
4648, 4652, 468 1. 1, 474 1 , 4744, 4746, 4747, 4748 and 479 1 , Welfare and Institu-
tions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of article heading and section filed 1 1-23-94; operative 1 1-23-94
(Register 94. No. 47).

4. Editorial cortection inserting subsection (c) and amending History 2 (Register
94, No. 47).

5. Editorial correction of subsection (b) and Authority cite (Register 95, No. 1 8).

6. Change without regulatory effect amending Note filed 12-2-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 49).

§ 56017. Consumer Placement and Relocation Assistance.

(a) When the consumer or the consumer's authorized representative
requests assistance to relocate, or the administrator or regional center
finds it necessary for a consumer to move from his/her current residential
location, the ID Team, shall determine the living arrangement appropri-
ate to the consumer's needs.

(b) When the appropriate living arrangement is determined to be a fa-
cility, the regional center shall release written information to the prospec-
tive administrator(s) for the purpose of determining if the residential ser-
vice provider can meet the consumer's service needs. The information
shall include:

(1) The current IPP;

(2) A description of the consumer's service needs;

(3) A statement of the consumer's ambulatory or nonambulatory sta-
tus;

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§ 56018

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(4) Known information regarding individual likes and dislikes, abili-
ties, interests and activities;

(5) Known information related to any history of aggressive or danger-
ous behavior of the consumer towards self or others;

(6) Identified needs for training and treatment of behaviors which in-
terfere with, or prevent participation in, activities;

(7) Identified medical needs including special dietary requirements;

(8) When the consumer has an authorized representative, the name,
address and telephone number of the consumer's authorized representa-
tive; and

(9) When the consumer has a parent(s) or other relative and the par-
entis) or other relative has been actively involved in the provision of the
services and supports specified in the consumer's IPP, the parent(s) or
other relative(s) name, address and telephone number.

NOTE: Authority cited: Sections 4681.1, 4748 and 479 l(i). Welfare and Institu-
tions Code; Chapter 722, Statutes of 1 992, Section 1 47. Reference: Sections 45 14,
4646, 4646.5. 4648, 468 1 . 1 , 47 10, 474 1 , 4744, 4747, 4748 and 479 1 , Welfare and
Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency: operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of section heading and text filed 11-23-94; operafive 11-23-94
(Register94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (b) (Register 95, No. 18).

6. Change without regulatory effect amending NOTE filed 12-2-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 49).

§56018. Preadmission Visits.

(a) The service coordinator shall advise the consumer, or the consum-
er's authorized representative, of the opportunity to arrange a preadmis-
sion visit to a facility for the purpose of determining the suitability of the
facility as a living environment for the consumer.

(b) When the consumer or the consumer's authorized representative
requests a preadmission visit, the service coordinator or the consumer or
the consumer's authorized representative shall contact the facility ad-
ministrator to establish an agreed-upon date and time for a preadmission
visit.

( 1) Be available to discuss the facility and its services pursuant to Sec-
tion 56013; and

(2) Determine if the facility can meet the service needs of the consum-
er.

(d) The service coordinator shall provide information to the adminis-
trator in accordance with Section 56017(b)(l)-(9), when the consumer
is on an overnight visit or is under the direct supervision of the facility
during a day visit.

NOTE: Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institu-
tions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections
4681.1, 4747, 4748 and 4791, Welfare and Insfitutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 1 1-23-94; operafive 1 1-23-94 (Register 94, No.
47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsections (c)(]) and (d) (Register 95, No. 18).

§56019. Consumer Admission.

(a) When the consumer or the consumer's authorized representative,
administrator and the service coordinator have reached an agreement re-
garding consumer placement or relocation to a specific facility, the ad-
ministrator shall:

(1) Establish with the consumer or the consumer's authorized repre-
sentative and the service coordinator a date and time for the consumer's
admission to the facility;

(2) Explain any facility rules and the facility grievance procedure to
the consumer and the consuiner's authorized representative via methods
appropriate to the communication skills of the consumer, and document
such explanation in the consumer notes;

(3) Determine, with the service coordinator, and consumer or the con-
sumer's authorized representative, how the consumer's personal and in-
cidental allowance shall be dispensed and recorded; and

(4) Meet with the consumer and the consumer' s family or the consum-
er's authorized representative on the day of admission.

(b) The service coordinator shall:

( 1 ) For a consumer who is 1 8 years of age or younger, and as appropri-
ate, up to 22 years of age:

(A) Identify the person responsible for representing the interests of the
consumer for educational and related services, and provide this informa-
tion in writing to the administrator;

(B) Notify the special education administrator for the school district
in which the facility is located of the date the consumer will be admitted
to the facility and any special educational services required.

(2) Document in the consumer's regional center record that the admin-
istrator was provided with the information specified in Section
56017(b)(I)-(9);

(3) Accompany the consumer to the facility at the time of admission
unless other arrangements have been made with the consumer, or the
consumer's authorized representative, and the administrator;

(A) The service coordinator shall, when not present on the day of ad-
mission, make a personal or telephone contact with the consumer, or the
consumer's authorized representative and the administrator within five
working days of the admission and meet with both the administrator and
consumer and/or the consumer's authorized representative when re-
quested by the administrator, consumer or the consumer's authorized
representative.

(4) Provide and explain to the consumer or the consumer's authorized
representative, information regarding the consumer's rights as specified
in Section 56002(a)(9); and

(5) Provide a telephone number to the consumer or the consumer's au-
thorized representative where he/she can contact the service coordinator.

( 1 ) The admission agreement shall include statements certifying that:

(A) No objection has been made to admission of the consumer to the
facility;

(B) The consumer or the consumer's authorized representative has
been informed of the consumer's rights as defined in Section
56002(a)(9); and

(2) The admission agreement shall be:

(A) Signed by the facility administrator, the regional center and the
consumer or the consumer's authorized representative; and

(B) Effective on the date the consumer is admitted to the facility.
Note: Authority cited: Sections 4681.1, 4748 and 4791(1), Welfare and Institu-
tions Code; Chapter 722, Statutes of 1992, Secfion 147. Reference: Sections 4648,
4659,4681.1, 4741,4742, 4747, 4748, 4803 and 4791, Welfare and Institutions
Code; Secdons 56026(c)(4) and 56156, Education Code.

History

1. New section filed 1-14-91: operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for prinfing only pursuant to Chapter 722, Statutes of 1992,
Section 1 47 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of section heading and text filed 11-23-94; operative 11-23-94
(Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsections (b)(2) and (4) and Reference cite (Register
95, No. 18).

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Title 17

Health and Welfare Agency — Department of Developmental Services

^ 56027

6. Change without regulatory effect amending Noth llled 6-19-95 pursuant to
section 100, title 1 , California Code of Regulations (Register 95, No. 25).

§ 56020. Emergency Placement and Relocation.

Each regional center shall develop and maintain procedures to be im-
plemented in the event of emergency situations requiring consumer
placement(s) or relocation(s).

NOTE: Authority cited: Sections 4681.1, 4748 and 479 l(i). Welfare and Institu-
tions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648,
4681 .1, 4741, 4748 and 4791. Welfare and Institutions Code.

History

1. New section filed 1-14-91: operative 2-13-91 (Register 91, No. 14).

2. Amendment of section fded 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.

47).

4. Editorial correction of History 2 (Register 94, No. 47).

Article 5. Consumer Services

§ 56022. Consumer IPP Objectives.

(a) Within 30 days after the consumer's admission, the service coordi-
nator shall review jointly with the ID Team the consumer's IPP objec-
tives as necessary pursuant to Welfare and Institutions Code Sections
4646.5 and 4647.

( 1 ) The service coordinator shall invite the administrator to meet with
the ID Team to provide information concerning the consumer.

(2) It shall be the responsibility of the administrator to notify the ser-
vice coordinator when there has been a change in the consumer's service
needs which may necessitate a reassessment of the type and amount of
services which are necessary to achieve the IPP objectives.

(b) The consumer's IPP shall include:

(1) The date of the IPP meeting;

(2) A determination of the type and amount of services which shall be
provided by the facility to meet the consumer's service needs;

(3) An identification of the appropriate .service level which is neces-
sary to implement the IPP; and

(4) A list of all participants present at the IPP meeting.

(c) The service coordinator shall provide the administrator and the
consumer, or the consumer's authorized representative and all persons
responsible for the implementation of the IPP with a copy of the IPP with-
in 30 days of the review specified in subsection (a) above.

(d) Administrators for all service levels shall provide services which
are consistent with the program design and the consumer's IPP objec-
tives for which the facility is responsible.

NOTE: Authority cited: Sections 4681.1, 4748, and 4791(i), Welfare and Institu-
tions Code: Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4646,
4647, 4681.1, 4740, 4743, 4748 and 4791, Welfare and In.stitutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (a)(2) filed 8-4-92; operative 8-4-92 (Register 92, No. 32).

3. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 1 47 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

4. Amendment of article heading, secfion heading and text filed 1 1-23-94; opera-
tive 1 1^23^94 (Register 94, No. 47).

5. Editorial correction of Hi.sTORY 3 (Register 94, No. 47).

6. Editorial correction of subsection (a) (Register 95, No. 18).

7. Change without regufafory effect amending Note filed 6-19-95 pursuant to
section 100, title 1, California Code of Regulations (Register 95, No. 25).

8. Change without regulatory effect amending Noti-; filed 12-2-98 pursuant to
section 100, title 1, California Code of Regulafions (Register 98, No. 49).

§ 56026. Consumer Notes, Quarterly and Semi-Annual
Reports.

(a) The administrator for each Service Level 2, 3 or 4 facility shall be
responsible for ensuring preparation and maintenance of on-going, writ-
ten consumer notes which shall include:

(1 ) Community and leisure activities;

(2) Overnight visits away from the facility;

(3) Illness;

(4) SIRS as defined in Section 54327(b);

(5) Medical and dental visits; and

(6) The date and signature of the staff person making the entry.

(b) The administrator for each Service Level 2 and 3 facility shall he
responsible for ensuring the preparation and maintenance of a written se-
mi-annual report of consumer progress toward achievement of each IPP
objective for which the facility is responsible. The report shall include the
date of completion of the report and signature of the person preparing the
report.

(c) The administrator for each Service Level 4 facility shall he respon-
sible for ensuring the preparation and maintenance of a written quarterly
report of consumer progress toward achievement of each IPP objective
for which the facility is responsible.The report shall include:

( 1 ) A summary of the data collected for each consumer as specified in
Section 56013(d)(4);

(2) Identification of barriers to consumer progress and actions taken
in response to these barriers; and

(3) The date of completion of the report and signature of the person
preparing the report.

(d) The administrator for each Service Level 4 facility shall submit the
quarterly report required in subsection (c) above to the service coordina-
tor within 30 days of the end of the quarter.

NOTE: Authority cited: Sections 4681.1, 4748 and 4791 (i). Welfare and Iiistitu
tionsCode; Chapter 722, Statutes of 1992, Section 147. Reference: .Sections 4646,
4646.5, 4681.1, 4742, 4748 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-1.3-91 (Register 91, No. 14).

2. New subsections (e) and (f) and amendment of Noti-. filed 1 1-4-91 as an emer-
gency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance
must be transmitted to OAL 3-3-92 or emergency language will be repealed by
operation of law on the following day.

3. New subsections (e) and (f) and amendment of Noti-: refiled 3-4-92 as an emer-
gency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of section
heading, and subsections (b)-(d) and repealer of sub.sections (c)(3), (e) and (f)
transmitted to OAL 6-25-92 and filed 8^-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of section heading and text filed 1 1-2.3-94; operative 1 1-23-94
(Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsection (a) filed 6-19-95 pur
suant to secfion 100, title 1, California Code of Regulations (Register 95. .No.
25).

9. Change without regulatory effect amending Note filed 12-2-98 pursuant to
section 100, title 1, CaHfomia Code of Regulations (Register 98. No. 49).

10. Certificate of Compliance as to 10-25-2001 order, including amendment of
subsection (a)(4) transmitted to OAL 2-28-2002 and filed 4-10-2002 (Reeis-
ter 2002, No. 15).

§ 56027. Special Incidents.

(a) Each regional center shall report speciid incidents to the Depart-
ment pursuant to Title 17, California Code of Regulations. Section
54327.1.

NOTE: Authority cited: Secfion 11 152, Government Code. Reference: Sections
4434, 4500, 4501, 4502, 4629, 4648, 4648.1 and 4742, Welfare and Institutions
Code.

History

1. New secfion filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operati\e 9-20 93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1 992.

Page 291

:Register 2007, No. 26; 6-29-2007

§ 56031

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Section 1 47 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of .section filed 1 1-23-94; operative 1 1-23-94 (Resister 94, No.
47).

4. Kditoriai con-ection of History 2 (Register 94, No. 47).

5. Hdilorial correction of subsection (c)(1) (Register 95, No. 18).

6. Amendment of subsection (a), repealer of subsections (b)-(d) and amendment
of N(m-; filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No.
27). A Certificate of Compliance must be transmitted to OAL by 10-27-98 or
emergency language will be repealed by operation of law on the following day.

7. Amendment of subsection (a), repealer of subsections (b)-(d) and amendment
of NoTK refiled 10-20-98 as an emergency; operative 10-27-98 (Register 98,
No. 43). A Certificate of Compliance must be transmitted to OAL by 2-24-99
or emergency language will be repealed by operation of law on the following
day.

8. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98
and filed 2-17-99 (Register 99, No. 8).

Article 6. Welfare and Institutions Code

Section 4695.2 Direct Care Staff Training

Regulations

§56031. Definitions.

(a) When used in this article, the following words and phrases shall
have the following meanings:

( 1 ) "Certified Family Home" means a family residence which is certi-
fied by a licensed Foster Family Agency (FFA) and is issued a certificate
or approved by that FFA as meeting licensing standards, and is used only
by that FFA for the placement of children.

(2) "Certified Parent" means the adult(s) residing in a home which has
been certified by a Foster Family Agency to provide care and supervision
to children placed exclusively by that FFA.

(3) "Challenge Test" means a Department-approved test which, if
passed, substitutes for and satisfies the requirement of one of the two
35-hour competency-based training segments required by Welfare and
Institutions Code Section 4695.2(a), (b) and (c).

(4) "Competency-based Training and Testing" means the two
35-hour competency-based training courses and related competency
tests which direct care staff are required by Welfare and Institutions Code
Section 4695.2(a), (b) and (c) to complete satisfactorily.

(5) "Foster Family Agency (FFA)" means a foster family agency as
defined in Health and Safety Code Section 1502(a)(4).

(6) "Satisfactory Completion" means attendance at each of the two
35-hour training courses required by Section 56033(a)(1) and (2),
completion of the training and taking the Department-approved compe-
tency test for the applicable training segment.

NOTE: Authority cited: Section 4695.2(e), Welfare and Institutions Code. Refer-
ence: Section 4695.2, Welfare and Institutions Code.

History

1. New article 6 (sections 56031-56034) and secdon filed 12-31-98 as an emer-
gency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance
must be transmitted to OAL by 4-30-99 or emergency language will be re-
pealed by operation of law on the following day.

2. New article 6 (sections 56031-56034) and section refiled 5-1 1-99 as an emer-
gency; operative 5-1 1-99 (Register 99, No. 20). A Certificate of Compliance
must be transmitted to OAL by 9-8-99 or emergency language will be repealed
by operation of law on the following day.

3. New article 6 (secfions 56031-56034) and section refiled 9-9-99 as an emer-
gency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance
must be transmitted to OAL by 1-7-2000 or emergency language will be re-
pealed by operation of law on the following day.

4. Repealed by operafion of Government Code section 1 1346.1(g) (Register 2000,
No. 2).

5. New article 6 (sections 56031-56034) and section filed 1-14-2000 as an emer-
gency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Com-
pliance must be transmitted to OAL by 5-1 5-2000 or emergency language will
be repealed by operation of law on the following day.

6. Amendment of article heading, repealer of article 6 (sections 56031-56034),
new article 6 (sections 56031-56035) and repealer and new secfion filed
3-13-2000 as an emergency; operative 3-13-2000 (Register 2000, No. 1 1). A
Certificate of Compliance must be transmitted to OAL by 7-1 1-2000 or emer-
gency language will be repealed by operation of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 1 1346.1(f) (Register 2000, No.
30).

8. Amendment of article heading, repealer of article 6 (secfions 56031-56034),
new article 6 (sections 56031-56035) and repealer and new section filed
7-26-2000 as an emergency; operative 7-26-2000 (Register 2000. No. 30). A
Certificate of Compliance must be transmitted to OAL by 1 1-27-2000 or emer-
gency language will be repealed by operation of law on the following day.

9. Refiling of 7-26-2000 order, including repealer of subsection (a)(5), subsection
renumbering and new sub.section (a)(6), 1 1-27-2000 as an emergency; opera-
tive 1 1-27-2000 (Register 2000. No. 48). A Certificate of Compliance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

1 1 . Change without regulatorv effect amending article heading, subsections
(a)(3)-(4)and Noth filed 2-2'8-2002 pursuant to section 100, titfe 1, California
Code of Regulations (Register 2002. No. 9).

§ 56032. Purpose.

NOTE: Authority cited: Section 11152, Government Code; and Section 4405,
Welfare and Institutions Code. Reference: Sections 4681.4 and 4681.5, Welfare
and Insututions Code.

History

1 . New section filed 1 2-3 1 -98 as an emergency; operati ve 1 2-3 1 -98 (Register 99,
No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operafion of law on the following
day.

2. New section refiled 5-1 1-99 as an emergency; operative 5-1 1-99 (Register 99,
No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8-99
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 9-9-99 as an emergency; operafive 9-9-99 (Register 99,
No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operafion of Government Code section 1 1 346. 1(g) (Register 2000,
No. 2).

5. New section filed 1-14-2000 as an emergency; operative 1-14-2000 (Register
2000, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-15-2000 or emergency language will be repealed by operation of law on the
following day.

6. Repealer filed 3-13-2000 as an emergency; operafive 3-13-2000 (Register
2000, No. 1 1). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2000 or emergency language will be repealed by operation of law on the
following day.

7. Repealer refiled 1 1-27-2000 as an emergency; operative 1 1-27-2000 (Regis-
ter 2000, No. 48). A Certificate of Compliance must be transmitted to OAL by
3-27-2001 or emergency language will be repealed by operation of law on the
following day.

§ 56033. Direct Care Staff Competency-Based Training
and Testing Requirements.

(a) The following competency-based training and testing require-
ments apply only to those direct care staff who are employed in Service
Level 2, 3, and 4 facilities.

( 1 ) Direct care staff employed in Service Level 2, 3, and 4 facilities be-
fore January 1, 2001 shall have until:

(A) January 1 , 2002 to satisfactorily complete the first 35-hour com-
petency-based training course and pass the competency test applicable
to that training segment, or to pass a challenge test applicable to that train-
ing segment; and

(B) January 1, 2003 to satisfactorily complete the second 35-hour
competency-based training course and pass the competency test applica-
ble to that training segment, or to pass a challenge test applicable to that
training segment.

(2) Direct care staff hired in Service Level 2, 3, and 4 facilities on or
after January 1, 2001 shall have:

(A) One year from the date on which the direct care staff was hired to
satisfactorily complete the first 35-hour competency-based training
course and pass the competency test applicable to that training segment,
or to pass a challenge test applicable to that training segment; and

(B) Two years from the date on which the direct care staff was hired
to satisfactorily complete the second 35-hour competency-based train-
ing course and pass the competency test applicable to that training seg-
ment, or to pass a challenge test applicable to that training segment.

•

Page 292

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56034

•

(b) After the direct care staff completes a challenge test for either of
the two 35-hour training segments, the Department shall provide the di-
rect care staff with written notification of the results of the challenge test.

( 1 ) A direct care staff who elects to take but does not pass the challenge
test shall take the applicable competency-based training and competen-
cy test required by subsection (a)( 1 ) or (2).

(2) A direct care staff may take only one challenge test for each of the
two 35-hour training segments prior to attending the related competen-
cy-based training segment.

(c) After completing either 35-hour training segment, each direct care
staff shall take a competency test to assess the direct care staffs compe-
tency in specific knowledge areas.

(d) Within 60 days of a direct care staff taking the competency test for
either of the 35-hour training segments, the Department shall provide the
direct care staff and his/her administrator with written notification that
the direct care staff has:

( 1 ) Satisfactorily completed the competency testing requirement for
the applicable 35-hour training segment; or

(2) Satisfactorily completed the competency testing requirement for
the applicable 35-hour training segment with knowledge area(s) identi-
fied as needing improvement; or

(3) Failed to satisfactorily complete the competency testing require-
ment for the applicable 35-hour training segment.

(e) The administrator shall be responsible for ensuring that any direct
care staff who has knowledge area(s) identified pursuant to subsection
(d)(2) as needing improvement obtains the additional training.

(0 Direct care staff who fail to satisfactorily complete the testing re-
quirement may continue to provide direct supervision and special ser-
vices to consumers only when the administrator ensures that the direct
care staff:

(1) Repeats the applicable 35-hour training segment and retakes the
competency test for that training segment; and

(2) Provides direct supervision and special services only in the pres-
ence of another direct care staff who has satisfactorily completed the ap-
plicable 35-hour training segment or has passed the challenge test appli-
cable to that training segment.

(A) If the facility is unable to satisfy the requirement in subsection
(f)(2), the administrator shall comply with any condition(s) that the re-
gional center may require to protect consumer health and safety.

(g) The requirement of subsection (0(2) shall remain in effect until
such time as the direct care staff has satisfactorily completed the compe-
tency test for the applicable 35-hour training segment.

(h) Upon written notification of satisfactory completion of the first
35-hour competency-based training and competency testing require-
ment pursuant to subsection (d), the direct care staff who has previously
failed to satisfactorily complete the competency test for the first 35-hour
training segment shall have:

( 1 ) One year from the date of written notification to satisfactorily com-
plete the second 35-hour training segment; and

(2) No more than two years from the date the direct care staff was hired
to satisfactorily complete the competency test for the second 35-hour
training segment.

(i) The administrator shall enroll direct care staff in the training re-
quired by subsection (a)(1) or (2) on a schedule which ensures the oppor-
tunity for satisfactory completion of the training by all of the facility's
direct care staff who are required to complete the training.

NOTE: Authority cited: Section 4695.2(e). Welfare and Institutions Code. Refer-
ence: Section 4695.2, Welfare and Institutions Code.

History

1 . New section filed 12-31-98 as an emergency; operative 1 2-31-98 (Register 99,
No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 5-1 1-99 as an emergency; operative 5-1 1-99 (Register 99,
No. 20). A Certificate of Comphance must be transmitted to OAL by 9-8-99
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99.
No. 37). A Certificate of Compliance must be transmitted to OAL b>' 1 7 2()()()
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operation of Govemment Code section 1 1346.1(g) (Register 2000.
No. 2).

5. New section filed 1-14-2000 as an emergency; operative 1-14-2000 (Register
2000, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-1 5-2000 or emergency language will be repealed by operation of law on the
following day.

6. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000, No. 1 1 ). A Certificate of Compliance must be trans-
mitted to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
tion of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 11 346. 1(f) (Register 2000, No.
30).

8. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eration of law on the following day.

9. Refiling of 7-26-2000 order, including amendment of subsections
(a)(l)-(a)(2), (b)(1) and (h)(l)-(i), 11-27-2000 as an emergency: operative
11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18),

11. Amendment of subsections (a)(l)-(2) filed 10-1 1-2001 as an emergency; op-
erative 10-11-2001 (Register 2001, No. 41). A Certificate of Compliance must
be transmitted to OAL by 2-8-2002 or emergency language will be repealed by
operation of law on the following day.

12. Reinstatement of section as it existed prior to 10-1 1-2001 emergency amend-
ment pursuant to Govemment Code section 1 1346.1(0 (Register 2002, No. 9).

13. Change without regulatory effect amending subsections (a)( 1 )-( 2) and (b) and
amending Note filed 2-28-2002 pursuant to section 100. title 1, California
Code of Regulafions (Register 2002, No. 9).

§ 56034. Waiver Requirements for Facilities.

(a) A facility may apply in writing to the regional center for a waiver
of the competency-based training and competency testing requirements
specified in Section 56033(a)(1) and (2) when the facility:

(1) Has a consumer population of less than one third (33.3%) regional
center consumers as defined in Section 56002(a)(5); and

(2) Is able to document in its written application to the regional center
that the granting of a waiver will not create an adverse impact on consum-
er health and safety.

(b) To apply for a waiver pursuant to subsection (a), the facility shall
submit a training plan to the regional center which shall include, but not
be limited to:

(1) A description of how the facility's training program meets the re-
quirements for competency-based training required by Welfare and
Institutions Code Section 4681.5;

(2) The titles of all facility staff who are required to attend the facility's
training;

(3) The number of hours of training required by the facility's training
plan;

(4) The period of time over which the facility's training is to be pro-
vided;

(5) A training schedule for facility staff who are currently employed
and another training schedule for facility staff who are hired following
the effective date of these regulations;

(6) The titles and qualifications of the individuals who will conduct the
facility's training; and

(7) A methodology for assessing individual competency in the knowl-
edge area(s) included in the training.

(c) Within 45 days of receiving a complete training plan from a facil-
ity, the regional center shall either approve or deny the facility's request
for a waiver and notify the facility in writing, by certified mail, of the re-
gional center's approval or denial.

(d) If the facility ' s request for a waiver is denied by the regional center,
the facility may, within fifteen days of receipt of the regional center's de-
nial of the facility's request for a waiver, appeal the regional center's de-
nial of the facility's request for a waiver to the Department.

Page 292.1

§ 56034.1

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(e) To file an appeal, the facility shall send to the Department:

(1) A copy of the training plan which was submitted to the regional
center by the facility;

(2) A copy of the regional center's written denial of the facility's re-
quest for a waiver; and

(3) Any other information which the facility considers appropriate to
the appeal.

(f) The Department shall render a written decision to uphold or deny
the regional center's denial of the facility's request for a waiver within
forty-five days of receipt of the information submitted pursuant to sub-
section (e)( I ) through (3).

(I) The Department's written decision shall be sent to the residential
facility and the regional center via certified mail within 1 5 days of the de-
cision being rendered.

(g) The Department's decision is final.

NOTE; Authority cited: Section 4695.2(e). Welfare and Institutions Code. Refer-
ence: Section 4695.2, Welfare and Institutions Code.

History

1 . New section filed 12-3 1-98 as an emergency; operative 12-3 1-98 (Register 99,
No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99,
No. 37). A Certificate of Compliance must be transmitted to OAL by 1-7-2000
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operation of Government Code section 1 1 346. 1 (g) (Register 2000,
No. 2).

5. New section filed 1-14-2000 as an emergency; operative 1-14-2000 (Register
2000. No. 2). A Certificate of Compliance must be transmitted to OAL by
5-15-2000 or emergency language will be repealed by operation of law on the
following day.

6. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 .3-2000 (Register 2000, No. 1 1 ). A Certificate of Compliance must be trans-
mitted to OAL by 7- 1 1 -2000 or emergency language will be repealed by opera-
tion of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 1 1346. 1(f) (Register 2000, No.
30).

8. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate of Comphance must be trans-
mitted to OAL by 1 1 -27-2000 or emergency language will be repealed by op-
eration of law on the following day.

9. Refiling of 7-26-2000 order, including repealer and new section, 11-27-2000
as an emergency; operative 1 1-27-2000 (Register 2000. No. 48). A Certificate
of Compliance must be transmitted to OAL by 3-27-2001 or emergency lan-
guage will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

1 1 . Change without regulatory effect amending Note filed 2-28-2002 pursuant
to section 100, title 1, California Code of RegulaUons (Register 2002, No. 9).

§ 56034.1 . Foster Family Agency Waiver Requirements.

(a) The regional center may waive the requirement for certified parents
and FFA staff, who provide direct supervision and special services to
children who are regional center consumers to complete the direct care
staff competency-based training and testing requirements described in
Section 56033(a)(1) and (2).

(b) To request a waiver pursuant to subsection (a), the FFA shall sub-
mit a training plan to the regional center which shall include, but not be
limited to:

(1) A description of how the FFA's training program meets the re-
quirements for competency-based training required by Welfare and
Institutions Code Section 4681.5;

(2) The titles of all FFA staff who are required to attend the FFA' s
training;

(3) The number of hours of training required by the FFA's training
plan;

(4) The period of time over which the FFA' s training is to be provided;

(5) A training schedule for FFA staff who are currently employed and
another training schedule for FFA staff who are hired following the effec-
tive date of these regulations;

(6) The titles and qualifications of the individuals who will conduct the
FFA's training; and

(7) A methodology for assessing individual competency in the knowl-
edge area(s) included in the training.

(c) Within 45 days of receiving a complete training plan from an FFA,
the regional center shall either approve or deny the FFA's request for a
waiver and notify the FFA in writing, by certified inail, of the regional
center's approval or denial.

(d) If the FFA's request for a waiver is denied by the regional center,
the FFA may, within fifteen days of receipt of the regional center's denial
of the FFA's request for a waiver, appeal the regional center's denial of
the FFA's request for a waiver to the Department.

(e) To file an appeal, the FFA shall send to the Department:

( 1 ) A copy of the training plan which was submitted to the regional
center by the FFA;

(2) A copy of the regional center's written denial of the FFA's request
for a waiver; and

(3) Any other information which the FFA considers appropriate to the
appeal.

(f) The Department shall render a written decision to uphold or deny
the regional center's denial of the FFA's request for a waiver witliin for-
ty-five days of receipt of the information submitted pursuant to subsec-
tion (e)(1) through (3).

( 1 ) The Department's written decision shall be sent to the FFA and the
regional center via certified mail within 1 5 days of the decision being ren-
dered.

(g) The Department's decision is final.

NOTE; Authority cited: Section 4695.2(e), Welfare and Institutions Code. Refer-
ence: Section 4695.2, Welfare and Institutions Code.

History

1 . New section filed 3-1 3-2000 as an emergency; operative 3-1 3-2000 (Register
2000, No. 11). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2000 or emergency language will be repealed by operaUon of law on the
following day.

2. Repealed by operation of Government Code section 1 1 346. 1 (g) (Register 2000,
No. 30).

3. New section filed 7-26-2000 as an emergency; operative 7-26-2000 (Register
2000, No. 30). A Certificate of Compliance must be transmitted to OAL by
1 1-27-2000 or emergency language will be repealed by operation of law on the
following day.

4. New section refiled 11-27-2000 as an emergency, including amendment of
subsection (b)(1); operafive 1 1-27-2000 (Register 2000, No. 48). A Certificate
of Compliance must be transmitted to OAL by 3-27-2001 or emergency lan-
guage will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 7-26-2000 order, including amendment of sub-
section (a), transmitted to OAL 3-22-2001 and filed 5-2-2001 (Register 2001,
No. 18).

6. Change without regulatory effect amending Note filed 2-28-2002 pursuant to
section 100, title 1, California Code of RegulaUons (Register 2002, No. 9).

§ 56035. Waiver for Prevailing Rate Facilities.

A facility which is paid a prevailing rate pursuant to Title 1 7, Califor-
nia Code of Regulations, Section 56919, is waived from the training and
competency testing requirements specified in Section 56033(a)(1) and
(2).

NOTE; Authority cited: Secfion 4695.2(e), Welfare and Institutions Code. Refer-
ence: Section 4695.2, Welfare and Institutions Code.

History

1 . New section filed 3-1 3-2000 as an emergency; operative 3-1 3-2000 (Register
2000, No. 1 1). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2000 or ernergency language will be repealed by operation of law on the
following day.

2. Repealed by operation of Government Code section 1 1346.1(g) (Register 2000,
No. 30).

4. New section refiled 1 1 -27-2000 as an emergency; operative 1 1-27-2000 (Reg-
ister 2000, No. 48). A Certificate of Compliance must be transmitted to OAL

Page 292.2

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56037

by 3-27-2001 or emergency language will be repealed by operation of law on
the following day.

.'S. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

6. Change without regulatory effect amending NoTi; filed 2-28-2002 pursuant to
section 1 00, title ^ California Code of Regulations (Register 2002. No. 9).

Article 7. Personnel

§ 56036. Training Plans.

(a) Service Level 2, 3 and 4 administrators shall assure the develop-
ment, implementation and maintenance of a written facility staff training
plan.

(b) The plan shall include a description of how each of the following
training components will be provided:

( 1 ) The on-site orientation for direct care staff specified in Section
56038(a)(1);

(2) The on-the-job training for direct care staff specified in Section
56038(a)(2);

(3) Continuing education requirements as specified in Sections
56037(a) and 56038(a)(3); and

(4) Any additional training in any knowledge area(s) which is identi-
fied as needing improvement in the written notice pursuant to Section
56033(d)(2).

(A) The written facility staff training plan shall specify a time frame
for completing the additional training which shall be no more than one
year from the receipt of the written notification pursuant to Section
56033(d)(2).

NOTIi; Authority cited: Sections 4681.1 and 4695.2(e), Welfare and Institutions
Code. Reference: Sections 4648, 4648.1, 4681.1, 4695, 4695.2, 4740 and 4843,
Welfare and Institutions Code.

History

1. New section filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. New subsection (a)( 1 ) and amendment of NoTii filed 1 1-4-9 1 as an emergency;
operative 1 1-4-91 (Register 92, No. 8). A Certificate of Compliance must be
transmitted to OAL 3-3-92 or emergency language will be repealed by opera-
tion of law on the following day.

3. New subsecdon (a)( 1 ) and amendment of Note refiled 3-4-92 as an emergen-
cy; operafive 3-4-92 (Register 92, No. 15). A Certificate of Compliance must
be transmitted to OAL 7-2-92 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including repealer of subsecdon
(a)(1) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Amendment of .section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Secdon 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Editorial correction of HISTORY 5 (Register 94, No. 47).

7. Change without regulatory effect amending Notk filed 12-2-98 pursuant to
section 100, dtle 1, California Code of Regulations (Register 98, No. 49).

8. New subsecdon (d) and amendment of Note filed 12-31-98 as an emergency;
operative 12-3 1-98 (Register 99, No. 1 ). A Certificate of Compliance must be
transmitted to OAL by 4-30-99 or emergency language will be repealed by op-
eration of law on the following day.

9. New subsection (d) and amendment of Note refiled 5-1 1-99 as an emergency;
operafive 5-1 1-99 (Register 99, No. 20). A Certificate of Compliance must be
transmitted to OAL by 9-8-99 or emergency language will be repealed by op-
eration of law on the following day.

10. New subsecdon (d) and amendment of Note refiled 9-9-99 as an emergency;
operafive 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be
transmitted to OAL by 1-7-2000 or emergency language will be repealed by
operadon of law on the following day.

1 1 . Reinstatement of section as it existed prior to 9-9-99 emergency amendment
by operation of Govemment Code section 1 1346.1(0 (Register 2000, No. 2).

12. New subsection (d) and amendment of Note filed 1-14-2000 as an emergen-
cy; operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance
must be transmitted to OAL by 5-15-2000 or emergency language will be re-
pealed by operadon of law on the following day.

13. Repealer and new section filed 3-13-2000 as an emergency; operafive
3- 1 3-2000 ( Register 2000, No. 1 1 ). A Certificate of Compliance must be trans-
mitted to OAL by 7-1 1 -2000 or emergency language will be repealed by opera-
don of law on the following day.

14. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Govemment Code secdon 1 1 346. 1 (f) (Register 2000, No.
.30).

15. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed b\ op-
eration of law on the following day.

16. Repealer and new .section refiled 1 1-27-2000 as an emergency; operative
11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

17. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

18. Change without regulatory effect amending Nori-; filed 2-28-2002 pursuant
to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§ 56037. Administrator Qualifications and Continuing
Education.

(a) Administrators for Service Level 2, 3 and 4 facilides shall fulfill
requirements for continuing education in one or more of the following
areas, as they relate to the administration and management of residential
services for persons with developmental disabilities:

(1) Consumer services as described in the program design;

(2) Promotion of consumers' rights, health, safety and social and phys-
ical integration; and

(3) The ID Team process, including development and implementation
oflPPs.

(b) An administrator of an adult residendal facility may meet the re-
quirements for continuing education specified in this section by meeting
the requirements for continuing education specified in Health and Safety
Code Section 1562.3(f)(1).

(c) The regional center shall count the hours required for the renewal
of the administrator certification as required by Health and Safety Code
Section 1562.3(f)(1), to the maximum extent allowed by that section, to-
ward the confinuing education requirements specified in this section
when the administrator provides documentation to the regional center
that the hours have been completed.

(1) Hours shall be counted on an hour-for-hour basis.

(d) Service Level 2 administrators shall:

(1) Have a minimum of six months of prior experience providing di-
rect supervision and special services to persons with developmental dis-
abilities;

(A) The regional center shall be permitted to waive the above require-
ment if the regional center determines that it is necessary to meet con-
sumer needs.

(2) Complete a minimum of eight hours of continuing education in the
areas specified in subsection (a) above within each twelve-month period
following the assumption of the duties of an administrator.

(e) Service Level 3 administrators shall:

(1) Have a minimum of nine months of prior experience providing di-
rect supervision and special services to persons with developmental dis-
abilities;

(A) The regional center shall be permitted to waive the above require-
ment if the regional center determines that it is necessary to meet con-
sumer needs.

(2) Complete a minimum of 12 hours of confinuing educafion in the
areas specified in subsection (a) above within each twelve-month period
following the assumption of the duties of an administrator.

(f) Service Level 4 administrators shall:

( 1 ) Have a minimum of 1 2 months of prior experience providing direct
supervision and special services to persons with developmental disabili-
ties;

(A) The regional center shall be permitted to waive the above require-
ment if the regional center determines that it is necessary to meet con-
sumer needs.

(2) Complete a minimum of 12 hours of confinuing education in the
areas specified in subsection (a) above within each twelve-month period
following the assumption of the duties of an administrator.

(g) Service Level 2, 3 and 4 administrators providing direct supervi-
sion and special services shall complete any additional training in a spe-
cific knowledge area(s) which has been identified as needing improve-
ment in the written nofification pursuant to Section 56033(d)(2).

Page 292.3

§ 56038

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(h) Successful completion of the competency-based training and pas-
sage of the competency test required by Section 56033(a)( 1 ) or (2) shall
satisfy the continuing education requirements specified in this section for
an administrator for the year in which the training is satisfactorily com-
pleted.

(i) For administrators, passing the challenge test without attending the
competency-based training required by Section 56033(a)(1) or (2) shall
not satisfy the continuing education requirements specified in this sec-
tion.

NOTE; Authority cited: Sections 468 1 . 1 , 4695.2(e) and 4748, Welfare and Institu-
tions Code. Reference: Sections 4648, 4681.1, 4695, 4695.2, 4748, 48.33 and
4843, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (b)(2)(A) and amendment of Notk filed 1 1^-91 as an emer-
gency; operative 11-4-91 (Register 92, No. 8). A Certificate of Compliance
must be transmitted to OAL 3-3-92 or emergency language will be repealed by
operation of law on the following day.

3. New subsection (b)(2)(A) and amendment of Note refiled 3^-92 as an emer-
gency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

4. Certificate of Compliance as to 3^-92 order including amendment of subsec-
tions (b)(2), (c)(2) and (d)(2) and repealer of subsection (b)(2)(A) transmitted
to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Editorial correction of subsection (d)(2) and Reference cite (Register 95, No.
18).

9. Change without regulatory effect amending subsections (b)(1)(A), (c)(1)(A)
and (d)( 1 )( A) filed 6-19-95 pursuant to section 100, title 1 , CaUfomia Code of
Regulations (Register 95, No. 25).

10. New subsections (e)-(g) and amendment of Note filed 3-13-2000 as an emer-
gency; operative 3-13-2000 (Register 2000, No. 11). A Certificate of Com-
pliance must be transmitted to OAL by 7-1 1-2000 or emergency language will
be repealed by operation of law on the following day.

11. New subsections (b)-(c)(l), relettering of former subsection (b) to subsection
(d), relettering of former subsection (c)-(d) to first pair of subsections (e)-(f)
and amendment of Note filed 3-23-2000; operative 4-22-2000 (Register
2000, No. 12).

12. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 1 1346.1(f) (Register 2000, No.
30).

13. New subsections (e)-(g) and amendment of Note filed 7-26-2000 as an emer-
gency; operative 7-26-2000 (Register 2000, No. 30). A Certificate of Com-
pliance must be transmitted to OAL by 11-27-2000 or emergency language
will be repealed by operation of law on the following day.

14. Refiling of 7-26-2000 order, including relettering of duplicate subsections
(e)-(g) as (g)-(i) and amendment of Note, 1 1-27-2000 as an emergency; op-
erative 1 1-27-2000 (Register 2000, No. 48). A Certificate of Compliance must
be transmitted to OAL by 3-27-2001 or emergency language will be repealed
by operation of law on the following day.

15. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

16. Change without regulatory effect amending Note filed 2-28-2002 pursuant
to secfion 100, title 1, California Code of Regulations (Register 2002, No. 9).

§ 56038. Direct Care Staff Qualifications and Continuing
Education Requirements.

(a) Service Level 2, 3 and 4 administrators shall ensure that each direct
care staff person meets applicable requirements as follows:

(1) Within the first 40 hours of providing consumer services in the fa-
cility, all new direct care staff shall complete an on-site orientation
which addresses the following:

(A) The facility's program design;

(B) Consumer IPPs;

(D) Assistance to consumers with prescribed medications, if applica-
ble;

(E) Health and emergency procedures, including fire safety;

(F) Identification and reporting of Special Incidents, as required by
Title 17, California Code of Regulations, Section 54327(a); and

(G) Identification and reporting of consumer abuse.

(2) Receive on-the-job training as necessary to implement consumer
IPPs.

(3) Receive continuing education in one or more of the following
areas, as they relate to planning and implementation of residential ser-
vices for persons with developmental disabilities:

(A) Consumer services as described in the program design;

(B) Promotion of consumers' rights, health, safety, and social and
physical integration; and

(b) Service Level 2 direct care staff shall complete a minimum of eight
hours of continuing education, as described in subsection (a)(3), above
within each twelve-month period following the assumption of the duties
of direct care staff.

(c) Service Level 3 direct care staff shall complete a minimum of 12
hours of continuing education specified in subsection (a)(3) above within
each twelve-month period following the assumption of the duties of di-
rect care staff.

(d) Service Level 4 direct care staff shall:

( 1 ) Have a minimum of six months of prior experience providing di-
rect supervision and special services; or

(2) Within six months of beginning to provide direct supervision and
special services in the facility, complete at least 12 additional hours of
continuing education as specified in subsection (a)(3) above.

(3) Complete a minimum of 12 hours of continuing education which
meets the requirements specified in subsection (a)(3) above within each
twelve-month period following the assumption of the duties of direct
care staff

(e) Direct care staff shall complete any additional training in a specific
knowledge area(s) which has been identified as needing improvement in
the written notification pursuant to Section 56033(d)(2).

(f) Successful completion of the competency-based training and pas-
sage of the competency test required by Section 56033(a)(1) or (2) shall
satisfy the direct care staff continuing education requirements specified
in this section for a direct care staff for the year in which the training is
satisfactorily completed.

(g) For direct care staff passing the challenge test without attending
the competency-based training required by Section 56033(a)(1) or (2)
shall not satisfy the direct care staff continuing education requirements
specified in this section.

Note: Authority cited: Sections 4681 . 1 , 4695.2(e) and 4748, Welfare and Institu-
tions Code. Reference: Sections 4648, 4681.1, 4695, 4695.2, 4791, 4833 and
4843, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. New subsection (b)( 1 ) and amendment of Note filed 1 1-4-91 as an emergency;
operative 1 1-4-91 (Register 92, No. 8). A Certificate of Compliance must be
transmitted to OAL 3-3-92 or emergency language will be repealed by opera-
tion of law on the following day.

3. New subsection (b)(1) and amendment of Note refiled 3-4-92 as an emergen-
cy; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must
be transmitted to OAL 7-2-92 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tions (b), (c), (d)(3) and repealer of subsection (b)(1) transmitted to OAL
6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulafions shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of section filed 1 1-23-94; operative 11-23-94 (Register 94, No.
47).

7. Editorial correcfion of History 5 (Register 94, No. 47).

8. Amendment of subsection (a)(1)(F) and Note filed 6-29-98 as an emergency;
operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be
transmitted to OAL by 10-27-98 or emergency language will be repealed by
operation of law on the following day.

Page 292.4

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56047

9. Amendment of subsection (a)( 1 ){F) and NoTi- refiled 10-20-98 as an emergen-
cy; operative 1 0-27-98 (Register 98, No. 43). A Certificate of Compliance must
be transmitted to OAL by 2-24-99 or emergency language will be repealed by
operation of law on the following day.

1 0. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-3 1-98
and filed 2-17-99 (Register 99, No. 8).

1 1 . Amendment of subsection (d)(2), new subsections (e)-(g) and amendment of
NoTi- filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000,
No. 11). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2000 or emergency language will be repealed by operation of law on the
following day.

12. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f) (Register 2000, No.
30).

13. Amendment of subsection (d)(2), new subsections (e)-(g) and amendment of
NoTh filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000,
No. 30). A Certificate of Compliance must be transmitted to OAL by
1 1 -27-2000 or emergency language will be repealed by operation of law on the
following day.

14. Refiling of 7-26-2000 order, including further amendment of subsection (b)
and NoTi:, 11-27-2000 as an emergency; operative 11-27-2000 (Register
2000, No. 48). A Certificate of Compliance must be transmitted to OAL by
3-27-2001 or emergency language will be repealed by operation of law on the
following day.

15. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

16. Change without regulatory effect amending subsections (a)(l)(F)-(G) and
amending Noxi-: filed 2-28-2002 pursuant to section 100, title 1, California
Code of Regulations (Register 2002, No. 9).

§ 56040. Consultant Qualifications.

(a) Consultant services provided by Service Level 4 facilities shall be
appropriate to meet individual consumer service needs.

(b) Consultants shall be individuals or groups eligible for vendoriza-
tion in accordance with Title 1 7, California Code of Regulations, Chapter
3, Subchapter 2:

(1) Section 54319, Group Practices; and/or

(2) Section 54342, Types of Services;

NOTE; Authority cited: Sections 4681.1 and 479 l(i). Welfare and Institutions
Code; Chapter 722. Statutes of 1992, Section 147. Reference: Sections 4648,
4681.1 and 4791, Welfare and Insfitudons Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for prindng only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Kditorial correction of subsecfion (b) (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 6-19-95 pursuant to
section 100. dtle 1, California Code of Regulations (Register 95, No. 25).

7. Change without regulatory effect amending subsections (b)(l)-(2) and repeal-
ing subsections (b)(3)-(4) filed 11-10-2005 pursuant to section 100, fitle 1,
California Code of Regulations (Register 2005, No. 45).

Article 8. Monitoring and Evaluation

§ 56046. Quality Assurance Plans.

(a) The regional center shaU develop, implement, and maintain a Qual-
ity Assurance (QA) Plan to ensure Service Level 2, 3 and 4 facility com-
pliance with these regulations.

(b) The QA Plan shall include, but not be limited to, the following:

( 1 ) A schedule of evaluations which ensures that each facility is eva-
luated a minimum of once every three years;

(2) The composition of the QA evaluation teams;

(3) The methods to be utilized by the service coordinator for monitor-
ing the facility's implementation of consumer IPP objectives for which
the facility is responsible;

(4) The methods to be utiUzed by the facility Haison for QA monitoring
of the facility's compliance with these regulations and provision of tech-
nical assistance to the facility;

(5) The methods, forms, and instruments, to be utilized by the regional
center for QA evaluations; and

(6) A description of training to be offered to persons who will partici-
pate in QA evaluations which includes familiarization with these regula-
tions and the individual life quahty outcomes identified in the "Looking
at Service Quality Provider's Handbook", and an overview of the QA
evaluation process.

NOTE: Authority cited: Sections 4681.1 and 479] (i). Welfare and Institutions
Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4501,
4648, 4648.1, 4681.1 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (a)(1)(A) and amendment of NoTi-; filed 1 1-4-91 as an emer-
gency; operative 11-4-91 (Register 92. No. 8). A Certificate of Compliance
must be transmitted to OAL 3-3-92 or emergency language will be repealed by
operation of law on the following day.

3. New subsection (a)(1)(A) and amendment of Noth refiled 3-^92 as an emer-
gency; operative 3-4-92 (Register 92, No. 15), A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order includine repealer of subsection
(a)( 1 )(A) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Relocation of article heading and amendment of section filed 9-20-93 as an
emergency; operative 9-20-93. Submitted to OAL for printing only pursuant
to Chapter 722, Statutes of 1992, Section 147 (Register 93, No. 39). These regu-
lations shall not be repealed by the Office of Administrative Law and shall re-
main in effect undl revised or repealed, as appropriate.

6. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Amendment of subsection (b) filed 6-6-96 as an emergency; operative 6-6-96.
Submitted to OAL for printing only ( Register 96, No. 23). A Certificate of Com-
pliance must be transmitted to OAL by 10-4-96 or emergency language will be
repealed by operation of law on the following day.

9. Editorial con-ection of History 8 (Register 96, No. 38).

10. Certificate of Compliance as to 6-6-96 order, including amendment of Noth,
transmitted to OAL 9-1 1-96 and filed 9-18-96. This filing was submitted to
OAL for printing only and is not subject to OAL review pursuant to Chapter 722,
Statutes of 1992, section 147 (Register 96. No. 38).

11. Amendment of subsections (a)(4)-(a)(6) and repealer of subsection (b) filed
6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certifi-
cate of Compliance must be transmitted to OAL by 1 0-28-98 or emergency lan-
guage will be repealed by operation of law on the following day.

12. Amendment of subsections (a)(4)-(6) and repealer of subsection (b) refiled
10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Cer-
tificate of Compliance must be transmitted to OAL by 2-1 7-99 or emergency
language will be repealed by operation of law on the following day.

13. Certificate of CompHance as to 10-20-98 order, including further amendment
of section and NOTi-:, transmitted to OAL 1 2-31-98 and filed 2-1 7-99 ( Register
99, No. 8).

§ 56047. Regional Center Monitoring of the IPP Objectives.

(a) The regional center representative shall meet with the consumer at
least quarterly to review the consumer's progress towards achieving IPP
objectives.

(1) At least two of the quarterly meetings required by subsection (a)
shall take place at the consumer's residence and a representative of the
facility shall be present at these meeti:ngs.

(2) Other quarterly meetings may take place at a site other than the con-
sumer's residence that is acceptable to the consumer.

(3) Quarterly meetings pursuant to subsection (a) may be conducted
during an unannounced visit pursuant to Welfare and Institutions Code
Section 4648. 1 , provided the requirements specified in subsection (a) are
met.

(4) When the consumer has a consumer's authorized representative,
the regional center representative shall notify the consumer's authorized
representative of the date and time of the meeting required by subsection
(a) if the meeting is announced.

(5) When the consumer's authorized representative is unable to attend
the meeting, the regional center representative shall confer with the con-
sumer's authorized representative regarding the consumer's progress to-
ward achieving IPP objectives.

(b) When the consumer is a child with special heath care needs, the re-
gional center representative shall meet with the representative of the fa-
cility and the consumer at the facility at least quarteriy to review the con-
sumer's progress toward achieving IPP objectives pursuant to the
requirements specified in subsection (a)(1) through (5).

Page 292.5

§ 56048

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

( 1 ) Review implementation of the consumer's IPP objectives, includ-
ing any related consumer notes and quarterly or semi-annual reports; and

(2) Meet privately with the consumer, when requested by the consum-
er or the consumer's authorized representative.

(d) The regional center representative may review the facility's re-
cords and accounts of the consumer's cash resources, personal property
and valuables for compliance with Title 22, California Code of Regula-
tions, Section 80026(e) through (/).

(e) Upon completing the review specified in subsection (a) or (b)
above, the regional center representative shall compile a progress report
which shall include:

( 1 ) The date of the visit specified in subsection (a) or (b) above;

(2) Documentation of the meeting required by subsection (a) or (b);

(3) Changes in consumer service needs, and actions taken in response
to these changes;

(4) An assessment of the provision of services in relation to the IPP;
and,

(5) The signature of the regional center representative.

NOTFi: Authority cited: Section 11152, Government Code; and Sections 4405,
468 1 . 1 and 4748. Welfare and Institutions Code. Reference: Sections 4502, 4646,
4646.5, 4647. 4648, 4648. 1 , 468 1 . 1 and 4742, Welfare and Institutions Code; and
Chapter 282, Statutes of 1997, Item 4300-101-0001, Provision 8.

History

1. New section filed 1-14-91; operative 2-13-91 (Register91, No. 14).

2. Amendment of first paragraph, new subsections (a)(1), (a)(2), (b)(1)(A) and
(b)(1)(B) and amendment of NOTi: filed 11-4-91 as an emergency; operafive
1 1-4-91 (Register 92. No. 8). A Certificate of Compliance must be transmitted
to OAL 3-3-92 or emergency language will be repealed by operation of law on
the following day.

3. Amendment of first paragraph, new subsections (a)(1), (a)(2), (b)(1)(A) and
(b)(1)(B) and amendment of Note refiled 3^-92 as an emergency; operative
3-4-92 (Register 92, No. 15). A Certificate of Compliance must be transmitted
to OAL 7-2-92 or emergency language will be repealed by operation of law on
the following day.

4. Certificate of Compliance as to 3^-92 order including amendment of subsec-
tions (a) and (b)(]) and repealer of subsections (a)(l)-(2) and (b)(l)(A)-(B)
transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92. No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722. Statutes of 1992,
Section 1 47 (Register 93 , No . 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of secfion heading and text filed 11-23-94; operative 11-23-94
(Register 94, No. 47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsection (b) filed 6-19-95 pur-
suant to section 100, dtle 1, California Code of Regulations (Register 95, No.
25).

9. Amendment of subsection (a) and Note filed 6-29-98 as an emergency; opera-
five 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be trans-
mitted to OAL by 10-27-98 or emergency language will be repealed by opera-
fion of law on the following day.

10. Amendment of subsecfion (a) and Note refiled 10-20-98 as an emergency;
operafive 10-27-98 (Register 98, No. 43). A Certificate of Compliance must be
transmitted to OAL by 2-24-99 or emergency language will be repealed by op-
eration of law on the following day.

1 1 . Cerfificate of Compliance as to 10-20-98 order, including additional amend-
ment of section heading and section, transmitted to OAL 12-31-98 and filed
2-17-99 (Register 99, No. 8).

§ 56048. Facility Liaison Quality Assurance (QA)
Monitoring of the Facility.

(a) The regional center shall designate a facility liaison for each Ser-
vice Level 2, 3 and 4 facility in the regional center's service catchment
area, in which consumers of the regional center reside.

(b) The regional center shall assign a facility liaison to each facility in
such a way as to minimize the number of staff responsible for monitoring
consumer services and providing technical assistance to the facility.

(1) Establish, with the facility liaison, an agreeable date and time for
the monitoring visit;

(2) Provide access to all records pertaining to the provision of consum-
er services.

(d) The facility liaison shall:

( 1 ) Complete a minimum of one monitoring visit, which may be unan-
nounced pursuant to Welfare and Institutions Code Section 4648.1, to
each facility each year;

(2) Review staff schedules for compliance with the approved service
level requirements;

(3) Review personnel training files to assure compliance with Sections
56033, 56034. 56034.1, and 56a36 through 56038;

(4) Select and review a randomly chosen sample of 20 percent,
rounded up to the nearest whole number, of the consumer records, to en-
sure that:

(A) Services are provided in accordance with the program design and
IPP;

(B) All documents pursuant to Section 56059(a) and (b) are complete
and current.

(5) Provide a copy of "Looking at Service Quality Provider's Hand-
book" bearing no publication or revision date, to and review the individu-
al life quality outcomes and self-assessment process with, the adminis-
trator.

(6) Review the Service Level 4 program design with the administrator
to determine program effectiveness in achieving the IPP objectives for
which the facility is responsible.

(e) In conducting facility liaison monitoring visits, the facility liaison
may inspect the residential service provider's grounds, buildings, and
services.

NOTE: Authority cited: Secfions 4681 .1 . 4695.2(e) and 4748, Welfare and Insfitu-
fions Code. Reference: Secfions 4422, 4646.5, 4648, 4648.1, 4681.1, 4695.2,
4740, 4742, 4743, 4745, 4746, 4748 and 4750, Welfare and Insfitution Code.

History

1. New secfion filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Amendment of subsection (c)(1), new subsecfion (c)(2) and subsecfion (c) re-
numbering, repealer of subsecfion (e), and amendment of Note filed 11-4—91
as an emergency; operative 1 1-4-9 1 (Register 92, No. 8). A Certificate of Com-
pliance must be transmitted to OAL 3-3-92 or emergency language will be re-
pealed by operafion of law on the following day.

3. Amendment of subsection (c)(1), new subsecfion (c)(2) and subsecfion (c) re-
numbering, repealer of subsecfion (e), and amendment of Note refiled 3-4—92
as an emergency; operative 3^1-92 (Register 92, No. 1 5). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operation of law on the following day.

4. Editorial correcfion of subsection (d)(3) (Register 92, No. 15)

5. Certificate of Compliance as to 3-4-92 order including repealer of subsections
(c)( 1 ) and (e) and amendment of newly designated subsection (c)(1) and renum-
bering of following subsections and amendment of subsection (d)(3) trans-
mitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

6. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for prinfing only pursuant to Chapter 722, Statutes of 1992,
Secfion 147 (Register 93, No. 39). These regulafions shall not be repealed by the
Office of Administrafive Law and shall remain in effect until revised or re-
pealed, as appropriate.

7. Amendment of secfion filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.

47).

8. Editorial correction of History 6 (Register 94, No. 47).

9. Amendment of subsecfion (b), new subsection (d)(6) and subsection renumber-
ing filed 6-30-98 as an emergency; operafive 6-3()-98 (Register 98, No. 27).
A Certificate of Compliance must be transmitted to OAL by 10-28-98 or emer-
gency language will be repealed by operation of law on the following day.

10. Amendment of subsecfion (b), new subsection (d)(6) and subsection renum-
bering refiled 10-20-98 as an emergency; operafive 10-20-98 (Register 98,
No. 43). A Cerfificate of Comphance must be transmitted to OAL by 2-17-99
or emergency language will be repealed by operation of law on the following
day.

11. Amendment of subsection (d)(4) and Note filed 12-31-98 as an emergency;
operafive 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be
transmitted to OAL by 4-30-99 or emergency language will be repealed by op-
eration of law on the following day.

12. Certificate of Compliance as to 10-20-98 order, including further amendment
of section and Note, transmitted to OAL 1 2-31-98 and filed 2-17-99 (Register
99, No. 8).

13. Amendment of subsecfion (d)(4) and Note refiled 5-1 1-99 as an emergency;
operafive 5-1 1-99 (Register 99, No. 20). A Certificate of CompUance must be
transmitted to OAL by 9-8-99 or emergency language will be repealed by op-
eration of law on the following day.

14. Amendment of subsecfion (d)(4) and Note refiled 9-9-99 as an emergency;
operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be
transmitted to OAL by 1-7-2000 or emergency language will be repealed by
operafion of law on the following day.

Page 292.6

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56052

15. Reinstatement of section as it existed prior to 9-9-99 emergency amendment
by operation of Government Code section 1 1 346.1(0 (Register 2000. No. 2).

16. Amendment of subsection (d)(3) and amendment of NoTK filed 1-14-2000 as
an emergency: operative 1-14-2000 (Register 2000, No. 2). A Certificate of
Compliance must be transmitted to OAL by 5-15-2000 or emergency language
will be repealed by operation of law on the following day.

17. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000, No. 1 1 ). A Certificate of Compliance must be trans-
mitted to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
tion of law on the following day.

1 8. Reinstatement of section as it existed prior to 3-1 3-2000 emergency amend-
ment by operation of Government Code section 1 1346.1(f) (Register 2000, No.
30).

19. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eration of law on the following day.

20. Refiling of 7-26-2000 order, including amendment of subsection (d)(5) and
further amendment of NoTii, 11-27-2000 as an emergency; operative
11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

21. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

22. Change without regulatory effect amending NoTi-: filed 2-28-2002 pursuant
to section 100, title 1, California Code of Regulations (Register 2002, No. 9).

§ 56049. Quality Assurance Evaluation Team.

(a) The Quality Assurance (QA) Evaluation Team shall complete the
QA Evaluations of facilities.

(b) Each regional center shall designate a QA Coordinator who shall
implement a QA Plan for the regional center. The QA Coordinator shall:

(1) Assure that each facility is evaluated in accordance with section
56046(a)(l)-(6);

(2) Select the QA Evaluation Team chairperson and members utilizing
the following criteria:

(A) The team shall consist of at least 2 members;

(B) The chairperson shall be a regional center employee.

NOTE: Authority cited: Sections 4681.1 and 479 l(i). Welfare and Institutions
Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1,
4740 and 479 L Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Secdon 147 (Register 93, No. 39). These regulafions shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Editorial correction of History 2 (Register 94, No. 47).

4. New subsection (b)(2)(C) filed 6-30-98 as an emergency; operative 6-30-98
(Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL
by 10-28-98 or emergency language will be repealed by operation of law on
the following day.

5. New subsection (b)(2)(C) refiled 10-20-98 as an emergency; operative
10-20-98 (Register 98, No. 43). A Certificate of Compliance must be trans-
mitted to OAL by 2-17-99 or emergency language will be repealed by opera-
tion of law on the following day.

6. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98
and filed 2-17-99 (Register 99, No. 8).

§ 56050. Preparation for the Quality Assurance Evaluation.

(a) All Service Level 2, 3 and 4 facilities providing residential services
shall participate in a Quality Assurance (QA) Evaluation conducted by
the regional center.

(b) The chairperson of the QA Evaluation Team shall:

( 1 ) Confirm the date and time of the on-site evaluation with the admin-
istrator;

(2) Assign duties to the Evaluation Team members;

(3) Obtain consumer consent for QA Evaluation Team members who
are not regional center employees to review consumer records.

(c) Members of the QA Evaluation Team who are not regional center
employees shall be instructed in the confidentiality of consumer informa-
tion in accordance with Welfare and Institutions Code Sections 45 14 and

4515, and sign a statement of confidentiality. Consumer consent shall
also be obtained for review of consumer records by any team member
who is not a regional center employee.

NOTE: Authority cited: Sections 4681.1 and 4791(i), Welfare and Institutions
Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681.1.
4740 and 4791. Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20 93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (b)(3) (Register 95, No. 18).

6. Amendment of subsection (b)(3) and new subsection (c) filed 6-30-98 as an
emergency; operative 6-30-98 (Register 98, No. 27). A Certificate of Com-
pliance must be transmitted to OAL by 10-28-98 or emergency language will
be repealed by operation of law on the following day.

7. Amendment of subsection (b)(3) and new subsection (c) refiled 10-20-98 as an
emergency; operative 10-20-98 (Register 98, No. 43). A Certificate of Com-
pliance must be transmitted to OAL by 2-17-99 or emergency language will be
repealed by operation of law on the following day.

8. Certificate of Compliance as to 10-20-98 order, including further amendment
of subsections (b)(3) and (c), transmitted to OAL 12-31-98 and filed 2-17-99
(Register 99, No. 8).

§ 56051 . Quality Assurance Evaluation.

(a) During the evaluation, the QA Evaluation Team members shall:

( 1 ) Review facility records both at the facility and at the regional center
for compliance with documentation requirements specified in sections
56059 and 56060 respectively;

(2) Review randomly selected consumers' records, both at the facility
and at the regional center for compliance with documentation require-
ments specified in sections 56059 and 56060 respectively, and manage-
ment of personal and incidental allowance;

(3) Observe consumer activities during regularly scheduled daily acti-
vities for compliance with the program design, and the IPP objectives;

(4) Talk to consumers living in the facility and authorized representa-
tives, when appropriate, to determine their satisfaction with facility ser-
vices;

(5) Assess the effectiveness of the facility in assisting consumers in
achieving the individual life quality outcomes.

NOTE: Authority cited: Sections 4681.1 and 4748, Welfare and Institutions Code.
Reference: Sections 4501, 4648, 4648.1, 4681.1, 4740, 4742 and 4746, Welfare
and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

3. New subsections (a)(4)-(a)(5)(C) filed 6-30-98 as an emergency; operative
6-30-98 (Register 98, No. 27). A Certificate of Compliance must be transmitted
to OAL by 10-28-98 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (a)(3) and new subsections (a)(4)-(a)(5)(C) refiled
10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Cer-
tificate of Compliance must be transmitted to OAL by 2-17-99 or emergency
language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 10-20-98 order, including further amendment
of subsection (a)(5), repealer of subsections (a)(5)(A)-(C) and amendment of
Note, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

§ 56052. Post-Evaluation Activities.

(a) After completion of the on-site QA Evaluation in accordance with
Section 56051(a)(1) through (5), the QA Evaluation Team chairperson
shall:

(1) Within five days, conduct an exit interview with the administrator,
which includes:

(A) Presentation of preliminary findings of compliance and/or non-
compliance with the provisions of these regulations including the effec-
tiveness of and consumer(s') satisfaction with, the assistance provided
by the facility to help consumers achieve the individual life quality out-
comes;

Page 292.7

§ 56053

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(B) An opportunity for the administrator to discuss and respond to tlie
findings and provide additional information, if any; and

(2) Within 30 days, provide the administrator with written results of
the evaluation which shall include, but not be limited to:

(A) Findings of compliance and/or noncompliance, with the provi-
sions of these regulations including the effectiveness of and consumer's
satisfaction with the assistance provided by the facility to help consumers
achieve the individual life quality outcomes, and any requirement(s) for
action(s) or follow-up; and

(B) The process for securing needed technical assistance and/or train-
ing.

NOTE; Authority cited: Sections 4681.1, 4748 and 4791(1), Welfare and Institu-
tions Code; Chapter 722. Statutes of 1 992. Section 1 47. Reference: Sections 4648.
4648.1. 4681.1. 4742, 4745, 4746 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsection (b) and Note filed 1 1-4-91 as an emergency; opera-
tive 1 1-4-91 (Register 92, No. 8). A Certificate of Compliance must be trans-
mitted to OAL 3-3-92 or emergency language will be repealed by operation of
law on the following day.

3. Amendment of subsection (b) and NOTE refiled 3-4-92 as an emergency; opera-
tive 3-4-92 (Register 92. No. 15). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (b) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92. No. 32).

3. Amendment of section filed 9-20-93 as an emergency; operafive 9-20-93.
Submitted to OAL for prinUng only pursuant to Chapter 722. Statutes of 1992.
Section 147 (Register 93. No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Editorial correction of History 5 (Register 94, No. 47).

7. Amendment of subsections (a), (a)(1)(A) and (a)(2)(A)-(B) and repealer of sub-
sections (b)-(b)(l) filed 6-3(>-98 as an emergency; operative 6-30-98 (Regis-
ter 98, No. 27). A Certificate of Comphance must be transmitted to OAL by
10-28-98 or emergency language will be repealed by operation of law on the
following day.

8. Amendment of subsections (a), (a)( 1 )(A) and (a){2)( A)-(B) and repealer of sub-
sections (b)-(b)(l) refilled 10-20-98 as an emergency; operative 10-20-98
(Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL
by 2-17-99 or emergency language will be repealed by operation of law on the
following day.

9. Certificate of Compliance as to 10-20-98 order, including further amendment
of subsections (a)(1)(A) and (a)(2)(A) and amendment of Note, transmitted to
OAL 12-31-98 and filed 2-17-99 (Register 99. No. 8).

Article 9.

Corrective Action Plans and
Sanctions

§ 56053. Immediate Danger.

(a) Situations which come to the attention of, or are reported to. the re-
gional center and which appear to constitute an immediate danger shall
be investigated immediately following the notification. Situations which
shall be investigated include but are not limited to:

(1) Life threatening structural conditions;

(2) Suspicion or allegations of abuse of a consumer;

(3) A consumer(s) in the facility with no direct supervision unless
there is an IPP objective and waiver or exception, approved pursuant to
Title 22, California Code of Regulations, Section 80024;

(4) Failure to provide a consumer(s) with a medically prescribed spe-
cial diet(s); or

(5) The presence of an individual exhibiting aggressive or assaultive
behavior which is life threatening to self or others.

(b) When the regional center determines that the purpose of the visit
would be thwarted if advance notice were given, the regional center shall
have the authority to make an unannounced visit to the facility to verify
the existence of the immediate danger.

( 1 ) Immediately forward any allegations regarding consumer abuse to
the applicable protective services agency; and

(2) Cooperate with the investigating agency as requested.

(d) Immediately after verifying that a situation exists which consti-
tutes an immediate danger, the regional center shall take the following
actions:

( 1 ) Meet with the administrator to describe the situation(s) which con-
stitutes the immediate danger: and

(2) Notify the Department of Social Services' Community Care Li-
censing Division district office of the conditions which constitute the im-
mediate danger.

(e) The regional center shall determine whether the immediate danger
can be corrected within 24 hours of verification.

( 1 ) When the immediate danger cannot be corrected within 24 hours
of verification, the regional center shall initiate the emergency relocation
of the consumer(s) subject to the immediate danger.

(2) When the immediate danger can be corrected within 24 hours of
verification, and the safety of the consumer(s) can be assured, the region-
al center shall verify that the correction of the immediate danger has oc-
curred.

(A) The regional center shall verify the correction of the immediate
danger within 24 hours of notification by the facility that the immediate
danger has been corrected.

(f) The regional center shall document all actions taken pursuant to

subsections (a) through (e) above.

NOTE: Authority cited: Secdons 4681.1, 4748 and 4791(i), Welfare and Institu-
tions Code; Chapter 722. Statutes of 1 992. Section 147. Reference: Sections 4502.
4648. 4648.1, 4681.1, 4741, 4748 and 4791. Welfare and Institutions Code.

History

1. New secnon filed 1-14-91; operative 2-13-91 (Register9I. No. 14).

3. Amendment of section filed 1 1-23-94; operafive 1 1-23-94 (Register 94, No.
47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial con-ecfion of subsecfion (a)(3) (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 12-2-98 pursuant to
section 100. title 1, California Code of Regulations (Register 98. No. 49).

§ 56054. Substantial Inadequacies.

(a) Substantial inadequacies are the following:

( 1 ) Conditions posing a threat to the health and safety of any consumer,
that are not considered an immediate danger as specified in Section
56053;

(2) Provision of fewer direct care staff hours than are required by the
facility's approved service level;

(3) Violations of consumers' rights as defined in Section 56002(a)(8);

(4) Failure to provide consumer services as specified in the consum-
er's IPP;

(5) Failure to comply with the terms of the consumer's Admission
Agreement;

(6) Deficiencies or irregularities in the handling of the consumer's
cash resources, personal property, and valuables;

(7) Failure to comply with the requirements for administrator and staff
qualifications and/or administrator and staff training;

(8) Failure of a Service Level 4 facility to utilize the instructional
methods and techniques which are specified in the facility's program de-
sign;

(9) Failure of a Service Level 4 facility to utilize the methodology for
measurement of consumer progress toward achievement of IPP objec-
tives which is specified in the facility's program design;

(10) Failure to take a required action pursuant to Section 56052 within
the specified timeframe;

(11) Failure to:

(A) File an accurate and complete report verifying the use of rate in-
crease funds authorized by Welfare and Institutions Code Section
468L4(a) or (b) as required by Title 17, Cahfomia Code of Regulations,
Section 56934(a);

Page 292.8

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56056

•

(B) Utilize Welfare and Institutions Code Section 468 1 .4 (a) or (b) rate
increase funds for the purposes specified in Title 1 7. California Code of
Regulations, Section 56932(a)(1) through (3);

(C) Utilize Welfare and Institutions Code Section 468 1 .4 (a) or (b) rate
increase funds for a purpose which has been approved by the Department
pursuant to Title 17, California Code of Regulations, Section
56932(a)(4); or

(12) Failure to ensure that a direct care staff:

(A) Completes the competency-based training and testing required by
Section 56033(a)(1) or (2); or

(B) Completes any additional training required by Section
56033(d)(2); or

(C) Complies with Section 56033(0( 1 ) or (2) when the direct care staff
has failed to satisfactorily complete the competency-based training and
competency testing.

(13) Failure to report special incidents pursuant to Section 54327.
(b) When the regional center receives a report that there are substantial

inadequacies in the services of a facility, or when the regional center dis-
covers that there are substantial inadequacies in the services of a facility,
the regional center shall have the authority to make an unannounced vis-
it(s) to the facility.

NOTE: Authority cited: Section 11152. Government Code; Sections 4681.1,
4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4646.5,
4647, 4648, 4648.1, 4681.1, 4681.4, 4695.2, 4742, 4743, 4745, 4746, 4747 and
4748. Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (a)(1) (Register 95, No. 18).

6. Amendment of subsections (a)(8) and (a)(9) and new subsection (a)(10) filed
6-30-98 as an emergency; operative 6-30-98 (Register 98, No. 27). A Certifi-
cate of Compliance must be transmitted to OAL by 10-28-98 or emergency lan-
guage will be repealed by operation of law on the following day.

7. Amendment of subsections (a)(8) and (a)(9) and new subsection (a)(10) refiled
10-20-98 as an emergency; operative 10-20-98 (Register 98, No. 43). A Cer-
tificate of Compliance must be transmitted to OAL by 2-17-99 or emergency
language will be repealed by operation of law on the following day.

8. New subsections (a)(l l)-(a)(12)(C) and amendment of Note filed 12-31-98
as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of
Compliance must be transmitted to OAL by 4-30-99 or emergency language
will be repealed by operation of law on the following day.

9. Certificate of Compliance as to 10-20-98 order, including further amendment
of subsection (a)(10), new subsection (a)(13) and amendment of Note, trans-
mitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

10. New subsections (a)(Il)-(a)(12)(C) and amendment of Note refiled 5-1 1-99
as an emergency; operative 5-11-99 (Register 99, No. 20). A Certificate of
Compliance must be transmitted to OAL by 9-8-99 oremergency language will
be repealed by operation of law on the following day.

1 1 . New subsections (a)( 1 1 )-(a)( 1 2)(C) and amendment of Note refiled 9-9-99
as an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Com-
pliance must be transmitted to OAL by 1-7-2000 or emergency language will
be repealed by operation of law on the following day.

12. Reinstatement of secfion as it existed prior to 9-9-99 emergency amendment
by operation of Government Code section 1 1346.1(f) (Register 2000, No. 2).

1 3. New subsections (a)( 1 1 )-(a)(l 2)(C) and amendment of Note filed 1-14-2000
as an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of
Compliance must be transmitted to OAL by 5-1 5-2000 or emergency language
will be repealed by operation of law on the following day.

14. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000, No. 1 1). A Certificate of Compliance must be trans-
mitted to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
tion of law on the following day.

15. Reinstatement of secdon as it existed prior to 3-13-2000 emergency amend-
ment by operafion of Government Code section 1 1346. 1 (f) (Register 2000, No.
30).

16. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eration of law on the following day.

17. Refiling of 7-26-2000 order, including amendment of sub.sections (a)(3) and
(a)l 10), new subsection (a)(13) and amendment of subsection (b), 1 1 27 2()()()
as an emergency; operative 1 1-27-2000 {Register 2000, No. 48). A Certificate
of Compliance must be transmitted to OAL by 3-27-2001 or emergency lan-
guage will be repealed by operation of law on the following day.

18. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

19. Change without regulatory effect amending Note: filed 2-28-2002 pursuant
to section 100, title T, California Code of Regulations (Register 2002. No. 9).

§ 56055. Insufficiencies.

Note: Authority cited: Section 468 1.1, Welfare and Institutions Code. Reference:
Sections 4648, 4648.1, 4681.1, 4742, 4745 and 4746. Welfare and Institutions
Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Repealer filed 9-20-93 as an emergency; operative 9-20-93. Submitted to
OAL for printing only pursuant to Chapter 722. Statutes of 1992, Section 147
(Register 93, No. 39). These regulations shall not be repealed by the Office of
Administrative Law and shall remain in effect until revised or repealed, as ap-
propriate.

3. Editorial con-ection of History 2 (Register 94, No. 47).

§ 56056. Corrective Action Plan (CAP).

(a) The regional center and the administrator shall meet to develop a
written corrective action plan (CAP) within 10 working days of the iden-
tification and verification of a substantial inadequacy.

(b) The CAP shall describe:

(1) TTie substantial inadequacy and cite the statute, regulation, IPP, or
Admission Agreement requirement for which noncompliance is identi-
fied and shall inform the administrator of the right to appeal the findings;
and

(2) The method(s) by which the administrator is to correct the substan-
tial inadequacy.

(c) Correction of the substantial inadequacy shall occur within a period
not to exceed 30 days of the development of the CAP unless the regional
center determines that correction cannot be accomplished within the spe-
cified time frame.

(1) When correction will take longer than 30 days from the develop-
ment of the CAP, the CAP shall specify interim dates by which specific
steps toward correction of the substantial inadequacy will take place,
with the total time period not to exceed six months.

(d) Within two working days of meeting with the administrator, the
regional center shall provide a copy of the CAP to the administrator.

(e) The regional center is authorized to send a copy of the CAP to the
appropriate Department of Social Services' Community Care Licensing
Division district office.

(0 The regional center shall send a copy of the CAP to any other re-
gional center which has consumers residing in the facility who are af-
fected by the substantial inadequacy.

(g) The administrator shall return the signed and dated CAP to the re-
gional center within seven days of its receipt, with any areas of disagree-
ment noted in writing.

(h) The facility liaison shall:

( 1 ) Visit the facility to review and document actions taken by the ad-
ministrator to implement the CAP; and

(2) Document any substantial inadequacy(ies) which is not corrected
within the specified time frame.

Note; Authority cited: Sections 4681.1, 4748 and 4791(i), Welfare and Institu-
Uons Code; Chapter 722, Statutes of 1992, Secfion 147. Reference: Sections 4647,
4648.1, 4742, 4745, 4746 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1 992.
Secfion 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of secfion filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.

47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Change without regulatory effect amending Note filed 12-2-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 49).

Page 292.8(a)

§ 56057

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 56057. Sanctions.

(a) The regional center shall apply sanction(s) to the facility when:

(1) A substantial inadequacy is not corrected within the time frame
specified in the CAP developed pursuant to Section 36056; or

(2) There are two findings of substantial inadequacy in the same facil-
ity within any twelve-month period.

(b) If the regional center determines that the substantial inadequa-
cy(ies) is related to the basic staffing level or the additional weekly direct
care staff hours being provided by a facility, the regional center may re-
duce the approved service level to the level associated with the total num-
ber of staff hours actually being provided by the facility.

(c) In determining the number of staff hours being provided by a facil-
ity, the regional center shall determine the basic staffing level and the av-
erage number of direct care staff hours provided by the facility during a
minimum of four one-week periods during the previous 12 months.

(d) In all findings of substantial inadequacy, the regional center may:

( 1 ) Meet with the consumer, or the consumer's authorized representa-
tive, to discuss the situation, recommend relocation, and discuss the con-
sequences of refusing to relocate; or

(2) Not place consumers into the facility until the facility complies
with the CAP.

(e) In addition to the actions specified in subsection (d), the regional
center may, upon discovering that a finding of substantial inadequacy
pursuant to Section 56054(a)(l 1)(A) through (C) has not been corrected
within the time frame specified in the CAP developed pursuant to Section
56056, take one of the following actions:

( 1 ) Recover any misused, undocumented or unreported portion of the
Welfare and Institutions Code Section 4681.4(a) or (b) rate increase
funds; or

(2) Offset an amount equal to the misused, undocumented or unre-
ported portion of the Welfare and Institutions Code Section 4681 .4(a) or
(b) rate increase funds from future reimbursements to the licensee.

(f) When the regional center determines the appropriate sanction, the
regional center shall provide written notification to the administrator, by
certified mail, return receipt requested, of the following:

(1) The action(s) to be taken;

(2) The reason(s) for such action(s); and

(3) The administrator's appeal rights pursuant to Sections 56061
through 56067.

Note: Authority cited: Section 11152, Government Code: Sections 4681.1,
4695.2(e) and 4748, Welfare and Institutions Code. Reference: Sections 4648,
4648.1, 4648.2, 4695.2, 4745, 4746 and 4747, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsection (e)(3) (Register 95, No. 18).

6. Change without regulatory effect amending Note filed 12-2-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 49).

7. Repealer of subsections (d)( 1 ) and (d)( 1 )( A), redesignation of former subsec-
tion (d)(1)(B) as new subsection (d)(1), new subsections (e)-(e)(2), subsection
relettering, and amendment of Note filed 12-3 1-98 as an emergency; operative
1 2-3 1 -98 (Register 99, No. 1 ). A Certificate of Compliance must be transmitted
to OAL by 4-30-99 or emergency language will be repealed by operation of law
on the following day.

8. Repealer of subsections (d)(1) and (d)(1)(A), designation of former subsection
(d)( 1 )(B) as new subsection (d)( 1 ), new subsections (e)-(e)(2), subsection relet-
tering, and amendment of Note refiled 5-1 1-99 as an emergency; operative
5-1 1-99 (Register 99, No. 20). A Certificate of Compliance must be transmitted
to OAL by 9-8-99 or emergency language will be repealed by operation of law
on the following day.

9. Repealer of subsections (d)(1) and (d)(1)(A), redesignation of former subsec-
tion (d)(1)(B) as new subsection (d)(1), new subsections (e)-(e)(2), subsection
relettering, and amendment of Note refiled 9-9-99 as an emergency; operative
9-9-99 (Register 99, No. 37). A Certificate of Compliance must be transmitted
to OAL by 1-7-2000 or emergency language will be repealed by operation of
law on the following day.

10. Reinstatement of section as it existed prior to 9-9-99 emergency amendment
by operation of Government Code section 1 1346.1(f) (Register 2000, No. 2).

11. Repealer of subsections (d)( 1 ) and (d)(1)(A), redesignation of former subsec-
tion (d)(1)(B) as new subsection (d)(1), new subsections (e)-(e)(2), subsection
relettering, and amendnieni of Note filed 1-14-2000 as an emergency: opera-
tive 1-14-2000 (Register 2000. No. 2). A Certificate of Compliance must be
transmitted to OAL by 5-15-2000 or emergency language will be repealed by
operation of law on the following day.

12. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000, No. 1 1 ). A Certificate of Compliance must be trans-
mitted to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
tion of law on the following day.

13. Reinstatement of section as it existed prior to 3-1 3-2000 emergency amend-
ment by operation of Government Code section 1 1346. 1(f) (Register 2000, No.
30).

14. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eration of law on the following day.

15. Refiling of 7-26-2000 order, including amendment of subsections (d)-(d)( 1 )
and (e)(f)-(2), 1 1-27-2000 as an emergency; operative 1 1-27-2000 (Register
200(), No. 48). A Certificate of Compliance must be transmitted to OAL by
3-27-2001 or emergency language will be repealed by operation of law on the
following day.

16. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

17. Change without regulatory effect amending Note filed 2-28-2002 pursuant
to section 100, titie 1, California Code of Regulations (Register 2002, No. 9).

Article 10. Records Maintenance

§ 56058. Confidentiality.

NOTE; Authority cited: Sections 4681 .1 and 4748, Welfare and Institutions Code.
Reference: Sections 4514, 4515, 4516 and 4744, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

§ 56059. Residential Services Records.

(a) Each Service Level 2, 3 and 4 facility shall maintain individual con-
sumer files, and a facility file.

(b) Individual consumer files shall contain the following:

(1) Current emergency information, including names, addresses and
telephone numbers of the consumer's authorized representative and
pharmacy;

(2) Recent consumer photograph and physical description;

(3) Consumer inoculation records and TB clearance;

(4) ConsuiTier allergy record;

(5) Signed consent for release of information form(s), if any;

(6) Current IPP in accordance with Section 56022;

(7) Consumer notes pursuant to Section 56026;

(8) Quarterly or semi-annual reports pursuant to Section 56026;

(9) Copies of SIRs prepared as required by Title 17, California Code
of Regulations, Section 54327(b); and

(10) Current information provided by the regional center pursuant to
Section 56017(b).

(1) All items specified in Section 56013;

(2) QA Evaluation reports pursuant to Section 56052;

(3) CAPs, pursuant to Section 56056;

(4) A weekly staff schedule which specifies the number of staff in the
facility during each hour of each day;

(5) A weekly schedule which specifies the number of consumers in the
facility during each hour of each day;

(6) Personnel and training records that verify compliance with Sec-
tions 56033, 56034 and, if applicable, 56034.1 which shall include, but
not be limited to:

(A) The date on which the direct care staff was hired;

(B) The date on which the direct care staffs employment was termi-
nated.

Page 292.8(b)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56060

(7) A copy of any direct care staffs written notification regarding
challenge or competency testing pursuant to Section 56033(b) or (d).

(8) Each written approval issued by the Department authorizing the
use of Welfare and Institutions Code Section 4681.4(a) or (b) rate in-
crease funds for a purpose other than those specified in Section
56932(a)(1) through (3); and

(9) For a Foster Family Agency (FFA):

(A) A copy of any approved FFA request for a waiver required by Sec-
tion 56034.1;

(B) A copy of the regional center's written approval of the FFA's re-
quest for a waiver; and

NOTE: Authority cited: Sections 468 1 . 1, 4695.2(e) and 4748, Welfare and Institu-
tions Code. Reference: Sections 4648.1, 4681.1, 4695.2. 4742 and 4745, Welfare
and Institutions Code.

History

1. New section filed 1-14-91: operative 2-13-91 (Register91, No. 14).

2. New subsection(b)(ll)(A)andamendment of Note filed 11-4-91 as an emer-
gency; operative 11-^^91 (Register 92, No. 8). A Certificate of Compliance
must be transmitted to OAL 3-3-92 or emergency language will be repealed by
operation of law on the following day.

3. New subsection (b)( 1 1 )(A) and amendment of Note refiled 3-4-92 as an emer-
gency; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

4. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (b)( 1 1 ) and repealer of subsection (b)(l 1)(A) transmitted to OAL 6-25-92
and filed 8-4-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

7. Kditorial correcUon of History 5 (Register 94, No. 47).

8. Change without regulatory effect amending subsecfions (a), (b)(7) and (c)(3)
filed 6-19-95 pursuant to section 100, title 1, California Code of Regulations
(Register 95, No. 25).

9. Amendment of subsection (b)(9) and Note filed 6-29-98 as an emergency; op-
erative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must be
transmitted to OAL by 10-27-98 or emergency language will be repealed by
operation of law on the following day.

10. Amendment ofsubsection (b)(9) and Note refiled 10-20-98 as an emergency;
operative 1 0-27-98 (Register 98, No. 43). A Certificate of Compliance must be
transmitted to OAL by 2-24-99 or emergency language will be repealed by op-
erafion of law on the following day.

11. Amendment of subsections (c)(5) and (c)(6), new subsections
(c)(6)(AHc)(9), and amendment of Note filed 1 2-31-98 as an emergency; op-
erative 12-31-98 (Register 99, No. 1). A Certificate of Compliance must be
transmitted to OAL by 4-30-99 or emergency language will be repealed by op-
eration of law on the following day.

1 2. Certificate of Compliance as to 1 0-20-98 order transmitted to OAL 1 2-3 1-98
and filed 2-17-99 (Register 99, No. 8).

13. Amendment of subsections (c)(5) and (c)(6), new subsections
(c)(6)(A)-(c)(9), and amendment of Note refiled 5-1 1-99 as an emergency;
operative 5-1 1-99 (Register 99, No. 20). A Certificate of Compliance must be
transmitted to OAL by 9-8-99 or emergency language will be repealed by op-
eradon of law on the following day.

14. Amendment of subsections (c)(5) and (c)(6), new subsections
(c)(6)(A)-(c)(9), and amendment of Note refiled 9-9-99 as an emergency; op-
erafive 9-9-99 (Register 99, No. 37). A Certificate of Compliance must be
transmitted to OAL by 1-7-2000 or emergency language will be repealed by
operation of law on the following day.

1 5. Reinstatement of section as it existed prior to 9-9-99 emergency amendment
by operation of Government Code section 1 1346.1(f) (Register 2000, No. 2).

16. Amendment of subsections (c)(5) and (c)(6). new subsections
(c)(6)(A)-(c)(9), and amendment of Note filed 1-14-2000 as an emergency;
operative 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must
be transmitted to OAL by 5-15-2000 or emergency language will be repealed
by operation of law on the following day.

17. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000, No. 1 1 ). A Certificate of Compliance must be trans-
mitted to OAL by 7- 1 1 -2000 or emergency language will be repealed by opera-
tion of law on the following day.

18. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f) (Register 2000, No.
30).

19. Repealer and new section filed 7-26-2000 as an emergency: operati\e
7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must he trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eration of law on the following day.

20. Repealer and new section refiled 11-27-2000 as an emergency; operati\c
11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must he
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

21. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

22. Change without regulatory effect amending Ncri'i-: filed 2 -28-2002 pursuant
to section 100, title 1, California Code of Regulations (Regi.ster 2002. No. 9).

§ 56060. Regional Center Records.

(a) The regional center shall maintain records which document:

(1) Facility service level approval;

(2) Quality assurance evaluations;

(3) Regional center monitoring of consumer IPP objectives;

(4) Facility liaison (QA) monitoring;

(5) Special Incident Reports (SIRs);

(6) Finding of Immediate Danger;

(7) Substantial Inadequacies;

(8) Corrective Action Plans;

(9) Sanctions;

(10) Facility appeals;

(11) Quarterly reports from Service Level 4 facilities; and

(12) The Department's approval of the use of Welfare and Institutions

Code Section 468 1 .4(a) or (b) rate increase funds for a purpose other than

those specified in Section 56932(a)( 1 ) through (3).

Note: Authority cited: Sections 468 1 . 1 . 4695.2(e) and 4748, Wei fare and Institu-
tions Code. Reference: Sections 4502-4504, 4646.5, 4648, 4648.1. 4681.1,
4695.2. 4742, 4743, 4745 and 4746, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Amendment of subsections (b)(1)(C) and (c)(5; and repealer of subsection
(b)(6) and subsection renumberinsi filed 8^-92; operative 8-4-92 (Register
92, No. 32).

3. Amendment of secdon filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1 992,
Secdon 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administradve Law and shall remain in effect until revised or re-
pealed, as appropriate.

4. Change without regulatory effect amending subsection (a)(4) filed 1 1-17-93
pursuant to dtle 1 , secdon 100, California Code of Reguladons (Register93, No.
47).

5. Amendment of section filed 11-23-94; operadve 1 1-23-94 (Register 94, No.
47).

6. Editorial correction of History 3 (Register 94, No. 47).

7. Editorial correcdon ofsubsection (a)(3) (Register 95, No. 18).

8. Change without regulatory effect amending subsecdons (a)(10)-(ll) filed
6-1 9-95 pursuant to section 100, tide 1 , California Code of Regulations (Regis-
ter 95, No. 25).

9. New subsections (a)(12) and (a)(13) and amendment of Note filed 12-31-98
as an emergency; operative 12-31-98 (Register 99, No. 1). A Certificate of
Compliance must be transmitted to OAL by 4-30-99 or emergency language
will be repealed by operation of law on the following day.

10. New subsecdons (a)(12)-(a)(13) and amendment of Ncm; refiled 5-1 1-99 as
an emergency; operadve 5-1 1-99 (Register 99, No. 20). A Certificate of Com-
pliance must be transmitted to OAL by 9-8-99 or emergency language will be
repealed by operation of law on the following day.

11. New subsections (a)(12)-(a)(13) and amendment of Note refiled 9-9-99 as
an emergency; operative 9-9-99 (Register 99, No. 37). A Certificate of Com-
pliance must be transmitted to OAL by 1-7-2000 or emergency language will
be repealed by operadon of law on the following day.

12. Reinstatement of secdon as it existed prior to 9-9-99 emergency amendment
by operadon of Government Code section 11346.1(f) (Register 2000, No. 2).

13. New subsections (a)(12)-(a)(13) and amendment of Note filed 1-14-2000 as
an emergency; operative 1-14-2000 (Register 2000, No. 2). A Certificate of
Compliance must be transmitted to OAL by 5-1 5-2000 or emergency language
will be repealed by operadon of law on the following day.

14. Editorial correcdon of History 13 (Register 2000, No. 1 1 ).

15. Repealer and new section filed 3-13-2000 as an emergency; operative
3-13-2000 (Register 2000, No. 1 1). A Certificate of Compliance must be trans-
mitted to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
don of law on the following day.

16. Reinstatement of section as it existed prior to 3-1 3-2000 emergency amend-
ment by operadon of Government Code secdon 1 1 346. 1 ( f) ( Register 2000, No.
30).

Page 292.8(b)(1)

§ 56061

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

17. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eration of law on the following day.

18. Repealer and new section refiled 11-27-2000 as an emergency; operative
11-27-2000 (Register 2000. No. 48). A Certificate of Compliance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

19. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

20. Change without regulatory effect amending NoTi-; filed 2-28-2002 pursuant
to secti'on 100, title T, California Code of Re^gulations (Register 2002, No. 9).

Article 11. Facility Appeals Process

§ 56061. Appeal Process.

(a) The administrator may appeal to the director of the regional center
the following specific actions taken by the regional center:

(1) Findings of substantial inadequacy pursuant to Section 56054;

(2) Findings of immediate danger pursuant to Section 56053;

(3) Sanctions pursuant to Section 56057;

(4) Service level disapproval pursuant to Section 56005; and

(5) Enforcement of any requirement by the regional center which is not
contained in Title 17, California Code of Regulations, Division 2, Chap-
ter 3, Subchapters 4 and 6.

NOTE: Authority cited: Sections 4405, 468 1. 1 , 4748 and 479 1 (i). Welfare and In-
stitutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections
4648, 4648.1, 4681. L 4748 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of secdon filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction capitalizing "S" of "Section" throughout (Register 95, No.
18).

§ 56062. Contents of Appeal and Hearing.

(a) The administrator's written appeal request shall be submitted to the
regional center director within 30 days after the receipt of written notifi-
cation from the regional center of the action specified in Section 56061
and shall:

( 1 ) Indicate the name and address of the facility;

(2) Identify the specific action being appealed;

(3) Describe the potential adverse impact on the facility;

(4) Describe the specific basis of the appeal;

(5) Include information necessary to substantiate the legal and factual
basis of the appeal;

(6) Be signed by the administrator; and

(7) Be deemed filed on the date submitted to the regional center.

(b) Within 15 days of receipt of the appeal, the regional center director
shall review the appeal to determine whether it includes the information
required by subsection (a) above.

(1) If all the required information has not been included and/or addi-
tional information is needed, the regional center director shall request, in
writing, the additional information from the appellant.

The request shall be made no later than 20 days from receipt of the ap-
peal.

(A) The appellant shall submit the required information no later than
15 days from the receipt of the request in subsection (b)(1) above.

(B) If the information requested is not submitted within the time speci-
fied, the appeal shall be deemed withdrawn and no further action will be
taken unless the appellant establishes good cause for the late submission.
Good cause shall be determined by the regional center director in accor-
dance with Section 56067.

(2) If all the required information has been received, notice of a hear-
ing date shall be sent to the administrator by certified mail, return receipt
requested, within 15 days of receipt of the information, specifying the
date, time, and place of the hearing and the matter(s) to be heard.

(A) The hearing date shall be set no later than 25 days from receipt of
all required information.

(B) All parfies to the appeal must agree to any extension of the hearing
date.

(c) The appeal process does not preclude the administrator from termi-
nating the proceeding at any fime prior to the hearing date if the matter
is settled.

(d) With regard to the hearing, the adininistrator shall have the right
to:

(1) Examine, prior to the hearing, all documents on file pertaining to
the subject of the appeal, which are not confidential or otherwise not dis-
coverable under existing statutes and regulations;

(2) Be represented by counsel;

(3) Attend the hearing and present written and/or oral evidence;

(4) Cross-examine witnesses; and

(5) Access documents at the hearing not previously accessed under
subsection ( 1 ) above.

NOTE: Authority cited: Sections 4405, 4681.1, 4748 and 4791(i), Welfare and In-
stitutions Code; Chapter 722, Statutes of 1992, Secfion 147. Reference: Sections
4648, 4648.1, 4648.2, 4681.1, 4748 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91: operaUve 2-13-91 (Register 91, No. 14).

2. Repealer of subsection (e) filed 8-4-92; operadve 8-4-92 (Register92. No. 32).

3. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

4. Editorial con-ection of History 3 (Register 94, No. 47).

5. Editorial con-ection of subsections (a) and (b)(1)(A) and (B) (Register 95, No.
18).

§ 56063. Decision.

(a) Within 60 days after the date of the hearing, the regional center di-
rector shall:

(1) Render a decision; and

(2) Submit a written noUficaUon of the decision to the administrator
by certified mail, return receipt requested.

(b) The written notification shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue(s);

(3) State the facts supporting each ruling;

(4) Specify the statute(s) and regulafion(s) upon which each ruling is
based; and

(5) Specify the procedure for appealing the regional center director's
decision to the Director.

NOTE: Authority cited: Secdons 4405, 4681 .1 and 4748, Welfare and Institutions
Code. Reference: Sections 4648, 4648.1, 4681.1 and 4748, Welfare and Institu-
tions Code.

History

1. New secdon filed 1-14-91; operative 2-13-91 (Register91, No. 14).

2. Amendment of Note filed 11-23-94; operadve 11-23-94 (Register 94, No.
47).

3. Editorial correction of subsection (c) (Register 95, No. 18).

§ 56064. Appeal of the Regional Center's Decision.

(a) The administrator, if dissatisfied with the decision rendered by the
regional center director, may appeal the decision to the Director. The
written appeal to the Director shall:

(1) Be submitted within 15 days from receipt of the written decision
in Section 56063(a)(2); and

(2) Be in writing and include the following informafion:

(A) A copy of the regional center director's written decision;

(B) A copy of all information submitted to the regional center pursuant
to Section 56062(a)(l)-(7) and (b)(2); and

(C) A statement of the issue(s), facts and any supporting statute(s) and
regulafion(s) identifying why the appellant believes the decision of the
regional center director should be reversed by the Director.

Page 292.8(b)(2)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56075

(b) Within five days of receipt of the appeal, the Director shall request,
in writing, from the regional center a copy of the appeal file.

(c) Tiie regional center director shall submit a copy of the complete ap-
peal file to the Director no later than 1 5 days from the submission of the
request for the copy of the appeal file.

(d) Within 30 days of submission of the record forwarded pursuant to
subsection (c) above, the Director shall review the record to determine
if additional informadon on which to base a decision is needed from the
appellant or the regional center.

( 1 ) If no additional information is needed, the Director shall render a
decision pursuant to SecUon 36065(a).

(2) If additional information is required, the Director shall request in
writing, within 35 days of submission of the record pursuant to subsec-
tion (c) above, the material from the appellant and/or the regional center.

(3) The appellant and/or the regional center shall submit the additional
information to the Director no later than 15 days from the submission of
the request in subsection (2) above.

(A) If the appellant does not submit the information requested within
the time specified, the appeal shall be deemed withdrawn and no further
action taken unless the appellant establishes good cause for late submis-
sion pursuant to Section 56067. Good cause shall be determined by the
Director.

(B) If the regional center does not submit the requested information
within the time specified, the Director shall proceed with the appeal and
render a decision based upon the available record pursuant to Section
56065(a).

NOTK; Authority cited: Sections 4681.1, 4748 and 4791 (i). Welfare and Institu-
tions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648,
4648.1, 4745, 4748 and 4791, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction capitalizing "S" of "Section" throughout (Register 95, No.
18).

5. Change without regulatory effect amending Note filed 12-2-98 pursuant to
section 100, title 1, California Code of Regulations (Register 98, No. 49).

§ 56065. Decision by the Director.

(a) The Director shall, within 60 days of the final submission of all re-
quired and/or requested information:

( 1 ) Render a decision; and

(2) Submit a written copy of the decision to the appellant, with a copy
to the regional center.

(b) The written notification shall:

( 1 ) Identify the specific issue(s) in dispute;

(2) Rule on each issue(s);

(3) State the facts supporfing each ruling; and

(4) Specify the statutes and regulations upon which each ruling is
based.

(d) The decision of the Director is the final level of appeal in the admin-
istrative process.

(1) This does not preclude any other judicial remedies.
NOTIi: Authority cited: Sections 4405, 4681.1 and 4748, Welfare and Institutions
Code. Reference: Sections 4648, 4648.1, 4648.2, 4681.1 and 4748, Welfare and
Institudons Code.

History

1. New section filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Change without regulatory effect amending subsection (b) and renumbering
second subsection (b) to subsection (c) and subsecfion (c) to subsection (d) filed
3-2 1 -9 1 pursuant to section 1 00 Title 1 , California Code of Regulations (Regis-
ter 91, No. 14).

§ 56066. Implementation of Regional Center Actions
During Appeal.

(a) Implementation of regional center acfions during the appeal pro-
cess shall occur as follows:

( 1 ) In the case of immediate danger, the action of the regional center
shall remain in effect throughout the appeal process;

(2) In the ca.se of substanfial inadequacies, corrective action shall be
suspended until the appeal process is complete, except in situations spe-
cified in Secfion 56054(a)(1);

(A) Nothing in the foregoing shall preclude the regional center from
taking immediate acfion if conditions in the facility deteriorate into an
immediate danger because the substantial inadequacy has not been cor-
rected.

(3 ) In the case of a disputed service level the rate paid during the appeal
shall be for the service level approved by the regional center and appealed
by the administrator.

NOTE: Authority cited: Sections 4405, 4681 .1 , 4748 and 479 l(i). Welfare and In-
stitutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections
4648, 4648.1, 4648.2, 4681.1, 4748 and 4791, Welfare and InstituUons Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992.
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Editorial correcfion of History 2 (Register 94, No. 47).

4. Editorial con-ection of subsection (a)(2) (Register 95, No. 1 8).

§ 56067. Good Cause.

(a) For the purposes of Section 56061 through 56066 of these regula-
tions, good cause for failure to act is limited to:

( 1 ) A violent act of nature, including but not limited to, flood, earth-
quake, blizzard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property by indi-
viduals other than the appellant which precludes the appellant from filing
a Umely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days
after the incident giving rise to its claim of good cause, submit to the re-
gional center director or the Director, whichever is appropriate, the docu-
ments or other evidence substantiating its claim. The regional center di-
rector or the Director, whichever is appropriate, shall, within 30 days of
receipt of the claim and supporting documentation, review the informa-
tion and render a decision regarding whether good cause has been estab-
lished.

(c) The director of the regional center or the Director, whichever is ap-
propriate, shall nofify the appellant in wriUng of the decision and shall
specify what action will be taken, if any, pursuant to Sections 56061
through 56066 of these regulations.

NOTE: Authority cited: Sections 468 1 . 1 and 4748, Welfare and Institutions Code.
Reference: Sections 4648, 4648. 1, 4745 and 4748, Welfai-e and Institutions Code.

History

1. New secfion filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Amendment of Note filed 11-23-94; operafive 11-23-94 (Register 94, No.

47).

3. Editorial correction of subsections (a) and (c) (Register 95, No. 18).

4. Change without regulatory effect amending Note filed 12-2-98 pursuant to
secfion 100, title 1, California Code of Regulations (Register 98, No. 49).

Subchapter 4.1. Family Home Agency
(FHA) Regulations

Article 1. Definitions

§ 56075. Meaning of Words.

Words shall have their usual meaning unless the context or a definition
clearly indicates a different meaning. Words used in their present tense
include the future tense. Words in the singular form include the plural

Page 292.8(b)(3)

§ 56076

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

form. Use of the word "shall" denotes mandatory conduct. "May" de-
notes permissive conduct.

NOTE; Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095. Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

1 . New subchapter 4. 1 . article 1 and section filed 7-24-95 as an emergency; opera-
tive 7-24-95 (Register 95, No. 30). A Certificate of Compliance must be trans-
initted to OAL by 1 1 -2 1-95 or emergency language will be repealed by opera-
tion of law on the following day.

2. New subchapter 4.1. article 1 and section refiled 1 1-14-95 as an emergency;
operative 1 1-14-95 (Register 95, No. 46). A Certificate of Compliance must be
transmitted to OAL by 3-1 3-96 or emergency language will be repealed by op-
eration of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and
filed 2-22-96 (Register 96, No. 8).

§ 56076. Definitions.

(a) As used in this Subchapter, the following phrase shall have the
meaning specified in Title 17, Section 54000:

(1) Developmental Disability

(b) As used in this Subchapter, the following words and phrases shall
have the meanings specified in Title 17, Section 54302:

( 1 ) Applicant;

(2) Vendor;

(3) Vendorization.

(c) As used in this Subchapter, the following words and phrases shall
have the meanings specified in Title 17, Section 56002:

( 1 ) Authorized Consumer Representative;

(2) Consumers' Rights;

(3) Department;

(4) Director;

(5) Individual Program Plan (IPP);

(6) Interdisciplinary Team (ID Team);

(7) Regional Center;

(8) Service Coordinator.

(d) As used in this Subchapter, the following words and phrases shall
have the meaning specified in Title 17, Section 58501:

(1) Cost Effective;

(2) Submit.

(e) The following definitions shall apply to the regulations used in this
Subchapter:

( 1 ) "Certificate of Approval" means the certificate issued to a family
home upon approval by an FHA.

(2) "Consumer" means a person with a developmental disability who
is at least 18 years of age and who does not require confinuous skilled
nursing care.

(3) "Continuous Skilled Nursing Care" means nursing care which is
provided to a consumer whose condition cannot be classified as chronic
or stable; or for whom performance of nursing care cannot be termed rou-
tine; or for whom the performance of nursing tasks by unlicensed persons
would pose potential harm.

(4) "Conviction" means a plea or verdict of guilty or a conviction fol-
lowing a plea of nolo contendere.

(5) "Family Home" means a home that has been approved by an FHA
and is owned, leased, or rented by, and is the family residence of, the fam-
ily home provider and in which services and supports are provided to a
maximum of two consumers regardless of their degree of disability, ex-
cept for those consumers who require continuous skilled nursing care as
defined in subsection (e)(3). As used in this subchapter, this term shall
be understood to include the term "family teaching home."

(6) "Family Home Agency (FHA)" means a private, not-for-profit
agency that is vendored to do all of the following: 1) recruit, approve,
train, and monitor family home providers; 2) provide services and sup-
ports to family home providers; and 3) assist consumers in moving into
or relocating from family homes.

(7) "Family Home Provider" means a person who has been recruited,
approved, and trained by an FHA to provide services and supports to a
consumer residing in a family home.

(8) "Family Teaching Home" means a home that has been approved
by an FHA and is owned, leased, or rented by the family home agency,
wherein the family home provider and the consumer(s) have independent
residences, either contiguous or attached, and in which services and sup-
ports are provided to a maximum of three consumers regardless of their
degree of disability, except for those consumers who require continuous
skilled nursing care as defined in subsection (e)(3). All requirements in
this subchapter applicable to family homes shall apply equally to family
teaching homes.

(9) "Person-Centered Planning" means the planning process for con-
sumers as specified in Welfare and Institutions Code Sections 4646 and
4646.5.

(10) "Positive Behavioral Supports" means the systematic application
of proactive and preventative behavioral interventions, excluding inter-
ventions which utilize pharmaceuticals or medications to achieve behav-
ioral change, and which result in lasting positive changes in the consum-
er's behavior, are based upon the positive reinforcement of appropriate
consumer behavior, and are designed to support consumers with chal-
lenging behaviors and ensure the consumer's right to reside in the least
restrictive environment.

(11) "Relative" means spouse, parent, stepparent, son, daughter,
brother, sister, stepbrother, stepsister, half-brother, half-sister, uncle,
aunt, niece, nephew, first cousin, or any such person denoted by the pre-
fix "grand" or "great" or the spouse of any of the persons specified in this
definition.

(12) "Seclusion" means the physical isolation of the consumer.

(13) "Service Catchment Area" means the geograpliical area in which
a regional center provides services.

NOTE; Authority cited: Section 4689.1, Welfare and Institutions Code. Reference:
Sections 4502 and 4689.1, Welfare and Institutions Code.

History

1. New section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95,
No. 30). A Certificate of Compliance must be transmitted to OAL by 1 1-21-95
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 1 1-14-95 as an emergency; operative 1 1-14—95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by
3-1 3-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and
filed 2-22-96 (Register 96, No. 8).

4. New subsections (e)(ll) and (e)(13), subsection renumbering, and amendment
of Note filed 6-24-98 as an emergency; operative 6-24-98 (Register 98, No.
26). A Certificate of Compliance must be transmitted to OAL by 10-22-98 or
emergency language will be repealed by operation of law on the following day.

5. New subsections (e)(l 1) and (e)(13), subsection renumbering, and amendment
of Noth refiled 10-22-98 as an emergency; operative 10-22-98 (Register 98,
No. 43). A Certificate of Compliance must be transmitted to OAL by 2-19-99
or emergency language will be repealed by operation of law on the following
day.

6. Certificate of Compliance as to 10-22-98 order, includins repealer of subsec-
tion (a)( 1 3), transmitted to OAL 1 2-31-98 and filed 2-16-99 (Register 99, No.
8).

7. Amendment of subsection (e)(5), new subsection (e)(8) and subsection reletter-
ing filed 1 1-7-2006; operative 12-7-2006 (Register 2006, No. 45).

Article 2. Competitive Procurement

§ 56077. Determination of Need.

(a) The regional center shall determine the need for FHA services
based upon the following criteria:

( 1 ) Whether there is a sufficient number of FHA' s currently providing
services;

(2) Whether the FHA will meet an unmet need which has been identi-
fied in a consumer's IPP; and

[The next page is 292.8(c).]

Page 292.8(b)(4)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56081

(3) Whether there is an anticipated future need for FHA services with-
in the regional center's service catchment area.

NOTH: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1 Oy.'S, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689. 1 . Welfare
and In.stitutions Code.

History

1 . New article 2 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95. No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 2 and section refiled 11-14-95 as an emergency; operative
1 1-14-95 (Register 95. No. 46). A Certificate of Compliance must be trans-
mitted to OAL by .3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tion (a)( 1 ), transmitted (o OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§ 56078. Public Notice.

(a) When the regional center has determined the need for FHA services
pursuant to Section 56077, the regional center shall give public notice of
the intent to contract for FHA services.

( 1 ) More than one contract may be announced in a public notice.

(b) The public notice shall be published in at least one newspaper of
general circulation in the regional center's service catchment area.

{ 1 ) The name, title, address and telephone number of the regional cen-
ter employee responsible for the public notice and for providing the infor-
mation required by Section 56079;

(2) A summary of the services and supports for which the regional cen-
ter intends to contract; and

(3) The deadline for submission of written applications and the address
to which applications should be mailed.

NOTE: Authority cited: Section 4689.1, Welfai'e and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689.1, Welfare
and Institutions Code.

History

2. New section refiled 1 1-14-95 as an emergency; operative 1 1-14-95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by
3-1 3-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (c)(l)-(2), repealer of subsections (c)(3)-(8) and subsecfion renumbering,
transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§ 56079. Application.

(a) An application for intent to contract submitted in response to the
public notice required by Section 56078 shall include, but not be limited
to:

( 1 ) The name, address and telephone number of the prospective FHA
administrator;

(2) The prospective FHA's program design as specified in Section
56084;

(3) The signature of the prospective FHA administrator and the date
on which the application was signed; and

(4) Any additional format or procedural requirements deemed neces-
sary by the regional center.

NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689.1, Welfare
and Institutions Code.

History

2. New section refiled 1 1-14-95 as an emergency; operative 1 1-14-95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by
3- 1 3-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (a) and (a)(4), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96.
No. 8).

§ 56080. Selection of FHA.

(a) The regional center shall utilize the following criteria to select the
prospective FHA:

(1) The prospective FHA's potential for providing cost-effective
quality services and supports as referenced in the program design pur-
suant to Section 56084;

(2) The degree to which consumer choice regarding the provision of
services and supports is identified as a factor in the program design;

(3) The experience of the prospective FHA or key agency personnel
in providing the same or comparable services;

(4) The reasonableness of the prospective FHA's overhead; and

(5) The capability of the regional center to monitor and evaluate the
prospective FHA.

(b) The regional center shall not discriminate in the selection of an
FHA on the basis of race, color, creed, national origin, ancestry, sex, mar-
ital status, disability, religious or political affiliation, age or sexual orien-
tation.

(c) The regional center may require the revision of an application prior
to, and as a condition of, further consideration by the regional center.
NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code: Chapter
1095, Statutes of 1994, Section 14. Reference: Sections 4646, 4648 and 4689.1,
Welfare and Institutions Code.

History

1. New section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95.
No. 30). A Certificate of Compliance must be transmitted to OAL by 1 1-2 1-95
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tion (a)(5) and new subsections (b)-(c), transmitted to OAL 1-8-96 and filed
2-22-96 (Register 96, No. 8).

§ 56081 . Notice of Intent.

(a) Within 30 days following the regional center's selection of an FHA
pursuant to Section 56080, the regional center shall give public notice of
its intent to contract with the selected FHA by posting a notice of its selec-
tion in an area of the regional center which is accessible to the general
public.

(b) The regional center shall notify, in writing, those not selected under
Section 56080.

(1) Notification shall include, but not be limited to, the right to appeal
the contract decision pursuant to subsection (c).

(c) The regional center shall develop a written appeal procedure for
those not selected under Section 56080 which includes, but is not limited
to, the following:

( 1 ) The format and content of the appeal;

(2) The grounds for the appeal;

(3) The process for submission of the appeal;

(A) The appeal shall be filed with the regional center within a reason-
able period of time not to exceed 1 5 days following receipt of the notifica-
tion pursuant to subsection (b).

(4) The process for resolution of the appeal;

(A) The regional center shall resolve the appeal within a reasonable
period of time not to exceed 15 days following the regional center's re-
ceipt of the appeal submitted pursuant to subsection (c)(3j.

(d) If the appeal is upheld, the prospective FHA which submitted the
appeal shall be eligible to enter into contract negotiations with the region-
al center pursuant to Secfion 56082(a).

(e) Nothing shall prevent the regional center from contracting with,
and vendoring, the selected FHA during the pendency of the appeal.
NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Sections 4648 and 4689. 1 . Welfare
and Institutions Code.

Page 292.8(c)

§ 56082

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

2. New section refiled 1 1-14-95 as an emergency; operative 1 1-14-95 (Register

95, No. 46). A Certificate of Compliance must be transmitted to OAL by
3-13-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (a) and (b)(1), transmitted to OAL 1-8-96 and filed 2-22-96 (Register

96, No. 8).

Article 3. Contract and Vendorization

§ 56082. Contract and Vendorization.

(a) The regional center shall negotiate a contract with the FHA se-
lected pursuant to Section 56080 which includes, but is not limited to:

(1) A rate(s) of reimbursement for the FHA; and

(2) A requirement that the vendor maintain service records to support
all billing/invoicing as specified in Section 50604(d)(1) through (3)(F),
as applicable; and

(3) A requirement that the vendor submit to the regional center with
their billings/invoices the information specified in (2) above for the bill-
ing period.

(b) Regional center reimbursement to FHAs shall not exceed rates for
similar individuals when residing in other types of out-of-home care es-
tablished pursuant to Welfare and Institutions Code Section 4681.1.

( 1 ) The FHA shall ensure that family homes receive a sufficient por-
tion of the rate of reimbursement to provide the services and supports
specified in a consumer's IPP.

NOTE: Authority cited: Chapter 157, Statutes of 2003; Section 4689.1, Welfare
and Institutions Code; and Chapter 1095, Statutes of 1994, Section 14. Reference:
Secfions 4648 and 4689. L Welfare and Institutions Code.

History

1. New article 3 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 3 and section refiled 11-14-95 as an emergency; operative
1 1-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (a) and (c), U-ansmitted to OAL 1-8-96 and filed 2-22-96 (Register 96,
No. 8).

4. Redesignation and amendment of portion of subsection (a) as new subsection
(a)(] ), new subsections (a)(2)-(3) and amendment of Note filed 10-9-2003 as
an emergency; operafive 10-9-2003 (Register 2003, No. 41). A Certificate of
Compliance must be transmitted to OAL by 2-6-2004 or emergency language
will be repealed by operation of law on the following day.

5. Redesignation and amendment of portion of subsection (a) as new subsection
(a)(1), new subsecfions (a)(2)-(3) and amendment of Note refiled 2-3-2004 as
an emergency; operative 2-3-2004 (Register 2004, No. 6). A Certificate of
Compliance must be transmitted to OAL by 6-2-2004 or emergency language
will be repealed by operation of law on the following day.

6. Redesignation and amendment of portion of subsection (a) as new subsection
(a)(1), new subsections (a)(2)-(3) and amendment of Note refiled 6-1-2004 as
an emergency; operafive 6-1-2004 (Register 2004, No. 23). A Certificate of
Compliance must be transmitted to OAL by 9-29-2004 or emergency language
will be repealed by operation of law on the following day.

7. Certificate of Compliance as to 6-1-2004 order, including amendment of sub-
section (a)(2), transmitted to OAL 9-15-2004 and filed 10-28-2004 (Register
2004, No. 44).

§ 56083. Residential Services Orientation and Training.

(a) Prior to a consumer residing in a family home, the following FHA
staff shall attend the residential services orientation provided by the ven-
doring regional center pursuant to the requirements of Title 17, Section
56003(a)(1)(A), (C), (D) and (E):

( 1 ) The FHA administrator;

(2) All FHA staff responsible for the direct supervision of other FHA
staff; and

(3) All FHA staff who have frequent and routine contact with the con-
suiTier.

(b) When there is a change in the FHA's administrator or staff as speci-
fied in subsection (a)(1) through (3). the new administrator or staff shall
attend the next scheduled residential services orientation provided by the
regional center.

(c) The vendoring regional center may require further training in addi-
tion to that specified in Section 56084(b)(6) and (7).

NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

3. Certification of CompHance as to 7-24-95 order transmitted to OAL 1-8-96
and filed 2-22-96 (Register 96, No. 8).

Article 4. Program Design

§ 56084. Program Design Requirements.

(a) The program design shall detail how the FHA will achieve and
monitor the following outcomes:

(1 ) That the consumer will live in a family home where he/she will re-
ceive respect and support and involvement in the normal routines of fam-
ily life;

(2) That the FHA and the family home will provide services and sup-
ports which will be consistent with the consumer's needs and preferences
for services and supports as specified in the consumer' s IPP;

(3) That the FHA and the family home will provide services and sup-
ports which are designed to encourage and support the consumer in the
formation of relationships with peers without disabilities and in partici-
pation in the community;

(4) That the FHA and the family home will provide services and sup-
ports which will respect the consumer's personal and cultural prefer-
ences and values;

(5) That the FHA will ensure an appropriate match between the needs
and preferences of the consumer and the family home;

(6) That the FHA will assist the consumer in building and maintaining
relationships with others, including, but not limited to, marital and inter-
personal relationships; family relationships; and friendships and social
networks;

(7) That the FHA will ensure that services and supports which are cho-
sen by the consumer and provided by the FHA will be satisfactory to the
consumer, or the consumer's authorized representative, if applicable;
and

(8) That FHA staff will be suited by experience, sensitivity, education
and training to achieve the outcomes specified in subsections (a)(1)

Page 292.8(d)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56085

through (7) and to perform the duties specified in subsection (b)(4)(A)
through (()) and Section 56086(a)(i) through (7).

(b) In addition to subsection (a), the program design shall include, but
not be limited to:

( 1 ) Complete job descriptions of all FHA positions, including number
of employees, classification, qualifications and duties;

(2) Information specifying lines of authority, reporting relationships
and staff responsibilities and an organizational chart for the FHA; and

(3) The FHA's proposed staffing ratio which pertains to the number
of specified staff to be maintained relative to:

(A) The number of homes which will serve consumers; and

(B) The number of, and specific needs of, consumers who will be
placed in family homes approved by the FHA.

(4) Written statements specifying the FHA's policies and procedures
for:

(A) Recruiting family homes;

(B) Assessing the qualifications of prospective family home provid-
ers;

(D) Assuring that the match between the consumer and the family
home takes into account the consumer's individual health and safety
needs as specified in the consumer's IPP;

(E) Utilizing and coordinating with community resources;

(F) Providing assistance to consumers in moving into, or out of, family
homes;

(G) Reporting and investigation of complaints concerning the FHA or
the family home(s);

(H) FHA monitoring of the family home(s);

(I) Providing or arranging for emergency or unanticipated termination
of services to, and relocation of, the consumer, including coordination
with the family home provider when the consumer terminates residence
pursuant to Section 56094(a);

(J) Assuring that each family home has a contingency plan in the event
of a disaster or emergency;

(K) Assuring that ancillary services and supports, including, but not
limited to, respite care, will be provided or arranged for by the FHA;

(L) Determining the portion of the FHA's rate of reimbursement to be
paid to the family home pursuant to Section 56082(b)(1);

(M) Providing technical assistance to the family home;

(N) Obtaining liability insurance; and

(O) Providing evidence that, when the family home provider has been
appointed as the consumer's representative payee for the consumer's
Supplemental Security Income (SSI) and State Supplemental Program
(SSP) payment, or the consumer has entrusted funds and/or property to
the care of the family home provider, the family home provider has filed
with the FHA a bond, issued by a surety company to the State of Califor-
nia as principal, in an amount sufficient to cover the amount of funds and/
or property entrusted to the family home provider.

(5) Written descriptions of the following:

(A) The range of services and supports to be provided to consumers
and family homes by the FHA to support and maintain the consumer in
a family home; and

(B) The 24— hour emergency response services to be provided, or ar-
ranged for, by the FHA including weekends, holidays and situations in
which the consumer requires immediate temporary or permanent living
alternative.

(6) A proposed training plan which addresses the initial and ongoing
training needs for FHA staff and the family home. The training plan shall
include, but not be limited to, the following topics:

(A) Health and safety in the FHA and the family home, including first
aid, CPR and nutrition;

(B) Positive behavioral supports and crisis intervention techniques;

(D) Fostering consumer participation in, and integration into, the com-
munity;

(E) Adjustment issues for consumers and families, including cultural
diversity and sensitivity to the needs of persons with developmental dis-
abilities;

(F) Building a new or extended family and fostering personal relation-
ships;

(G) Values and philosophy of the developmental disabilities service
system pursuant to Welfare and Institutions Code Section 4501 ;

(H) Person-centered planning, consumer choice and the IPP process,
including implementation of consumer IPP objectives for which the FHA
or family home is responsible;

(I) Identification and reporting of adult abuse; and

(J) Record-keeping.

(7) The proposed training plan shall specify:

(A) The frequency of the training to be provided, which shall occur
with sufficient frequency and regularity to enable FHA staff and family
home providers to keep abreast of changes and developments in the field
of developmental disabilities and to meet the needs of individual con-
sumers;

(B) The FHA's procedures for assessing the training needs of FHA
staff and the family home;

(C) The FHA's procedures for assessing the training plan's effective-
ness and making necessary revisions to the training plan; and

(D) That new FHA staff will be trained prior to providing services and
supports to consumers.

Note.- Authority cited: Section 4689.1, Welfai-e and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

1. New article 4 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 4 and section refiled 11-14-95 as an emergency; operative
1 1-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-1 3-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (a)(6), (b), (b)(4)(K), (b)(4)(0), (b)(6)(G), (b)(7)(A)-(C), and (c), trans-
mitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 5. Criminal Record Clearance

§ 56085. Fingerprints and Criminal History.

(a) The Department shall conduct a criminal record review of all per-
sons specified in Welfare and Institutions Code Section 4689.2(c) and
shall have the authority to approve or deny an application for vendoriza-
tion as an FHA, or employment, residence, or presence in the family
home based upon the results of such a review.

(1 ) All completed, signed and dated Department of Justice fingerprint
cards (BID-7) shall be submitted directly to the Department.

(2) Fingerprint cards shall be provided by the Department.

(b) When the person who is subject to the criminal record review speci-
fied in subsection (a) has not resided continuously in California for the
past two years, the criminal record review required by subsection (a)
shall include criminal history record information (CHRI) maintained by
the Federal Bureau of Investigation (FBI).

(d) Subsequent to vendorization of the FHA, all persons subject to
criminal record review pursuant to Welfare and Institutions Code Section
4689.2(c) shall, prior to employment by the FHA, or residence or initial
presence in the family home, be frngei^jrinted and sign, under penally of
perjury, a DS 5407 (New 5/95) regarding any prior criminal convictions.

Page 292.8(e)

§ 56086

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1) The FHA shall submit fingerprint cards to the Department within
four calendar days following employment, residence or initial presence
in the family home.

(2) The original signed and dated DS 5407 (New 5/95) shall be re-
tained by the FHA.

(A) A copy of the signed and dated DS 5407 (New 5/95) shall be sub-
mitted to the Department within four calendar days following the em-
ployment, residence or initial presence of the declarant in the family
home.

(B) A copy of the signed and dated DS 5407 (New 5/95) shall be re-
tained by the regional center.

(e) If the criminal record transcript discloses that any person specified
in Welfare and Institutions Code Section 4689.2(c) has been convicted
at any time of a crime, except a minor traffic violation, the Department
is authorized to:

( 1 ) For an applicant for vendorization as an FHA, deny the application
for vendorization pursuant to Welfare and Institutions Code Section
4689.4.

(2) For an FHA, terminate the vendorization of the FHA.

(3) For a family home, terminate the approval of the family home.

(f) If the criminal record transcript of a current or prospective em-
ployee of the FHA discloses that a current or prospective employee of an
FHA has been convicted at any time of a cri me, except a minor traffic vio-
lation, the FHA, upon notification by the Department, shall act immedi-
ately to do the following:

(1 ) For current or prospective employees, terminate the current em-
ployee's employment or bar the prospective employee from entering the
family home; or

(2) Seek an exemption pursuant to Welfare and Institutions Code Sec-
tion 4689.2(f).

(g) If the criminal record transcript of any adult person, other than the
consumer, residing in the family home discloses that the person has been
convicted at any time of a crime, except a minor traffic violation, the
FHA, upon notification by the Department, shall:

(1) Remove the consumer from the family home; or

(2) Remove the adult person from the family home; or

(3) Bar the adult person from entering the family home; or

(4) Seek an exemption for the adult person pursuant to Welfare and In-
stitutions Code Section 4689.2(f).

(h) After a review of the criminal record transcript, the Director shall
have the authority to grant an exemption from subsections (e), (f) and (g)
when:

(1) The Director has substantial and convincing evidence to support
a reasonable belief that the applicant for vendorization, or other person
specified in Welfare and Institutions Code Section 4689.2(c), is of such
good character as to justify approval of vendorization or an exemption.

(A) The Director shall have the authority to consider factors, including
the following, as evidence of good character and rehabilitation:

1 . The nature of the crime;

2. The period of time since the crime was committed and the number
of offenses;

3. The circumstances surrounding the commission of the crime that
would demonstrate the unlikelihood of repetition;

4. Activities since conviction, including employment or participation
in therapy or education, that would indicate changed behavior;

5. The granting of a full and unconditional pardon by the Governor;

6. Character references; or

7. A certificate of rehabilitation from a superior court.

(2) Any person specified in Welfare and Institutions Code Section
4689.2(c) who has been rehabilitated as provided in Penal Code Section
4852.03 has maintained the conduct required in Penal Code Section
4852.05 for at least 10 years and has the recommendation of the district
attorney representing the employee's county of residence.

(3) The applicant for vendorization or, other person specified in Wel-
fare and Institutions Code Section 4689.2(c), has received a certificate of
rehabilitation pursuant to Chapter 3.5 (commencing with Section
4852.01) of Title 6 of Part 3 of the Penal Code.

(i) Following the receipt of all information which will enable the Di-
rector to grant or deny an exemption from subsections (e), (f) and (g), the
Director shall either grant or deny the exemption within a period of time
which shall not exceed 30 days.

(j) The Director shall specify, in writing, the reasons for any exemp-
tion granted.

(k) Any person specified in Welfare and Institutions Code Section
4689.2(c) shall be permitted to transfer a current criminal record clear-
ance pursuant to subsection (b), from one FHA or family home to another
as long as the criminal record clearance has been processed through the
Department.

(/) Except as otherwise provided in Welfare and Institutions Code Sec-
tion 4689.2(f), no exemption shall be granted if the conviction was for
an offense specified in Penal Code Sections 220, 243.4, 264. 1 , paragraph
(1) of subdivision (a) of 273a, 273d, 288, 289 or 368(a) or (b), or for
another crime against an individual specified in Penal Code Section
667.5(c).

NOTE: Authoritv cited: Section 4689.1. Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Sections 4689.1, 4689.2, 4689.3,
4689.4, 4689.5, 4689.6 and 4741, Welfare and Institutions Code.

History

1 . New article 5 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 5 and section refiled 11-14-95 as an emergency; operative
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-1 3-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tion (h)(l)(A)5., new subsection (i) and subsection relettering, transmitted to
OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 6. The FHA

§56086. The FHA.

(a) The FHA shall employ sufficient staff with the combined experi-
ence, training and education to perform the following duties:

(1) Administration of the FHA;

(2) Recruitment of family homes;

(3) Training of FHA staff and family homes;

(4) Ensuring an appropriate match between the needs and preferences
of the consumer and the family home;

(5) Monitoring of family homes;

(6) Provision of services and supports to consumers and family homes
which are consistent with the consumer's preferences and needs and the
consumer's IPP; and

(7) Coordination with the regional center and members of the consum-
er's family and/or the consumer's authorized representative, if applica-
ble, as necessary to ensure consumer satisfaction and the stability of the
family home.

(b) In order to accomplish the duties specified in subsection (a)(1)
through (7) and Section 56084(b)(4)(A) through (O), the FHA shall con-
sider selection criteria for hiring purposes, which shall include, but not
be limited to:

( 1 ) Education in the fields of social work, psychology, education, or
related areas;

(2) Experience, either personal or professional, working or living with
persons with developmental disabilities;

(3) Experience and training in program management, fiscal manage-
ment, and organizational development;

(4) Training in any related areas that augment the individual's educa-
tion and experience; or

(5) Any combination of the above.

Page 292.8(f)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56088

(c) A new FHA administrator shall meet with the regional center direc-
tor or his/her designee within 1 4 days of assuming the duties of adminis-
trator.

(d) No FHA administrator, staff member. Board of Directors member
or officer shall be a family home provider of the FHA with which he/she
is affiliated.

(e) No person employed by the FHA shall enter into any independent
financial relationship or transaction with a family home provider, includ-
ing but not hmilcd to, rental agreements, personal cash loans, or sale,
trade or transfer of property.

NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Section
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfai-e and Insti-
tutions Code.

History

1 . New article 6 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 6 and section refiled 11-14-95 as an emergency; operative
1 1-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and
filed 2-22-96 (Register 96, No. 8).

Article 7. The Family Home

§ 56087. Home Visit.

(a) Prior to approval, the FHA shall visit each prospective family home
to:

(1) Interview all adults who reside in the home;

(2) Interview or see all family members who reside in the home;

(3) Provide the prospective family home with copies of these regula-
tions and the Lanterman Developmental Disabilities Services Act;

(4) Discuss the content of Section 56088(b)(8)(A) through (C) with the
prospective family home provider; and

(5) Discuss the training specified in Sections 56083(c) and
56084(b)(6) and (7); and

(6) Determine that the family home provides:

(A) A safe, clean, and pleasant living environment;

(B) Age-appropriate living space; and

(C) Accommodations for ensuring safe and reasonable accessibility
for entrance to, movement within and exit from the family home.

(7) Determine, pursuant to subsections (a)( 1 ) through (6), that the pro-
spective family home providers have the experience, knowledge, coop-
eration, history and interest to become an approved family home.
NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

1. New article 7 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 7 and section refiled 11-14-95 as an emergency; operafive
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
fion (a)(5), new subsecdon (a)(6), repealer of subsection (b) and redesignafion
of former (b)(l)-(3) as new (a)(6)(A)-(C), and new subsection (a)(7), trans-
mitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§ 56088. Certificate of Approval.

(a) The FHA shall issue a Certificate of Approval to each family home
which has:

(1) Completed the criminal record review required by Section
56085(a);

(2) Been visited by the FHA as required by Section 56087(a); and

(3) Met the criteria specified in Section 56087(a)(6) and (7).

(b) The Certificate of Approval shall include, but not be limited to:

( 1 ) The name, address and telephone number of the FHA;

(2) The name, address, location and telephone number of the family
home provider;

(3) The number of consumers for which the family home has been ap-
proved;

(4) Any limitations of the home, including ambulatory status of con-
sumers to be served;

(5) The date of issuance of the certificate;

(6) The date of expiration of the certificate which shall not exceed one
year from the date of issuance;

(7) A statement that the family home shall be used exclusively as a res-
idence by the FHA which issued the Certificate of Approval;

(8) A statement which shall include, but not be limited to, the follow-
ing information:

(A) The relationship between the consumer and the family home is
voluntary and may be terminated by any party to the agreement at any
time subject to the requirements of Section 56094.

(B) The Department and the regional center shall enforce applicable
provisions of law and regulation, investigate allegations of abuse or ne-
glect, and impose sanctions on FHAs, including the following:

1 . Requiring movement of a consumer from a family home; and/or

2. Requiring termination of the approval of a family home; and/or

3. Requiring termination of the FHA's vendorization.

(C) The Department and the regional center shall monitor services and
supports provided by the family home in accordance with Welfare and
Institutions Code Section 4648.1(a) and (b) as necessary to implement
the consumer's IPP.

(9) The date and signature of the FHA's administrator.

(1) The original shall be maintained on the premises of the family
home; and

(2) A copy of the original shall be maintained by the FHA.

(d) Within 1 0 working days of the issuance of a Certificate of Approval
pursuant to subsection (a), the FHA shall send written notice to the re-
gional center of the family home provider's name, address, telephone
number and location.

(e) A Certificate of Approval shall not be transferable and shall be void
upon a change of location of the family home.

(f) The family home provider shall immediately notify the regional
center and the FHA of a change in the location of a family home.

(1) Verbal notification shall be put in writing within 5 working days.

(g) The family home provider shall notify the regional center and the
FHA in writing at least 30 days prior to a non-emergency change in the
location of a family home.

(h) The FHA shall conduct a site visit to the new location of the family
home within 5 working days of notification as required by subsections
(f) and (g) for the purpose of:

( 1 ) Approving the new location; and

(2) Issuing a new Certificate of Approval.

(i) When the FHA does not approve the new location pursuant to sub-
section (h)( 1 ), the FHA shall notify the family home and the regional cen-
ter in writing of the FHA's decision not to approve the family home.

( 1 ) The notification required by subsection (i) shall occur within a rea-
sonable period of time not to exceed 5 working days following the site
visit required by subsection (h).

NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

1. New section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95,
No. 30). A Certificate of Compliance must be transmitted to OAL by fl -2 1 -95
or emergency language will be repealed by operation of law on the following
day.

2. New secfion refiled 1 1-14-95 as an emergency; operative 1 1-14-95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by

Page 292.8(g)

§ 56089

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

3-13-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24—95 order, including amendment of subsec-
tions (a)(3), (b), (b)(8) and (b)(8)(B)l.-2., new subsection (g) and subsection
relettering, and amendment of newly desienated subsections (h), (i) and (i)(l),
transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

§ 56089. Prohibited Interventions and Treatment.

(a) All behavior modification interventions that cause pain or trauma,
as specified in Title 17, Division 2, Chapter 1 , Subchapter 8, are prohib-
ited.

(b) Electroconvulsive therapy (ECT) as defined in Title 17, Division
2, Chapter 1, Subchapter 8, Section 5080 l(j) is a prohibited treatment
procedure.

(c) A consumer who resides in a family home shall be free from corpo-
ral or unusual punishment, infliction of pain, humiliation, intimidation,
ridicule, coercion, threat, mental abuse, restraint or other actions of a pu-
nitive nature, including, but not limited to: interference with the daily liv-
ing functions, including eating, sleeping, or toileting; or withholding of
shelter, clothing, medication or aids to physical functioning.

(d) A consumer who resides in a family home shall not be placed in
seclusion.

NOTE: Authority cited: Section 4689. 1 , Welfare and Institutions Code. Reference:
Sections 4502 and 4689.1, Welfare and Institutions Code.

History

2. New section refiled 1 1-14-95 as an emergency; operative 1 1-14-95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by
3-13-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (a) and (b), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96,
No. 8).

4. New subsections (c)-(e) and amendment of Note filed 6-24-98 as an emergen-
cy; operative 6-24-98 (Register 98, No. 26). A Certificate of Compliance must
be transmitted to OAL by 1 0-22-98 or emergency language will be repealed by
operation of law on the following day.

5. New subsections (c)-(e) and amendment of Note refiled 10-22-98 as an emer-
gency; operative 10-22-98 (Register 98, No. 43). A Certificate of Compliance
must be transmitted to OAL by 2-19-99 or emergency language will be re-
pealed by operation of law on the following day.

6. Certificate of CompHance as to 10-22-98 order, including repealer of subsec-
tion (e), transmitted to OAL 12-31-98 and filed 2-16-99 (Register 99, No. 8).

Article 8. Referral for Service

§ 56090. Referral for Service.

(a) When the consumer and the consumer's authorized representative,
if applicable, has expressed an interest in the services and supports pro-
vided by an FHA, the regional center shall coordinate with the FHA for
a meeting between the FHA, the consumer and/or the consumer's autho-
rized representative, if applicable.

(b) Prior to the meeting required in subsection (a), the regional center
shall obtain the consent of the consumer, or the consumer's authorized
representative, if applicable, to release information to the FHA which in-
cludes, but is not limited to:

(1) The consumer current Individual Program Plan (IPP);

(2) A statement of the consumer' s ambulatory or nonambulatory sta-
tus as determined by the consumer's ID Team;

(3) A statement that the consumer does not require continuous skilled
nursing care;

(4) Known information regarding the consumer's Hkes and dislikes,
strengths and needs, interests and activities;

(5) A medical history which includes any identified medical and/or
special care needs, including special dietary requirements;

(6) Any health and safety requirements which are specific to the needs
of the consumer;

(7) When the consumer has an authorized representative, the autho-
rized representative's name, address and telephone number;

(8) When a conservator has been appointed for the consumer, a state-
ment that the regional center has obtained the consent of the consumer's
conservator, if the conservator has been granted the legal authority to fix
residence, for the consumer to reside in a family home; and

(9) The name and telephone number of the regional center service
coordinator who is responsible for the implementation of the consumer's
IPP.

(c) No consumer shall reside in a family home in which the family
home provider is a relative of the consumer as defined in Section
56076(e)(10).

(1) The regional center may make an exception to the requirement of
subsection (c) when:

(A) The residence is consistent with the services and supports refer-
enced in the consumer's IPP; and

(B) The relative has no legal obligation to support the consumer.

(d) When the FHA has identified an appropriate family home, the FHA
shall coordinate at least one visit to the family home by the consumer and
the consumer's authorized representative, if applicable.

(e) When the consumer has made a decision to reside in the family
home, the FHA shall execute a residence agreement which specifies the
following:

(1) The portion of the FHA's rate of reimbursement to be paid to the
family home provider by the FHA pursuant to Section 56082(b)(1); and

(2) The services and supports which the FHA and the family home will
provide to the consumer.

(f) The residence agreement shall be signed by the:

( 1 ) Consumer;

(2) Consumer's authorized representative, if applicable;

(3) FHA;

(4) Regional center; and

(5) Family home provider.

(g) The original residence agreement shall be maintained by the family
home provider.

(h) Copies of the signed residence agreement shall be maintained by
the entities specified in subsection (f)(1) through (4).
NOTE: Authority cited: Section 4689.1. Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Secfion 14. Reference: Sections 4689. 1 and 4648, Welfare
and Institutions Code.

History

1. New article 8 and section filed 7-24-95 as an emergency; operafive 7-24—95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 8 and section refiled 11-14-95 as an emergency; operative
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tion (b)(8), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 9. Consumer Funds and Property

§ 56091 . Consumer Funds and Property.

(a) When the family home provider has been appointed as the consum-
er's representative payee for the consumer's Supplemental Security In-
come (SSI) and State Supplemental Program (SSP) payment or the con-
sumer has entrusted funds and/or property to the care of the family home
provider, the following shall apply:

(1) A consumer's funds and property shall be used only for the con-
sumer's benefit;

(2) A consumer's funds and property shall be free of any liability in-
curred by the FHA or the family home provider;

(3) Consumer funds and/or property shall be maintained separate and
intact and shall not be commingled with family home or FHA funds and/
or property, or the funds and/or property of other consumers; and

Page 292.8(h)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56093

•

(4) Except for that portion of the consumer's SSI/SSP benefit which
is designated for the consumer's room, board, care and supervision, the
FHA or the family home provider shall not make expenditures from con-
sumers' funds for any services or supports required by this Subchapter.
Consumers' SSI/SSP benefits are also deemed to include any income
used to determine the SSI/SSP payment.

(b) The family home provider shall maintain accurate records of ac-
counts of funds and/or property entrusted to the family home provider's
care which include, but not be limited to:

( 1 ) Personal possessions and/or funds received by or entrusted to the
family home provider;

(2) Disbursements made to, or for, the consumer; and

(3 ) All transactions on behalf of a consumer as specified in subsections
(c) (d) and (e).

(c) All consumer funds which are entrusted to the family home provid-
er and which are not kept on the premises of the family home shall be de-
posited in the consumer's name in an interest-bearing account in a local
bank, savings and loan or credit union authorized to do business in Cali-
fornia, the deposits of which are insured by a branch of the Federal Gov-
ernment.

(d) The family home provider shall provide access to the consumer's
cash resources when requested by the consumer or the consumer's autho-
rized representative, if applicable.

(e) All interest accruing to funds deposited by the family home provid-
er in an account pursuant to subsection (c) shall be the property of the
consumer.

NOTE: Authority cited; Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

1 . New article 9 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 9 and section refiled 11-14-95 as an emergency; operative
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tion (b), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 10. Health-Related Services

§ 56092. Health-Related Services.

(a) The FHA and the family home shall provide, or arrange for, any
health-related services which are:

(1) Referenced in the consumer's IPP and for which the FHA or the
family home provider is responsible; or

(2) Prescribed for the consumer; or

(3) Needed by the consumer.

NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689. 1, Welfare and Insti-
tutions Code.

History

1. New article 10 and section filed 7-24—95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 10 and section refiled 11-14-95 as an emergency; operative
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24 -95 order transmitted to OAL 1-8-96 and
filed 2-22-96 (Register 96, No. 8).

Article 11. Abuse and Special Incident
Reporting

§ 56093. Abuse and Special Incident Reporting.

(a) The family home provider shall report any occurrence or allegation
of consumer abuse to the FHA and either the adult protective services

agency or the local law enforcement agency pursuant to Welfare and In-
stitutions Code Section 15630.

(1) In addition to (a), the family home provider shall also report any
occurrence or allegation of neglect or exploitation to the FHA.

(b) The report in subsection (a) shall be:

( 1 ) By telephone, FAX or electronic mail immediately, but in no case
more than 24 hours after the occurrence; and

(2) Submitted in writing within 48 hours after the occurrence.

(c) Upon receipt of the report in subsection (b)(1), or upon the FHA's
independent suspicion or knowledge of abuse, the FHA shall notify:

( i ) The regional center pursuant to Title 1 7, California Code of Regu-
lations, Section 54327(b);

(2) The consumer's authorized representative, if applicable;

(3) The applicable protective services agency or local law enforce-
ment agency; and

(4) Any person designated in the consumer's IPP to receive informa-
tion regarding any occurrence of consumer abuse or allegations of con-
sumer abuse.

(d) The notification in subsection (c) shall be:

( 1 ) By telephone, FAX or electronic mail immediately, but in no case
later than the end of the FHA's business day; and

(2) Submitted in writing within 48 hours after the occurrence.

(e) The regional center, the FHA and the family home provider shall
cooperate as requested by any agency vv'hich has the responsibility for in-
vestigating the occurrence.

(f) The Family home provider shall report to the FHA the following
special incidents in which consumers are involved:

(1) Incidents as defined in Section 54327(b);

(2) Incidents which may result in criminal charges or legal action;

(3) Incidents which may result in the denial of a consumer's rights;

(4) Poisonings;

(5) Catastrophes;

(6) Emergency treatment;

(7) Fires or explosions; or

(8) Any other incident which appears to have a negative effect on the
consumer's health, safety and well-being.

(g) The report in subsection (f) shall be:

( i) By telephone, FAX or electronic mail immediately, but in no case
more than 24 hours after the incident; and

(2) Submitted in writing within 48 hours after the incident.

(h) Upon receipt of the report in subsection (g), or upon the FHA's in-
dependent suspicion or knowledge of a special incident, the FHA shall
notify:

( 1 ) The regional center pursuant to Title 1 7, California Code of Regu-
lations, Section 54327(b);

(2) The consumer's authorized representative, if applicable;

(3) Any person designated in the consumer's IPP to receive such infor-
mation.

(i) The report required by subsection (h) shall be:

( 1 ) By telephone, FAX or electronic mail immediately, but in no case
later than the end of the FHA's business day; and

(2) In writing within 48 hours after the incident.

Note: Authority cited: Section 4689. 1, Welfare and Institutions Code. Reference:
Section 4689.1, Welfare and Institutions Code.

History

1. New article 1 1 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 11 and section refiled 11-14-95 as an emergency; operative
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tion (a), new subsection (a)( 1), amendment of subsections (c)(3) and ( f), repeal-
er of subsection (g), new subsections (g)-(h) and subsection relettering, redesig-
nation of former subsections (g)(l)-(3) as (h)(l)-(3), and amendment of newly
designated subsection (i), transmitted to OAL 1-8-96 and filed 2-22 96 (Reg-
ister 96, No. 8)

Page 292.8(i)

§ 56094

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Amendment of subsections (b)(]), (c)(I ). (c)(4), (d)(1), (g)(1), (h)(1) and (i)(l)
and amendment of Noth filed 6-29-98 as an emergency; operative 6-29-98
(Register 98, No. 27). A Certificate of Compliance must be transmitted to OAL
by 10-27-98 or emergency language will be repealed by operation of law on
the following day.

5. Amendment of subsections (b)(1). (c)(1), (d)(1), (g)(1), (h)(1) and (i)(]) and
amendment of NoTii refiled 10-20-98 as an emergency; operative 10-27-98
(Register 98, No. 43). A Certificate of Compliance must be transmitted to OAL
by 2-24-99 or emergency language will be repealed by operation of law on the
following day.

6. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12-31-98
and filed 2-17-99 (Register 99, No. 8).

7. Amendment filed 6-27-2001 as an emergency; operative 7-1-2001 (Register
2001, No. 26). A Certificate of Compliance must be transmitted to OAL by
1 0-29-2001 or emergency language will be repealed by operation of law on the
following day.

8. Reinstatement of section as it existed prior to 6-27-2001 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f) (Register 2001 , No.
43).

9. Amendment filed 10-25-2001 as an emergency; operative 10-31-2001 (Regis-
ter 2001. No. 43). A Certificate of Compliance must be transmitted to OAL by
2-28-2002 or emergency language will be repealed by operation of law on the
following day.

10. Certificate of Compliance as to 10-25-2001 order, including amendment of
subsections (c)(1), (f)(1) and (h)(1), transmitted to OAL 2-28-2002 and filed
-^10-2002 (Register 2002, No. 15).

Article 12. Termination of Residency

§ 56094. Termination of Residency.

(a) The consumer may terminate residency at any time with or without
cause.

(I) The family home provider shall notify the FHA and the regional
center when the consumer decides to terminate residency as specified in
subsection (a).

(b) The notification required in subsection (a)(1) shall be:

( 1 ) By telephone immediately; and

(2) In writing within 24 hours after the termination of residence.

(c) When the consumer's decision to terminate residency is unantici-
pated by the family home provider or the FHA or the consumer' s decision
to terminate residency is due to an emergency, the FHA shall provide or
arrange for services pursuant to Section 56084(b)(4)(I).

(d) Upon notification as required by subsection (a)(1), the regional
center shall convene the consumer's ID Team within a reasonable period
of time not to exceed 5 working days following receipt of the notification
required by subsection (b) to assess the consumer's residence in terms of
subsection (h)( 1 ) through (3).

(e) When a family home provider determines that the family home is
unable to continue to meet the needs of the consumer as specified in the
consumer's IPP, the family home provider shall notify the following, in
writing, at least 30 days prior to the date of termination of residency:

( 1 ) The consumer;

(2) The regional center;

(3) The FHA; and

(4) The consumer's authorized representative, if applicable.

(f) When an FHA determines that it is unable to continue to meet the
needs of the consumer as specified in the consumer's IPP, the FHA shall
notify the following, in writing, at least 30 days prior to the dale of termi-
nation of residency:

(1) The consumer;

(2) The regional center;

(3) The family home provider; and

(4) The consumer's authorized representative, when applicable.

(g) When the regional center determines that the FHA or the family
home provider is unable to continue to meet the needs of the consumer
as specified in the consumer' s IPP, the regional center shall notify the fol-
lowing, in writing, at least 30 days prior to the date of termination of resi-
dency:

(1) The consumer;

(2) The FHA;

(3) The family home provider; and

(4) The consumer's authorized representative, if applicable.

(h) Upon the determination in subsections (e), (f), or (g), the regional
center shall convene the consumer's ID Team to assess:

( 1 ) The need for additional or different services and supports in order
for the consumer to remain in the family home; or

(2) If a move becomes necessary, the consumer's choices and needs
for services and supports before, during and after the move to a new resi-
dence; and

(3) Any additional measures necessary to meet the consumer's health
and safety needs until the move has been accomplished.

(i) A place of residence shall be selected by the regional center and the
FHA within a reasonable period of fime based upon concerns for the
health and safety of the consumer.

(j) The FHA shall provide the services and supports necessary to en-
able the consumer to continue to reside in the fairiily home until a new
residence is selected pursuant to subsection (i).

(k) If a new residence is not available by the designated termination
date, the regional center shall coordinate with the FHA to ensure that the
services and supports necessary to enable the consumer to continue to re-
side in the family home are provided until a new residence is available.
NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Secfion 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

1. New article 12 and section filed 7-24-95 as an emergency; operative 7-24—95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 12 and section refiled 11-14-95 as an emergency; operadve
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
fions (d) and (h)-(h)(2). new subsecfion (h)(3), amendment of subsection (i), re-
pealer of subsections (i)(])-(2) and new subsecfion (k), transmitted to OAL
1-8-96 and filed 2-22-96 (Register 96, No. 8).

Article 13. Monitoring and Sanctions

§ 56095. Monitoring and Sanctions.

(a) The FHA's social service staff shall monitor family homes on at
least a monthly basis to ensure:

( 1 ) Consistency between the services and supports being provided by
the family home and the services and supports specified in the consum-
er's IPP;

(2) Consistency between the services and supports being provided by
the family home and the FHA's program design;

(3) Consumer satisfacfion;

(4) Appropriateness of the match between the needs of the consumer
and the family home;

(5) Consumer health and safety; and

(6) Accountability of consumer funds and property.

(b) The FHA's social service staff shall report deficiencies identified
pursuant to subsection (a) to the regional center.

( 1 ) That the services and supports referenced in the consumer' s IPP are
being provided as specified;

(2) That the consumer is achieving the outcomes specified in the con-
sumer's IPP;

(3) That the consumer's health and safety are not endangered;

(4) That the consumer is satisfied as a resident in the family home, as
determined by the consumer, the consumer's authorized representative,
if any, the consumer's family, or significant others, or all of these; and

•

Page 292.8(j)

Title 17

Health and Welfare Agency — Department of Developmental Services

ij 56097

{5} That the consumer's funds and property are accounted for.

(d) Wlicn the meeting pursuant to subsection (c) is announced, the re-
gional center representative shall provide advance notice to the consum-
er's authorized representative, if any. of the date and time of the meeting.

( 1 ) A maximum of two of the quarterly meetings per year may be con-
ducted during an unannounced visit pursuant to Welfare and Institutions
Code Section 4648. 1 provided that the regional center representative also
satisfies the requirements of (c).

(e) At least two of the quarterly meetings required by subsection (c)
shall take place at the family home and a representative of the FHA shall
be present.

( 1 ) Other quarterly meetings may take place at a place other than the
consumer's residence at a site acceptable to the consumer.

(f) When the consumer's authorized representative, if any, is unable
to attend the meeting, or the meeting is unannounced pursuant to Welfare
and Institutions Code Section 4648.1(a), the regional center representa-
tive shall confer with the consumer's authorized representative regarding
the consumer's progress toward achieving his/lier Lanterman Act IPP
objectives.

(g) A regional center representative shall monitor the FHA on at least
an annual basis to ensure:

( 1 ) That services and supports provided by the FHA and the family
home conform to applicable laws and regulations;

(2) That the administration of the FHA is consistent with the contract
negotiated between the FHA and the regional center pursuant to Section
56082(a); and

(3) That the services and supports provided by the FHA and the family
home are consistent with the FHA's program design as required by Sec-
tion 56084.

(h) In the event that the regional center learns of or identifies a defi-
ciency pursuant to subsections (a) through (c) and (g), the regional center
shall require the FHA to implement a written plan of corrective action
which specifies:

( 1 ) A description of the condition(s) or complaint(s) which led to the
need for corrective action;

(2) The method(s) by which the administrator is required to correct the
condition(s) or complaint(s);

(3) The technical assistance to be provided by the regional center or
the Department; and

(4) The time frame for the correction of the condition(s) or com-
plaint(s).

(i) When the FHA fails to make the required corrections specified in
subsection (h), the regional center shall impose any or all of the following
sanctions on the FHA by requiring:

( 1 ) Movement of a consumer from a family home;

(2) Termination of approval of a family home and revocation of the
family home's Certificate of Approval; and

(3) Termination of the FHA's vendorization.

(j) When the regional center imposes a sanction pursuant to subsection
(i), the regional center shall inform the FHA in writing of the following:

(1) The sanction to be imposed;

(2) The deficiency which led to the sanction; and

(3) The effective date of the sanction.

NOTE: Authority cited: Section 1 1 1 52, Government Code; and Sections 4405 and
4689.1, Welfare and Institutions Code. Reference: Sections 4501, 4646.5,
4648. 1(a), 4689. 1 and 4742, Welfare and Institutions Code; and Chapter 282, Stat-
utes of 1997, Item 4300-101-0001, Provision 8.

History

1 . New article 1 3 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95. No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 13 and section refiled 11-14-95 as an emergency; operative
1 1-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by .VI 3-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (a)(3) and (c)(4), transmitted to OAL 1-8-96 and filed 2-22-96 (Register
96, No. 8).

4. Amendment of subsection (c) and Non-. fled 6-29- 98 as an cniergenc\ : opera
live 6-29-98 (Register 98, No. 27). A Certificate of Compliance niusi "be trans
mitted to OAL by 10-27-98 or emergency language will be repealed In opera
tion of law on the following day.

5. Amendment of subsection (c) and Non-. refiled 1 0-20 98 as an enicrucnc\ : op
eiative 10-27-98 (Register 98, No. 43). A Certificate of Compliance miist be
transmitted to OAL by 2-24-99 or emergency language will be repealed by op
eration of law on the following day.

6. Certificate of Compliance as to 10-20-98 order transmitted to OAL 12 31 98,
disapproved by OAL and order of repeal of 10-20-98 order filed on 2-17 99
(Register 99, No. 8).

7. Amendment of subsections (c)-(c)(l ) and (c)(4), new subsections (d) (f). sub-
section reletterine, amendment of newly designated subsections (h). (i) and (j)
and amendment of Notf- filed 9-20-99: operative 10-20 99 (Retiistcr 99. No.
39).

Article 14. Appeals

§ 56096. Appeals.

(a) The FHA may appeal the denial of an application for vendorization
pursuant to Title 17. Section 54380.

(b) The FHA may appeal sanctions imposed pursuant to Section
56095(0(1) through (3) to the Director.

(c) The FHA shall file a written appeal with the Director within 30 days
after nolificadon of the imposifion of a sanction.

(d) If the appeal is not filed within the time specified in sub.section (c).
it shall be denied unless good cause pursuant to Section 56098 is estab-
lished for the late submission.

(1) Good cause shall be determined by the Director.

(2) If good cause for late submission is established, the Director shall
proceed to decide the appeal in accordance with Section 56097(c).

(e) Appeals of the denial of an application for vendorization or the ter-
minafion of vendorization pursuant to Welfare and Institutions Code
Section 4689.4 shall be filed and conducted pursuant to Welfare and In-
sfitufions Code Secfion 4689.5.

NOTE; Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History
1. New article 14 and section filed 7-24-95 as an emergency; operative 7-24-95
(Register 95, No. 30). A Certificate of Compliance must be transmitted to OAL
by 1 1-21-95 or emergency language will be repealed by operation of law on
the following day.

2. New article 14 and section refiled 11-14-95 as an emergency; operative
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1 8-96 and
filed 2-22-96 (Register 96, No. 8).

§ 56097. Content of Appeal and Decision.

(a) The appeal filed pursuant to Section 56096(c) shall be in writing
and shall include, but not be limited to, the following:

(1) The appellant's:

(A) Name, business address, and telephone number; and

(B) Vendor identification number, service code and subcode, if appli-
cable.

(2) Idenfificafion of the action being appealed;

(3) The specific basis for the appeal; and

(4) All supporfing documentation and any other information necessary
to substantiate and/or justify the appeal, including the specific regulation
used as the basis for the appeal.

(b) Within 15 days after receipt of the appeal, the Director shall review
the appeal to determine whether the appeal contains the information re-
quired by subsection (a)(1) through (4).

(1) If all the required information has been submitted, the Director
shall render a decision pursuant to subsection (c).

(2) If all the required information has not been submitted and/or addi-
tional information is needed, the Director shall request the infi)rmation
in writing from the appellant.

(3) The appellant shall submit the required or additional infi)rmation
to the Director within 15 days after receipt of the request.

Page 292.8(k)

§ 56098

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(A) If the information is not submitted witliin the time specified in sub-
section (b)(3). the appeal shall be deemed to be withdrawn and no further
action will be taken unless the appellant establishes good cause pursuant
to Section 56098.

1. If good cause for late submission is established, the Director shall
proceed with the appeal and render a decision pursuant to subsection (c).

(B) If the information is submitted but does not comply with the re-
quest, the appeal shall be deemed withdrawn and no further action will
be taken.

(c) The Director shall render a decision on the appeal within 60 days
after receipt of all required and/or requested information. The decision
shall include, but not be Hmited to:

(1) Date of the decision;

(2) Identify the specific issue(s) in dispute;

(3) Rule on each issue identified;

(4) State the facts supporting each mling; and

(5) Specify the statutes and/or regulations upon which each ruling is
based.

(d) A written copy of the decision shall be mailed to the appellant with-
in 1 5 days after the decision is rendered.

NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994. Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

2. New section refiied 1 1-14-95 as an emergency; operative 1 1-14-95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by
.VI 3-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24-95 order, including amendment of subsec-
tions (a) and (c), transmitted to OAL 1-8-96 and filed 2-22-96 (Register 96,
No. 8).

§ 56098. Good Cause.

(a) For the purposes of Sections 56096(d) and 56097(b)(3)(A), good
cause for a failure to act includes but is not limited to:

( 1 ) A violent act of nature, including, but not limited to, flood, earth-
quake, blizzard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property by indi-

viduals other than the appellant which preclude the appellant from filing
a timely appeal.

(b) The appellant shall, within 60 days after the incident giving rise to
its claim of good cause, submit to the Director the basis for the claim of
good cause and all supporting documents or other evidence substantiat-
ing the claim.

(c) The Director shall, within 30 days of receipt of the claim and sup-
porting documentation, review the information and render a decision re-
garding whether good cause has been established.

(d) The Director shall notify the appellant in writing of the decision.
NOTIi. Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Section 4689.1, Welfare and Insti-
tutions Code.

History

1. New section filed 7-24-95 as an emergency; operative 7-24-95 (Register 95,
No. 30). A Certificate of Compliance must be transmitted to OAL by 1 1-2 1-95
or emergency language will be repealed by operation of law on the following
day.

2. New section refiied 11-14-95 as an emergency; operative 1 1-14-95 (Register
95, No. 46). A Certificate of Compliance must be transmitted to OAL by
3-1 3-96 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and
filed 2-22-96 (Register 96, No. 8).

§ 56099. Review of Documents Only.

(a) An appeal made pursuant to this Article shall be decided only on
the merits of the documents submitted.

(b) There shall not be oral testimony or argument.

(c) Nothing in Sections 56096 through 56099 shall preclude the re-
gional center and the appellant from holding an informal conference at
any time to discuss or resolve the issues in dispute.

NOTE: Authority cited: Section 4689.1, Welfare and Institutions Code; Chapter
1095, Statutes of 1994, Section 14. Reference: Secfion 4689.1 , Welfare and Insti-
tutions Code.

History

1. New section and form DS5407 filed 7-24-95 as an emergency; operative
7-24-95 (Register 95, No. 30). A Certificate of Compliance must be transmitted
to OAL by 1 1-21-95 or emergency language will be repealed by operation of
law on the following day.

2. New section and form DS5407 refiied 11-14-95 as an emergency; operative
11-14-95 (Register 95, No. 46). A Certificate of Compliance must be trans-
mitted to OAL by 3-13-96 or emergency language will be repealed by opera-
tion of law on the following day.

3. Certificate of Compliance as to 7-24-95 order transmitted to OAL 1-8-96 and
filed 2-22-96 (Register 96, No. 8).

Page 292.8(1)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56099

STATE OP CMJFOfOUA • HEALTH AND WELf Aft£ AGENCY
0SS407{NEW&99)

DEPARTMEW OF DEVELOPMENTAL SERVICES

POST-VENDORIZATION

FAMILY HOME AGENCY (FHA) AND FAMILY HOME
CRIMINAL RECORD DECLARATION

PURSUANT TO WELFARE AND INSTITUTIONS CODE SECTION 4689.2(c) AND (d)
THIS STATEMENT MUST BE COMPLETED BY

Sf ANY ADULT NEWLY RESPONSIBLE FOR ADMINISTRATION OR DIRECT SUPERVISION OF FHA STAFF

^ ANY ADULT OTHER THAN A CONSUMER NEWLY RESIDING IN AN APPROVED FAMILY HOME IN WHICH
THE FAMILY HOME PROVIDERS. OTHER OCCUPANTS. AND EMPLOYEES HAVE BEEN GRANTED
CRIMINAL RECORD CLEARANCES

^ ANY ADULT NEWLY PROVIDING ASSISTANCE TO THE CONSUMER IN DRESSING. GROOMING. BATHING.
OR PERSONAL HYGIENE

^ ANY NEW STAFF PERSON. EMPLOYEE, CONSULTANT. OR VOLUNTEER WHO HAS FREQUENT AND
ROUTINE CONTACT WITH THE CONSUMER

sf ANY NEW EXECUTIVE DIRECTOR OF THE FHA

^ ANY NEW OFFICER OF THE GOVERNING BODY OF THE FHA

^ ANY OTHER NEW PERSON WITH A FINANCIAL INTEREST IN THE FHA

HAVE YOU EVER BEEN CONVICTED OF A CRIME OTHER THAN A
MINOR TRAFFIC VIOLATION?

IF YES. ATTACH A SIGNED STATEMENT INDICATING THE
NATURE AND CIRCUMSTANCES OF THE CRIME(S)

YES

□

HAVE YOU EVER BEEN CONVICTED OF A CRIME AND HAD
THAT CONVICTION SET ASIDE UNDER PENAL CODE
SECTIONS 1203.4 AND/OR 1203.4a?

IF YES. ATTACH A SIGNED STATEMENT INDICAVNG THE
NATURE AND CIRCUMSTANCES OF THE CRIME{S)

YES

D "^ D

I DECLARE UNDER PENALTY OF PERJURY THAT I HAVE READ AND UNDERSTAND THE
INFORMATION CONTAINED IN THIS AFFIDAVIT, AND THAT MY RESPONSES AND ANY
ACCOMPANYING ATTACHMENTS ARE TRUE AND CORRECT.

PRINT NAME CLEARLY

i SIGNATURE

CITY/COUNTY WHERE SIGNED

1 DATE OF SIGNATURE

DATE OF BIRTH

FHA NAME

i FHA ADDRESS

WHITE COPY (ORIGINAL) - FHA
CANARY COPY . DOS

PINK COPY - REGIONAL CENTER
GOLDENROO COPY . DECLARANT

Page 292.8 (m)

§ 56100

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Subchapter 4.2. Intermediate Care Facility

(ICF); Intermediate Care
Facility/Developmentally Disabled (ICF/DD);
Intermediate Care Facility/Developmentally

Disabled-Habilitative(ICF/DD-H);

Intermediate Care Facility/Developmentally

Disabled-Nursing (ICF/DD-N); Skilled

Nursing Facility (SNF) Monitoring

Requirements

Article 1. Definitions

§ 561 00. Meaning of Words.

A word or a phrase shall have its usual meaning unless the context or
a definition clearly indicates a different meaning. Words and phrases
used in their present tense include the future tense. Words and phrases in
the singular form include the plural form. Use of the word "shall" denotes
mandatory conduct. "May" denotes permissive conduct.
NOTE: Authority cited: Section 11152, Government Code; and Section 4405,
Welfare and Institutions Code. Reference: Sections 4648.1 and 4742, Welfare and
Institutions Code.

History

1 . New subchapter 4.2 (articles 1-2), article 1 (sections 56100-56101 ) and section
filed 6-29-98 as an emergency; operative 6-29-98 (Register 98, No. 27). A
Certificate of Compliance must be transmitted to OAL by 10-27-98 or emer-
gency language will be repealed by operation of law on the following day. For
prior history of article 1 (sections 56550-56609) see Register 91, No. 14.

2. New subchapter 4.2 (articles 1-2), article 1 (sections 56 100-56 101) and section
refiled 10-26-98 as an emergency; operative 10-26-98 (Register 98, No. 44).
A Certificate of Compliance must be transmitted to OAL by 2-23-99 or emer-
gency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 10-26-98 order, including amendment of sub-
chapter heading, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99,
No. 8).

§56101. Definitions.

(a) The following definitions shall apply to the regulations set forth in
this subchapter:

(1 ) "Consumer" means a person who has a disability which meets the
definition of "developmental disability" as specified in Welfare and In-
stitutions Code, Section 4512(d).

(2) "Consumer's Authorized Representative" means a person who
meets any of the qualifications for an "authorized representative" as set
forth in Welfare and Institutions Code Section 4701.6.

(3) "Facility Representative" means a person who is employed or des-
ignated by the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF to represent
that facility.

(4) "Immediate Danger" means an immediate and serious threat hav-
ing a high probability that serious harm or injury to the consumer's health
and safety could occur at any time, or already has occurred and may occur
again if the consumer(s) is not protected effectively from the harm or in-
jury or the threat to the consumer's health and safety is not removed.

(5) "Intermediate Care Facility (ICF)" means an Intermediate Care Fa-
cility as defined in Health and Safety Code Section 1250(d).

(6) "Intermediate Care Facility/Developmentally Disabled (ICF/
DD)" means an Intermediate Care Facility/Developmentally Disabled as
defined in Health and Safety Code Section 1250(g).

(7) "Intermediate Care Facility/Developmentally Disabled/Habilita-
tive (ICF/DD-H)" means an Intermediate Care Facility/Developmental-
ly Disabled-Habilitative as defined in Health and Safety Code Section
1250(e).

(8) "Intermediate Care Facility/Developmentally Disabled/Nursing
(ICF/DD-N)" means an Intermediate Care Facility/Developmentally
Disabled-Nursing as defined in Health and Safety Code Section 1 250(h).

(9) "Lanterman Act Individual Program Plan (IPP)" means a written
plan for consumer services developed by the consumer's planning team
in accordance with the provisions of Welfare and Institutions Code Sec-
tions 4646 and 4646.5.

( 1 0) "Regional Center" means a private nonprofit diagnostic, counsel-
ing and service coordination center for developmentally disabled per-
sons and their families which is established and operated pursuant to
Welfare and Institutions Code Sections 4620 through 4669.

(11) "Regional Center Representative" means a person who is
employed or designated by the regional center to represent that agency.

(12) "Skilled Nursing Facility (SNF)" means a skilled facility as de-
fined in Title 22, California Code of Regulations, Section 51 121.
NOTE: Authority cited: SecUon 11152, Government Code; and Section 4405,
Welfare and Institutions Code. Reference: Sections 4502 and 4742, Welfare and
Institutions Code; Section 1250, Health and Safety Code; and Chapter 282, Stat-
utes of 1997, Item 4300-101-0001, Provision 8.

History

1 . New section filed 6-29-98 as an emergency; operative 6-29-98 (Register 98,
No. 27). A Certificate of Compliance must be transmitted to OAL by 1 0-27-98
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 10-26-98 as an emergency; operative 10-26-98 (Register
98, No. 44). A Certificate of Compliance must be transmitted to OAL by
2-23-99 or emergency language will be repealed by operation of law on the fol-
lowing day.

3. Certificate of Compliance as to 10-26-98 order, including amendment of sec-
tion, transmitted to OAL 12-31-98 and filed 2-17-99 (Register 99, No. 8).

Article 2. Monitoring

§ 56102. State Developmental Centers.

The requirements of Subchapter 4.2 shall not apply to State Develop-
mental Centers.

NOTE: Authority cited: Section 11152, Government Code; and Section 4405,
Welfare and Institutions Code. Reference; Sections 4502 and 4742, Welfare and
Institutions Code; Section 1250, Health and Safety Code; and Chapter 282, Stat-
utes of 1997, Item 4300-101-0001, Provision 8.

History

1 . New article 2 (secdons 56102-56 104) and section filed 6-29-98 as an emergen-
cy; operative 6-29-98 (Register 98, No. 27). A Certificate of Compliance must
be transmitted to OAL by 10-27-98 or emergency language will be repealed by
operation of law on the following day.

2. New article 2 (sections 56102-56104) and section refiled 10-26-98 as an emer-
gency; operative 10-26-98 (Register 98, No. 44). A Certificate of Compliance
must be transmitted to OAL by 2-23-99 or emergency language will be re-
pealed by operation of law on the following day.

3. Certificate of Comphance as to 10-26-98 order, including renumbering of for-
mer section 56102 to secfion 56103 and new section 56102, transmitted to OAL
12-31-98 and filed 2-17-99 (Register 99, No. 8).

§ 56103. Service Delivery Monitoring.

(a) The regional center representative shall meet with the consumer at
least quarterly to review the consumer's progress toward achieving his/
her Lanterman Act IPP objectives.

( 1 ) At least two of the quarterly meetings per year required by subsec-
tion (a) shall take place in the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or
SNF and a facility representative shall be present at these meetings.

(2) Other quarterly meetings may take place at a location other than the
ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF at a site acceptable to the
consumer.

(3) A maximum of two of the quarterly meetings per year pursuant to
subsection (a) may be conducted during an unannounced visit pursuant
to Welfare and Institutions Code Section 4648. 1 (a), provided the require-
ment specified in subsection (b) is met.

(4) The regional center representative shall provide advance notifica-
tion to the facility, the consumer' s authorized representative, if any, and
the consumer of the date and time of the meeting required by subsection
(a) if the meeting is to be announced.

(5) When the consumer's authorized representative is unable to attend
the meeting required by subsection (a), or the meeting is unannounced
pursuant to Welfare and Institutions Code 4648. 1(a), the regional center
representative shall confer with the consumer's authorized representa-

Page 292.8(n)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56702

ti\e regarding the consumer's progress toward achieving his/her Lanter-
man Act IFF objectives.

(b) The regional center representative shall review the documentation
of the implementation and progress toward achievement of the consum-
er's Lanterman Act IPP objectives.

(c) When the meeting is announced, and the notification requirements
of (a)(4) have been met. the regional center representative shall meet pri-
vately with the consumer when requested by the consumer or the con-
sumer's authorized representative, if any.

(d) The regional center representative may review the ICF, ICF/DD,
ICF/DD-H, ICF/DD-N or SNF's records and accounts of the consum-
er's cash resources, personal property and valuables.

(e) Upon completing the reviews specified in subsections (a) and (b).
the regional center representative shall complete a written progress re-
port which includes, but is not limited to:

(1) The date of the meeting(s) required by subsection (a) and the re-
view required by subsection (b);

(2) Documentation of the meeting(s) required by subsection (a);

(3) Any changes in the consumer's needs for services and supports and
all actions taken in response to those changes;

(4) A summary of the provision of services and supports to the con-
sumer pursuant to the consumer's Lanterman Act IPP; and

(5) The signature of the regional center representative.

(0 The written progress report shall be retained by the regional center
in the consumer's file.

(g) If the regional center representative finds any evidence of sus-
pected licensing violations during a review, he/she shall report such
violations immediately to the appropriate State Department of Health
Services' Licensing and Certification district office.
NOTIi: Authority cited: Section in52. Government Code; and Section 4405,
Welfare and Institutions Code. Reference: Sections 4502, 4648.1(a) and 4742,
Welfare and Institutions Code; and Chapter 282, Statutes of 1997, Item
4?0O- 10 1-0001, Provision 8.

History

1 . New section filed 5-10-2000; operative 6-9-2000 (Register 2000, No. 19). For
prior history, see Register 99, No. 8.

§56104. Suspension of Placements.

(a) The regional center shall not place new consumers into an ICF.
ICF/DD, ICF/DD-H. ICF/DD-N or SNF when any of the following cir-
cumstances exist at the facility:

(1 ) The ICF, ICF/DD. ICF/DD-H, ICF/DD-N or SNF's license has
been suspended;

(2) A revocation action against the ICF. ICF/DD. ICF/DD-H, ICF/
DD-N or SNF's license is pending or has been referred to the Attorney
General;

(3) The court has been petitioned for a receiver, or a receiver has been
appointed, for the ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF; or

(4) The Department of Health Services has issued written notice to the
ICF, ICF/DD, ICF/DD-H, ICF/DD-N or SNF that the facihty's certifica-
tion for Medi-Cal funding will not be renewed or is being suspended.
NOTlv. Authority cited: Section 11152, Government Code; and Section 4405,
Welfare and Institutions Code. Reference: Sections 4501. 4502, 4502.1, 4646.5,
4648.1 and 4742, Welfare and Institutions Code; and Chapter 282, Statutes of
1997, Item 4300-101-0001, Provision 8.

History

1 . New section filed 6-29-98 as an emergency; operative 6-29-98 (Register 98,
No. 27). A Certificate of Compliance must be transmitted to OAL by 10-27-98
or emergency language will be repealed by operation of law on the following
day.

3. Certificate of Compliance as to 10-26-98 order, including renumbering and
amendment of former section 56103 to section 56104, transmitted to OAL
12 -31-98 and filed 2-17-99 (Register 99, No. 8).

§ 56105. Termination of Consumer(s) Residence.

(a) The regional center shall have the authority to relocate a consumer
residing in an ICF. ICF/DD. ICF/DD-H, ICF/DD-N or SNF w hen:

( 1 ) The consumer or the consumer's authorized representativ c asks for
the consumer to be moved.

(2) No other agency has jurisdiction to act or an agency with jurisdic-
tion is unable to do so in a timely manner, and the regional center has de-
termined that:

(A) The consumer is in immediate danger; or

(B) The consumer's health or safety would be compromised by contin-
ued residence in the ICF, ICF/DD, ICF/DD-H. ICF/DD-N or SNF'.
NOTl- Authority cited: Section 11152, Government Code; and Section 4405.
Welfare and Institutions Code. Reference: Sections 4501, 4502, 4502.1. 4646.5.
4648.1 and 4742, Welfare and Institutions Code; and Chapter 282. Statutes of
1997, Item 4300-101-0001, Provision 8.

History
1. Renumbering and amendment of former section 56104 to section 56105 filed
2-17-99; operative 2-17-99 (Register 99, No. 8).

§56610. Compliance.

NOTK: Authority cited: Section 4748, Welfare and Institutions Code. Reference:
Sections 4746 and 4748, Welfare and Institutions Code.

History
1. Repealer filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

Subchapter 5.

Standards for Nonresidential
Services

Article 1. Definitions

§ 56702. Terms Defined in Other Subchapters.

(a) As used in this subchapter, the following words and phrases have
the meanings specified in section 54302 of these regulations;

( 1 ) Activity Center

(2) Adult Day Programs

(3) Adult Development Center

(4) Authorized Consumer Representative

(5) Behavior Management Program

(6) Community-based Day Programs

(7) Community Integration

(8) Consumer

(9) Days

(10) Department

(11) Direct Care Staff

(12) Direct Services

(13) Functional Skills

(14) Generic Agency

(15) Independent Living Program

(16) Individual Program Plan (IPP)

(17) In-home Respite Services

( 1 8) Infant Development Program

(19) Interdisciplinary Team (ID Team)

(20) Natural Environment

(2 1 ) Program Preparation Functions

(22) Regional Center

(23) Self-Care

(24) Social Recreation Program

(25) Special Incident Report

(26) Staffing Ratio

(27) Vendor

NOTE: Authority cited: Sections 4648, 4690, 4690.2 and 4691 , Welfare and Insti-
tutions Code. Reference: Sections 4646, 4648, 4690. 4690.2 and 4691 . Welfare
and Institutions Code.

History
1. New section filed 6-26-90 as an emergency: operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29 90
or emergency language will be repealed by operation of law on the foikm ing
day.

Page 292.8(0)

§ 56704

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a)(4), repealing subsec-
tion (a)(6), renumbering subsections, and adding new subsection (a)(8) filed
1 - 1 7-97 pursuant to section 1 00, title I . California Code of Regulations (Regis-
ter 97, No. 3).

§ 56704. Additional Terms Defined.

(a) As used in this subchapter, the following words and phrases have
the following meanings:

( 1 ) "Care Giver" means an adult, other than a parent, who has primary
responsibility for the care and custody of a child. A care giver may be a
relative, such as an aunt, uncle, or grandparent, or an unrelated adult,
such as a foster care parent;

(2) "Center-Based Environment" means within a day care facility or
on the grounds of such a facility;

(3) "'Consumer Program Coordinator" means the individual specified
in Welfare and Institutions Code, section 4648 (a) who has the responsi-
bility for, implementing, overseeing, and monitoring, the consumer's
IPP and for maintaining the consumer's case management or service
coordination file. Consumer program coordinator is synonymous with
regional center case manager, counselor or service coordinator;

(4) "Employment Training" means individually planned activities and
instruction which enable adults with developmental disabilities to obtain
and maintain paid work and which can occur in group or individual situa-
tions. This term is synonymous with vocational training;

(5) "Non-mobile Persons" means persons who are confined to wheel-
chairs or gurneys, and who are unable to move from one place to another
place independently;

(6) "Personal Needs", means a condition or situation pertaining to one
s own intimate and immediate care, such as eating, toileting, personal hy-
giene;

(7) "Program Curriculum" means the array of consumer training ser-
vices offered by a vendor; and

(8) "Self-Help" means those skills and abilities which are considered
as normal developmental milestones for non disabled children.
NOTE; Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Section 4691. Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a)(3) filed 1-17-97
pursuant to section 100, fitle 1, California Code of Regulations (Register 97, No.
3).

Article 2. Standards for All
Community-Based Day Programs

§ 56710. General Requirements.

(a) Community-based day program vendors shall adopt and review,
annually, a written internal grievance procedure for consumers pursuant
to Welfare and Institutions Code, Section 4705.

(b) A community-based day program vendor may subcontract for pro-
vision of a portion of the direct service if both of the following conditions
are met:

(1) The unique needs of the consumer(s) require an intermittent ser-
vice for a portion of the direct service day which can only be provided
by a licensed professional not available within the program staff; and

(2) Written approval of the regional center is obtained.

NOTE: Authority cited: Section 4691, Welfare and InsUtutions Code. Reference:
Sections 4705 and 4691, Welfare and InsUtutions Code.

History
1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90

or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (c)-(c)(2) and amendment of Note filed as an emergency: op-
erative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be
transmitted to OAL 3-4-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. New subsections (c)-(c)(2) and amendment of Note refiled 3-4-92 as an emer-
gency: operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 3-^-92 order including repealer of subsection
(c) and amendment of NoTi-: transmitted to OAL 6-25-92 and filed 8-6-92
(Register92, No. 33).

6. Change without regulatory effect amending subsections (a) and (b)(1) filed
1-1 7-97 pursuant to section 100. title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 5671 1 . Waiver of Service Standards.

(a) Regional centers, in negotiating service contracts pursuant to Sec-
tion 57540 or a lower level of payment pursuant to 57300(d), may waive
or modify any of the following program standards for the duration of the
service contract or lower level of payment:

(1) Personnel functions and qualifications specified in Sections
56724(a), (b), (c) and (e), 56754, and/or 56770;

(2) Staff training requirements specified in Section 56726 and/or
56774; and/or

(3) Program evaluation requirements specified in Section 56732.

(b) Regional centers may waive or modify any of the program stan-
dards pursuant to (a) above only if waiver or modification of the program
standard(s) will not adversely affect the health and safety of the consum-
ers or place the consumers in a more restrictive environment.

NOTE; Authority cited: Chapter 722, Statutes of 1992, Section 147 and Section
4791(i), Welfare and InsUtutions Code. Reference: Section 4791, Welfare and In-
stitutions Code.

History

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to
OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1 992) Sec-
tion 147(a) (Register 93, No. 26).

2. Amendment of subsection (a)(1) filed 4-22-94; operative 4-22-94. Submitted
to OAL for printing only (Register 94, No. 16).

3 . Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

4. Change without regulatory effect amending subsection (b) filed 1-17-97 pur-
suant to section 100, title 1, California Code of Regulations (Register 97, No.
3).

§56712. Program Design.

(a) The program design shall include the following items:
(1) A program description which includes:

(A) The purpose and goals of service;

(B) Anticipated consumer outcomes resulting from participation in the
program stated in measurable terms;

(D) Description of the location(s) in which consumer training occurs,
such as a center-based environment, the consumer's place of residence
or a natural environment;

(E) Consumer attendance policy which includes the following:

1 . The requirement for the vendor to notify the regional center on or
before a consumer's fifth consecutive day of unplanned absence;

2. The attendance requirements for consumers to remain enrolled in
the program; and

3. The efforts the program will make to assure attendance at the pro-
gram as frequently as determined necessary by the ID Team.

(F) Statement of the staffing ratio required pursuant to Section 56756
or 56772 of these regulations;

(G) Schedule of the vendor's direct service operating hours including
a sample of a current weekly schedule; and

(H) A staff training plan, if developed pursuant to Sections 56726 and
56774 of these regulations, if applicable.

Page 292.8(p)

Title 17

Health and Welfare Agency — Department of Developmental Services

§56716

(2) A description of the entrance/exit criteria pursuant to Sections
56714 and 56746 of these regulations, if applicable, including the intake
procedure and any screening processes used by the vendor;

(3) A description of the process used to determine how the vendor will
assist each consumer served in achieving his/her IPP objectives for
which the vendor is responsible including:

(A) Consumer assessment procedures, timelines, and instalments
used, including an explanation of how each instrument is applicable in
assessing the consumer's needs;

(B) Utilization of assessment data for determining the specific activity
and program services that consumers receive; and

(C) Evaluation procedures used to determine the extent of a consum-
er's progress toward achieving the specific outcomes in each IPP objec-
tive for which the vendor is responsible.

(4) A description of the method of evaluating pi"ogram effectiveness
in accordance with Section 56732 of these regulations; and

(5) A description of the internal consumer grievance procedures re-
quired pursuant to Section 56710(a) of these regulations.

(b) When modifications are made to the program design which consti-
tute a change in the type of services provided, the vendor must, at least
30 days prior to the change, notify the consumers or their authorized con-
sumer representatives and submit to the vendoring regional center, a re-
vised program design as described in (a) above. A revised program de-
sign is required when any of the following elements of the program
design are changed:

(1) Locations in which consumer training occurs;

(2) Curriculum training components;

(3) Existing approved staffing ratio;

(4) Approved service code;

(5) Entrance and/or exit criteria;

(6) Hours of operation.

(c) A rate adjustment request which results from a program design
change shall be submitted to the vendoring regional center prior to De-
cember 1 of the current calendar year in accordance with section 57922
of these regulations.

Note: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Section
4691, Welfare and Institutions Code. Reference: Chapter 101 1, Statutes of 1992,
Section 11, Sections 4646, 4646.5, 4648, 4691, 4690.2, 4705 and 4791, Welfare
and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register W.
No. 36). A Certificate of Compliance must be iransmitled to OAL b\ 10 29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9 28 90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative (> 17 93.
SubmiUed to OAL for printins only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (RegiW 93. No. 26).

4. Amendment of subsections (a)( 1 )(A)-(a)(5) filed 4-22-94: operative 4-22-94.
Submitted to OAL for printing only (Register 94, No. 16).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, fitle 1, California Code of Regulations (Register 97, No. 3).

§ 56714. Vendor Entrance and Exit Criteria for Consumers.

(a) The vendor shall have written entrance and exit criteria that shall
be used by a consumer' s ID Team to determine the appropriateness of the
vendor's program for meeting the objective(s) of an individual consum-
er's IPP. The criteria shall include all of the following:

( 1 ) Ages of consumers to be served;

(2) Any other prerequisites required for participation in the program;
and

(3) The level of skills and ability development which would indicate
that placement in the vendor's program may no longer meet the consum-
er's needs.

Note: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Sections 4648 and 4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 35). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and section filed
1-17-97 pursuant to section 100, title 1, CaHfomia Code of Regulations (Regis-
ter 97, No. 3).

§ 56716. Consumer Placement Procedures.

(a) Interdisciplinary Teams shall identify community-based day pro-
grams which can meet the objectives of the consumer's IPP developed

[The next page is 292.9.]

Page 292.8(q)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56718

pursuant to Welfare and Institutions Code, section 4646.5 and which are
located as close to the consumer's residence as possible as required by
Welfare and Institutions Code, section 4501.

(b) Placement in a program shall occur providing all of the following
conditions exist:

(1) The consumer or authorized consumer representative consents to
the placement;

(2) The regional center concurs that the placement is appropriate;

(3) The consumer's needs can be met within the staffing ratio ap-
proved for the program pursuant to section 56756 or 56772 of these regu-
lations;

(4) The consumer meets the vendor's entrance, criteria; and

(5) The vendor agrees to the consumer's placement in the program.

(c) A consumer's continued placement in a community-based day
program shall be based upon a determination by the ID Team during the
IPP review that:

(1) There is documentation that all of the conditions in paragraph (b)
above exist; and

(2) The consumer has been assisted by the program in making reason-
able progress toward the IPP objective(s) for which the consumer was
originally placed into the program.

NOTE; Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691 and 4791(1), Welfare and Institutions Code. Reference: Chapter 1011, Stat-
utes of 1992, Section 1 1; and Sections 4501, 4646, 4646.5, 4648, 4691 and 4791,
Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and secfion filed
1-17-97 pursuant to secfion 100, title 1 , California Code of RegulaUons (Regis-
ter 97, No. 3).

§ 56718. Consumer Placement and Funding Termination
Procedures.

(a) Funding of a consumer's placement in a vendor's program shall be
terminated when one or more of the following occur:

( 1 ) The regional center issues a written determination stating that con-
tinued participation jeopardized the consumer's health and safety;

(2) The consumer or authorized consumer representative makes a
written or oral request to the regional center to discontinue participation
or the consumer can no longer attend the program due to an unanticipated
change in residence;

(3) The ID Team has determined through a consumer evaluation that
the vendor's program no longer meets the consumer's needs;

(4) The vendor determines that its program may no longer meet the
consumer's needs; or

(5) The consumer, or authorized consumer representative acting on
behalf of the consumer, consents to an alternate placement identified by
the ID Team as being able to meet the consumer's needs and as being
more cost effective. The alternate placement shall be considered more
cost effective if the combined cost of the alternate placement and the cost
of transporting the consumer to and from the alternate placement is less
than the combined cost of the consumer' s current placement and the cost
of transporting the consumer to and from the current placement.

(b) When a determination is made pursuant to (a)(1), (3), (4) or (5)
above, the basis for the determination shall be documented in writing in
the consumer' s case file by the regional center for (a)( 1 ) and/or (3) and/or
(5) and by the vendor for (a)(4). The regional center shall also include
written documentation in the consumer's file that the consumer or autho-
rized consumer representative has been informed of the fair hearing
rights pursuant to Welfare and Institutions Code, Sections 4701, 4705

and 4710 when the determination is made pursuant to (a)(1), (3) or (5)
above.

(c) When the regional center or the vendor proposes to terminate the
consumer's placement in the vendor's program, other than in accordance
with (a)( 1 ) or (a)(2) above, the initiating party shall notify the other party
and the consumer in writing at least 30 days prior to the proposed termi-
nation date. Such notice shall include a written statement of reasons for
the termination. If the regional center terminates the placement prior to
the end of the 30 day notice period, except as specified in (a)( 1 ) and (a)(2)
above, the vendor shall be paid for those days of program services during
that 30 days period for which the consumer would have been authorized
to receive services as identified in the IPP. Funding shall not continue un-
der either of the following circumstances:

( 1 ) There is agreement between the regional center, vendor, and the
consumer or authorized consumer representative for an earlier termina-
tion date. In this instance, funding shall be provided through the date the
consumer leaves the program.

(2) The consumer's vacated place in the program has been filled by
another consumer. In this instance, funding for the consumer who is no
longer in the program shall cease on the date the substitute consumer be-
gins attending.

(d) When the conditions specified in (a)(1) above exist, terminafion
shall be immediate and no further payment shall be made, except as spe-
cified in (e) below.

(e) When the conditions specified in (a)( 1 ), (a)(3) or (a)(5) above exist,
termination of funding shall not be made if the consumer files a fair hear-
ing request pursuant to Welfare and Institutions Code, Secfions 4700
through 4730.

(f) When the conditions specified in (a)(2) above exist, funding shall
terminate immediately upon the consumer's nonparticipation. The re-
gional center shall notify the vendor in writing of the reason that the con-
sumer no longer wishes to participate in the program. Such notification
shall be made within 10 days of the date the regional center is notified by
the consumer or authorized consumer representative.

(g) A vendor may exclude a consumer from participation in the pro-
gram during periods when the vendor determines that the consumer is a
threat to the health and safety of other individuals in the program. Such
exclusion shall be followed by a meeting scheduled by the vendor within
three working days to include the consumer program coordinator, the
consumer and authorized consumer representative to discuss the basis of
the exclusion and any program changes that may be required. The provi-
sions of this paragraph shall not apply to exclusions that are made in ac-
cordance with a prior written agreement with the regional center pertain-
ing to the individual consumer.

NOTE; Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Sections 4648, 4648.1, 4691, and 4700 through 4730, Welfare and Institutions
Code.

History

1. New secfion filed 6-26-90 as an emergency: operafive 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(4) and Note and new subsecfion (a)(5) filed
1 1-5-91 as an emergency; operafive 1 1-5-91 (Register 92, No. 21). A Certifi-
cate of Compliance must be transmitted to OAL 3-4-92 or emergency language
will be repealed by operafion of law on the following day.

4. Amendment of subsection (a)(4) and Note and new subsection (a)(5) refiled
3-4-92 as an emergency; operafive 3-4-92 (Register 92, No. 25). A Certificate
of Compliance must be transmitted to OAL 7-2-92 or emergency language will
be repealed by operafion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tions (a)(5), (b) and (e) transmitted to OAL 6-25-92 and filed 8-6-92 (Register
92, No. 33).

6. Amendment of secfion filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7 . Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20 94 and
filed 8-2-94 (Register 94, No. 31).

Page 292.9

§ 56720

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

8. Change without regulatory effect amending section heading and section filed
1-17-97 pursuant to section 100, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56720. Consumer IPP Documentation.

(a) The vendor shall be responsible for establishing, maintaining, and
modifying, as necessary, documentation regarding the manner in which
it will assist each consumer served in achieving his/her IPP objective(s)
for which the vendor is responsible.

(b) The following time lines shall be followed in establishing, main-
taining, and modifying the documentation required in (a) above.

(1) The regional center shall provide the vendor a written copy of the
consumer's IPP within 30 days following:

(A) The consumer's admission to the vendor's program; and

(B) Any modification made by the ID Team to the consumer's IPP.

(2) The vendor shall prepare the documentation required in (a) above
within 30 days of receipt of the IPP pursuant to (b)(1)(A) or (B) above.

(1) Review the consumer's performance and progress in relation to
each IPP objective for which the vendor is responsible; and

(2) Submit written documentation to the regional center which in-
cludes all of the following:

(A) An evaluation of the consumer' s performance and progress based
upon the review conducted pursuant to (c)( 1 ) above;

(B) Identification of the barriers to the consumer's success in achiev-
ing the IPP objective(s) for which the vendor is responsible and how such
barriers shall be overcome in the future; and

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Sections 4646, 4648, 4648.1 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (c) and Note filed 1 1-5-91 as an emergency; opera-
tive 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (c) and Note refiled 3-4-92 as an emergency; opera-
tive 3-4-92 (Register 92, No. 25). A Certificate of CompUance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secdon 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section heading and section filed
1 - 1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56722. Personnel Requirements.

(a) Each vendor shall maintain current written job descriptions, or in-
teragency agreements with the generic agency providing the staff, for all
personnel, including staff whose wages are not paid by regional center
purchase of service funds.

(b) Each job description shall include:

(1) Position title;

(2) Role and responsibility of the position within the organizational
structure of the program;

(3) Duty statement;

(4) Work hours;

(5) Minimum qualifications

(6) Positions supervised, if applicable; and

(7) Reporting supervisor.

(d) Volunteers shall not be used to replace paid staff, but may be used
to augment such staff, pursuant to Section 56724 of these regulations.

(e) Staff whose wages are not paid by regional center purchase of ser-
vice funds shall demonstrate the minimum qualifications as identified in
Section 56724 of these regulations necessary for each job function per-
formed.

(f) The vendor is authorized to ufilize consultants to develop the pro-
gram design pursuant to Section 567 1 2 of these regulations, and to devel-
op and carry out staff development and training.

NOTE: Authority cited: Sections 4648 and 4691, Welfare and Institutions Code.
Reference: Sections 4648 and 4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a) and (d) and Note filed 1 1-5-91 as an emergen-
cy; operative 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance must
be transmitted to OAL 3-4-92 or emergency language will be repealed by oper-
ation of law on the following day.

4. Amendment of subsections (b)(4) and amendment of Note refiled 3-4-92 as
an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operafion of law on the following day.

5. Certificate of Compliance as to 3^-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of secfion filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93. No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 56724. Personnel Functions and Qualifications.

(a) Each vendor shall assign staff to carry out the duties described here-
in. The vendor is authorized to designate positions by different tiUes than
those listed, but is responsible for assuring the functions described are
carried out. Staff who are hired by the vendor to carry out the functions
listed shall meet the minimum qualifications listed in this section.

(b) The vendor shall assign a director to carry out the administrative
responsibilities for the program.

(1) The director shall have primary responsibility for the following
functions:

(A) Organizing and supervising the program in accordance with the
program's established policies;

(B) Overseeing the areas of budgeting, program design and implemen-
tation, project planning, staff development and training, evaluation and
the direction of program services; and

(2) The vendor is authorized to delegate to the director additional func-
tions not identified in (b)(1) above and which are directiy related to the
overall administration of the program; and

(3) The director shall possess the minimum qualifications specified in
section 56754 (a) or 56770 (a) of these regulations.

(1) The supervisor shall have primary responsibility for one or more
of the following functions:

(A) Selection, training, and supervision of assigned staff;

(B) Planning, managing, coordinating and evaluating, assigned staff
efforts to achieve the program's objectives and consumer outcomes;

(C) Coordinating with the regional center the implementation of con-
sumer IPP objectives for which the vendor is responsible;

(D) Assessing the program's effectiveness in achieving consumer IPP
objectives; and

Page 292.10

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56728

(E) Identifying barriers to consumer success in obtaining the IPP ob-
jective(s) and how those shall be overcome pursuant to section
56720(c)(2)(B) of these regulations.

(2) The vendor is authorized to delegate to the supervisor additional
functions not identified in (c)(1) above and which are directly related to
the supervision of the program.

(3) The supervisor shall possess the minimum qualifications specified
in section 56754 (b) or 56770 (b) of these regulations.

(d) The vendor shall assign staff to carry out direct service and pro-
gram preparation functions for the program.

( 1 ) Each direct care staff person shall be responsible for the following
functions:

(A) Implementing program curricula;

(B) Directly delivering individual and group learning experiences to
assist each consumer served in obtaining his/her IPP objective(s) for
which the vendor is responsible;

(D) Participating in consumer assessment, planning and evaluation
processes.

(2) The vendor shall not assign other duties to the direct care staff from
the above noted functions during hours when direct service is provided.

(3) The direct care staff shall possess the following minimum qualifi-
cations:

(A) Education and experience required in the job description; and

(B) The ability to perform the functions required in the program de-
sign.

(e) The vendor shall assign staff to carry out administrative support
functions, including clerical, janitorial, and bookkeeping or accounting.

( 1 ) The vendor is authorized to hire staff directly to carry out such
functions or to secure the performance of such functions from other enti-
ties.

(2) The administrative support staff shall demonstrate experience and
the ability to perform the functions described in the job description.

(f) The vendor is authorized to use volunteers to augment paid staff
providing the conditions in sections 56722 (a) through (d) of these regu-
lations are met.

(g) The vendor is authorized to assign staff to operate a motor vehicle
for the purpose of carrying out assigned functions. The vendor shall as-
sure that such staff possess a current valid driver' s license which is appro-
priate for the type of vehicle to be driven.

(h) The vendor shall assure that any consultant it utilizes shall comply
with all California licensing, certification, registration and vendorization
requirements applicable to the functions to be carried out.
NOTE; Authority cited: Sections 4648 and 4691, Welfare and Institutions Code.
Reference: Sections 4648 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsecfions (c)(l)(B)-(c)(l)(E)
and (d)(U(B)-(d)(l)(D) filed 1-17-97 pursuant to section 100, title 1, Califor-
nia Code of Regulations (Register 97, No. 3).

§ 56726. Staff Training.

(a) A vendor may develop and implement a written staff training plan
for new employee orientation and ongoing employee staff training.

(b) If a training plan is developed pursuant to (a) above, it shall at a
minimum:

(1) Describe the amount, type, subject, and frequency of training for
different categories of staff, including staff who are not paid by regional
center purchase of service funds or who are volunteers;

(2) Describe training curricula and techniques, including training in
consumer safety procedures to be used in the event of an emergency; and

(3) Indicate time frames for accomplishing the training.

(1) Be provided within the first two weeks of employment;

(2) Be based on the prior experience and qualifications o\' the em-
ployee and the needs of the vendor; and

(3) Use a curriculum that includes, but is not limited to:

(A) Welfare and Institutions Code, sections 4502, 4504. 45 1 8. 4646.5.
4648, 4655, 4705, 4710 and 4710.5;

(B) Consumer's rights as defined in title 17, section 50510;

(D) The policies, procedures and practices of the vendor's program;
and

(E) Specific job requirements for that employee.

(d) If ongoing staff training is developed pursuant to (a) above, it shall
at a minimum:

( 1 ) Be provided for all direct care staff and supervisors on an annual
basis; and

(2) Use a curriculum that addresses the particular instructional meth-
odology and techniques used by the vendor in training consumers to meet
their IPP objectives for which the vendor is responsible.

(e) The vendor shall document all training provided to employees.
NOTE: Authority cited: Chapter 722, Statutes of 1992, SecUon 147; and Sections
4691 and 479 l(i). Welfare and Institutions Code. Reference: Chapter 1011, Stat-
utes of 1 992, Section 1 1 ; and Sections 4646.5, 4648. 1 , 469 1 and 479 1 , Welfare and
Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsecfion (a)(1) and amendment of Note filed 8-6-92; operative 8-6-92
(Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsections (b)(2), (c)(3)(B) and
(d)(2) filed 1-1 7-97 pursuant to section 1 00, dtle 1 , California Code of Regula-
tions (Register 97, No. 3).

§ 56728. Program Records.

(a) A vendor shall develop the following records and maintain them
at its business office:

( 1 ) The program design as required in Section 567 1 2(a) of these regu-
lations and changes made to the program design;

(2) Employee time sheets specifying each employee's shift hours;

(3) Employee payroll records;

(4) Consumer attendance, maintained daily, indicating the date of ser-
vice;

(5) Documentation of all training attended by each employee;

(6) All records used by the vendor in completing the DS 1 897 ( 1 2/92)
submitted to the Department for a rate determination pursuant to Sections
57430 through 57534 of these regulations;

(7) All written approvals from regional centers or the Department re-
quired by these regulations;

(8) The program evaluation required by Section 56732 of these regula-
tions; and

(9) The written description of the vendor's organizational structure as
specified in Section 54326(b) of these regulations.

(b) Records required pursuant to (a)(2) through (a)(7) above shall be
retained for five years from the date of origination or until audit adjust-
ments have been resolved, whichever is longer.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4648, 4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4648,
4648.1, 4691 and 4791, Welfare and Institutions Code.

Page 292.11

§ 56730

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(6) and NOTi-: filed 1 1-5-91 as an emergency; op-
erative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be
transmitted to OAL 3-4—92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment of subsection (a)(6) and Note refiled 3^-92 as an emergency; op-
erative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (a)(6) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Subnutted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (a)(4) filed 1-17-97
pursuant to section 100, title 1 , California Code of Regulations (Register 97, No.

3).

§ 56730. Consumer Records.

(a) Vendors shall maintain consumer information and records as con-
fidential documents pursuant to Welfare and Institutions Code, sections
45 14 through 45 18, and shall also maintain consumer confidentiality as
required in Health and Safety Code, sections 199.20 through 199.27.

(b) Vendors shall maintain an individual consumer case file for each
consumer admitted to the program.

( 1 ) The most current copies of:

(A) Emergency and personal identification information, including the
consumer's address, telephone number, names and telephone numbers
of residential care provider, relatives, and/or guardian or conservator,
physician's name(s) and telephone number(s), pharmacy name, address
and telephone number, and health plan if appropriate;

(B) A medical history which includes:

1. Current medications;

2. Known allergies;

3. Medical disabilities;

4. Infectious, contagious or communicable conditions;

5. Special nutritional needs; and

6. Immunization records.

(C) Any consumer medical, psychological, and social evaluations
identifying the consumer's ability and functioning level, which shall be
supplied by the regional center;

(D) Authorization for emergency medical treatment;

(E) Documentation that the consumer and/or the authorized consumer
representative has been informed of his/her personal rights;

(F) The IPP as prepared and forwarded by the regional center; and

(G) Consumer IPP documentation as required by section 56720 of
these regulations.

(2) All copies of:

(A) Special incident reports, if any;

(B) Case notes reflecting important events or information not docu-
mented elsewhere;

(D) Documentation of reviews conducted pursuant to section 56732
(c) of these regulations, including summaries of the data collection that
indicate consumer performance and progress toward consumer outcom-
es for which the vendor is responsible.

(3) Documentation of attempts to obtain required information not con-
tained in the consumer record.

(d) Records pertaining to the consumer shall be stored at the program
site in a secure and locked place which shall be readily accessible. The

vendor is authorized to keep pertinent consumer data, including, but not
limited to, emergency telephone numbers, important medical data, cur-
rent IPP objectives, and data collection sheets with the consumer when
the consumer is participating in an activity or training at a location which
is away from the program's central filing area.

(e) The individual consumer, case file shall be retained for five years
following the consumer's termination from the program.

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Sections 4514, 4646, 4646.5. 4648, 4648.1 and 4691, Welfare and Institutions
Code.

History

1. New section filed 6-26-90 as an emergency; operadve 7-1-90 (Register 90,
No. 36). A Certificate of CompHance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94. No. 31).

5. Change without regulatory effect amending section heading and section filed
1-17-97 pursuant to section 100. title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56732. Program Evaluation.

(a) Each fiscal year the vendor shall conduct an annual review of its
program's effectiveness in relation to the program design. This shall in-
clude a documented review of:

(1) The program's objecfives as required in Section 56712(a)(1)(B) of
these regulations; and

(2) Aggregate data on progress in relation to the IPP objectives for
which the vendor is responsible.

(b) The vendor shall have a written evaluation design specifying:

(1) The purpose of the evaluation;

(2) The type of data to be collected and used;

(3) The frequency of data collection;

(4) Data collection and analysis methods;

(5) A description of the distribution, communication of, and acfions
taken upon the results of the evaluation;

(6) The frequency of evaluations; and

(7) The reason this pardcular evaluation design was selected and how
it relates to program objectives.

(c) The vendor shall submit to the vendoring regional center, user re-
gional centers and the Department a written summary of the annual pro-
gram evaluation which shall be maintained in the vendor file at the ven-
doring regional center and at the Department. The vendor shall maintain
on file pursuant to Secfion 56728 of these regulations the full program
evaluation for review by the regional center and the Department.
NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Secfions
4648, 469 1 and 4791 (i). Welfare and Insfitufions Code. Reference: Sections 4648,
4648. L 4691 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of CompHance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Note filed 1 1-5-91 as an emergency; opera-
tive 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (a) and Note refiled 3-4-92 as an emergency; opera-
tive 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

Page 292.12

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56742

7. Anicndnicnt of subsection (a)(] ) filed 4-22-94; operative 4-22-94. Submitted
to OAL for printing only (Register 94, No. 16).

8. Certificate of Compiiance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Change without regulatoi^y effect amending subsection (a) filed 1-17-97 pur-
suant to section 100, title 1, California Code of Regulations (Register 97, No.
3).

§ 56734. Effective Date of Compliance.

(a) The effective date of compliance of community-based day pro-
grams with the provisions of sections 56710 through 56734, 56740
through 56756, and 56760 through 56774 of these regulations shall be as
follows:

(1) Programs vendored after the effective date of these regulations
shall be in coinpliance with these provisions upon the date of vendoriza-
tion.

(2) Programs vendored prior to the effective date of these regulations
which:

(A) Do not ineet one or more provision(s) specified in sections 56710
through 56734, 56740 through 56756, and 56760 through 56774 of these
regulations, except for the licensing provisions in sections 56740 and
56760 of these regulations, shall have a maximum of one year from the
effective date of these regulations to come into compliance with the
applicable provision(s).

(B) Equal or exceed any provision(s) specified in sections 56710
through 56734, 56740 through 56756, and 56760 through 56774 of these
regulations, shall be deemed in compliance with the applicable provi-
sion(s) upon the effective date.

NOTE: Authority cited: Sections 4648 and 4691. Welfare and Institutions Code.
Reference: Sections 4648 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

Article 3.

Additional Standards for Adult
Day Programs

§ 56740. General Requirements.

In addition to the general requirements specified in section 56710 of
these regulations, adult day program vendors shall comply with applica-
ble licensing requirements pursuant to the Health and Safety Code, sec-
tions 1500 through 1569.87.

NOTE: Authority cited: Sections 4648 and 4691, Welfare and Institutions Code.
Reference: Sections 4648 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 56742. Program Curriculum and Components.

(a) The program curriculum shall:

(1) Be developed by the vendor based upon:

(A) The program's philosophy and goals as stated in the program de-
sign; and

(B) The needs of the consumer population to be served.

(2) Reflect a pattern of activities similar to those of non-disabled
adults; and

(3) Be designed to develop and maintain the consumer's functional
skills.

(b) The program curriculum shall be developed as follows:

( 1 ) Activity centers, adult development centers, and behavior manage-
ment programs shall have at least one of the training components speci-

fied in (b)(1)(A) through (D) below and shall be conducted in center-
based and/or natural environments:

(A) Self-advocacy;

(B) Employment training;

(D) Self-care.

(2) Social recreation programs shall provide community integration
and self-advocacy training as they relate to recreation and leisure pur-
suits. Social recreation programs shall be conducted in center-based and/
or natural environments.

(3) Independent living programs shall have all of the functional skills
training components specified in (b)(3 )(A) through (M) below, and shall
not be conducted in a center-based environment:

(A) Cooking;

(B) Cleaning;

(D) Menu planning;

(E) Meal preparation;

(F) Money management, including check cashing and purchasing acti-
vities;

(G) Use of public transportation in natural environments;
(H) Personal health and hygiene;

(I) Self-advocacy training;

(J) Independent recreation and participation in natural environments;

(K) Use of medical and dental services, as well as other community
resources;

(L) Community resource awareness such as police, fire, or emergency
help; and

(M) Home and community safety.

(4) Independent living programs may also, or in lieu of (b)(3) above,
provide the supports necessary for a consumer to maintain a self-sustain-
ing, independent living situation in the community.

(c) The curriculum for all programs shall describe the location(s) pur-
suant to Section 56712(a)(1)(D) of these regulations in which consumers
will receive instruction and perform those skills taught.

(d) The curriculum for all programs shall describe:

(1 ) The schedule of consumer training activities which is designed to
ensure that the entire direct services time is focused toward the achieve-
ment of the individual objectives contained in the IPP;

(2) Consumer training activities;

(3) Age appropriate materials and activities which shall be used; and

(4) Specific consumer outcomes which are anticipated from participa-
tion in each training component.

Note: Authority cited: Chapter 722, Statutes of 1992, Section 147; Section
I I346.I, Government Code; and Sections 4648, 4691 and 4791(i), Welfare and
Institutions Code. Reference: Secfions 4501 , 4646, 4646.5, 4648, 4651, 4691 and
4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsection (b)(4) and amendment of Noth filed 1 1-5-9 1 as an emergency;
operative 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance must be
transmitted to OAL 3-4-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. New subsection (b)(4) and amendment of Note refiled 3-4-92 as an emergen-
cy; operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must
be transmitted to OAL 7-2-92 or emergency language will be repealed by oper-
ation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (c) filed 4-22-94; operative 4-22-94. Submitted to
OAL for priming only (Register 94, No. 16).

Page 292.13

§ 56744

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

9. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, Cahfornia Code of Regulations (Register 97, No. 3).

§ 56744. Consumer Eligibility for Services.

(a) A consumer shall be eligible for an Adult Day Program pursuatit
to a determination of the ID Team that the consumer meets all of the fol-
lowing criteria:

( 1 ) The consumer is at least 1 8 years of age;

(2) The consumer is not eligible for the same or similar services from
a generic agency that is funded to provide the service to the general public
with the exception of programs jointly funded by generic agencies and
the regional center; and

(3) The consumer's IPP includes an objective(s) which can be met by
an adult day program.

NoTE: Authority cited; Section 4691, Welfare and Institutions Code. Reference:
Sections 4646, 4646.3, 4648 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed
l-1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56746. Vendor Entrance and Exit Criteria for Consumers.

(a) In addition to the criteria specified in section 567 1 4 of these regula-
tions, adult day program vendor entrance and exit criteria shall also in-
clude a description of the level of all of the following attributes required
for participation in the vendor's program:

(1) Self-care skills;

(2) Physical and medical conditions; and

(3) Behavioral characteristics.

NOTE: Authority cited: Section 4691, Welfare and Insfitutions Code. Reference:
Section 4648 and 4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading filed 1-17-97 pur-
suant to section 100, title 1, California Code of Regulations (Register 97, No.
3).

§ 56748. Consumer Placement Procedures.

(a) Notwithstanding sections 56716 (b)(3) and/or (4) of these regula-
tions, a consumer shall be eligible for placement in an adult day program
pursuant to a determination of the ID Team that, while the consumer' s
needs exceed the level of service provided by the program, the IPP objec-
tive(s) can be addressed in such program. The ID Team shall include all
of the following as documentation for the determination:

( 1 ) The factual basis and rationale leading to the decision for the alter-
nate placement including a statement that a more appropriate program is
not available;

(2) The duration of the alternate placement; and

(3) A statement that:

(A) The program provides the least restrictive environment;

(B) The health and safety of the consumer and others will not be jeop-
ardized by the alternate placement;

(D) The conditions specified in (b) below are met.

(b) When a placement pursuant to paragraph (a) above occurs:
(i) A copy of the documentation shall be:

(A) Placed in the consumer's regional center record; and

(B) Provided to the vendor who shall maintain the copy in accordance
with section 56728 of these regulations.

(2) The consumer's IPP shall be reviewed by the ID Team no less than
once every six months to determine the continued appropriateness of the
alternate placement.

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Sections 4646, 4646.5, 4648 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed
l-1 7-97 pursuant to section 100, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56750. Consumer Placement and Funding Termination
Procedures.

In addition to the reasons specified in section 56718 (a), of these regu-
lations, funding of a consumer's placement in a vendor's program shall
also be terminated when a more appropriate program becomes available
for consumers placed pursuant to section 56748 of these regulations.
When such a termination occurs, the procedures specified in section
56718 (c) of these regulations shall apply.

NOTE; Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Sections 4646, 4646.5, 4648 and 4691, Welfare and Institutions Code.

History

2 . Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
fded 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed
1-1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56752. Personnel Requirements.

(a) In addition to the requirements specified in section 56722 of these
regulations, if consumers perform chores or work for the vendor beyond
the secondary tasks resulting from a planned activity during the vendor' s
direct service hours, both of the following conditions shall be met:

( 1 ) Such chores or work are identified in the consumer' s IPP documen-
tation as activities relevant to his/her achievement of specific IPP objec-
tives; and

(2) The consumer is compensated pursuant to the requirements of the
Cahfornia Labor Code, sections 1191 through 1 193 and 29 United States
Code, sections 211 and 214.

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:

Sections 4646.5 and 4691, Welfare and Institutions Code.

History

I. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

Page 292.14

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56756

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 3 1 ).

.S. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 56754. Personnel Functions and Qualifications.

(a) The director of an adult day program shall possess the following
minimum qualifications:

(1) A bachelor's degree and a minimum of 18 months of experience
in the management of a human services delivery system; or

(2) Five years of experience in a human services delivery system, in-
cluding at least two years in a management or supervisory system.

(b) The supervisor of an adult day program shall possess the following
minimum qualifications:

(1) Three years of experience in a human services delivery system, in-
cluding at least one year in a comparable program or a bachelor's degree
in a human services related field; and

(2) The demonstrated ability to provide staff training, supervision and
planning.

NOTE: Authority cited: Sections 4648 and 4691, Welfare and Institutions Code.
Reference: Sections 4648 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(I)-(2) and (b)(l)-(2) and relettering and amendment of
NoTii filed 11-5-91 as an emergency; operative 11-5-91 (Register92, No. 21).
A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency
language will be repealed by operation of law on the following day.

4. New subsections (a)(l)-(2) and (b)(l)-(2) and relettering and amendment of
Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25).
A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency
language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
dons (a)(1)(B) and (b)(1)(A) transmitted to OAL 6-25-92 and filed 8-6-92
(Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 56756. Staffing Ratio.

(a) A staffing ratio shall be approved for each adult day program by
the Department pursuant to this section. This ratio shall be based on the
program design, the curriculum as vendored, the characteristics and
needs of the consumers to be served, and the number of consumers en-
rolled.

(b) For activity centers, adult development centers, behavior manage-
ment programs, and social recreation programs, the vendor may supple-
ment direct care staff by one staff person, six hours per day, for every ten
non-mobile consumers attending. Programs serving more or less than
ten non-mobile consumers shall have their supplemental staff calculated
on a proportionate basis. For the purpose of this section, non-mobile
means persons who are confined to wheelchairs or gumeys and who are
unable to independently move from one place to another place.

(1) Vendors shall submit requests for supplemental staff in writing to
the regional center.

(2) Regional centers shall notify vendors in writing that they are autho-
rized to receive payment to maintain the staffing ratio specified in (b)
above for non-mobile consumers.

(c) The vendoring regional center shall provide the Department with
its recommendations for those vendors requesting a staffing ratio pur-
suant to (d)(1) or (e)(1) below.

(d) Activity centers shall provide a direct care staff-to-consumer ratio
of 1:8.

( 1 ) The vendor is authorized to request Department approval for modi-
fication of the staffing for an Activity Center to an overall direct care
staff-to-consumer ratio of 1 :7 or 1 :6. A written request and justification
shall be submitted to the Department by the regional center which docu-
ments the findings pursuant to the criteria listed below. The overall direct
care staffing ratio shall be determined by averaging the specific staff-to-
consumer ratio needed for each individual consumer. The regional center
shall consider whether the activity center meets at least one of the follow-
ing criteria for modification of the direct care staffing ratio of 1 :8:

(A) The activity center is providing community integration or employ-
ment training in natural environments to groups of three or fewer con-
sumers for at least two hours in duration on a daily basis.

1 . If each group of consumers receives at least one two-hour session
per week, then the staffing ratio shall be 1:7.

2. If each group of consumers receives at least two-hour sessions per
week, then the staffing ratio shall be 1 :6.

(B) The activity center is providing services to consumers whose IPPs
include an objective to modify behaviors that may represent a threat to
the individual, others, and/or property.

1 . If consumers require intermittent spontaneous/unplanned behavior
intervention to prevent or minimize disruption of activities or injury to
persons or property, the staffing ratio shall be 1:7. For purposes of this
paragraph and (d)(l)(C)l. below, "intermittenf means more often than
once a week, but less than once per day.

2. If consumers require frequent spontaneous/unplanned behavior in-
tervention to prevent or minimize disruption of activities or injury to per-
sons or property, the staffing ratio shall be 1 :6. For purposes of this para-
graph and (d)(l)(C)2. below, "frequent" means at least once per day.

3. Such behaviors may include:

a. Physical aggression resulting in physical injury to others;

b. Displays of self-injurious behavior that could result in serious inju-
ry;

c. Causing severe damage to property;

d. Running or wandering away;

e. Smearing of feces;

f Displays of inappropriate sexual behavior.

1. If consumers require intermittent, as defined in (d)(l)(B)l. above,
assistance or supervision in earing, toilefing or caring for their personal
hygiene needs, then the staffing rafio shall be 1:7.

2. If consumers require frequent, as defined in (d)( 1 )(B)2.above, assis-
tance or constant supervision in eating, toileting or caring for their per-
sonal hygiene needs, then the staffing ratio shall be 1 :6.

(2) If a given consumer meets more than one criterion as specified in
(d)(1)(A) through (d)(1)(C) above, the staffing raUo which provides the
most direct care staff for the vendor shall prevail.

(3) Modifications approved under (d)(1) above shall be reviewed at
least annually by the regional center to assure that the condition on which
the modification was approved continues.

(e) Adult development centers shall provide a direct care staff to-con-
sumer ratio of 1 :4,

( 1 ) The vendor is authorized to request Department approval for modi-
fication of the staffing for an Adult Development Center to an overall di-
rect care staff-to-consumer ratio of 1:3. A written request and justifica-
tion shall be submitted to the Department by the regional center which
documents the findings pursuant to the criteria listed below. The overall
direct care staffing ratio shall be determined by averaging the specific
staff-to-consumer rafio needed for each individual consumer. The re-
gional center shall consider whether the Adult Development Center
meets the following criteria for modificafion of the direct care staffing
ratio of 1:4.

(A) The Adult development center is providing community integration
or employment training in natural environments to groups of three or few-
er consumers for at least two hours duration on a daily basis with each

Page 292.15

§ 56760

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

group of consumers receiving at least two two-hour sessions per week;
and

(B) Tlie consumers receiving community integration or employment
training require constant assistance and constant supervision. For pur-
poses of this section, "constant assistance" means providing direct physi-
cal aid and help with self-care needs at all times during service hours. For
purposes of this section "constant supervision" means maintaining visual
or physical proximity to an individual consumer during all service hours.

(2) Modifications approved under (e)( I ) above, shall be reviewed at
least annually by the regional center to assure that the conditions on
which modifications were approved continue.

(f) Behavior management programs shall provide a direct care staff-
to-consumer ratio of 1:3.

(g) Social recreation programs shall provide a direct care staff-to-
consumer ratio of 1:10.

(h) Independent living programs shall provide a direct care staff-to-
consumer ratio of:

( 1 ) 1:1 when the service is conducted on an individual basis;

(2) 1 :2 when the service is provided to two consumers; or

(3) 1:3 when the service is conducted on a group basis.

(i) The vendor shall maintain the approved staffing ratio during its di-
rect service hours. The vendor shall not be required to schedule the ratio
with each subgroup of consumers at all times, but shall maintain both:

( 1 ) The ratio of staff on duty to consumers in attendance during all ser-
vice hours which shall be determined by a numerical comparison of the
number of individuals on duty as direct care staff with the number of con-
sumers in attendance. If the numerical comparison results in a fraction,
more than one-half of a staff person shall be rounded up to the next whole
number. Less than one-half of a staff person shall be rounded up to the
next one-half of a whole number. One-half of a staff person shall not be
rounded.

(2) Sufficient supervision for each subgroup to protect the health and
safety of the consumers.

(j) The vendor shall not count consumers, or subcontractors autho-
rized pursuant to section 56710 (b) of these regulations, as staff for the
purpose of computing the direct care staff-to-consumer ratio or for rate-
setting purposes.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691 and 4791 (i). Welfare and Institutions Code. Reference: Sections 4691 and
4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsection (h)(2), subsection redesignation and amendment of Note filed
6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing
only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No.
25).

4. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Additional Standards for Infant
Development Programs

§ 56760. General Requirements.

(a) In addition to the general requirements specified in section 56710
of these regulations, infant development program vendors shall:

(1) Comply with applicable licensing requirements pursuant to Health
and Safety Code, sections 1596.70 through 1596.894; and

(2) Make the grievance procedure specified in section 56710(a) of
these regulations available to the consumer's parent, care giver or autho-
rized consumer representative.

Note: Authority cited: Sections 4648 and 4691, Welfare and Institudons Code.
Reference: Sections 4648, 4691 and 4705, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsecdon (a) filed 1-17-97 pur-
suant to section 100, title 1, California Code of Reguladons (Register 97, No.
3).

§ 56762. Program Design.

(a) In addition to the items specified in section 56712 (a) of these regu-
lations, the program design for infant development programs shall also
include the written procedures used by the vendor for review of consum-
er assessment information. Such information shall include the following
areas if applicable to the consumer's IPP:

(1) Audiology services;

(2) Medical services;

(3) Nursing services;

(4) Nutritional evaluation;

(5) Occupational and/or physical therapy;

(6) Psychological services;

(7) Social work services;

(8) Speech pathology; and

(9) Visual screening.

(b) In addition to the items specified in Section 56712(a) of these regu-
lations, the program design for infant development programs shall also
include the expected level of participation and attendance by parents,
care givers or authorized consumer representadves in the infant develop-
ment program.

(c) When modificadons are made to the program design which consti-
tute a change in the type of services provided, the vendor must, at least
30 days prior to the change, nodfy the consumer's parents, care givers or
authorized consumer representatives and submit to the vendoring region-
al center a revised program design as described in (a) above. A revised
program design is required when any of the following elements of the
program design are changed:

(1) Locadons in which consumer training occurs;

(2) Curriculum training components;

(3) Existing approved staffing ratio;

(4) Approved service code;

(5) Entrance and/or exit criteria;

(6) Hours of operadon.

(d) A rate adjustment request which results from a program design
change shall be submitted to the vendoring regional center prior to De-
cember 1 of the current calendar year in accordance with secdon 57922
of these regulations.

Note: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4648, 4691 and 4791(i), Welfare and Institutions Code. Reference: Secfions 4514
through 4518, 4646.5, 4648, 4685, 4691 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of secdon filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsections (a), (b), (c) and (c)(1)
filed 1-17-97 pursuant to section 100, title 1, California Code of Reguladons
(Register 97, No. 3).

§ 56764. Program Curriculum and Components.

(a) The program curriculum for infant development programs shall be
developed by the vendor based upon the program' s philosophy and goals
and the needs of the population to be served.

(b) The program curriculum for infant development programs shall in-
clude the following items:

Page 292.16

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56772

( 1 ) Intervention activities which promote development in all of the fol-
lowing areas according to basic principles of child growth and develop-
ment:

(A) Physical development;

(B) Cognitive development;

(D) Psychosocial development; and

(E) Self-help and feeding.

(2) Activities which:

(A) Increase parent, care giver or authorized consumer representative
and child interaction by training parents, care givers or authorized con-
sumer representatives to recognize and respond to the child's unique
characteristics, temperament, and non-verbal communication signaling
distress or the need for interaction;

(B) Increase and develop parents, care givers or authorized consumer
representatives and child interpersonal relationships through the day-to-
day activides, such as bathing, dressing, feeding and comforting.

(3) Parenting skills relating to the parents' givers' care or authorized
consumer representatives' ability to care for the special needs of the child
including:

(A) Demonstrations of developmentally appropriate activides for the
child;

(B) Training and consultation; and

(C) Access to various developmentally appropriate equipment and
material, and the use of play as a vehicle for intervention.

(c) The curriculum for all programs shall describe the location(s) pur-
suant to Section 567 1 2 (a)( 1 )(D) of these regulations in which consumers
will receive instruction and perform those skills taught.

(d) The curriculum for all programs shall describe:

( 1 ) The schedule of training activities which is designed to ensure that
the entire direct services time is focused toward the achievement of the
individual objective(s) contained in the IPP;

(2) Training activities;

(3) Age appropriate materials and activities which shall be used; and

(4) Specific consumer outcome(s) which are anticipated from partici-
pation in each training component.

Note. Authority cited: Chapter 722, Statutes of 1992, Section 147, and Sections
4648, 4691 and 479 l(i). Welfare and Institutions Code. Reference: Sections 4648,
4691 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Amendment of subsection (c) filed 4-22-94; operative 4-22-94. Submitted to
OAL for printing only (Register 94, No. 16).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsections (b)(2)(A)-(b)(3), (c)
and (d)(4) filed 1-17-97 pursuant to section 100, title 1, California Code of Reg-
ulations (Register 97, No. 3).

§ 56766. Consumer Eiigibility for Services.

(a) A consumer shall be eligible for an infant development program
pursuant to a determination of the ID Team that the consumer meets all
of the following criteria:

(1) The consumer is under age five;

(2) The consumer either does not qualify for services from a publicly
supported local school program or, if qualified, is awaiting service be-
cause the local school program is inactive or there are no current vacan-
cies. Services joinUy funded by Special Educadon and the regional center
are exempted from this provision; and

(3) The consumer's IPP includes an objective(s) which can be met by
an infant development program.

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Sections 4646.5, 4648, 4685 and 4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29 90
or emergency language will be repealed by operation of law on the folIov\ing
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed
1-1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56768. Consumer Placement Termination Procedures.

(a) When a vendor makes a determination to exclude a consumer from
participation in the infant development program pursuant to section
56718 (g) of these regulations, a meeting need not be scheduled if the ex-
clusion is for routine health problems associated with infancy and early
childhood.

(b) A meeting or consultation shall be held between the vendor, parent,
care giver, or authorized consumer representadve and the consumer pro-
gram coordinator when a consumer is between the ages of two years and
six months and two years and nine months and prior to discharge of the
consumer from the infant development program. The purpose of the
meedng or consultation shall be to discuss the consumer's entrance into
local public special educadon programs in order to provide for continuity
of services. The consumer program coordinator shall initiate the meeting
or consultation.

NOTE: Authority cited: Secfion 4691, Welfare and Institutions Code. Reference:
Sections 4648 and 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and section filed
1-17-97 pursuant to section 100, fitle 1 , California Code of Regulafions (Regis-
ter 97, No. 3).

§ 56770. Personnel Functions and Qualifications.

(a) The director of an infant development program shall possess the
following minimum qualifications:

(1) A bachelor's degree and a minimum of 18 months of experience
in the management of a human services delivery system; or

(2) Five years of experience in a human services delivery system, in-
cluding at least two years in a management or supervisory posidon.

(b) The supervisor of an infant development program shall possess the
following minimum qualifications:

(1) Three years of experience in a human services delivery system, in-
cluding at least one year in a comparable program or a bachelor's degree
in child development, early childhood educadon, developmental disabil-
ity education, or a closely related child-focused specialty; and

(2) The demonstrated ability to provide staff training, supervision and
planning.

NOTE: Authority cited: Sections 4648 and 4691, Welfare and Institutions Code.
Reference: Secfions 4648 and 4691, Welfare and Institufions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 56772. Staffing Ratio.

(a) A staffing ratio shall be approved for each infant development pro-
gram by the Department pursuant to this section. This ratio shall be based

Page 292.17

§ 56774

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

on the program's design, the curriculum as vendored, the characteristics
and needs of the consumers to be served and the number of consumers
enrolled.

(b) Infant development programs shall provide a direct care staff-to-
consumer ratio of:

( 1 ) 1:1 when the service is conducted on an individual basis;

(2) 1 :2 when the service is conducted on both an individual and group
basis and the proportion of consumers receiving direct services on an in-
dividual basis when averaged with the consumers receiving direct ser-
vices on a group basis yields a staffing ratio of 1 :2; or

(3) 1:3 when the service is conducted on a group basis.

(c) The vendor shall maintain the approved staffing ratio during its di-
rect service hours, which shall be determined by a numerical comparison
of the number of individuals on duty as direct care staff with the number
of consumers in attendance. If the numerical comparison results in a frac-
tion, more than one-half of a staff person shall be rounded up to the next
whole number. Less than one-half of a staff person shall be rounded up
to the next one-half of a whole number. One-half of a staff person shall
not be rounded. The vendor shall not count subcontractors authorized
pursuant to section 567 1 0 (b) of these regulations as staff for the purpose
of computing the direct care staff-to-consumer ratio for rate-setting pur-
poses.

NOTE; Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulafions (Register 97, No. 3).

§ 56774. Staff Training.

(a) In addition to the requirements of section 56726 of these regula-
tions:

( 1 ) Training plans shall also describe child development intervention
curricula and techniques; and

(2) The curriculum for new employee orientation shall include:

(A) The early intervention service system for at-risk and/or handi-
capped children; and

(B) Philosophy and models of early intervention.

NOTE; Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Secdon 4691, Welfare and Insfitutions Code.

History

1. New section filed 6-26-90 as an emergency; operaUve 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

Article 5. Standards for In-Home Respite
Services Agencies

§ 56776. Definitions.

(a) As used in this article, the following words and phrases have the
meanings specified in section 54302 of these regulations:

(1) Authorized Consumer Representative

(2) Consumer

(3) Days

(4) Department

(5) Family Member

(6) Generic Agency

(7) Individual Program Plan (IPP)

(8) In-home Respite Services

(9) Interdisciplinary Team (ID Team)

(10) Regional Center

(11) Self-Care

(12) Service Contract

(13) Special Incident Report

(14) Vendor

(b) As used in this article, the following words and phrases have the
meanings specified in section 56704 of these regulations:

(1) Consumer Program Coordinator

(2) Personal Needs

(3) Self Help

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4648,
4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4646,
4646.5, 4648, 4690.2 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or einergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Regrster 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

5. Change without regulatory effect amending subsections (a)( 1), (a)(2) and (b)( 1 )
filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations
(Register 97, No. 3).

6. Amendment of article heading filed 4-25-2000; operafive 5-25-2000 (Register
2000, No. 17).

§ 56778. Waiver of Service Standards.

(a) Regional centers, in negotiating service contracts pursuant to Sec-
tion 57540 or a lower level of payment pursuant to Section 57300(d),
may waive or modify any of the following program standards for the du-
ration of the service contract or lower level of payment:

(1) Personnel requirements specified in Section 56790;

(2) Personnel functions and quahfications specified in Section
56792(a), (b), (c), (d) and (f);

(3) Staff training requirements specified in Section 56794;

(4) In-home respite service evaluation requirements specified in Sec-
tion 56800;

NOTE; Authority cited: Chapter 722, Statutes of 1992, Section 147; and Secdon
4791(i), Welfare and Institudons Code. Reference: Section 4791, Welfare and In-
stitudons Code.

History

1 . New section filed as an emergency 6-17-93; operadve 6-17-93. Submitted to
OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Sec-
tion 147(a) (Register 93, No. 26).

2. Amendment of subsecUon (a)(2) filed 4-22-94; operadve 4-22-94. Submitted
to OAL for prindng only (Register 94, No. 16).

3 . Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

4. Change without regulatory effect amending subsection (b) filed 1-17-97 pur-
suant to secdon 100, title 1, California Code of Regulafions (Register 97, No.
3).

§ 56780. Service Design.

(a) The service design of an in-home respite services agency shall in-
clude the following items in the order listed below:

(1) An in-home respite service description which includes:

(A) The purpose and goals of the service;

(B) Anticipated consumer outcomes from participation in the service
stated in measurable terms;

(D) Schedule of the vendor's service operating hours including days
and times when the service is available;

(E) A staff training plan, if developed, pursuant to Section 56794 of
these regulations;

(2) A description of the consumers served pursuant to Section 56784
of these regulations;

Page 292.18

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56788

(3) A description of the process used by the vendor to organize and
carry out the requested services from the point of first contact by the per-
son requesting services through the provision of the service;

(4) A description of the method of evaluating the in-home respite ser-
vice's effectiveness in accordance with Section 56800 of these regula-
tions; and

(5) A written internal grievance procedure for consumers pursuant to
Welfare and Institutions Code, Section 4705.

(b) When modifications are made to the service design which consti-
tute a change in the type of consumer served or the times when the service
is available, the vendor shall, at least 30 days prior to the change, notify
the consumers scheduled to receive in-home respite services or their au-
thorized consumer representatives and submit to the vendoring regional
center a revised service design as described in (a) above.
NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690.2 and 4791(1), Welfare and Institutions Code. Reference: Sections 4646,
4646.5, 4648, 4690.2 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(4) and Note filed 1 1-5-91 as an emergency; op-
erative 11-5-91 (Register 92, No. 21). A Certificate of Compliance must be
transmitted to OAL 3-4-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment of subsection (a)(4) and Note refiled 3-^-92 as an emergency;
operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secdon 147(a) (Register 93, No. 26).

7. New subsection (a)(4) and subsection redesignation and amendment of subsec-
tion (a)(3) filed 4-22-94; operafive 4-22-94. Submitted to OAL for printing
only (Register 94, No. 16).

8. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 56782. Consumer Eligibility for Services.

(a) A consumer shall be eligible for services from an in-home respite
services agency pursuant to a determination by the ID Team that:

(1) The consumer resides with a family member(s) as described in
54302(a)(22) and the need for the service is agreed by the family mem-
ber(s) and the ID Team.

(2) The consumer' s IPP includes an objective which can be met by an
in-home respite services agency.

Note: Authority cited: Section 11 346.1, Government Code; and Section 4690.2,
Welfare and Institutions Code. Reference: Sections 4646.5, 4648, 4685 and
4690.2, Welfare and Insfitutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 11-5-91 as an emergency; operative 11-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (a)( ] ) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20 -94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section heading and section filed
1-1 7-97 pursuant to section 100, title 1 , California Code of Regulations ( Regis-
ter 97, No. 3).

§ 56784. Identification of Consumers Served.

(a) The vendor shall have a written description of the population
served that shall be used by a consumer's ID Team to determine the ap-
propriateness of the vendor's agency for meeting the consumer's need
for in-home respite services and shall include all of the following:

( 1 ) Ages of consumers to be served;

(2) A description of the range of consumer needs in the following areas
that the vendor is able to meet:

(A) Self-care skills;

(B) Physical and medical condition;

(D) Any other prerequisites.

Note: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4646.5 and 4690.2, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prinfing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secdon 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed
1-1 7-97 pursuant to secdon 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 56786. Procedures for Service Authorization.

(a) Interdisciplinary Teams shall identify in-home respite, services
agencies which can meet the objectives of the consumer's IPP developed
pursuant to Welfare and Institutions Code, section 4646 and 4646.5.

(b) Authorization for services from an in-home respite services
agency shall occur providing all of the following conditions exist:

(1) The consumer or authorized consumer representative consents to
receive the service from the agency;

(2) The regional center concurs that the agency's services are appro-
priate;

(3) The consumer meets the vendor's service criteria pursuant to sec-
tion 56784 of these regulations; and

(4) The vendor agrees to provide the service.

Note: Authority cited: Chapter 722, Statutes of 1992. Section 147; and Sections
4690.2 and 479 l(i). Welfare and Insdtudons Code. Reference: Chapter 101 1, Stat-
utes of 1 992, Secdon 11 ; and Secdons 4646, 4646.5, 4648, 4685, 46902 and 4791 ,
Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of CompHance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90 No. 46).

3. Amendment of secdon filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to
secdon 100, dtle 1, CaUfomia Code of Regulations (Register 97, No. 3).

§ 56788. Service Termination Procedures.

(a) Funding for a consumer's services from an in-home respite ser-
vices agency shall be terminated when one or more of the following oc-
cur:

(I) The regional center issues a determination that continued receipt
of services from the agency jeopardizes the consumer's health or safety;

Page 292.19

§ 56790

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) The consumer or authorized consumer representative makes a
written or oral request to the regional center to discontinue receipt of the
agency's service;

(3) The consumer moves to an area outside the vendor's service area;

(4) The ID Team determines that in-home respite services are no long-
er required to meet consumer needs;

(5) The vendor, determines that its agency no longer meets the con-
sumer's need.

(b) When a determination is made pursuant to (a)(1), (4) or (5) above,
the basis for, the determination shall be documented in writing in the con-
sumer's case file by the regional center for (a)(1) and/or (4) and by the
vendor for (a)(5). The regional, center shall also include written docu-
mentation in the consumer's case file that the consumer or authorized
consumer representative has been informed of the fair hearing rights pur-
suant to Welfare and Institutions Code, sections 4700 through 4730,
when the determination is made pursuant to (a)(1) or (a)(4) above.

(c) When the conditions specified in (a)( 1 ) or (a)(4) above exist, termi-
nation of funding shall not be made if the consumer files a fair hearing
request pursuant to Welfare and Institutions Code, sections 4700 through
4730.

(d) A vendor may terminate in-home respite services during periods
when the vendor determines that serving the consumer presents a threat
to the health and welfare of the consumer, other individuals in the home,
or the vendor agency's staff. The basis of such termination shall be docu-
mented within three working days by the vendor in the consumer case file
maintained pursuant to section 56798 of these regulations.

(e) A vendor shall take action to assure consumer safety when the cir-
cumstances specified in (d) above, or any other circumstances, prevent
the carrying out or completion of in-home respite services during the
time of authorized service delivery. Such actions shall include instruct-
ing the agency's respite worker to immediately contact:

(1 ) The consumer's family member or authorized consumer represen-
tative;

(2) The director or supervisor of the in-home respite services agency;
and

(3) The consumer program coordinator.

(f) In addition to the persons specified in (e)(1) through (e)(3) above,
actions to assure consumer safety may also include immediately contact-
ing the local law enforcement, fire or public health authorities.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4648, 4690.2 and 4700 through 4730, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, fitle 1, California Code of Regulations (Register 97, No. 3).

§ 56790. Personnel Requirements.

(a) Each vendor shall maintain current written job descriptions for aU
personnel, including staff whose wages are not paid by the regional cen-
ter purchase of service funds.

(b) Each job description shall include;

(1) Position title;

(2) Role and responsibility of the position;

(3) Duty statement;

(4) Work hours;

(5) Minimum qualifications;

(6) Positions supervised; and

(7) Reporting supervisor.

(c) Staff whose wages are not paid by regional center purchase of ser-
vice funds shall demonstrate the minimum qualifications, as identified in
Section 56792 of these regulations, necessary for each job function per-
formed.

(d) The vendor is authorized to utilize consultants to develop the in-
home respite service description required in Section 56780(a)(1) of these
regulations, and to develop and carry out staff development and training.
NOTE: Authority cited: Sections 4648 and 4690.2, Welfare and Institutions Code.
Reference: Sections 4648 and 4690.2, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of subsection (a) and Note filed 1 1-5-91 as an emergency; opera-
tive 1 1-5-91 (Register 92, No. 2 1 ). A Certificate of Compliance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (a) and Notf: refiled 3-4-92 as an emergency; opera-
tive 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94. No. 31).

§ 56792. Personnel Functions and Qualifications.

(a) Each vendor shall assign staff to carry out the duties described. The
vendor is authorized to designate positions be different titles than those
listed but is responsible for assuring the functions described are carried
out. Staff who are hired by the vendor to carry out the functions listed
shall meet the minimum qualifications listed in this section.

(b) The vendor shall assign a director to carry out the administrative
responsibilities for the in-home respite services agency.

(1) The director shall have primary responsibility for the following
functions:

(A) Organizing and supervising the agency in accordance with the
agency's established policies;

(B) Overseeing the areas of budgeting, service design and implemen-
tation, project planning, staff development and training, evaluation and
the direction of the in-home respite services;

(D) Assuring that individual respite service workers are matched with
consumers based on respite worker skill and experience and consumer
supervision needs.

(2) The vendor is authorized to delegate to the director additional func-
tions to those listed in (b)(1) above, related to the overall administration
of the in-home respite service.

(3) The director shall possess the following minimum qualifications;

(A) A bachelor's degree and a minimum of 18 months of experience
in the management of a human services delivery system; or

(B) Five years of experience in a human services delivery system, in-
cluding at least two years in a management or supervisory position.

( 1 ) The vendor is authorized to delegate to the supervisor the following
functions;

(A) Selection and supervision of assigned staff; and

(B) Matching individual respite service workers with consumers
based on respite worker experience and consumer supervision needs.

(2) The vendor is authorized to delegate to the supervisor additional
functions to those listed in (c)(1) above directly related to supervision of
the in-home respite services.

(3) The supervisor shall possess the following minimum qualifica-
tions;

(A) Three years of experience in a human services related field; and

(B) The demonstrated ability to provide staff training, supervision and
planning.

Page 292.20

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56794

(d) A vendor may assign staff to carry out scheduling responsibilities
for the in-home respite services agency.

( 1 ) The vendor is authorized to delegate to the scheduler the function
of arranging the times and dates for service delivery.

(2) The vendor is authorized to delegate to the scheduler additional
functions to those listed in (d)(1) above.

(3) The scheduler shall possess the following minimum qualifications:

(A) Education and experience required in the job description; and

(B) The ability to perform the functions required in the service design.

(e) The vendor shall assign staff to carry out in-home respite services.

(1) Each respite worker shall be responsible for the following func-
tions:

(A) Performing the in-home respite services;

(B) Maintaining information as required in Sections 56796(a)(4) and
56798(c)(2)(B) of these regulations;

(C) Obtaining information concerning any specific care needs unique
to the individual consumer at the time, or prior to the time, when services
are delivered.

(D) Obtaining phone numbers and locations where family members
can be contacted during the provision of in-home respite services.

(2) The vendor shall not assign other duties to the respite worker from
the above noted functions during hours the that worker is providing in-
home respite services.

(3) The respite worker shall possess the following minimum qualifica-
tions:

(A) Has received Cardiopulmonary Resuscitation (CPR) and First Aid
training from agencies offering such training, including, but not limited
to, the American Red Cross;

(B) Education and experience required in the job description; and

(f) The vendor may assign staff to carry out administrative support
functions, including clerical, janitorial, and bookkeeping or accounting.

( 1 ) The vendor is authorized to hire staff directly to carry out or to se-
cure the performance of such functions from other entities.

(2) The administrative support staff shall demonstrate experience and
the ability to perform the functions described in the job description.

(g) The vendor is authorized to assign staff to operate a motor vehicle
for the purpose of carrying out assigned functions. The vendor shall as-
sure that such staff possess a current vahd driver's license which is appro-
priate for the type of vehicle to be driven.

(h) The vendor shall assure that any consultants it utilizes shall comply
with all California licensing, certification, registration and vendorization
requirements applicable to the functions to be carried out.
NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4648, 4690.2 and 479 l(i). Welfare and Institutions Code. Reference: Sections
4648, 4690.2 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (b)(3)(A)-(B) and (c)(3)(A)-(B) with renumbering of follow-
ing subsections (A)-(B) to 1.-2., repealer of subsection (g) and relettering and
amendment of Note filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Reg-
ister 92, No. 21). A Certificate of Compliance must be transmitted to OAL
3-4-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

4. New subsections (b)(3)(A)-(B) and (c)(3)(A)-(B) with renumbering of follow-
ing subsections (AHB) to 1.-2., repealer of subsection (g) and relettering and
amendment of Note refiled 3-4-92 as an emergency; operative 3-4-92 (Regis-
ter 92, No. 25). A Certificate of Compliance must be transmitted to OAL
7-2-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tions (b)(3)(A)2. and (cj(3j(A)I . transmitted to OAL 6-25-92 and filed 8-6-92
(Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17 93.
SubmiUed to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (e)(3)(A) filed 4-22-94; operative 4-22-94. Sub-
mitted to OAL for printing only (Register 94, No. 16).

8. Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

9. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulation.s (Register 97. No. 3).

§ 56793. Staffing Ratio.

(a) The vendor shall maintain a staff-to-consumer ratio of 1 : 1 during
its direct service hours.

(b) When a respite service is provided to more than one consumer at
the same rime and location, regional centers may allow a staff-tt)-con-
sumer raUo other than 1 : 1 only if the modification of the staffing ratio is
agreed to by each consumer and, where appropriate, each consumer's
family and if the modification will not adversely affect the health and
safety of the consumers or result in placing the consumers in a more re-
strictive environment.

NOTE; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2 and 4691, Welfare and Institutions Code.

History
1. New section filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§ 56794. Staff Training.

(a) A vendor may develop and implement a written staff training plan
for new employee orientation and ongoing employee staff training.

(b) If a training plan is developed pursuant to (a) above, it shall at a
minimum:

(2) Describe contents of training, including training in consumer safe-
ty procedures to be used in event of an emergency.

(1) Be provided within the first two weeks of employment;

(2) Be based on the prior experience and qualifications of the em-
ployee and needs of the vendor;

(3) Use a curriculum that includes but is not limited to:

(A) Welfare and InsUtuUons Code, sections 4502, 4504, 45 1 8, 4646.5,
4648, 4655, 4710 and 4710.5;

(B) Consumer's rights as defined in title 17, section 50510;

(D) The policies, procedures and practices of the vendor's in-home re-
spite services agency; and

(E) Specific job requirements for that employee.

(d) If ongoing staff training is developed pursuant to (a) above, it shall
at a minimum:

(1) Be provided for all respite workers and supervisors on an annual
basis; and

(2) Use curriculum that addresses the parricular activities used by the
vendor in assisting consumer to meet the consumer's in-home respite
service needs.

(e) The vendor shall document all training provided to employees.
NOTE: Authority cited: Chapter 722, Statutes of 1992. Section 147; and Sections
4690.2 and 479 1 (i). Welfare and Insfitutions Code. Reference: Chapter 1011, Stat-
utes of 1992, Section 1 1 ; and Sections 4646.5, 4690.2 and 4791 , Welfare and Insti-
tutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

Page 292.21

§ 56796

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Certificate ofCompliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Editorial connection of subsection (d)(2) (Register 95, No. 49).

6. Change without regulatory effect amending subsections (a)(2), (c)(3)(B) and
(d)(2) filed 1-17-97 pursuant to section lOOT title 1, California Code of Regula-
tions (Register 97, No. 3).

§ 56796. Required Agency Records.

(a) A vendor shall develop the following records and maintain them
at its business office:

( 1 ) Service design as required in Section 56780(a) of these regulations
and changes made to the service design;

(2) Employee time sheets specifying each employee's work hours;

(3) Employee payroll records;

(4) Consumer(s) served, indicating the dates and hours of service;

(5) Documentation of all training attended by each employee;

(6) All records used by the vendor in developing the DS 1 897B (12/92)
submitted to the Department for a rate determination;

(7) All written approvals from regional centers or the Department re-
quired by these regulations; and

(8) The In-home Respite Service evaluation required by Section
56800 of these regulations; and

(9) The written descriptions of the vendor's organizational structure
as specified in Section 54326(b) of these regulations.

(b) Records required pursuant to (a)(2) through (7) above, shall be re-
tained for five years from the date of origination or until audit adjust-
ments have been resolved, whichever is longer.

NOTE: Authority cited: Chapter 722. Statutes of 1992, Section 147; and Sections
4648, 4690.2 and 479 l(i). Welfare and InstituUons Code. Reference: Sections
4648, 4690.2 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate ofCompliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate ofCompliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsecfions (a)(7) and (a)(8) and Note filed 1 1-5-91 as an
emergency; operative 11-5-91 (Register 92, No. 21). A Certificate ofCom-
pliance must be transmitted to OAL 3-4-92 or emergency language will be re-
pealed by operation of law on the following day.

4. Amendment of subsections (a)(7) and (a)(8) and Note refiled 3^-92 as an
emergency; operative 3^-92 (Register 92. No. 25). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate ofCompliance as to 3-4-92 order including amendment of subsec-
tions (a)(1) and (a)(6) transmitted to OAL 6-25-92 and filed 8-6-92 (Register
92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate ofCompliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsections (a)(4) and (a)(8) filed
1-17-97 pursuant to section 100, fitle 1, California Code of Regulations (Regis-
ter 97, No. 3).

§ 56798. Consumer Records.

(a) Vendors shall maintain consumer information and records as con-
fidential documents pursuant to Welfare and Institutions Code, sections
4514 through 4518, and shall also maintain consumer confidentiality as
required in Health and Safety Code, sections 199.20 through 199.27.

(b) Vendors shall maintain an individual consumer case file for each
consumer served by the in-home respite services agency.

(A) Any emergency and personal identification information, which
may effect the delivery of services, including the consumer's address,
telephone number, names and telephone numbers of relative's, and/or
guardian or conservator, physician's name(s) and telephone number, and
health plan, if appropriate;

(B) Pertinent information related to consumer respite needs including:

1 . Known medications;

2. Known allergies;

3. Medical disabilities;

4. Infectious, contagious or communicable conditions;

5. Special nutritional needs; and

6. Specific care needs unique to the individual consumer.

(C) Any other available medical, psychological, and social informa-
tion which may effect the delivery of In-home Respite Services, includ-
ing the consumer's ability and functioning level; and

(D) Authorization for emergency medical treatinent.

(2) All copies of:

(A) Special incident reports; and

(B) Case notes reflecting important events or information not docu-
mented elsewhere.

(3) Documentation of attempts to obtain required information not con-
tained in the consumer record.

(d) Records pertaining to the consumer shall be stored in a secure and
locked place which shall be readily accessible when needed. The vendor
is authorized to keep pertinent consumer data, including, but not limited
to, emergency telephone numbers, and important medical data with the
consumer when services are rendered.

(e) The individual consumer case file shall be retained for five years
from the time a consumer no longer receives services from the agency.
NOTE: Authority cited: Section 4690.2, Welfare and Insfitutions Code. Reference:
Sections 4646.5, 4648, 4648.1 and 4690.2, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate ofCompliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate ofCompliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of secfion filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Regfster 93, No. 26).

4. Certificate ofCompliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending section heading and section filed
1-17-97 pursuant to secfion 100, title I , California Code of RegulaUons (Regis-
ter 97, No. 3).

§ 56800. In-Home Respite Services Evaluation.

(a) The vendor shall conduct an annual review of its effectiveness in
relation to the service design. This shall include a review of:

(1) The ability of the vendor to meet the in-home respite needs of con-
sumers served;

(2) The aggregate data on:

(A) The number of consumers served;

(B) The different type of consumer needs encountered during service
delivery; and

(C) Outcomes in relation to the expectations identified in the service
design as required in Section 56780(a)(1)(B) of these regulations; and

(3) The degree to which family members were satisfied with the ser-
vice as provided by the in-home respite services agency.

(b) The vendor shall have a written evaluation design specifying:

(1) The purpose of the evaluation;

(2) The type of data to be collected and used;

(3) The frequency of data collection;

(4) The role of consumers, families or authorized consumer represen-
tatives in the evaluation process;

(5) Data collection and analysis methods;

(6) A description of the distribution, communication of, and actions
taken upon the results of the evaluation;

(7) The frequency of evaluations; and

(8) A description of how the particular evaluation design chosen by the
vendor relates to the service design.

(c) The vendor shall submit to the vendoring regional center, user re-
gional centers and the Department a written summary of the annual in-
home respite service evaluation which shall be maintained in the vendor

Page 292.22

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56901

•

file at the regional center and at the Department. The vendor shall main-
tain on file, pursuant to Section 56796 of these regulations, the full in-
home respite service evaluation for review by the vendoring regional
center and the Department.

NOTH: Authority cited: Sections 4648 and 4690.2, Welfare and Institutions Code.
Reference: Sections 4501, 4648, 4648.1 and 4690.2, Welfare and Institutions
Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Noti-; filed 1 1-5-91 as an emergency; opera-
tive 1 1-5-91 (Register 92, No. 21 ). A Certificate of Compliance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (a) and Note refiled 3^-92 as an emergency; opera-
tive 3^1-92 (Register 92, No. 25). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending sub.sections (a), (a)(1), (a)(2)(A),
(a)(2)(B) and (b)(4) filed 1-17-97 pursuant to section 100, title 1, California
Code of Regulations (Register 97, No. 3).

§ 56802. Effective Date of Compliance.

(a) The effective date of compliance by in-home respite services agen-
cies with the provisions of this article shall be as follows:

(1) Agencies vendored after the effective date of these regulations
shall be in compliance with these provisions upon the date of vendoriza-
tion.

(2) Agencies vendored prior to the effective date of these regulations
which:

(A) Do not meet one or more provision(s) specified in sections 56780
through 56802 shall have a maximum of one year from the effective date
of these regulations to come into compliance with the applicable provi-
sion(s).

(B) Equal or exceed any provision(s) specified in sections 56780
through 56802 shall be deemed in compliance with the applicable provi-
sion(s) upon the effective date of these regulations.

NOTE: Authority cited: Sections 4648 and 4690.2, Welfare and Institutions Code.
Reference: Sections 4648 and 4690.2, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

Subchapter 6. Ratesetting Procedures for
Residential Services

History
1. Change without regulatory effect renumbering subchapter 6 (filed 1-14 91 but
not printed) sections 56100 through 561 19 to .sections 56900 through 56919.
(Register91,No. 14).

Article 1. Definitions

§ 56900. Meaning of Words.

Note: Authority cited: Section 4681 . 1 , Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History
1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

§56901. Definitions.

(a) As used in this Subchapter, the following words and phrases have
the meanings specified in Section 56002.

( 1 ) Administrator;

(2) Consumer;

(3) Days;

(4) Department;

(5) Direct Care (DC) Staff;

(6) Facility;

(7) Individual Program Plan (IPP);

(8) Personal and Incidental Allowance;

(9) Residential Service Provider; and

(10) Regional Center.

(b) When used in this subchapter, the following words and phrases
have the following meanings:

( 1 ) "Administrative Duties" means those tasks performed by facility
staff which pertain to the management of the facility and are not consid-
ered direct care.

(2) "California Consumer Price Index (California CPI)" means the his-
torical index of the cost of living in California published by the Depart-
ment of Industrial Relations, Division of Labor Statistics and Research,
under the authority of California Labor Code Section 150. and the proj-
ected California CPI published by the Department of Finance.

(3) "Conserve" means an action taken by a regional center which has
been appointed as a consumer's representative payee, to save or invest
consumer funds pursuant to Title 20, Code of Federal Regulations, Sec-
tion 416.645(a).

(4) "Cost Components" means the sublisting under cost items listed in
Section 56908(b).

[The next page is 292.23.]

Page 292.22(a)

•

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56902

(5) "Cost Elements" means Basic Living Needs, Indirect Costs, Direct
Supervision and Special Services and Proprietary Fee.

(6) "Cost Items" means the major headings (Items 1 through 14) listed
under Section 569()8(b).

(7) "Cost Study Facility" means a facility which participates in the
triennial survey to determine facility costs.

(8) "Customary Fee" means a fee that is within the range of usual fees
charged and received by providers of similar training for the same service
within the geographic location.

(9) "Direct Program Costs" means facility costs related to the provi-
sion of residential services.

(10) "Enrolled" means the days in which a resident is in placement in
a facility during the cost study reporting period.

(11) "Established Rate" means the proposed rate after any adjustment
pursuant to Section 56902(b) and (c).

(12) "Facility Cost Study" means the triennial collection and analysis
of facility cost data.

(13) "Facility Size" means the licensed capacity of a facility.

(14) "Fixed Asset" means an item of tangible property which is used
for a period of more than one year and must be depreciated, rather than
expensed, pursuant to generally accepted accounting principles.

(15) "Geographic Location" means a county or group of counties
which share a common cost of living.

(16) "Housekeeping Duties" means tasks which pertain to cooking,
housecleaning, and laundry services.

(17) "Live-in Staff means wage-earning facility employees who re-
side in the facihty, such as house parents who meet the definition of an
"employee residing on the employer's premises" pursuant to Section
785.23 of "Interpretive Bulletin, Part 785: Hours Worked Under the Fair
Labor Standards Act of 1938, As Amended," published by the U.S. De-
partment of Labor.

(18) "Maintenance and Repair Duties" means tasks which pertain to
the upkeep of facility premises.

(19) "Management Organization" means a separate and distinct cor-
poration or entity which operates two or more programs or services.

(20) "Mandated Minimum Wage" means the higher wage required by
federal or state law.

(21 ) "Median" means the fiftieth percentile of a statistical distribution.

(22) "Occupant" means any individual living in the facility, including
consumers and non-consumers, the owner/operator and his/her family
members, and live-in staff.

(23) "Occupant Day" means a day that one occupant resides in a facil-
ity.

(24) "Operation Type" means owner operated or staff operated.

(25) "Operative Rate" means the rate being paid on June 30 of the cur-
rent fiscal year.

(26) "Out-of-home Respite Services" means regional center ap-
proved intermittent or regularly scheduled temporary non-medical care
and supervision, provided by a residential service provider.

(27) "Owner operated" means that the facility is the residence of the
licensee or a member of the corporate board of directors.

(28) "Prevailing Rate" means the rate of payment which is being paid
to a residential service provider by other governmental agencies to pro-
vide services to residents.

(29) "Proprietary Fee" means the amount which reflects a reasonable
rate of return on the net value of a facility's fixed assets.

(30) "Proposed Rate" means the residential rate proposed by the De-
partment pursuant to Section 56902.

(31) "Regional Center Supplement" means that portion of the estab-
lished rate which the regional center uses to pay the portion of the resi-
dential rate that exceeds the amount of the consumer's SSI/SSP payment.

(32) "Reporting Period" means the period of time specified by the De-
partment for the purpose of a facility cost study.

(33) "Resident" means a person placed in a licensed facility to receive
care and supervision pursuant to Title 22, California Code of Regulations

(CCR), Division 6. Resident includes both regional center and non-re-
gional center consumers.

(34) "Resident Day" means any portion of a day in which a resident
is placed in the facility.

(35) "Residential Respite Services" means intermittent or regularly
scheduled temporary non-medical care and supervision provided to the
consumer in an out-of-home setting.

(36) "Service Code" means a number which is assigned by the vendor-
ing regional center to a residential service provider which indicates the
type of authorized service to be provided.

(37) "Staffing Standards (SS)" means the average number of staff
hours per consumer per month allowed for each service level and step
which includes hours for direct care, and relief coverage for vacations,
holidays, night coverage, and training.

(38) "Staff Operated" means that the facility is not the residence of the
licensee or a member of the corporate board of directors, and the licensee
employs personnel to provide direct care to consumers.

(39) "Subcode" means a series of a maximum of five numbers and/or
letters which is assigned by the vendoring regional center to a residential
service provider for billing purposes.

(40) "Target Fiscal Year" means the fiscal year in which the Depart-
ment recommends that a proposed rate be implemented.

(41) "Usual Fee" means the fee which is regularly charged and re-
ceived for a given service by an individual provider. If more than one fee
is charged for a given service, the fee determined to be the usual fee shall
not exceed the lowest fee which is regularly charged.

(42) "Vehicle Miles" means the miles a facility vehicle is used for ad-
ministrative functions, to transport residents for direct services, or for
other facility operations.

(43) "Vendoring Identification Number" means the unique number
which is assigned to each residential service provider in order to establish
a record-keeping and tracking system for regional centers' billing pur-
poses.

NOTE: Authority cited: Sections 468L1 and 4791(i), Welfare and Institutions
Code;Chapter722,Statutesof 1992, Section 147. Reference: Sections 4681. land
4791(i), Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-L3-91 (Register 91, No. 14).

2. New subsections (a)(8), (b)(3) and (b)(31) and subsection renumbering filed
8^-92; operative 8-4-92 (Register 92, No. 32).

3. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing on]y pursuant to Chapter 722, Statutes of 1992.
Section 147 (Register93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

4. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

5. Editorial correction of History 3 (Register 94, No. 47).

6. Editorial correction of subsections (b)(4). (6), (11) and (30) (Register 94, No.
50).

7. Editorial correction of subsections (a) and (b)(] 1) and (26) and capitalizing "S"
of "Section" and "D" of "Division" throughout (Register 95, No. 1 8).

Article 2. General Provisions

§ 56902. General Provisions.

(a) Proposed residential rates shall be determined for a specific target
fiscal year in accordance with generally accepted accounting principles
pursuant to Article 5.

(b) Payment of proposed rates is subject to appropriation of sufficient
funds for that purpose in the Budget Act.

(c) Absent specific direction from the Legislature, when sufficient
funds are not appropriated in the Budget Act to fully provide for payment
of the proposed rates, in lieu of the proposed rates, the Department shall
increase operative rates on a pro rata basis if the amount appropriated is
sufficient for an increase.

(d) Once the vendor has received notice of the maximum rate cstab-
hshed by the Department for the facihty' s approved service level, each

Page 292.23

§ 56903

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

regional center, or its designee, which has placed consumers in the facil-
ity may negotiate with the vendor a level of payment for its consumer(s)
that is lower than the rate established by the Department.

( 1 ) A payment at the lower level may only occur after both the regional
center and the vendor mutually agree in writing:

(A) To the negotiated level of payment; and

(B) To the effective date and termination date for the regional center
to reimburse the vendor at the negotiated level of payment.

(2) Upon termination of the level of payment negotiated by the region-
al center and a vendor, the regional center shall resume reimbursements
to the vendor for services at the maximum rate established by the Depart-
ment for the facility's approved service level.

(3) The negotiated level of payment between each regional center and
the vendor shall not modify any other requirement specified in Subchapt-
ers 4 and 6.

(4) The negotiated level of payment between each regional center and
the vendor may be renegotiated or terminated at any time upon the re-
quest of either party.

(5) Each regional center shall provide the Department and the vendor
with a copy of the agreement specified in subsection (d)(1).

NOTE: Authority cited: Sections 4680, 4681 .1. 4786 and 479 l(i). Welfare and In-
stitutions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections
4680, 4681.1, 4786 and 479 l(i), Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. New subsection (e) and amendment of NOTK filed 1 1-4-91 as an emergency;
operative 1 1-4-91 (Register 92, No. 8). A Certificate of Compliance must be
transmitted to OAL 3-3-92 or emergency language will be repealed by opera-
tion of law on the following day.

3. New subsecdon (e) and amendment of Note refiled 3-4-92 as an emergency;
operative 3^-92 (Register 92, No. 15). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Certificate of Compliance as to 3-4-92 order includingrepealer of subsections
(eHe)(6) transmitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Amendment of section filed 9-20-93 as an emergency; operafive 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These reguladons shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

7. Editorial correction of History 5 (Register 94, No. 47).

Article 3. Cost Studies

§ 56903. Facility Cost Study.

(a) The Department shall conduct a facility cost study every three
years pursuant to Welfare and Institutions Code Section 4681.1(b).

(b) In conducting the facility cost study, the Department shall make ev-
ery reasonable effort to:

( 1 ) Design a facility sample to produce estimates which are statistical-
ly valid at the 95% confidence interval;

(2) Ensure the cost data utilized is reliable; and

(3) Analyze the cost data utilizing standard accepted statistical meth-
ods.

(c) When a facility is selected to participate in a cost study, the admin-
istrator shall provide data from the facility's financial records for the spe-
cified reporting period, as requested by the Department or its designee,
pursuant to this subchapter.

NOTE: Authority cited: Section 4681.1, Welfare and Institutions Code; Chapter
722, Statutes of 1992, Section 147. Reference: Section 468 1 . 1 , Welfare and Insd-
tutions Code.

History

1. New secdon filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Editorial correction of History 2 (Register 94, No. 47).

4. Change without regulatory effect amending article 3 heading filed 6-19-95 pur-
suant to section 100, title 1, California Code of Regulations (Register 95, No.

25).

§ 56904. Cost Study Records Maintenance Requirements.

(a) The administrator shall make available to the Department for the
cost study, all financial and service records. Such records shall include
the California Revenue and Taxation Code (R&TC) and Internal Reve-
nue Codes (IRC) information statements or returns and all pertinent doc-
umentation for a reporting period specified by the Department.

(b) Facility financial records shall be maintained in a manner consis-
tent with:

( 1 ) A single inethod of accounting, clearly reflecting the nature and
amounts of all cost (expenses) and all income;

(2) The Internal Revenue Code (IRC) and the California Revenue and
Taxation Code (R&TC) information statements; and

(3) Title 17, CCR, Sections 50604 and 56908.

( 1 ) For all individuals living in the facility, the total number of occu-
pant days, including the following:

(A) Resident days;

(B) Live-in staff days; and

(2) The number of staff hours performing the following functions:

(A) Direct care pursuant to Section 56004;

(B) Housekeeping;

(D) Supervision and management; and

(E) Administration.

(3) Allowable expenses pursuant to Section 56908;

(4) A description of all donated goods and services, including the fair
market value at the time of donation, and the date of donation;

(5) For each fixed asset:

(A) A description including a serial number or other identifying infor-
mation;

(B) A description of whether the item is to be used for adnunistrative
purposes or for basic living needs;

(6) The program design requirements pursuant to Titie 17, CCR. Sec-
tion 56013(a);

(7) Vendoring identification number, service code and subcode;

(8) Name of the vendoring regional center and any other regional cen-
ters utilizing the facility;

(9) Name of the management organization, if any;

(10) A reasonable estimate of the square footage of the facility as fol-
lows:

(A) Living space used by residents;

(B) Administrative functions; and

(11) Vehicle miles related to:

(A) Direct services to residents;

(B) Administrative functions; and

NOTE; Authority cited: Secdon 468 1.1, Welfare and Institutions Code. Reference:
Sections 4648.1 and 4681.1, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Editorial correction of subsections (b)(3) and (c)(3) (Register 94, No. 50).

3. Editorial correction capitalizing "S" of "Section" throughout (Register 95, No.
18).

§ 56905. Depreciation.

(a) In conducting a cost study pursuant to Section 56903, the Depart-
ment shall utilize depreciation costs of all assets which are:
(1) Directly related to the facility's operations as a facility; and

Page 292.24

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Health and Welfare Agency — Department of Developmental Services

§ 56908

(2) Rect)gni/.ed as an allowable business expense in accordance with
federal and slate income tax guidelines and actually reported as such on
the residential service provider's state and federal tax returns for the date
year of the cost study. In the event of inconsistencies between state and
federal income tax depreciation guidelines, the California State Fran-
chise Tax Board requirements shall prevail for the purpose of data collec-
tion for the cost study.

NOTE: Authority cited: Sections 4681.1 and 479 l(i). Welfare and Institutions
Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4681 .1 and
479 l(i). Welfare and Institutions Code.

History

1. New section fded 1-14-91; operative 2-13-91 (Register 91, No. 14).

3. Kditorial correction of History 2 (Register 94, No. 47).

4. Editorial con-ection of subsection (a) (Register 94, No. 50).

§ 56906. Cost Allocation Methods.

(a) To allocate cost items in a facility cost study, the Department shall
review the data presented to determine:

(1 ) That allowable costs are directly identified with the cost study fa-
cility (CSF) or specific cost element; or

(2) That allowable costs are combined with the allowable costs of oth-
er facilities, cost elements, or a management organization.

(b) When the nature of the allowable cost of the accounting records
provided by the facility permits, allowable costs shall be directly allo-
cated to each CSF or cost element.

(c) When any allowable cost cannot be directly identified with a CSF
or a cost element, the Department shall allocate a percentage of the cost
to the CSF or cost element using the following steps:

( 1 ) Determine a percentage which reflects that portion of time, number
of residents, hours of direct service, space, or vehicle miles which is at-
tributable to the CSF.

(2) Multiply the total cost by the percentage determined in (1) above.
NOTE: Authority cited: Section 4681 . 1 , Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1 992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Editorial correction of History 2 (Register 94, No. 47).

§ 56908. Allowable Costs.

(a) In order to propose rates of reimbursement, the Department shall
include in the facility cost study only those costs which are:

(1) Directly related to the operadon of the facility;

(2) Recognized as an allowable business expense in accordance with
federal and state income tax guidelines and reported as such on the resi-
dential service provider' s state and federal tax returns for the data year
of the cost study; and

(3) As otherwise specified in subsection (b) below. In the event of in-
consistencies between state and federal tax reporting guidelines, the Cal-
ifornia State Franchise Tax Board requirements shall prevail for the pur-
pose of data collection for the cost study.

(b) In order for the Department to conduct the cost study in accordance
with state law, it is necessary for the Department to organize the data col-
lected for the cost study in a manner not entirely consistent with state and
federal tax reporting formats. The Department shall organize its cost
study and include the following cost items if they are allowable business
expenses consistent with subsections (a)(1) and (2) above and are in-
curred by the residential service provider and necessary for the operation
of the facility. The cost components presented under each cost item are

presented only as examples of allowable costs and are not intended to he
exclusive.

(1 ) Staff wages and fringe benefits which include the following cost
components:

(A) Expenditures for wages and salaries paid to all facility employees
performing housekeeping, direct care, adininistration and management,
staff supervision, clerical, accounting/bookkeeping, maintenance and re-
pair functions;

(B) Expenditures for fringe benefits including the residential service
provider's share of Old Age Security Disability Insurance (OASDI),
Workers' Compensation, Unemployment Insurance, Employment
Training Tax, health insurance, dental insurance, vision insurance, life
insurance, disability insurance, and retirement.

(2) Housing expenses which include the following cost components:

(A) Rent or lease for the facility building;

(B) Depreciation and interest for the facility building, additions and
mandated or other capital and leasehold improvements; and

(3) Furniture and equipment expenses which include the following
cost components:

(A) Rent or lease payments; and

(B) Depreciation and interest.

(4) Insurance expenses which include the following cost components:

(A) Property insurance, including fire, theft and earthquake;

(B) Flood insurance;

(D) Director's and officer's liability insurance; and

(E) Surety bonds.

(5) Utilities expenses which include the following cost components:

(A) Energy including gas, electricity, wood, coal, and oil;

(B) Water;

(D) Garbage and refuse disposal.

(6) Food expenses which include the following cost components:

(A) Groceries for food prepared at home for occupants; and

(B) Restaurant meals for residents and the facility staff who accompa-
ny them.

(7) Expenses for housekeeping supplies and services including the fol-
lowing cost components:

(A) Housekeeping, cleaning, paper products, and maintenance sup-
plies; and

(B) Payments to external housekeeping or laundry services.

(8) Clothing and personal care expenses, which are not purchased with
a resident's personal and incidental allowance funds, and which include
the following cost components:

(A) Resident clothing, toiletries, and other personal items; and

(B) Over-the-counter medications and prescriptions.

(9) Transportation expenses which include the following cost compo-
nents:

(A) Costs of the facility vehicle, including:

1 . Rental and lease payments;

2. Depreciation and interest;

3. Insurance;

4. GasoUne and oil;

5. Maintenance and repair; and

6. License fees.

(B) Public transportation fares including bus, light rail, and taxi; and

(10) Program supply expenses for resident use or for the care or train-
ing of residents.

(1 1) Consultant expense for activities pursuant to Section 56()4()(a).

(12) Other professional consultant expenses including:

(A) The costs of legal, accounting, clerical, or managerial services not
provided by facility staff; and

Page 292.25

§ 56909

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(B) Consultants other than those required by Section 56040(a).

(13) Facility repair and maintenance expenses including the following
cost components:

(A) Materials and supplies; and

(B) Contract labor for maintenance or repair of the facility, furniture,
and equipment.

( 14) General and administrative expenses including the following cost
components:

(A) Dues/Subscriptions which shall include:

1. Dues for professional organizations related to residential care;

2. Subscriptions for publications which are used in the operation of the
facility, for residents, or for the purpose of staff development.

(B) Business taxes that must be paid as a condition of operating a facil-
ity, excluding property taxes, business income taxes and personal in-
come taxes;

(C) Fees for licenses, certifications, registrations, or permits required
in order to operate a community care facility providing residential care;

(D) Staff recruitment and other personnel costs including advertising,
charges and fees for screening prospective employees, such as finger-
printing, driving record checks performed by the Department of Motor
Vehicles, and physical examinations or other health and safety checks re-
quired prior to employment; costs for inoculations or clinical tests of em-
ployees for the health and safety of staff or consumers;

(E) Staff training expenses related to the requirements of Sections
56036 through 56038;

(F) Communications expenses including telephone charges and long
distance charges related to facility business, postage, telegraph, teletype,
centrex, telepak, message services, facsimiles, and TDD; and

(G) Office supplies including paper products, pens, typewriter, com-
puter, printer and other equipment and supplies.

NOTE: Authority cited: Sections 4681.1 and 479 l(i). Welfare and Institutions
Code; Chapter722, Statutes of 1992, Section 147. Reference: Sections 468 1.1 and
479 l(i). Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722. Statutes of 1992,
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Amendment of subsection (b)(14)(D) filed 11-23-94; operative 11-23-94
(Register 94, No. 47).

4. Editorial correction of History 2 (Register 94, No. 47).

5. Editorial correction of subsections (b)(l 1) and (b)(14)(E) (Register 95, No. 18).

6. Change without regulatoiy effect amending subsections (a)(3) and (b) filed
6- 1 9-95 pursuant to section 1 00, title 1 , California Code of Reaulations (Regis-
ter 95, No. 25).

§ 56909. Costs Not to Be Reported.

(a) The Department shall exclude from the facility cost study those
costs which are not:

(1) Directly related to the operation of the facility;

(2) Recognized as an allowable business expense in accordance with
federal and state income tax guidelines.

(b) In order to comply with state laws, the following costs shall not be
included in the facility cost study, in addition to those cost items excluded
in accordance with the provisions of subsection (a) above:

(1) Personal expenses of the owner-operator and his/her family which
include those items, activities, or services that are used strictly by occu-
pants who are not residents and are unrelated to facility business, includ-
ing but not be limited to:

(A) Personal clothing;

(B) Use of facility vehicles for personal business; and

(2) Expenses of an activity other than residential care, such as any oth-
er business or non-residential program which uses space, equipment, or
supplies on the facility grounds;

(3) Camperships or other expense of sending a resident to summer
camp;

(4) Resident relocation expense;

(5) Donations to public or private agencies or organizations;

(6) Fund raising expenses;

(7) Gifts to employees;

(8) Legal fees directly related to a resident or employee, or expenses
for the prosecution of claims against a regional center or state agency;

(9) Public relations expenses;

(10) Refundable deposits;

(11) The following management organization expenses:

(A) Services which duplicate those provided by the facility;

(B) Those applicable to, associated with, or claimed by other facilities
operated by the management organization; and

(C) Costs which do not support facility operations and which cannot
be allocated to any of the direct program cost items in Section 56908.

(12) The value of capital improvements, except as allowed pursuant

to Section 56905.

NOTE: Authority cited: Section 4681 . 1 , Welfare and Institudons Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992,
Section 147 (Register 93, No. 39). These reguladons shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Editorial correcUon of History 2 (Register 94, No. 47).

4. Editorial correcfion of subsecdons (b)( 1 l)(C)and (b)(12) (Register 94, No. 50).

5. Editorial correction of subsection (b)(ll)(C) (Register 95, No. 18).

6. Change without regulatory effect amending subsecdon (b) filed 6-19-95 pur-
suant to section 100, dtle 1, California Code of Regulations (Register 95, No.

25).

Article 4. Rates Development Methodology

§ 56910. General Provisions for Rate Proposals.

(a) The Department shall udlize a rate development methodology to
determine the amounts for the cost elements for the proposed rates.

(b) The Department shall develop proposed rates pursuant to Section
56902 which shall:

( 1 ) Be based upon median cost per consumer per month;

(2) Vary by Service Levels 2, 3 and 4(A-I); and

(3) Vary by geographic location.

(c) The proposed rates shall be the sum of the cost elements pursuant
to Secdons 5691 1 through 56914, updated pursuant to Section 56915.
NOTE: Authority cited: Section 468 1.1, Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.
47).

3. Editorial correction of subsections (b) and (c) (Register 94, No. 50).

4. Editorial correction of subsecdon (c) (Register 95, No. 18).

5. Change without regulatory effect amending subsecdon (b)(2) filed 6-19-95
pursuant to section 100, title 1 , California Code of Regulations (Register 95, No.

25).

§ 5691 1 . Basic Living Needs.

(a) The basic living needs (BLN) cost element represents the cost of
meedng consumers' basic living needs, allocated pursuant to Section
56906, and shall include the following:

(1) Wages and fringe benefits of staff performing housekeeping du-
des;

(2) Housing;

(3) Furniture and equipment;

(4) Insurance;

(5) Utilides;

(6) Food;

(7) Housekeeping supplies and services;

•

Page 292.26

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56913

(8) Clothing and personal care items which are not purchased with a
resident's personal and incidental allowance; and

(9) Transportation.

(b) The following steps shall be completed by the Department to deter-
mine the proposed amount for BLN:

( 1 ) For each CSF. calculate the total BLN costs as follows:
(A) To derive the BLN cost per occupant day, calculate the costs per
day for subsections (a)( 1 ) through (7) above using the following formula:

COST PER OCCUPANT DAY =

Dollar amount per cost item
total number of occupant days

(B) To derive the BLN cost per resident day, calculate the costs per day
for subsections (a)(8) and (9) above using the following formula:

COST PER RESIDENT DAY

Dollar amount per cost item
total number of resident days
enrolled

(2) Using generally accepted statistical techniques:

(A) Analyze the total BLN cost for all CSFs to determine if there are
any significant differences by:

1. Service Levels 2, 3 and 4;

2. Operation type;

3. Facility size; and

4. Geographic location.

(B) Group together those with a significant similarity, except geo-
graphic locations;

(C) Group together those that are similar by geographic location, re-
gardless of whether or not the differences between locations are signifi-
cant;

(D) Where the distinct groups have been identified in subsections (B)
and (C) above, determine the median total BLN cost for each group.

(3) Convert each median cost identified in subsection (2)(D) above to
the cost per resident per month using the following formula:

MEDIAN COST PER RESIDENT MONTH = Median cost per day
for each item X 30.44 days

NOTE: Authority cited: Section 4681 . 1 , Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of subsection (a) filed 1 1-23-94; operative 11-23-94 (Register
94, No. 47).

3. Editorial correction of subsection (a) (Register 94, No. 50).

4. Editorial correction of subsecfions (a), (b)(1)(B), and (b)(3) (Register 95, No.
18).

5. Change without regulatory effect amending subsections (b)(l)(A)-(C),
(b)(2)(A)l., (b)(2)(D) and (b)(3) filed 6-19-95 pursuant to section 100, title 1,
California Code of Regulations (Register 95, No. 25).

§ 56912. Indirect Costs.

(a) The indirect costs cost element represents that portion of indirect,
overhead, and administrative costs allocated pursuant to Section 56906,
and includes the following:

(1) Wages and fringe benefits to staff performing facility administra-
tion and management, clerical, bookkeeping/accounting, staff supervi-
sion, maintenance and repair duties;

(2) Housing;

(3) Furniture and equipment;

(4) Insurance;

(5) Utilities;

(6) Housekeeping supplies and services;

(7) Transportation;

(8) Program supplies;

(9) Other professional consultant services;

(10) Repair and maintenance; and

(11) General and administrative costs.

(b) The following steps shall be completed by the Department to deter-
mine the proposed amount for indirect costs:

(1) Calculate total costs per resident day using the following formula:

Dollar amount per cost item
Total number of resident days enrolled

(2) Using generally accepted statistical techniques:

(A) Analyze the total indirect cost per resident day for all CSFs to de-
termine if there are any significant differences by:

1 . Service Levels 2, 3 and 4;

2. Operation type;

3. Facility size; and

4. Geographic location.

(B) Group together those with a significant similarity, except geo-
graphic locations;

(C) Group together those that are similar by geographic location,
whether or not the differences between locations are significant;

(D) Where distinct groups have been identified in subsections (B) and
(C) above, determine the median total indirect costs per resident day for
each group.

(3) Convert each median cost per resident day identified in subsection
(1) or (2)(D) above to the cost per resident month using the formula for
median cost per resident month in Section 5691 1 (b)(3).

NOTE: Authority cited: Section 468 1.1, Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Editorial correcfion of subsections (a) and (b)(3) (Register 94, No. 50).

3. Change without regulatory effect amending subsecfions (b)(2)(A) I., (b)(2)(D)
and (b)(3) filed 6-1 9-95 pursuant to section 1 00, fitle 1 , California Code of Reg-
ulations (Register 95, No. 25).

§ 56913. Direct Supervision and Special Services.

(a) The direct supervision and special services cost element represents
the expenditures for personnel who provide direct services to residents,
allocated pursuant to Section 56906, and includes the following:

(1) Wages and fringe benefits for direct care staff; and

(2) Consultant expense.

(b) The following steps shall be completed by the Department to deter-
mine the proposed amount for direct supervision for all CSFs:

( 1 ) For each staff-operated CSF, identify the following DC staff costs:

(A) Wages for DC staff;

(B) Fringe benefits for DC staff

(2) Calculate DC staff hourly wages for each CSF using the following

formula:

DC STAFF HOURLY WAGE = Total DC staff wages

Total DC staff hours

(A) If the DC staff hourly wage in subsection (b)(1)(A) above for any
CSF is below the state minimum wage, the Department shall substitute
the state minimum wage in lieu of the actual wage.

(3) Using generally accepted statistical techniques, analyze the DC
staff wages for all CSFs, determined in subsection (b)(1)(A) above, to:

(A) Group together, by service level, those with a significant similari-
ty;

(B) Group together those that are similar by geographic location,
whether or not the differences between the locations are significant;

(4) Calculate the DC staff fringe benefit ratio for all CSFs by complet-
ing the following steps:

(A) For each staff-operated facility participating in the study, calcu-
late the fringe benefit ratio for DC staff, stated as percentage of wages,
using the following formula with the data for the wages and fringe bene-
fits costs in subsections (b)(1)(A) and (B) above:

DC STAFF FRINGE BENEFIT RATIO = Fringe benefits for DC staff

DC staff wages

(B) Determine the median fringe benefit ratio from the data developed
in step (A) above;

(C) Determine a mandated fringe benefit ratio for the reporting period
that includes all required staff fringe benefits including OASDI, Unem-
ployment Insurance, Employment Training Tax, and Worker's Compen-
sation; and

Page 292.27

§ 56914

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(D) Compare the median fringe benefit ratio determined in subsection
(B) above witli the mandated fringe benefit ratio determined in subsec-
tion (C) above, and select the higher ratio.

(5) Calculate the total median hourly compensation for DC staff using
the following formula:

TOTAL MEDIAN HOURLY COMPENSATION = median
hourly wage for each group in subsection (3)(C) above + median hourly
wage X fringe benefit ratio in subsection (4)(D) above.

(6) Determine the DC staff cost per consumer per month for Service
Levels 2, 3 and 4 as follows:

DC STAFF COST PER CONSUMER PER MONTH = [Total
hourly compensation produced in step (5)] x the residential services
staffing standard (SS) per consumer per month.

(A) The chart below shows the staffing standard in terms of level of
service and facility operation type:

acilitv level

Owner/operated

Staff operated

hours/cl/mo.

Level 2

55.1

l\.l

Level 3

87.7

t03.8

Level 4

—

140.0

—

153.7

—

167.7

—

18L7

—

200.0

—

218.6

—

236.8

—

260.0
292.2

(c) The following steps shall be completed by the Department to deter-
mine the proposed amount for consultant expenses for all Service Level
4 CSFs:

( 1 ) Calculate the consultant cost per hour for each Service Level 4 CSF
utilizing the following formula:

COST PER CONSULTANT HOUR =

Total expenditures for
consultant services
total houi's of
consultant service delivered

(2) Determine the median hourly cost for consultant services for all
Service Level 4 CSFs.

(3) Determine the consultant cost per consumer per month by multi-
plying the hourly cost produced in subsection ( 1 ) above by the consultant
hours required below:

Step Consultant

Hrs/Consumer/Month

4A
4B
4C
4D
4E
4F
4G
4H
41

(d) The amount for direct supervision and special services for Service
Levels 2 and 3 is the amount determined in subsection (6) above.

(e) The amount for direct supervision and special services for Service
Level 4 (A-I) is the sum of subsections (b)(6)and (c)(2) above.
NOTE: Authority cited: Section 4681. 1 , Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

\. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Register 94, No.

47).

3. Editorial correction of subsection (a) (Register 94, No, 50).

4. Editorial correction of subsections (b)(6)(A) amd (c)(3) (Register 95, No. 18).

5. Change without regulatory effect amending section filed 6-19-95 pursuant to
section 100, title 1, Cahfornia Code of Regulations (Register 95, No. 25).

§ 56914. Proprietary Fee.

(a) The proprietary fee cost element shall be calculated for each CSF
as follows:

( 1 ) Identify the amount of the allowable, unrecovered basis for depre-
ciation of all fixed assets to determine the total net fixed asset value;

(2) Divide the total net fixed asset value by the average number of resi-
dents residing at the facility during the reporting period to get total net
fixed asset value per resident.

(b) Using generally accepted statistical techniques:

( 1 ) Analyze total net fixed asset value per resident to determine if there
are any significant differences by:

(A) Service level;

(B) Operation type;

(D) Geographic location.

(2) Group together those with a significant similarity, except geo-
graphic locations;

(3) Group together those that are similar by geographic location,
whether or not the differences between locations are significant;

(4) Where distinct groups have been identified in subsections (2) and
(3) above, determine the median total net fixed asset value per resident
for each group.

(c) Determine the pre-tax rate of return on assets for residential care
facilities (Standard Industrial Code 8361) using Dun and Bradstreet data
reports; and

(d) For each median idenfified in subsecUon (b)(4) above, calculate the
monthly amount for the proprietary fee cost element utiHzing the follow-
ing formula:

Median total net fixed asset value per
PROPRIETARY FEE = consumer x [rate of retum identified in (c) above]

the number of months in the reporting period
NOTE: Authority cited: Section 468 1.1, Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

1. New secdon filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Amendment of subsecdon (d) filed 11-23-94; operative 11-23-94 (Register
94, No. 47).

3. Change without regulatory effect amending subsections (b)(4) and (d) filed
6-19-95 pursuant to section 100, title 1 , California Code of Regulations (Regis-
ter 95, No. 25).

§ 56915. Cost Data Update Methodology.

(a) The Department shall update the amounts of the cost elements by
the California Consumer Price Index (CPI) as follows:

(1) Idenfify the amount for the reporting period (ARP);

(2) Determine the mid-point of the reporfing period used for the cost
study;

(3) Determine the mid-point of the target fiscal year;

(4) Obtain the historical and projected California CPI for subsections
(2) and (3) above;

(5) Update each amount using the following formula:

UPDATED COST = CPI for mid-point of target fiscal year x ARP in ( n above

CPI for mid-point of reporting period

NOTE: Authority cited: Secdon 4681 . 1 , Welfare and Institudons Code. Reference:
Secdon 4681.1, Welfare and Insdtutions Code.

History

1. New secdon filed 1-14-91; operadve 2-13-91 (Register 91, No. 14).

2. Change without regulatory effect amending subsecdon (a)(4) filed 6-19-95
pursuant to section 100, dde 1 , California Code of Reguladons (Register 95, No.
25).

Article 5. Rate Proposals

§ 56916. Proposed Rates.

(a) The Department shall update the cost elements resulting from its
most recent cost study as follows:

(1) The BLN amount determined in Secdon 5691 1(b)(3) shall be up-
dated by the California CPI pursuant to Section 56915;

(2) The Indirect Costs amount determined in Section 56912(b)(3) shall
be updated by the California CPI pursuant to Section 56915;

(3) The Direct Supervision and Special Services shall be updated by:
(A) Updating the median hourly wage amount determined in Section

56913(b)(3)(C) by:

•

Page 292.28

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 56918

1 . Any federal or state minimum wage changes with an effective date
between the cost study reporting period and the target fiscal year; and

2. By the California CPI pursuant to Section 56915.

(B) Updating the ratio determined in Section 56913(c)(4)(D) for any
mandated changes in employer's contributions for fringe benefits be-
tween the cost study reporting period and the target fiscal year;

(4) The Proprietary Fee amount determined in Section 56914(d) shall
be updated to reflect the most recent Dun and Bradstreet data.

(b) Each cost element shall be adjusted to reflect any additional costs
identified by the Department since the time of the reporting period which
were not captured by the cost study data.

(c) The rates to be proposed pursuant to Section 569 1 0 shall be the sum
of the cost elements determined in subsection (a) above after adjusting
according to subsection (b) above.

NOTE; Authority cited: Sections 4681.1 and 479 l(i). Welfare and Institutions
Code; Chapter 722. Statutes of 1992, Section 147. Reference: Sections 4681 .1 and
4791(1), Welfai-e and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992.
Section 147 (Register93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

3. Editorial correction of History 2 (Register 94, No. 47).

4. Editorial correction of subsections (a)(l)-(4) and (c) (Register 94, No. 50).

5. Editorial correction capitalizing "S" of "Section" throughout (Register 95, No.
18).

6. Change without regulatory effect amending subsection (c) filed 6-19-95 pur-
suant to section 100, title 1, Cahfornia Code of Regulations (Register 95, No.

25).

Article 6. Reimbursement Policies

§ 5691 7. Payment of Established Rates.

(a) Regional centers shall pay residential service providers monthly at
the rate established by the Department pursuant to Section 56902(b) and
(c).

(b) The source of funds for the monthly payment of residential service
providers shall consist of the Regional Center Supplement and, where ap-
propriate, any Supplemental Security Income (SSI) and State Supple-
mental Program (SSP) funds for which the consumer is eligible minus the
consumer's Personal and Incidental Allowance as defined in Title 17,
California Code of Regulations, Section 56002(a)(26).

(c) When the regional center has been appointed as the consumer's
representative payee for the consumer's SSI/SSP payment, the regional
center shall:

( 1 ) Forward that portion of the consumer' s Personal and Incidental Al-
lowance which is not conserved by the regional center on the consumer's
behalf to the consumer no later than the 1 0th day of the month in which
the regional center receives the consumer's SSI/SSP payment; and

(2) Forward the consumer's SSI/SSP payment to the residential ser-
vice provider no later than the 1 0th day of the month following the month
in which the regional center receives the consumer's SSI/SSP payment.

(d) The regional center shall reimburse the residential service provider
in arrears with funds from the Regional Center Supplement for that por-
tion of the residential rate which exceeds the amount of the consumer's
SSI/SSP payment.

( 1 ) The regional center shall not increase the amount of the Regional
Center Supplement when:

(A) The residential service provider has been appointed as the con-
sumer's representative payee for the consumer's SSI/SSP payment; and

(B) The amount of the consumer's SSI/SSP payment is temporarily re-
duced or terminated due to:

I. The representative payee's failure to submit required documenta-
tion; and/or

2. The accumulation of consumer funds to the extent that the amount
of the consumer's SSI/SSP payment is reduced or the consumer's eligi-
bility for SSI/SSP is terminated.

(e) All consumer SSI/SSP funds which have been conserved by the re-
gional center shall be deposited in an interest-bearing account in a local
bank, savings and loan or credit union authorized to do business in Cali-
fornia, the deposits of which are insured by a branch of the Federal Gov-
ernment. The account shall meet the following requirements:

(1 ) The account shall be maintained as a trust account separate from
the accounts of the regional center; and

(2) The account title shall clearly note that the account contains con-
sumer cash resources.

(f) The regional center shall provide access to the consumer's cash re-
sources when requested by the consumer or hi.s/her authorized represen-
tative.

(g) All interest accruing to funds conserved by the regional center on
behalf of a consumer in an account pursuant to Section 569 1 7(e ) shall be
the property of the consumer.

(h) The established rate shall be paid for the full month when the con-
sumer is temporarily absent from the facility 14 days or less per month.

( 1 ) When the consumer's temporary absence is due to the need for in-
patient care in a health facility as defined in Health and Safety Code Sec-
tion 1250(a), (b) or (c) the regional center shall continue to pay the estab-
lished rate as long as no other consumer occupies the vacancy created by
the consumer's temporary absence, or until the ID Team has determined
that the consumer will not return to the facility.

(i) The established rate shall be prorated for a partial month of service
in all other cases by dividing the established rate by 30.44, then multiply-
ing by the number of days the consumer resided in the facility.
Note: Authority cited: Sections 4648, 4681.1 and 4791(i), Welfare and Institu-
tions Code; Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4648,
4659(a), 4681.1 and 4791 (i), Welfare and Institutions Code.

History

1. New section filed 1-14-91; operafive 2-13-91 (Register 91, No. 14).

2. Amendment of subsections (a) and (b) and Noth filed 1 1-4-91 as an emergen-
cy; operative 1 1-4-91 (Register 92, No. 8). A Certificate of Compliance must
be transmitted to OAL 3-3-92 or emergency language will be repealed by oper-
aUon of law on the following day.

3. Amendment of subsections (a) and (b) and Note refiled 3-4-92 as an emergen-
cy; operative 3-4-92 (Register 92, No. 15). A Certificate of Compliance must
be transmitted to OAL 7-2-92 or emergency language will be repealed by oper-
ation of law on the following day.

4. Certificate of Compliance as to 3^-92 order including amendment of sub.sec-
tion (a), designation of former text of subsection (a) to subsection (b), new sub-
sections (c)-(g), renumbering and amendment of former subsection (b) to (h),
new subsection (h)(1) and renumbering of former subsection (c) to (i) trans-
mitted to OAL 6-25-92 and filed 8-4-92 (Register 92, No. 32).

5. Amendment of secfion filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992.
Section 147 (Register 93, No. 39). These regulations shall not be repealed by the
Office of Administrative Law and shall remain in effect until revised or re-
pealed, as appropriate.

6. Amendment of secfion filed 1 1-23-94; operafive 1 1-23-94 (Register 94, No.
47).

7. Editorial correction of History 5 (Register 94, No. 47).

8. Editorial correction of subsection (a) (Register 94, No. 50).

9. Editorial correction of subsection (g) (Register 95, No. 18).

10. Change without regulatory effect amending subsection (b) filed 6-19-95 pur-
suant to section 100, fitle 1, California Code of Regulations (Register 95, No.
25).

§ 56918. Reimbursement for Residential Respite Services.

A provider of residential respite services shall be reimbursed pursuant
to Title 17, California Code of Regulations, Section 57332(c)(6).

NOTE: Authority cited: Sections 4648 and 4681.1, Welfare and Institutions Code:
Chapter 722, Statutes of 1992, Section 147. Reference: Sections 4418.6. 4648.
4681.1 and 4791(i), Welfare and Institutions Code.

History

1. New secfion filed 1-14-91; operafive 2-13-91 (Register 91. No. 14).

2. Amendment of section filed 9-20-93 as an emergency; operative 9-20-93.
Submitted to OAL for printing only pursuant to Chapter 722, Statutes of 1992.
Secfion 147 (Register 93, No. 39). These regulations shall not be repealed h\ the
Office of Administrafive Law and shall remain in effect until revised or re-
pealed, as appropriate.

Page 292.29

§ 56919

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

3. Amendment of section filed 1 1-23-94; operative 1 1-23-94 (Reaister 94, No.

47).

4. Editorial con-ection of History 2 (Register 94, No. 47).

5. Editorial correction (Register 95, No. 18).

6. Change without regulatory effect amending section filed 6-19-95 pursuant to
section 100, title 1, California Code of Regulations (Register 95, No. 25).

7. Change without regulatory effect amending section filed 1 1-10-2005 pursuant
to seclion 100, title 1 , CaUfoniia Code of Regulations (Register 2005, No. 45).

§ 56919. Usual and Customary Fees and Prevailing Rates.

(a) The regional center shall request approval by the Department for
the payment of usual and customary fees or prevailing rates.

(b) At the Department's discretion, usual and customary fees or pre-
vailing rates may be approved for facilities which meet the criteria in Sec-
tion 56004(a) and have a rate established by another governmental
agency.

NOTE: Authority cited: Section 468 1.1, Welfare and Institutions Code. Reference:
Section 4681.1, Welfare and Institutions Code.

History

1. New section filed 1-14-91; operative 2-13-91 (Register 91, No. 14).

2. Editorial conection of subsection (b) (Register 95, No. 18).

Article 7.

Verification of Use of Rate
Increase Funds

§ 56931 . Definitions.

(a) When used in this article, the following words and phrases shall
have the following meanings:

(1) "Benefits" means health insurance, dental insurance, vision insur-
ance, life insurance, long-term disability insurance, retirement plans,
sick leave, bonus, paid vacation, holidays, employee assistance pro-
grams, employment-related education and training, social security,
workers' compensation, unemployment insurance, and any other man-
datory state and federal employer taxes.

(2) "Compensation" means the total of:

(A) Benefits as defined in subsection (a)(1);

(B) Salaries as defined in subsection (a)(7);

(D) The fair market value of all payments in kind, including, but not
limited to, lodging and meals.

(3) "Competency-based Training and Testing" means competency-
based training and testing as defined in Title 1 7, California Code of Regu-
lations, Section 56031(a)(4).

(4) "Coverage" means employing qualified substitute direct care staff
to provide direct supervision and special services to consumers while di-
rect care staff are attending competency-based training and competency
testing or taking a challenge test.

(5) "Direct Care Staff means direct care facility staff in Service Level
2, 3 and 4 facilities who personally provide direct supervision and special
services to consumers and is synonymous with "Direct Support Profes-
sionals". The term includes the licensee, the administrator, management
and supervisory staff during that time when they are providing direct su-
pervision and special services to consumers.

(6) "Licensee" means the adult, firm, partnership, association or cor-
poration, having the authority and responsibility for the operation of a li-
censed community care facility.

(7) "Salaries" means a fixed dollar amount of pay per pay period paid
to direct care staff on a regular basis.

(8) "Wages" means an hourly rate of pay which is paid to direct care
staff.

NOTE: Authority cited: Section 4681.4(e), Welfare and Institutions Code. Refer-
ence: Section 4681.4, Welfare and Institutions Code.

History
1. New article 7 (sections 56931-56937) and section filed 12-31-98 as an emer-
gency; operative 12-31-98 (Register 99, No. 1). A Certificate of Compliance
must be transmitted to OAL by 4-30-99 or emergency language will be re-
pealed by operation of law on the following day.

2. New article 7 (sections 56931-56937) and section refiled 5-1 1-99 as an emer-
gency; operative 5-1 1-99 (Register 99, No. 20). A Certificate of Compliance
must be transmitted to OAL by 9-8-99 or emergency language will be repealed
by operation of law on the following day.

3. New article 7 (sections 56931-56937) and section refiled 9-9-99 as an emer-
gency; operative 9-9-99 (Register 99, No. 37). A Certificate of Compliance
must be transmitted to OAL by 1-7-2000 or emergency language will be re-
pealed by operation of law on the following day.

4. Repealed by operation of Government Code section 11 346. 1 (g) (Register 2000,

No. 2).

5. New article 7 (sections 5693 1-56937 ) filed 1-14-2000 as an emergency; opera-
tive 1-14-2000 (Register 2000, No. 2). A Certificate of Compliance must be
transmitted to OAL by 5-1 5-2000 or emergency language will be repealed by
operation of law on the following day.

6. Repealer and new article 7 (sections 56931-56937) and repealer and new sec-
tion filed 3-13-2000 as an emergency; operative 3-13-2000 (Register 2000,
No. 11). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2000 or emergency language will be repealed by operation of law on the
following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 11 346. 1(f) (Register 2000, No.
30).

8. Repealer and new article 7 (sections 56931-56937) and repealer and new sec-
tion filed 7-26-2000 as an emergency; operative 7-26-2000 (Register 2000,
No. 30). A Certificate of Compliance must be transmitted to OAL by
1 1 -27-2000 or emergency language will be repealed by operation of law on the
following day.

9. Refiling of 7-26-2000 order, including amendment of subsection (a)(5),
1 1-27-2000 as an emergency; operative ri-27-2000 (Register 2000, No. 48).
A Certificate of Compliance must be transmitted to OAL by 3-27-2001 or
emergency language will be repealed by operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§ 56932. Purposes.

(a) Rate increase funds received pursuant to Welfare and Institutions
Code Section 4681.4 (a) or (b) shall be used only for the following pur-
poses:

(1) Increasing direct care staff salaries, wages and benefits.

(2) Reducing turnover of direct care staff and improving the overall
quality of consumer care by increasing direct care staff salaries, wages
and benefits in a manner which fairly and equitably allocates the rate in-
crease funds derived from Welfare and Institutions Code Section
4681 .4(a) or (b) among direct care staff employees with consideration for
job tenure, duties, and relative number of hours worked.

(3) Providing coverage while direct care staff are attending competen-
cy-based training and testing or taking a challenge test.

(4) Other purposes which have been approved by the Department.
NOTE: Authority cited: Section 4681.4(e), Welfare and Institutions Code. Refer-
ence: Secfion 4681.4, Welfare and Institutions Code.

History

1 . New section filed 12-31-98 as an emergency; operative 12-3 1-98 (Register 99,
No. 1). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operation of Government Code section 1 1346.1(g) (Register 2000,

No. 2).

5. New secfion filed 1-14-2000 as an emergency; operafive 1-14-2000 (Register
2000, No. 2). A Certificate of Compliance must be transmitted to OAL by
5-15-2000 or emergency language will be repealed by operation of law on the
following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code secfion 1 1 346. 1 (f) (Register 2000, No.
30).

Page 292.30

Title 17

Health and Welfare Agency — Department of Developmental Services

ij 56934

S. RcpcalLM- and new section filed 7-26-2000 as an emergency; operative
7-26 2(K)() ( Register 2000, No. 30). A Certificate ofCompliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eratit)n of law on the following day.

'■). Repealer and new section refiled 11-27-2000 as an emergency; operative
11-27-2000 (Register 2000, No. 48). A Certificate of Compliance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§ 56933. Verification Requirement.

Each licensee of a Service Level 2, 3, or 4 facility who receives rate
increase funds authorized by Welfare and Institutions Code Section
468 1 .4 (a) or (b) for the purposes specified in Section 56932 shall provide
to the regional center verification of the use of any rate increase funds re-
ceived by the licensee.

NOTK: Authority cited: Section 4681.4(e), Welfare and Institutions Code. Refer-
ence: Section 4681.4, Welfare and Institutions Code.

History

1 . New section filed 1 2-31-98 as an emergency; operative 1 2-3 1 -98 (Register 99,
No. 1 ). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99,
No. 37). A Certificate ofCompliance must be transmitted to OAL by 1-7-2000
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operafion of Government Code section 1 1 346. 1 (g) (Register 2000,
No. 2).

6. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000, No. 1 1 ). A Certificate ofCompliance must be trans-
mitted to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
tion of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 11 346. 1(f) (Reeister 2000, No.
30).

8. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000, No. 30). A Certificate ofCompliance must be trans-
mitted to OAL by 1 1 -27-2000 or emergency language will be repealed by op-
eration of law on the following day.

9. Repealer and new section refiled 11-27-2000 as an emergency; operative
11-27-2000 (Register 2000, No. 48). A Certificate ofCompliance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§ 56934. Rate Increase Funds Verification Procedures.

(a) Each licensee who receives rate increase funds authorized by Wel-
fare and Institutions Code Section 4681.4(a) during the 1999 calendar
year shall report in writing the use of those rate increase funds to the re-
gional center.

(b) Each licensee who receives rate increase funds authorized by Wel-
fare and Institutions Code Section 4681.4(b) during the 2000 calendar
year shall report in writing the use of those rate increase funds to the re-
gional center.

(1) Not less than 30 days prior to the date specified in subsection (c),
the regional center shall notify the licensee in writing of the necessity to
report the use of rate increase funds.

(c) The licensee' s written report, pursuant to subsection (a) or (b), shall
be postmarked no later than March 1 of the calendar year following the
year in which the rate increase funds were received by the licensee.

(d) The licensee's written report, pursuant to subsection (a) or (b),
shall contain, but not be limited to, the following information:

( 1 ) The name, address and telephone number of the facility submitting
the report;

(2) The licensee's vendor identification number;

(3) The amount of rate increase funds the licensee received during the
calendar year for which the written report is being submitted:

(4) A signed statement that the licensee declares under penalty of per-
jury under the laws of the State of California that the licensee:

(A) Has read and understands the requirements of Sections 56932
through 56935;

(B) Has increased direct care staff salaries, wages and benefits in a
manner which fairly and equitably allocates the increased funds derived
from Welfare and Institutions Code Section 4681 .4(a) or (b) among di-
rect care staff with consideration for job tenure, duties, and relative num-
ber of hours worked, if applicable; and

(C) Has spent the entire amount of rate increase funds received for the
calendar year exclusively and entirely for the purposes authorized pur-
suant to Welfare and Institutions Code Section 4681.4(c)( 1 ) through (3);

(e) The licensee's written report, pursuant to subsection (a) or (b), for
those facilities where the licensee has received the Department's approv-
al to use the rate increase funds for a purpose other than those specified
in Section 56932(a)( 1 ) through (3) shall contain, but not be limited to, the
following:

(1) The information required by subsecdon (d)(1) through (3); and

(2) A signed statement that the licensee declares under penalty of per-
jury under the laws of the State of California that the licensee has spent
the entire amount of rate increase funds received for the prior calendar
year exclusively and entirely for the purposes approved by the Depart-
ment pursuant to Section 56937.

(0 The regional center shall review a sample of the reports submitted
by the licensees pursuant to subsection (a) and (b) to verify that the rate
increase funds were spent in accordance with the requirements specified
in Section 56932(a)(1) through (4).

(g) Verification of the use of rate increase funds shall include, but is
not limited to, reviewing any of the work records employers are required
to maintain by the Employment Development Department's regulations
at Title 22, California Code of Regulafions, Section 1085-2.

(h) The regional center shall retain one copy of each report filed pur-
suant to subsection (a) and (b) as well as documentation of findings of
regional center reviews of verification reports pursuant to subsection (g)
for a three year period.

NOTE: Authority cited: Section 4681 .4(e), Welfare and Institutions Code. Refer-
ence: Section 4681.4, Welfare and Institutions Code; and Section 1085-2. Title
22, California Code of Regulations.

History

1 . New section filed 1 2-3 1 -98 as an emergency; operati ve 1 2-3 1 -98 ( Register 99,
No. 1 ). A Certificate of Compliance must be transmitted to OAL b) 4-30-99
or emergency language will be repealed by operation of law on the following
day.

2. New section refiled 5-1 1-99 as an emergency; operative 5-1 1-99 (Register 99.
No. 20). A Certificate of Compliance must be transmitted to OAL by 9-8 99
or emergency language will be repealed by operation of law on the following
day.

3. New section refiled 9-9-99 as an emergency; operative 9-9-99 (Register 99,
No. 37). A Certificate ofCompliance must be transmitted to OAL by l-7-20()()
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operation of Government Code section 1 1 346. Kg) (Register 2000,
No. 2).

5. New section filed 1-14-2000 as an emergency; operative 1-14-2000 (Regi.ster
2000. No. 2). A Certificate of Compliance must be transmitted to OAL by
5-15-2000 or emergency language will be repealed by operation of law on the
following day.

6. Repealer and new section filed 3-13-2000 as an emergencv: operative
3-1 3-2000 (Register 2000. No. 1 1 ). A Certificate ofCompliance must be trans-
mitted to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
tion of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emcrgenc_\ amend-
ment by operation of Government Code section 1 1346.1(f) (Register 2()()(), No.
30).

8. Repealer and new section filed 7-26-2000 as an emergencv; ()perati\c
7-26-2000 (Register 2000, No. 30). A Certificate ofCompliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency lunguuge will he repealed b^ up
eration of law on the following day.

9. Repealer and new secdon refiled 1 1-27-2000 as an emergencv: operatixe
11-27-2000 (Register 2000, No. 48). A Certificate ofCompliance must be

Page 292.31

§ 56935

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

transmitted to OAL by 3-27-2001 or emergenc) language will be repealed by
operation of law on the following day.

10. Certifieate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001, No. 18).

§ 56935. Failure to File.

NOTI-:; Authority cited: Section 11152, Government Code; and Section 4405,
Welfare and Institutions Code. Reference: Sections 4681.4 and 4681.5, Welfare
and Institutions Code.

History

1 . New section filed 1 2-3 1 -98 as an emergency; operative 1 2-3 1 -98 (Register 99,
No. 1 ). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operation of Government Code section 1 1 346. 1 (g) (Register 2000,

No. 2).

6. Repealer filed 3-13-2000 as an emergency; operative 3-13-2000 (Register
20(i0, No. 1 1 ). A Certificate of Compliance must be transmitted to OAL by
7-1 1-2000 or emergency language will be repealed by operation of law on the
following day.

7. Repealer of 1-14-2000 and 3-1 3-2000 emergency orders by operation of Gov-
ernment Code section 1 1 346.1 , subsections (1) and (g) (Register 2000, No. 48).

§ 56936. Criteria for Approving Rate Increase Funds Use
for Other Purposes.

(a) A licensee who receives rate increase funds authorized by Welfare
and Institutions Code Section 468 1 .4(b) may apply to the Department for
approval to use the rate increase funds for purposes other than those spe-
cified in Section 56932(a)(1) through (3) when the licensee can docu-
ment that, effective December 31,1 999, all direct care staff with a mini-
mum of six (6) months of experience were receiving compensation at
least equivalent to two-hundred and ten percent (210%) of California' s
minimum wage which was in effect on December 31, 1998 ($12.08 per
hour).

(b) When the licensee has complied with subsection (a), compensation
of direct care staff with a minimum of six (6) months of experience shall
be maintained at an amount equivalent to an hourly rate of no less than
two-hundred and ten percent (210%) of California's minimum wage
which was in effect on December 31, 1998 ($12.08 per hour).

(c) The use of rate increase funds for purposes other than those speci-
fied in Section 56932(a)(1) through (3) shall be limited to expenditures
which improve the quality of care provided to a consumer(s).

NOTE: Authority cited: Section 4681.4(e), Welfare and Institutions Code. Refer-
ence: Section 4681.4, Welfare and Institutions Code.

History

1 . New section filed 1 2-3 1 -98 as an emergency; operative 1 2-3 1 -98 (Register 99,
No. 1 ). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operation of Government Code section 1 1 346. 1 (g) (Register 2000,

No. 2).

6. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000. No. 1 1 ). A Certificate of Compliance must be trans-
mitted to OAL by 7-1 1-2000 oremergency language will be repealed by opera-
tion of law on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f ) ( Register 2000. No.
.30).

8. Repealer and new section filed 7-26-2000 as an emergency; operative
7-26-2000 (Register 2000. No. 30). A Certificate of Compliance must be trans-
mitted to OAL by 1 1-27-2000 or emergency language will be repealed by op-
eration of law on the following day.

9. Repealer and new section refiled 1 1-27-2000 as an emereencv; operative
11-27-2000 (Register 2000. No. 48). A Certificate of Conipliance must be
transmiued to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed .5-2-2001 (Register 2001. No. 18).

§ 56937. Procedures for Approving the Use of Rate
Increase Funds for Other Purposes.

(a) To request the Department's approval to use rate increase funds re-
ceived during calendar year 2000 for purposes other than those specified
in Section 56932(a)(1) through (3), the licensee shall submit to the De-
partment all of the following:

(1) Payroll records and other relevant documentation which establish
the compensation paid to every direct care staff member for the pay peri-
od including December 31, 1999, and which clearly demonstrate that on
an hourly basis, the compensation of each direct care staff member with
a minimum of six months of experience, for every hour worked that pay
period, equaled or exceeded two hundred and ten percent (210%^) of
California's minimum wage in effect on December 31, 1998 ($12.08 per
hour).

(2) Work records which employers are required to maintain by Title
22. California Code of Regulations, Section 1085-2 for all employees;
and

(3) A description of the proposed use of the rate increase funds and an
explanation of how the proposed use of rate increase funds is consistent
with the criteria specified in Section 56936.

(b) The licensee's application shall be received by the Department no
later than April 30, 2000.

(c) The proposed use of rate increase funds for a purpose other than
those specified in Section 56932(a)(1) through (3) shall not be imple-
mented until the licensee is notified in writing of the Department's ap-
proval.

(1) The Department's written approval for the use of rate increase
funds for a purpose other than those specified in Section 56932(a)(1)
through (3) shall be sent to the licensee and the regional center via certi-
fied mail within 60 days of the receipt of the information required by sub-
sections (a)(1) through (3).

(d) The Department's decision is final.

NOTE: Authority cited: SecUon 4681.4(e), Welfare and Institutions Code. Refer-
ence: Section 4681.4, Welfare and Institutions Code; and Section 1085-2, Title
22, California Code of Regulations.

History

1 . New secfion filed 12-31-98 as an emergency; operative 12-31-98 (Register 99,
No. 1 ). A Certificate of Compliance must be transmitted to OAL by 4-30-99
or emergency language will be repealed by operation of law on the following
day.

4. Repealed by operation of Government Code section 1 1346.1(g) (Register 2000,
No. 2).

6. Repealer and new section filed 3-13-2000 as an emergency; operative
3-1 3-2000 (Register 2000, No. 1 1 ). A Certificate of Compliance must be trans-

Page 292.32

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57210

niitlcd to OAL by 7-1 1-2000 or emergency language will be repealed by opera-
tion of Iav\ on the following day.

7. Reinstatement of section as it existed prior to 3-13-2000 emergency amend-
ment by operation of Government Code section 1 1 346. 1 ( f) (.Reeister 2000, No.
30).

9. Repealer and new section refiled 11-27-2000 as an emereency; operative
11-27-2000 (Register 2000. No. 48). A Certificate of Com^iance must be
transmitted to OAL by 3-27-2001 or emergency language will be repealed by
operation of law on the following day.

10. Certificate of Compliance as to 7-26-2000 order transmitted to OAL
3-22-2001 and filed 5-2-2001 (Register 2001. No. 18).

Subchapter 7. Nonresidential Service
Vendor Rate-Setting Provisions

Article 1. Definitions

§ 57200. Terms Defined In Other Subchapters.

(a) As used in Sections 57300 through 57948, the following words and
phrases have the meanings specified in Sections 54302 and 56704:

(1) Activity Center

(2) Adult Development Center

(3) Authorized Consumer Representative

(4) Behavior Management Program

(5) Community-Based Day Programs

(6) Consumer

(7) Days

(8) Department

(9) Direct Care Staff

(10) Direct Services

(11) Director

(12) Family Member

(13) Generic Agency

(14) Independent Living Program

(15) Infant Development Program

(16) Management Organization

(17) Non-mobile Consumers

(18) Nonresidential Services

(19) Regional Center

(20) Service Code

(21) Service Contract

(22) Social Recreation Program

(23) Staffing Ratio

(24) Subcode

(25) Units of Service

(26) User Regional Center or Utilizing Regional Center

(27) Vendor

(28) Vendor Identification Number

(29) Vendoring Regional Center

(30) Voucher

NOTE; Authority cited: Chapter 722. Statutes of 1992, Secdon 147; and Sections
4691, 4691.5 and 479 l(i). Welfare and Institutions Code. Reference: Sections
4691, 469 L5 and 4791, Welfare and Institutions Code.

History

1 . New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(12) and (a)(24) and subsection renumbering and amend-
ment of Note filed 1 1-5-91 as an emergency; operafive 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3^-92 or
emergency language will be repealed by operation of law on the following day.

4. New subsecfions (a)(I2) and (a)(24) and subsection renumbering and amend-
ment of NOTI-: refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7 2 92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of secdon filed as an emergency 6-17-93; operative 6-17 93.
Submitted to OAL for printins only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Regi'ster 93. No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 3 1 ).

8. Change without regulatory effect amending subsection (a)(3 ), repealing subsec-
tion (a)(5), renumbering subsections, adding new subsection (6), and amending
subsection (a)(16) filed 1-17-97 pursuant to section 100, title 1, California
Code of Regulations (Register 97, No. 3).

§ 57210. Additional Terms Defined.

(a) As used in Sections 57300 through 57948, the following words and
phrases have the following meanings:

( 1 ) "Allowable Range" means the distance from the lower limit to the
upper limit in a distribution of amounts among like programs determined
pursuant to Step four, Secdon 57513;

(2) "Cost-of-Living Adjustment" or "COLA" means an amount of
funds appropriated in the Budget Act for increases in rates established by
the Department which is representative of an overall increase in the cost
of providing services to consumers;

(3) "Direct Service Hours" means the number of hours during which
direct services are provided to consumers by direct care staff to meet the
objectives of the program design pursuant to Section 56712 or 56762
and, for vendors reimbursed for absences pursuant to Section
54326(a)(l 1), the number of direct service hours for which reimburse-
ment was received shall also be included;

(4) "Fiscal Year" means the 12-month period which begins July 1 of
one calendar year and ends June 30 the following calendar year;

(5) "Gap" means the difference between the amount determined for
each vendor in Step five, Secdon 575 1 4(a)( 1 ) and the amount determined
for each vendor in Step two, Secdon 5751 1(a)(1) based upon allowable
cost and consumer attendance reported to the Department;

(6) "Gap Funding" means an amount of funds appropriated in the Bud-
get Act pursuant to Secdon 57820;

(7) "Like Programs" means programs that are assigned the same ser-
vice code and have the same approved staffing rados;

(8) "Level of Payment" means the total amount which a regional cen-
ter reimburses a vendor for services provided to its consumers;

(9) "Lower Limit" means the lowest amount allowed in the distribu-
don of amounts among like programs, without an increase in the amount
pursuant to Step six. Section 57515;

(10) "Permanent Payment Rate" means a rate established by the De-
partment subsequent to the effecdve date of Secdons 57200 through
57948, which is based upon each vendor's program, allowable cost, con-
sumer attendance, vendor income, and as applicable, regional center pay-
ment information;

(11) "Profit", for profit organizadons, or "Surplus", for not-for-profit
organizadons, means the amount remaining after all allowable costs re-
lated to services for consumers are deducted from a vendor's reimburse-
ment received for those consumers;

(12) "Public Agency" means federal, state, and local government, in-
cluding school districts, colleges and/or universides supported by public
funds;

(13) "Regional Center Payments" means the total amount of income
which the vendor received from the vendoring regional center and/or uti-
lizing regional center(s), if any, for services provided to consumers;

(14) "Schedule of Maximum Allowances (SMA)" means the schedule
of the maximum allowable rate for the service provided as established by
the Department of Health Services (DHS) for services reimbursable un-
der the Medi-Cal program. If the vendor's usual and customary rate is
less than the maximum rate allowed pursuant to the SMA, the regional
center shall pay the vendor's usual and customary rate.

Page 292.33

§ 57300

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(15) "Staff Relief Time" means time worked by substitute staff for di-
rect care staff who are absent because of vacation, illness, staff training,
jury duty, military leave or administrative leave;

( 1 6) "Straight-line Depreciation" means a depreciation method where
the cost of property or equipment is deductible in equal annual amounts
over the estimated useful life of the property or equipment;

(17) "Temporary Payment Rate" means a rate established by the De-
partment subsequent to the effective date of Sections 57200 through
57948, for vendors who do not have an actual cost history which the De-
partment can use to establish a permanent payment rate;

( 1 8) "Upper Limit" means the highest amount allowed in the distribu-
tion of amounts among like programs, without a decrease in the amount
pursuant to Step six. Section 57515;

(19) "Usual and Customary Rate" means the rate which is regularly
charged by a vendor for a service that is used by both regional center con-
sumers and/or their families and where at least 30% of the recipients of
the given service are not regional center consumers or their families. If
more than one rate is charged for a given service, the rate determined to
be the usual and customary rate for a regional center consumer and/or
family shall not exceed whichever rate is regularly charged to members
of the general public who are seeking the service for an individual with
a developmental disability who is not a regional center consumer, and
any difference between the two rates must be for extra services provided
and not imposed as a surcharge to cover the cost of measures necessary
for the vendor to achieve compliance with the Americans With Disabih-
ties Act. New programs applying for vendorization shall provide a writ-
ten declaration to the vendoring regional center that it is their intent to
comply with this subsection, and will be allowed up to 12 months to
achieve compliance. The vendoring regional center may audit a vendor's
records to determine compliance with this subsection and, if the vendor
is found not to be in compliance, shall revoke the vendor' s usual and cus-
tomary rate and negotiate a rate pursuant to Section 57300; and

(20) "Vendor Income" means all income received from any public
agency, with the exception of the Department, regional centers, or the
Department of Rehabilitation and/or the Department of Health Services
if the vendor reported costs pursuant to Section 57422(c)(2), for services
to consumers pursuant to Section 57438.

Note: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691, 4691.3 and 4791(i), Welfare and Institutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 3^4-92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including new subsection (a)(21)
and subsection renumbering transmitted to OAL 6-25-92 and filed 8-6-92
(Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Amendment of subsection (a)(2]) filed 4-22-94; operative 4-22-94. Sub-
mitted to OAL for printing only (Register 94, No. 16).

8. Amendment of subsection (a)(3) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

9. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

10. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96
and filed 3-29-96 (Register 96, No. 13).

11. Change without regulatory effect amending secfion filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

12. Amendment of subsection (a)(3) and (a)(19) filed 4-25-2000; operative
5-25-2000 (Register 2000, No. 17).

13. Change without regulatory effect amending subsection (a)(3) filed 1-14-2003
pursuant to section 1 00, title 1 , California Code of Regulations (Register 2003,
No. 3).

Article 2. General Provisions

§ 57300. Rate-Setting Requirements Applicable to All
Nonresidential Service Vendors.

(a) In order for the Department to establish a rate of reimbursement for
nonresidential service vendors, each vendor shall:

( 1 ) Be approved as a vendor by a regional center pursuant to Section
54322(d)(1);

(2) Submit complete and accurate information and documentation;
and

(3) Comply, if applicable, with the submission requirements specified
in:

(A) Sections 57422 through 57439 for community-based day pro-
grams; or

(B) Sections 58020 through 58039 for in-home respite service agen-
cies.

(b) Vendors shall not charge regional centers more for services to con-
sumers than they charge for comparable services to any other person
served by the vendor, solely because the consumer is a person with a de-
velopmental disability whose services are publicly rather than privately
funded.

(1) Unless they have a rate established pursuant to these regulations
which is currently in effect; nor

(2) For services in an amount greater than the rate established pursuant
to these regulations.

(d) For those vendors for whom the Department establishes a rate,
once the vendor has received notice of the rate established by the Depart-
ment, any regional center, or its designee, purchasing or intending to pur-
chase services from the vendor may negotiate with the vendor the level
of payment for services provided to its consumers for a specified period
of time. The level of payment may be less than but shall not exceed the
maximum reimbursement possible during the period specified, using the
rate established by the Department and the units of service used by the
vendor to charge and invoice the regional center for services provided to
consumers as the basis for determining the maximum reimbursement
possible.

(1) Each regional center and vendor shall mutually agree in writing
upon the level of payment and the effective date for commencing and ter-
minating payment at the agreed upon amount.

(2) Upon termination of the level of payment negotiated by a regional
center and vendor, the vendor shall be reimbursed for services at the rate
established by the Department.

(3) Within the limitations specified in this section, the level of payment
negotiated by a regional center and vendor may be renegotiated.

(4) Each regional center shall provide the Department and vendor with
a copy of the written agreement specifying the terms of the level of pay-
ment.

(e) If a vendor does not have a rate established by the Department, and
if the SMA is not applicable to the service provided by the vendor, and
if the vendor does not have an established usual and customary rate as
defined in Section 57210(a)(19), the vendoring regional center shall ne-
gotiate with the vendor the level of payment for services provided to con-
sumers for a specified period of time.

(1 ) Once the vendor has received written notice of vendorization and
rate approval from the vendoring regional center, any regional center
purchasing or intending to purchase services from the vendor may utilize
the approved rate or negotiate with the vendor for a level of payment for
a specified period of time.

(f) Rates of reimbursement established pursuant to the Schedule of
Maximum Allowances (SMA) or the vendor's usual and customary rate

Page 292.34

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57330

or rates set by negotiation with a regional center in accordance with this
section do not require approval by the Department.

(g) For nonresidential rate-setting purposes, a change in ownership,
pursuant to Section 54330, will not result in a change in the vendor's rate
if the staffing ratio and program activities, as identified in the program
design, remain unchanged.

NOTH: Authority cited: Chapter 722. Statutes of 1992, Section 147: and Sections
4690, 4690.1. 4690.2. 4691. 4691.5 and 4791(i). Welfare and Institution.s Code.
Reference: Sections 4648(a), 4690, 4690. 1 , 4690.2, 4691 , 469 1 .5 and 479 1 , Wel-
fare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

.3. New subsections (d)-(d)(5) and amendment of Noth filed 1 1-.S-91 as an emer-
gency; operative 1 1-5-91 (Register 92, No. 21). A Certificate of Compliance
must be transmitted to OAL 3^4-92 or emergency language will be repealed by
operation of law on the following day.

4. New subsections (d)-(d)(5) and amendment of Noth refiled 3-4-92 as an emer-
gency; operative 3^1-92 (Register 92, No. 25). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of subsection
(d)(5) and amendment of subsections (a)(1) and (a)(3)(B) transmitted to OAL
6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

8. Change without regulatory effect amending subsections (a)( 1 ), (b) and (d) filed
1 17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

9. Amendment of subsections (c)( 1 )-(d), new subsection (e)-(e)( 1 ), subsection re-
letterins and amendment of subsection (f) filed 4-25-2000; operative
5-25-2000 (Register 2000, No. 17).

Article 3. Vouchers

§ 5731 0. Method of Reimbursement for Voucher Services.

(a) Each regional center may offer vouchers to family members or
adult consumers to allow the families and consumers to procure the fol-
lowing services:

( 1 ) Nursing Service - Family Member - Service Code 415; and/or

(2) Day Care - Family Member - Service Code - 405; and/or

(3) Respite Service - Family Member- Service Code 420; and/or

(4) Transportation - Family Member - Service Code 425; and/or

(5) Diapers and Nutritional Supplements - Family Member - Service
Code 410.

(b) If a voucher is issued, the maximum reimbursement authorized by
the regional center for the service provided shall be specified in the
voucher and shall not exceed the maximum rate of reimbursement as spe-
cified below:

(1) Nursing Service - Family Member - Service Code 415 - the
Schedule of Maximum Allowances for the Home and Community Based
Services, In-Home Medical Care Waiver Program, as developed by the
Department of Health Services;

(2) Day Care - Family Member - Service Code 405 - the usual and
customary rate, as defined in Section 57210(a)( 1 9), which the direct pro-
vider of the service charges or, if the direct provider of the service does
not have an established usual and customary rate, a negotiated rate pur-
suant to Section 57300(e);

(3 ) Respite Service - Family Member - Service Code 420 - $ 1 0.7 1 per
consumer per hour, including fringe benefits, effective January 1 , 2008;

(4) Transportation - Family Member - Service Code 425 - the stan-
dard rate schedule developed by the regional center pursuant to Title 17,
California Code of Regulations, Section 58543; and

(5) Diaper and Nutritional Supplements - Family Member - Service
Code 410 - the usual and customary rate charged by the supplier.

Note: Authority cited: Chapter 722, Statutes of 1992. Section 147; and Sections
4690, 4690.1 and 4690.2, Welfare and Institutions Code. Reference: Sections
4690, 4690.1, 4690.2 and 4690.5. Welfare and Institutions Code; Budget Act of
2000-01. Item 4300-101-0001.

History

1 . New .section filed 1 1-5-91 as an emergency; operative 1 1 5-91 (Register 92.
No. 21 ). A Certificate of Compliance must be transmitted to OAL 3 4 92 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 3-4-92 as an emergency: operative 3 4-92 (Register 92.
No. 25). A Certificate of Compliance must be transmitted to OAL 7 2 92 or
emergency language will be repealed by operation of law on the following da_\.

3. Certificate of Compliance as to 3^4-92 order including amendment of te.xl and
Noth transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92. No. 33).

4. Amendment of section filed as an emergency 6 17-93; operative 6 17 93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93. No. 26).

5. New article 3 heading and amendment of section heading, text and Nou filed
6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing
only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94. No.
25).

6. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20 94 and
filed 8-2-94 (Register 94. No. 31).

7. Certificate of Compliance as to 6-20-94 order, including amendment of subsec
tions (a) and (a)(5). repealer of sub.sections (a)(6)-(13). amendment of sub.sec-
tion (b)(5) and repealer of subsections (b)i6)-( 13). transmitted to OAL 2 20-96
and filed 3-29-96 (Register 96. No. 13).

8. Change without regulatory effect amending subsections (a) and (b)(3) filed
1 -1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations ( Regis-
ter 97, No. 3).

9. Change without regulatory effect amending subsection (b)(3) filed 3-6-97 pur
suant to section 100, title 1, California Code of Regulations (Register 97. No.
10).

10. Change without regulatory effect amending subsection (b)(3) filed 1-15-99
pursuant to section 1 00, title 1 , California Code of Regulations ( Register 99. No.
3).

1 1 . Amendment of subsection (b)(2) filed 4-25-2000; operative 5-25-2000 ( Reg-
ister 2000, No. 17).

12. Amendment of subsection (b)(3) and amendment of NoTi- filed 3-14-2001 as
an emergency; operative 3-14-2001 (Regi.ster 2001 . No. 1 1 ). A Certificate of
Compliance must be transmitted to OAL by 7-12 2001 oremergency language
will be repealed by operation of law on ihe following day.

13. Amendment of subsection (b)(3) and amendment of Noth refiled 7-12-2001
as an emergency, including further amendment of subsection (b)(3) and Notk;
operative 7-12-2001 (Regi.ster 2001. No. 28). A Certificate of Compliance
must be transmitted to OAL by 1 1-9-2001 or emergency language will be re-
pealed by operation of law on the following day.

14. Reinstatement of section as it existed prior to 7-12-2001 emergency amend-
ment by operation of Government Code section 1 1346.1(f) (Register 2001 . No.
47).

15. Amendment of subsection (b)(3) and amendment of Noth filed 11-19 2001
as an emergency; operative 1 1-19-2001 (Register 2001. No. 47). A Certificate
of Compliance must be transmitted to OAL by 3-19-2002 oremergency lan-
guage will be repealed by operation of law on the following day.

16. Certificate of Compliance as to 11-19-2001 order transmiUed to OAL
3-15-2002 and filed 3-27-2002 (Register 2002, No. 13).

17. Change without regulatory effect amending subsection (b)(3) and Nori filed
10-4-2006 pursuant to section 100, title 1, California Code of Regulations
(Register 2006, No. 40).

18. Amendment of subsection (b)(3) filed 11-16-2007; operative 11-16 2007
pursuant to Government Code section 1 1343.4 (Register 2007, No. 46).

19. Amendment of subsection (b)(3) filed 7-14-2008; operative 7-14-2008 pur-
suant to Government Code section 1 1343.4 (Register 2008, No. 29).

Article 5. Rates of Reimbursement

Based on the Schedule of Maximum

Allowances or the Vendor's Usual and

Customary Rate

§ 57330. Generic Agencies.

(a) The maximum rate of reimbursement shall be the usual and cus-
tomary rate charged by the generic agency to all participants in the pro-
gram.

NOTE: Authority cited: Chapter 722, Statutes of 1992. Section 147-. and Sections
4690, and 4791(i). Welfare and Institutions Code. Reference: Sections 4648(a).
4690 and 4791, Welfare and Institutions Code.

Page 292.35

§ 57331

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1 . New section filed as an emergency 6-1 7-93: operative 6-1 7-93. Submitted to
OAL for printing only pursuant to SB485 (Chapter 722. Statutes of 1992) Sec-
tion 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94. No. 31).

§ 57331 . Group Practices.

(a) The rate of reimbursement for group practices shall be determined
based on the method of reimbursement established, pursuant to Sections
57332 through 57335, for an individual providing the same service.
NOTH: Authority cited: Chapter 722. Statutes of 1992, Section 147: and Sections
4690. and 479 l(i). Welfare and Institutions Code. Reference: Sections 4648(a),
4690 and 4791 . Welfare and Institutions Code.

History

1 . New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to
OAL for printing only pursuant to SB483 (Chapter 722, Statutes of 1992) Sec-
fion 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 57332. Maximum Rates of Reimbursement for
Non-Residential Services.

(a) The inaximum rate of reimbursement for the following services
shall be the vendor's usual and customary rate as defined in Section
5721 ()(a)( 19) or, if the vendor does not have an established usual and cus-
toinary rate, a negotiated rate pursuant to Section 57300(e):

( 1 ) Adaptive Skills Trainer - Service Code 605

(2) Adult Day Care - Service Code 855

(3) Art Therapist - Service Code 691

(4) Associate Behavior Analyst - Service Code 613.

(5) Attorney - Service Code 610

(6) Behavior Analyst - Service Code 612

(7) Camping Services - Service Code 850 (Day Camp, Residential
Camp, and Traveling Camp)

(8) Child Day Care - Service Code 851

(9) Counseling Services - Service Code 625 (Family Counselors and
Social Workers)

(10) Dance Therapist - Service Code 692

(11) Developmental Specialist - Service Code 670

(12) Diaper Service - Service Code 627

(13) Dietary Services - Service Code 720 (Dietician and Nutritionist)

(14) Driver Trainer - Service Code 630

(15) Educational Psychologist - Service Code 672

(16) Homemaker- Service Code 858

(17) Homemaker Service - Service Code 860

(18) Independent Living Specialist - Service Code 635

(19) Interpreter - Service Code 642

(20) Mobility Training Services Agency - Service Code 645

(2 1 ) Mobility Training Services Specialist - Service Code 650

(22) Music Therapist - Service Code 693

(23) Psychiatric Technician - Service Code 790

(24) Recreational Therapist - Service Code 694

(25) RetailAVholesale Stores - Service Code 660

(26) Teacher - Service Code 674

(27) Teacher of Special Education - Service Code 678

(28) Teacher's Aide - Service Code 676

(29) Translator - Service Code 643

(30) Tutor - Service Code 680

(b) The maximum rate of reimbursement for the following medical
services shall be in accordance with the Schedule of Maximum Allow-
ances (SMA):

( 1 ) Acute Care Hospitals - Service Code 700
(Acute Care Hospitals and Acute Psychiatric Hospital)

(2) Adult Day Health Center - Service Code 702

(3) Audiology - Service Code 706

(4) Clinical Psychologist - Service Code 785

(5) Day Treatment Centers - Service Code 710

(6) Dentistry - Service Code 715

(7) Durable Medical Equipment Dealer - Service Code 725

(8) Genetic Counselor - Service Code 800

(9) Hearing and Audiology Facilities - Service Code 730

(10) Home Health Agency - Service Code 854

(11) Home Health Aide - Service Code 856

(12) Infant Development Specialist - Service Code 810

(13) Laboratory and Radiology Services - Service Code 735

(14) Nurse Anesthetist - Service Code 741

(15) Occupational Therapy - Service Code 773

(16) Orthoptic Services — Service Code 745
(Orthoptic Technician and Optoinetrist)

(17) Orthotic and Prosthetic Services - Service Code 750
(Orthotist and Prosthetist)

(18) Other Medical Equipment or Supplies - Service Code 755
(Dispensing Optician, Hearing Aid Dispenser, and Prosthetic and Ort-
hoptic Appliance Factory)

( 19) Other Medical Services - Service Code 760

(20) Pharmaceutical Services - Service Code 765
(Pharmacist and Pharmacy)

(21) Physical Therapy - Service Code 772

(22) Physicians or Surgeons - Service Code 775

(23) Psychiatrist - Service Code 780

(24) Respiratory Therapist - Service Code 793

(25) Speech Pathology - Service Code 707

(1 ) Behavior Management Assistant - Service Code 615

(A) The usual and customary rate, as defined in Section 57210(a)( 19),
charged for the behavior management assistant services or, if the vendor
does not have an established usual and customary rate, a negotiated rate
pursuant to Section 57300(e), not to exceed the rate of reimbursement es-
tablished for the licensed professional with whom the Behavior Manage-
ment Assistant is registered.

(2) Behavior Management Consultant - Service Code 620

(A) The maximum rate of reimbursement shall be based on the method
of reimbursement established, pursuant to Section 57332, for an individ-
ual with the same licensed classification.

(3) In-Home Respite Worker - Service Code 864

(A) Effective January 1 , 2008, the maximum rate of reimbursement for
in-home respite workers shall not exceed $10.71 per consumer per hour,
including fringe benefits, except:

1 . When the family member has more than one consumer residing with
them who has been authorized by the regional center to receive in-home
respite services, the maximum level of payment shall be determined pur-
suant to Section 58140 of these regulations.

(4) Licensed Vocational Nurse - Service Code 742

(A) The rate of reimbursement shall be in accordance with the Sched-
ule of Maximum Allowances (SMA) for the Home and Community-
Based Services, In-Home Medical Care Waiver Program.

(5) Nurse's Aide or Assistant - Service Code 743

(A) The rate of reimbursement shall be in accordance with the Sched-
ule of Maximum Allowances (SMA) for the Home and Community-
Based Services, In-Home Medical Care Waiver Program.

(6) Out-of-Home Respite Services - Service Code 868

(A) Day care homes providing out-of-home respite services shall be
reimbursed in accordance with the vendor's usual and customary rate, as
defined in Section 572 1 0(a)( 1 9) or, if the vendor does not have an estab-
lished usual and customary rate, a negotiated rate pursuant to Section
57300(e).

(B) Licensed residential facilities providing out-of-home respite ser-
vices, for whom the Department of Social Services or the Department of
Health Services has established a rate, shall be reimbursed in accordance
with the rate of reimbursement as established by the appropriate Depart-
ment.

(C) Licensed residential facilities providing out-of-home respite ser-
vices, for whom the Department of Social Services has not established

Page 292.36

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57335

a rale, shall be reimbursed at 1/21 of the monthly rate established by the
regional center for the facility's service level as approved pursuant to
Title 17, California Code of Regulations, Section 56005.

(7) Out-of-State Manufacturer or Distributor - Service Code 655

(A) Out-of-State Manufacturers or Distributors supplying products
that are reimbursable under the Medi-Cal program shall be reimbursed
in accordance with the Schedule of Maximum Allowances (SMA).

(B) Out-of-State Manufacturers or Distributors supplying products
that are not reimbursable under the Medi-Cal program shall be reim-
bursed according to the vendor's usual and customary rate.

(8) Registered Nurse - Service Code 744.

(A) The rate of reimbursement shall be in accordance with the Sched-
ule of Maximum Allowances (SMA) for the Home and Community-
Based Services, In-Home Medical Care Waiver Program.

(9) Respite Facility - Service Code 869

(A) Vendors classified as a respite facility shall be reimbursed as fol-
lows:

1 . Either 1/2 1 of the established monthly rate for the facility's service
level as approved pursuant to Title 17, California Code of Regulations,
Section 56005; or

2. The agreed-upon level of payment for a service contract negotiated
pursuant to Section 57540(b) through (f).

a. Effective January 1 , 2008, the level of payment shall not exceed
$10.71 per consumer per hour, including fringe benefits, authorized by
the Department for an In-Home Respite Worker, Service Code 864, for
the same units of service.

( 10) Genetic Counselor - Service Code 800

Genetic counselors to whom the SMA does not apply shall be reim-
bursed in accordance with the vendor's usual and customary rate, as de-
fined in Section 57210(a)( 19) or, if the vendor does not have an estab-
lished usual and customary rate, a negotiated rate pursuant to Section
57300(e).

(11) Infant Development Specialist - Service Code 810

Infant development specialists to whom the SMA does not apply shall
be reimbursed in accordance with the vendor' s usual and customary rate,
as defined in Section 57210(a)(19) or, if the vendor does not have an es-
tablished usual and customary rate, a negotiated rate pursuant to Section
57300(e).

Note: Authority cited: Section 4690, Welfare and Institutions Code. Reference:
Sections 4648(a), 4690 and 4691.6, Welfare and Institutions Code.

History

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to
OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Sec-
tion 147(a) (Register 93, No. 26).

2. New subsections (a)(4), (a)(ll)(A)-(D) and (a)(12) and subsection redesigna-
tion filed 6-20-94 as an emergency; operative 6-2()-94. Submitted to OAL for
printing only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register
94, No. 25).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

4. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect amending section, including incorporation
and amendment of former section 57333, filed 1-17-97 pursuant to section 100,
title 1, California Code of Regulations (Register 97, No. 3).

6. Change without regulatory effect amending subsections (c)(3)(A) and
(c)(9)(A)2.a. filed 3-6-97 pursuant to section 100, title 1, California Code of
Regulations (Register 97, No. 10).

7. Editorial correction of subsecdon (a)(3) (Register 97, No. 21).

8. Change without regulatory effect amending subsections (c)(3)(A) and
(c)(9)(A)2.a. filed 1-15-99 pursuant to secUon 100, title 1, California Code of
Regulations (Register 99, No. 3).

9. Amendment of subsections (a), (c)(1)(A), (c)(6)(A) and (c)(10)-(ll) filed
4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

10. Amendment of subsections (c)(3)(A), (c)(6)(A) and (c)(9)(A)2.a. and amend-
ment of Note filed 3-14-2001 as an emergency; operative 3-14-2001 (Regis-
ter 2001, No. 1 1). A Certificate of Compliance must be transmitted to OAL by
7-12-2001 or emergency language will be repealed by operation of law on the
following day.

1 1 . New subsection (a)(5) and subsection renumbering filed 5-3-2001 ; operative
6-2-2001 (Register 2001, No. 18).

12. Amendment of subsections (c)(3)(A), (c)(6)(A) and (c)(9)(A)2.a. and amend-
ment of NoTi; refiled 7-12-2001 as an emergency, including further amend-
ment of Noth; operative 7-12-2001 (Register 2001, No. 28). A Certificate of
Compliance must be transinitted to OAL by 1 1-9-2001 or emergency language
will be repealed by operation of law on the following day.

13. Reinstatement of section as it existed prior to 7-12-2001 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f) (Register 2001 , No.
47).

14. Amendment of subsections (c)(3)(A). (c)(6)(A) and (c)(9)(A)2.a. and amend-
ment of NoTii filed 11-19-2001 as an emergency; operative 11-19-2001 (Reg-
ister 2001, No. 47). A Certificate of Compliance must be transmitted to OAL
by 3-19-2002 or emergency language will be repealed by operation of law on
the following day.

15. Certificate of Compliance as to 11-19-2001 order transmitted to OAL
3-15-2002 and filed 3-27-2002 (Register 2002. No. 13).

16. Amendment of subsections (c)(3)(A) and (c)(9)(A)2.a. and amendment of
NoTi- filed 8-29-2002 as an emergency; operative 8-29-2002 (Register 2002,
No. 35). A Certificate of Compliance must be transmitted to OAL by
12-27-2002 or emergency language will be repealed by operation of law on the
following day.

17. Amendment of subsections (c)(3)(A) and (c)(9)(A)2.a. and amendment of
NoTt; refiled 12-19-2002 as an emergency; operative 12-27-2002 (Register
2002, No. 51). A Certificate of Compliance must be transmitted to OAL by
4-28-2003 or emergency language will be repealed by operation of law on the
following day.

18. Certificate of Compliance as to 12-19-2002 order transmitted to OAL
4-25-2003 and filed 6-5-2003 (Register 2003, No. 23).

19. New subsecdon (a)(4) and subsection renumbering filed 4-29-2004; opera-
tive 5-29-2004 (Register 2004, No. 18).

20. Change without regulatory effect amending subsections (c)(3)(A) and
(c)(9)(A)2.a. and amending Note filed 10-4-2006 pursuant to section 100, title
1, California Code of Regulations (Register 2006, No. 40).

21. Amendment of subsections (c)(3)(A) and (c)(9)(A)2. filed 11-16-2007; op-
erative 11-16-2007 pursuant to Government Code section 1 1343.4 (Register

2007, No. 46).

22. Amendment of subsections (c)(3)(A) and (c)(9)(A)2.a. filed 7-14-2008; op-
erafive 7-14-2008 pursuant to Government Code section 11343.4 (Register

2008, No. 29).

§ 57333. Other Services: Medical Services.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690 and 4791 (i). Welfare and Insdtudons Code. Reference: Sections 4648(a),
4690 and 4791, Welfare and Institutions Code.

History

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to
OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Sec-
don 147(a) (Register 93, No. 26).

2. Amendment filed 6-20-94 as an emergency; operadve 6-20-94. Submitted to
OAL for printing only pursuant to Chapter 722, Statutes of 1992, Section 147
(Register 94, No. 25).

3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

4. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

5. Change without regulatory effect incorporating former secdon 57333 into sec-
don 57332, including amendments, and repealing former section 57333, filed
1-17-97 pursuant to section 100, title 1, California Code of Reguladons( Regis-
ter 97, No. 3).

§ 57334. Prevention Services/infant Development
Services.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690 and 4791(i), Welfare and Insdtudons Code. Reference: Sections 4648(a),
4690 and 4791, Welfare and Insdtudons Code.

History

1. New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to
OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Sec-
don 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20 94 and
filed 8-2-94 (Register 94, No. 31).

3. Change without regulatory effect repeahng section filed 1-17-97 pursuant to
secdon 100, title 1, CaUfornia Code of Reguladons (Register 97, No. 3).

§ 57335. Supportive Services.

Note; Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690 and 4791(i), Welfare and Insdtudons Code. Reference: Sections 4648(a),
4690 and 4791, Welfare and Insdtudons Code.

Page 292.36(a)

§ 57336

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

1 . New section filed as an emergency 6-17-93; operative 6-17-93. Submitted to
OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Sec-
lion 147(a) (Register 93, No. 26).

2. Amendment of subsection (b)(2) and new subsections (b)(2)(A)-(B) filed
6-20-94 as an emergency; operative 6-20-94. Submitted to OAL for printing
only pursuant to Chapter 722, Statutes of 1992, Section 147 (Register 94, No.

23).

3. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
fded 8-2-94 (Register 94, No. 31).

4. Certificate of Compliance as to 6-20-94 order, including amendment of subsec-
tions (c)(3)(A)2. and (c)(3)(A)2.a., transmitted to OAL 2-20-96 and filed
3-29-96 (Register 96, No. 13).

5. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 57336. Miscellaneous Services.

(a) The maximum rates of reimbursement for Miscellaneous Services
shall be established in accordance with the following:

(1) Schedule of Maximum Allowances (SMA); or

(2) The vendor's usual and customary rate, as defined in Section
57210(a)(19), if the SMA does not apply to the services provided; or

(3) A negotiated rate pursuant to Section 57300(e) if the vendor does
not have an established usual and customary rate, as defined in Section
57210(a)(19), and the SMA does not apply to the services provided.
NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690 and 479 l(i). Welfare and Institutions Code. Reference: Sections 4648(a),
4690 and 4791, Welfare and Institutions Code.

History

1. New section filed as an emergency 6-17-93; operative 6-17-93. Subinitted to
OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Sec-
tion 147(a) (Register 93, No. 26).

2. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

3. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

Subchapter 8. Rate-Setting Procedures for
Community-Based Day Programs

Article 1 . (Reserved)

Article 2. General Provisions

§ 57422. General Requirements.

(a) If a vendor serves both consumers and persons other than consum-
ers, the vendor shall:

( 1 ) Report only the program, cost and vendor income information re-
lated to services to consumers; and

(2) Allocate its costs and vendor income to consumers and to other per-
sons served by the vendor based upon:

(A) Actual days of attendance if the service is an activity center, adult
development center or behavior management prograin; and

(B) Actual hours of attendance if the service is a social recreation pro-
gram, independent living program, or infant development program.

(b) If a vendor operates more than one service and the services share
costs and/or vendor income, the vendor shall allocate these costs and/or
vendor income based upon each service's representative share of the cost
and/or vendor income.

(c) If a vendor provides services to consumers for the Department of
Rehabilitation and/or the Department of Health Services, the vendor
shall:

(1) Report only the allowable program, cost and vendor income infor-
mation related to the program activities vendored by the regional center;
or

(2) Report the total allowable program, cost and vendor income infor-
mation, including the costs associated with services provided for the De-
partment of Rehabilitation and/or the Department of Health Services.

Only those allowable costs which would otherwise be funded by the De-
partment shall be included.

NOTE: Authority cited: Chapter 722. Statutes of 1992, Section 147; and Sections
4691. 4691.5 and 479 l(i). Welfare and Institutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93. No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulator effect amending subsections (a)-(a)(2) and (c) filed
1-1 7-97 pursuant to secdon 100. title 1, California Code of Regulations (Regis-
ter 97, No. 3).

Article 3.

Submission of Required
Information

§ 57430. Submission of Information.

(a) Each community-based day program vendor shall submit the pro-
gram, cost and vendor income information specified in Sections 57433
through 57438, and as applicable, the regional center payment informa-
tion specified in Section 57439, on Form DS1897, dated 12/92, entitled
Community-Based Day Program: Program, Cost and Vendor Income
Statement, for each service for which the vendor is requesting that a rate
be established. The vendor shall sign and date Form DS 1 897 which in-
cludes a certification that the information is true and correct and complies
with Sections 57422 through 57439. The vendor shall submit the original
document to the Department with a copy of this document submitted to
the vendoring regional center at the same time the original document is
submitted to the Department.

NOTE; Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691, 4691.5 and 4791(i), Welfare and Insfitutions Code. Reference: Secfions
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operafive 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2 . Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment transmitted
to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for priming only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 57431 . Reporting Periods for Submission of Information.

(a) Information submitted pursuant to Sections 57433 through 57439
shall cover the following reporting periods:

( 1 ) For vendors receiving a temporary payment rate and whose tempo-
rary payment rate will be converted to a permanent payment rate, the re-
porting period shall be 1 2 consecutive months of representative actual al-
lowable cost information, incurred within 1 8 months from the date the
temporary payment rate became effective. The Department may grant an
extension of the temporary payment rate for a period of up to six months
if the vendor is unable to submit the required cost information due to
delayed consumer enrollment into the program; and

Page 292.36(b)

Title 17

Health and Welfare Agency — Department of Developmental Services

i? 57433

(2) For vendors receiving a permanent payment rate and whose perma-
nent payment rate will be established in Fiscal Year 1997-98, and each
alternate fiscal year thereafter, the reporting period shall be Fiscal Year
1995-96, and each alternate fiscal year thereafter.

NOTH: Authority cited: Chapter 722. Statutes of 1992, Section 147; and Sections
4(S9 1 , 469 1 .5 and 479 1 . Welfare and Institutions Code. Reference: Sections 469 1 ,
4691.5 and 4791, Welfiire and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Non-: filed 1 1-5-91 as an emergency; opera-
tive 1 1-5-91 (Register 92, No. 21 ). A Certificate of Compliance must be trans-
mitted to OAL .3^-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (a) and NoTi-: refiled 3-4-92 as an emergency; opera-
tive 3^4-92 (Register 92, No. 25). A Certificate of Coinpliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Amendment of subsection (a)(1) filed 4-25-2000; operative 5-25-2000 (Reg-
ister 2000, No. 17).

§ 57432. Required Due Dates for Submission of
Information.

(a) The required dates for submission are as follows:

( 1 ) Within 1 8 months from the date the temporary payment rate be-
came effective, for vendors whose temporary payment rate is being con-
verted to a permanent payment rate, unless an extension of the temporary
payment rate has been granted pursuant to Section 57431(a)(1);

(2) Prior to expiration of the temporary payment rate for those vendors
who received an extension pursuant to Section 57431(a)(1);

(3) September 30, 1996, and each alternate September 30 thereafter,
for vendors whose permanent payment rate is being established in Fiscal
Year 1997-98, and each alternate fiscal year thereafter; and

(4) At the time the vendor requests establishment of a temporary pay-
ment rate, for vendors requesting a temporary payment rate.

(b) If the information is received by the dates specified in (a), the ven-
doring regional center and the Department shall review the information
pursuant to Secfions 57440 and 57442.

(c) If the information is not received by the dates specified in (a), the
Department shall, within 15 days, notify in writing, the vendor, the ven-
doring regional center, and utilizing regional center(s), if any, as follows:

(1 ) For the following vendors, that payment of the vendor's rate was
suspended, the effective date of the suspension and that payment shall re-
main suspended until the information is received:

(A) For vendors required to submit information pursuant to (a)(1), sus-
pension is effective at the end of 1 8 months, unless an extension of the
temporary payment rate has been granted pursuant to Section
57431(a)(1); and

(B ) For vendors required to submit information pursuant to (a)(2), sus-
pension is effective upon expiration of the extension; and

(C) For vendors required to submit information pursuant to (a)(3), sus-
pension is effective on September 30, 1996, and each alternate Septem-
ber 30, thereafter.

(2) This provision does not apply to vendors requesting a temporary
payment rate, since the Department cannot initiate any action until the
vendor submits its request for establishment of a temporary payment rate.

(d) If the information is submitted after the dates specified in (a) when
payment of the vendor's rate has been suspended, the vendoring regional

center and the Department shall review the information pursuant to Sec-
tions 57440 and 57442. and the Department shall authorize the \ endoriny
regional center and utilizing regional center(s), if any, to reinstate pay-
ment of the vendor's rate as of the date payment was suspended.

NOTE: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and In.stitutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7- 1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9- 28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title L California Code of Regulations (Register 97, No. 3).

4. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§ 57433. Required Program Information.

(a) In order for the Department to establish a temporary payment rate
or permanent payment rate, the vendor shall submit the following pro-
gram information:

(1) Vendor name, and name of the management organization, if any,
vendor idenfification number, service code and subcode;

(2) Facility or office telephone number, business and mailing address-
es;

(3) Name of the service director;

(4) Name of the vendoring regional center and utilizing regional cen-
ter(s), if any; and

(5) A copy of the program design which was submitted to the vendor-
ing regional center pursuant to Section 54310(a)(10)(D).

(b) In addition to the information in (a), vendors requesting a perma-
nent payment rate shall also submit for each month of the reporting peri-
od:

(1) The total number of direct service hours actually provided to con-
sumers. For vendors reimbursed for absences pursuant to Section
54326(a)(l 1), the total number of direct service hours actually provided
to consumers shall also include direct service hours for which the vendor
received reimbursement;

(2) For activity centers, adult development centers or behavior man-
agement programs the:

(A) Maximum number of consumers enrolled;

(B) Actual number of days of attendance for all consumers, which
shall also include the actual number of consumer days for which the ven-
dor was reimbursed for absences pursuant to SecUon 54326(a)( 1 1 );

(C) Number of days in which service was actually provided, which
shall also include the actual number of days for which the vendor was re-
imbursed for absences pursuant to Secfion 54326(a)(l 1); and

(D) Number of direct service hours operated per-day.

(3) For social recreation programs, independent living programs or in-
fant development programs the:

(A) Authorized number of direct service hours for all consumers;

(B) Number of consumers scheduled to receive services within the
hours idendfied in (A);

(C) Number of consumers who actually received services within the
hours identified in (A), which shall also include the number of consumers
for whom the vendor was reimbursed for absences pursuant to Section
54326(a)(ll);and

(D) Actual number of hours of attendance for all consumers identified
in (C), which shall also include the actual number of hours for which the
vendor was reimbursed for absences pursuant to Section 54326(a)( 1 1 ).

(1) The date that the vendor began, or intends to begin, providing ser-
vices to consumers; and

(2) A copy of the vendorization approval letter specified in section
54322(d).

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147 and Sections
4691, 4691.5 and 4791(i), Welfare and In.sfitutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Insfitutions Code.

Page 292.36(c)

:Register 2008, No. 29; 7-18-2008

§ 57434

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

?>. Amendment of subsections (a)(5) and (c)(2) filed 8-6-92: operative 8-6-92
(Register92. No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsections (b)(1). (b)(2)(B)-(C) and (b)(3)(C)-(D) filed
6-20-94 as an einergency; operative 6-20-94. Submitted to OAL for printing
only pursuant to Chapter 722, Statutes of 1992. Section 147 (Register 94, No".
25).

6. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to
.section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. Change without regulatory effect amending subsections (b)(1), (b)(2)(B)-(C)
and (b)(3)(C)-(D) filed 1-14-2003 pursuant to section 100, title 1, California
Code of Regulations (Register 2003, No. 3).

§ 57434. Required Cost Information.

(a) In order for the Department to establish a permanent payment rate,
the vendor shall submit information for the following allowable costs for
the reporting period, if they are incurred by the vendor and are necessary
for the vendored service.

(1) Salary and wage expense which shall include:

(A) The total gross salary and wages, including overtime and staff re-
lief time, for the staff functions specified in Section 56724; and

(B) The average hourly salary and wage and fringe benefit cost for the
direct service function specified in section 56724(d).

(2) Fringe benefit costs associated with the salary and wage costs for
the staff functions identified in (1)(A) which shall be limited to the fol-
lowing:

(A) Old Age Security Disability Insurance (OASDI) or Federal Insur-
ance Compensation Act (FICA);

(B) Workers' compensation;

(D) Life insurance;

(E) Health insurance;

(F) Dental insurance;

(G) Retirement;

(H) Vision insurance;

(I) Employee Training Tax, as specified in the California State Unem-
ployment Insurance Code Section 976.6; and
(J) Long-term disability insurance.

(3) Operating expenses which shall not duplicate other allowable costs
and shall be limited to the following cost categories:

(A) Accounting fees of the vendor for the establishment and mainte-
nance of accounting records and other information systems required for
the fiscal management of the vendored service;

(B) Bank service fees of the vendor;

(C) Communication costs for services including telephone, telegraph,
teletype, centrex, telepak, postage, message services, facsimiles and
TDD;

(D) Contractual/consultant fees for program operation that do not have
a specific cost category;

(E) Depreciation costs, except for vehicles which are covered under
(P). The following items shall be depreciated using the straight-line de-
preciation method and the useful life of the item. The useful life of an item
shall be that used for federal tax purposes.

1 . Facilities which have been purchased by the vendor;

2. Furniture and equipment which has been purchased by the vendor
and has a unit acquisition cost of at least $500 and a normal useful life
of at least four years; and

3. Capital improvements that add to the value or useful Hfe of the facil-
ity or equipment. Capital improvements shall be treated as a permanent
investment to be added to the cost basis of the facility or equipment and
charged to depreciation.

(F) General expense costs for the following items only:

1. Furniture and equipment which do not meet the criteria specified in
{E)2.;

2. Interest on loans attributable to the vendored service;

3. Subscriptions for periodicals which are used in the operation of the
vendored service or for the puipose of staff development;

4. Staff reciiiitment costs; staff screening costs, such as fingerprinting
prospective employees; and staff hiring costs which shall include the
costs for physical examinations or other health and safety costs that may
be required prior to employment;

5. Fees for licenses, certifications, registrations or permits, if neces-
sary for vendorization or the continued operation of the service subse-
quent to vendorization;

6. Accreditation fees;

7. Association dues or fees;

8. Costs for providing or preparing information related to the vendored
service which is used as general information to the consumers or to the
authorized consumer representatives;

9. Local business fees or taxes;

10. Costs related to inoculations or clinical tests of an employee, for
the employee's or consumer's health and safety; and

11. Fuel and oil.

(G) Insurance costs;
(H) Janitorial fees;
(I) Legal fees;

(J) Maintenance costs for repair and upkeep of furniture and equip-
ment, vehicles, facilities and grounds which neither adds to the perma-
nent value nor prolongs its useful life, but maintains it in an efficient op-
erating condition;

(K) Office and program supply costs for items which are expendable
or consumable and are used by or on behalf of the consumers in the ven-
dored service. Food supply items shall only be included for consumers
when used to reinforce positive behaviors, as a necessary item for in-
struction only when supported by the program design pursuant to Section
56712 or 56762, or as required by the appropriate licensing agency;

(L) Rental and lease costs. On a lease-purchase, while the item is being
leased, the cost shall be reported under this category. When the option-
to-purchase has been exercised, the residual value of the item shall be de-
preciated and shall be reported, as applicable, under category (E) or (P).
Rental and lease costs shall apply to the following items:

1 . Furniture and equipment;

2. Vehicles; and

3. Facilities, including rental costs for vacant apartments which are
used for independent living programs.

(M) Staff training costs for in-service training and employee develop-
ment which meet the requirements specified in Section 56726 or 56744.
Staff training costs which were incurred shall be allowable to the extent
the vendor implemented the staff training plan specified in Section
56726(a)(1);

(N) Travel costs for consumer or staff travel that is a part of the pro-
gram curriculum.

1. When the program curriculum is conducted solely in natural envi-
ronments, only consumer travel which occurs between the first and last
training site shall be included, unless the regional center, pursuant to Sec-
tion 54342(a)(78)(A), also approves inclusion of travel associated with
transporting consumers to the first and from the last training site as part
of the operating expenses of the vendored service;

2. Consumer travel shall also include travel costs for travel to and from
the vendored service site on an emergency basis when the consumer's
health or safety is at risk.

(O) Utility costs such as gas. electricity, water, garbage, sewer fees or
other utility expenses which occur at the vendored service site;

Page 29236(d)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57436

(P) Vehicle depreciation costs for owned vehicles shall be calculated
h> using the straight-line depreciation method and the minimum normal
service life specified below. Vehicles which have been purchased using
a combination of funds obtained through Section 16(b)(2) of the Urban
Mass Transportation Act of 1964, 49 United States Code, Section
1 6 1 2(b). and funds from the vendor, shall only be depreciated for the por-
tion of the costs incurred by the vendor. The minimum normal service lifc
for:

1. Standard size heavy duty (approximately 35 ' ^0' ) transit busses
is at least twelve years of service or an accumulation of at least 500,000
total miles on the vehicle;

2. Medium si/e heavy duty (approximately 30' ) transit busses is at
least ten years of service or an accumulation of at least 350.000 total
miles on the vehicle;

3. Small medium duty (under 30' ) transit busses is at least seven years
of service or an accumulation of at least 200,000 total miles on the ve-
hicle. A 1 6-passenger bus shall be considered a small medium duty tran-
sit bus and not a van; and

4. Other vehicles such as regular and specialized vans and cars is at
least four years of service or an accumulation of at least 100,000 total
miles on the vehicle.

(4) Management organization costs which:

(A) Shall include for staff functions of the management organization,
the allowable costs specified in (a)(1) through (3) of this section.

(B) Shall not include:

1 . More than 1 00 percent of the allocated costs of the management or-
ganization;

2. Costs applicable to or claimed by other services operated by the ven-
dor;

3. Any non-allowable costs pursuant to Section 57436; and

4. Costs for staff relief time and direct care staff.

(C) Shall be allocated on a basis consistent with the administrative
support provided to each separate service, and each vendor shall:

1 . Indicate whether the methodology used to allocate the costs of the
management organization is based upon:

a. Actual days of attendance if the service is an activity center, adult
development center, or behavior management program; or actual hours
of attendance if the service is a social recreation program, independent
living program, or infant development program; or

b. The total costs of each service.

2. Include the total allowed costs of the management organization for
the reporting period.

(b) Cost information submitted pursuant to (a) shall not include sala-
ries and wages and fringe benefits for staff hired to supplement staffing
ratios for non-mobile consumers, pursuant to Section 56756(b). These
costs shall be reimbursed pursuant to Sections 57530 through 57534.
NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691, 4691.5 and 4791(i), Welfare and Institutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by fO-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(3)(N) and Note filed 11-5-91 as an emergency;
operative 1 l-.'i-91 (Register 92, No. 21). A Certificate of Compliance must be
transmitted to OAL 3^1-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment of subsection (a)(3)(N) and Note refiled 3^1—92 as an emergency;
operative 3--4-92 (Register 92, No. 25). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tions (a)(3)(M) and (a)(3)(N)l. and 2. transmitted to OAL 6-25-92 and filed
8-6H-92 (Register 92. No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6- 20 94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed I -17 97 pursuant to
section 100, title 1, California Code of Regulations (Register 97. .No. ?).

9. Amendment of subsection (a)(3)(F)2. and redcsignation of subsection
(a)(4)(C)(l) to (a)(4)(C)l. filed 4-25-2000; operative .V25 2()()() (Retiistcr
2000. No. 17).

§ 57436. Costs Not to Be Reported.

(a) Non-allowable costs shall not be reported and are limited to the fol-
lowing:

( 1 ) Camperships. student aid funds and scht)larships;

(2) Consumer entertainment and admission fees;

(3) Consumer moving expenses,

(4) Contractual/consultant fees for individual services which can be
obtained through a generic agency and which the generic agency is legal-
ly responsible to provide;

(5) Depreciation costs for furniture, equipment, facilities or vehicles
that are donated, secured or purchased through government grants;

(6) Depreciation costs for owned land;

(7) Donated services, facilities, furniture, equipment, or vehicles;

(8) Donations to other agencies;

(9) Employee bonuses and commissions;

(10) Facility, furniture, equipment, or vehicle rental or lease co.sts as-
sociated with items which are owned by a management organization, its
affiliates or a commonly owned entity; and are leased or rented back to
the management organization, its affiliates or a commonly owned entity,
or the services it operates, when submission of such costs would result
in the vendor being reimbursed twice for the same costs;

(11) Federal/state income tax and penalties or fees associated with
payment of federal or state income taxes;

(12) Fund raising costs;

(13) Gifts for consumers or employees;

(14) Legal fees directly related to a consumer, or expenses for the
prosecution of claims against the regional center or state agencies;

(15) Management organization costs pursuant to Section
57434(a)(4)(B);

(16) Payroll tax penalties

(17) Profit;

( 1 8) Public relations costs;

(19) Refundable deposits;

(20) Supplements to consumers for their daily living needs;

(21) Surplus as defined in Section 57210(a)(l 1); and

(22) Travel costs associated with transporting consumers to or from
the vendored service site, or to the first and from the last training site for
programs which conduct their curriculum solely in natural environments,
except as specified in Section 57434(a)(3)(N).

NOTE: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10- 29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment ofsubsecfion(a)(21) and Note filed 1! 1-V91 as an emergency; op-
erative 1 1-5-91 (Register 92, No. 21 ). A Certificate of Compliance must be
transmitted to OAL 3-4-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment of subsection (a)(21) and Note refiled 3-4-92 a.s an emergcncv;
operative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (a)(20) transmitted to OAL 6-25-92 and filed 8-6-92 (Reuistcr 92. No.
33).

6. Amendment of section filed as an emergency 6-17-93; operative 6 17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-2l)-94 and
filed 8-2-94 (Register 94, No. 31).

[The next page is 292.37.]

Page 292 J6(e)

•

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57442

8. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

9. New subsection (a)(16) and subsection renumbering filed 4-25-2000; opera-
tive 3-23-2000 (Register 2000, No. 17).

§ 57438. Required Vendor Income Information.

(a) In order for the Department to establish a permanent payment rate,
the vendor shall submit the following vendor income information:

( J ) The name of each vendor income source;

(2) The total amount of vendor income received from each source; and

(3) The duration of funding provided by each vendor income source.

(b) Vendor income shall not include income:

(1) Received from private sources;

(2) Used for non-allowable costs or for persons other than consumers;

(3) Received from the Department or regional centers; and

(4) Received from the Department of Rehabilitation and/or the De-
partment of Health Services for services to consumers.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691, 4691.5 and 4791(i), Welfare and Institutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsections (b)(2) and (b)(4) filed
1-17-97 pursuant to secfion 100, title 1 . California Code of Regulations (Regis-
ter 97, No. 3).

§ 57439. Required Regional Center Payment and Vendor
Cost Reduction Information.

(a) In order for the Department to establish a permanent payment rate
for vendors whose temporary payment rate is being converted to a per-
manent payment rate, or for vendors whose permanent payment rate is
being established, each vendor who agreed, pursuant to Section
57300(d), to a negotiated level of payment shall submit regional center
payment information for each regional center with whom the vendor
agreed to a negotiated level of payment as follows:

( 1 ) The total amount of the actual regional center payments which the
vendor received for services provided to consumers during the reporting
period; and

(2) The maximum amount of the regional center payment which the
vendor would have received during the reporting period, had the vendor
not agreed to a negotiated level of payment. The maximum amount of the
regional center payment shall be computed by multiplying the vendor's
established temporary payment rate or permanent payment rate for the
reporting period, by the actual number of consumers days or hours of at-
tendance which the vendor charged and invoiced the regional center for
services provided to consumers.

(b) In addition to the information specified in (a) above, each vendor
who agreed, pursuant to Section 57300(d), to a negotiated level of pay-
ment shall submit the total amount of cost reductions implemented as a
result of the agreed upon lower level of payment.

(c) Each vendor who agreed, pursuant to Section 57540, to enter into
a service contract may report regional center payment information and
cost reduction information pursuant to (a) and (b) above if the method of
payment agreed to in the service contract results in a reduced level of pay-
ment to the vendor.

NOTiv. Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691, 4691.5 and 479 l(i). Welfare and Institutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

1. New secfion filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3 4 92 or
emergency language will be repealed by operation of law on the follov\ing day.

3. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

4. Amendment of secfion filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

6. New subsection (c) filed 6-28-96; operative 6-28-96 (Register 96, No. 26).

7. Change without regulatory effect amending subsecfions (a)( 1) and (a)(2) filed
1-1 7-97 pursuant to section 100, title 1 , California Code of Reeulations (Regis-
ter 97, No. 3).

Article 4. Review Requirements

§ 57440. Vendoring Regional Center Review Procedures.

(a) Vendoring regional center review procedures shall apply only to
the establishment of permanent payment rates, including conversion of
temporary payment rates to a permanent payment rate.

(b) Within 30 days from the date of the Department's written notifica-
tion pursuant to Section 57442(a)(1)(A), the vendoring regional center
shall:

(1) Review the information submitted by the vendor to determine the
following:

(A) That services being provided are consistent with the program de-
sign, pursuant to Section 56712 or 56762;

(B) That the staffing ratio is consistent with that specified in Section
56756 or 56772;

(C) That the information submitted by the vendor is complete and
complies with Sections 57422, and 57433 through 57439; and

(D) Any known inconsistencies in the vendor's reporting of cost and/
or vendor income and/or, as applicable, regional center payment infor-
mation.

(2) Forward a written copy of the review results to the Department and
the vendor.

(c) If the vendoring regional center does not notify the Department of
the results of its review pursuant to (b), the Department shall proceed
with its review procedures pursuant to Section 57442.

NOTE: Authority cited: Secfions 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (b)(l)(C)-(D) and Noth filed 1 1-5-91 as an emer-
gency; operafive 11-5-91 (Register 92, No. 21 ). A Certificate of Compliance
must be transmitted to OAL 3-4-92 or emergency language will be repealed by
operafion of law on the following day.

4. Amendment of subsecfions (b)( 1)(C)-(D) and Norr; refiled 3-4-92 as an emer-
gency; operafive 3-4-92 (Register 92, No. 25). A Certificate of Compliance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of secfion filed as an emergency 6-17-93; operative 6-17 93.
Submitted to OAL for prinfing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20 94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (a) filed 1-17-97 pur-
suant to section 100, fitle 1, California Code of Regulafions (Register 97, No.
3).

§ 57442. Department Review Procedures.

(a) Department review procedures are as follows:

Page 292.37

§ 57444

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1) For vendors whose temporary payment rates are being converted
to permanent payment rates, and for vendors whose permanent payment
rate is being estabHshed. the Department shall:

(A) Within five days from receipt of the information required from the
vendor, send a written notification to the vendoring regional center which
shall indicate that the Department has received the information; and

(B) Upon receipt of the information required from the vendoring re-
gional center pursuant to Section 57440, or within 50 days of receipt of
the information required from the vendor:

1. Review the information to determine if it is complete and complies
with the requirements of Sections 57422, and 57433 through 57439; and

2. Determine the annual number of direct service hours allowed or re-
quired in order to maintain the approved staffing ratio pursuant to Section
57444.

(2) For vendors who are requesting a temporary payment rate, the De-
partment shall, within 30 days of receipt of the information required from
the vendor, review the information to determine if it is complete and com-
plies with the requirements of Section 57433.

(b) If the information is complete and complies with the requirements
of:

(1) Sections 57422, and 57433 through 57439, the Department shall,
for those vendors identified in (a)( 1 ), establish a permanent payment rate
pursuant to Sections 57500 through 57519; or

(2) Section 57433, the Department shall, for those vendors identified
in {a)(2), establish a temporary payment rate pursuant to Sections 57520
and 57522.

(c) If the information is not complete or does not comply with the re-
quirements of Sections 57422, and 57433 through 57439, for establish-
ment of a permanent payment rate, or Section 57433, for establishment
of a temporary payment rate:

(1) The Department shall, within the time specified in (a)(1)(B) or
(a)(2):

(A) Make a written request to the vendor for any additional or clarify-
ing information; and

(B) Send a copy of the request to the vendoring regional center and uti-
lizing regional center(s), if any.

(2) Tlie vendor shall submit the required information to the Depart-
ment with a copy to the vendoring and utilizing regional center(s), if any,
within 15 days from receipt of the Department's written request:

(A) If the vendor submits the required information within the time spe-
cified, and it is complete and complies with the requirements of:

1. Sections 57422, and 57433 through 57439, the Department shall,
for those vendors identified in (a)(1), establish a permanent payment rate
pursuant to Sections 57500 through 57519; or

2. Section 57433, the Department shall, for those vendors identified
in (a)(2), establish a temporary payment rate pursuant to Sections 57520
and 57522.

(B) If the vendor fails to submit the required information within the
time specified, the Department shall notify, in writing, the vendor, the
vendoring regional center, and utilizing regional center(s), if any, of the
following:

1. For those vendors identified in (a)(1):

a. That unless their rate has expired, payment of their rate shall be sus-
pended within 1 5 days from the date of the Department' s written notifica-
tion; and

b. That payment shall remain suspended until the required information
is received.

2. For those vendors identified in (a)(2), that the Department shall take
no further action on their rate request until all required information has
been received.

(C) If the required information is received after the vendoring regional
center and utilizing regional center(s), if any, have suspended payment
of the vendor's rate pursuant to (B)l. or 2. and the information is com-
plete and it complies with the requirements of:

1 . Sections 57422, and 57433 through 57439, the Department shall,
for those vendors identified in (a)( 1 ) :

a. Establish a permanent payment rate pursuant to Sections 57500
through 57519; and

b. Authorize the vendoring regional center and utilizing regional cen-
ter(s), if any, to reinstate payment of the vendor's rate as of the date pay-
ment was suspended. The reinstated rate shall be effective until the new
permanent payment rate is effective.

2. Section 57433, the Department shall, for those vendors identified
in (a)(2), establish a temporary payment rate pursuant to Sections 57520
and 57522.

NOTE; Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2 . Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(l)(B)l, (b)(1). (c), (c)(2)(A)l, (c)(2)(c)l and
Note filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92. No. 21 ).
A Certificate of Compliance must be transmitted to OAL 3-4-92 or emergency
language will be repealed by operation of law on the following day.

4. Amendment of subsections (a)(l)(B)l, (b)(1), (c). (c)(2)(A) 1, (c)(2)(C) 1 and
Note refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92, No. 25).
A Certificate of Compliance must be transmitted to OAL 7-2-92 or emergency
language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secnon 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsection (a)(1) filed 1-17-97
pursuant to section 100, title 1 , California Code of Regulations (Register 97, No.

3).

§ 57444. Determination of the Direct Service Hours

Allowed or Required to Maintain the Approved
Staffing Ratio.

(a) For determining the mean and allowable range of rates, the Depart-
ment shall review the program information reported pursuant to section
57433 to determine if the vendor' s annual number of direct service hours
actually provided to consumers is greater or less than the direct service
hours allowed or required in order to maintain the staffing ratio approved
by the Department, pursuant to section 56756 or 56772.

(b) The Department shall determine the annual number of direct ser-
vice hours allowed using the program information reported pursuant to
section 57433, the approved staffing ratio and the total number of con-
sumers enrolled:

( 1 ) For activity centers, adult development centers, and behavior man-
agement programs:

(A) For each month in the reporting period determine the total monthly
direct service hours by:

1 . Multiplying the reported number of direct service hours operated
per-day, by the reported number of days in which service was actually
provided; and

2. Multiplying the amount computed in I . by the reported consumer
enrollment.

(B) Add together the total computed for each month pursuant to (A);
and

(C) Divide the total computed in (B) by the approved staffing ratio to
compute the annual number of direct service hours allowed, based on the
approved staffing ratio.

(2) For social recreation programs, independent living programs, and
infant development programs:

Page 292.38

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Health and Welfare Agency — Department of Developmental Services

§57511

•

(A) Determine the total number of direct service hours authorized by
adding together the authorized direct service hours reported for each
month of the reporting period; and

(B) Di\ ide the total computed in (A) by the approved staffing ratio to
compute the annual number of direct service hours allowed, based on the
approved staffing ratio.

(c) The Department shall determine the annual number of direct ser-
vice hours required using the program information reported pursuant to
section 57433, the approved staffing rafio and the number of consumers
in attendance:

( 1 ) For activity centers, adult development centers, and behavior man-
agement programs:

(A) For each month of the reporting period determine the total monthly
direct services hours by multiplying the reported number of actual days
of attendance by the reported number of direct service hours operated
per-day;

(B) Add together the total computed for each month pursuant to (A);
and

(C) Divide the total computed in (B) by the approved staffing ratio to
compute the annual number of direct service hours required to maintain
the approved staffing ratio.

(2) For social recreation programs, independent living programs, and
infant development programs:

(A) Determine the total number of direct service hours actually pro-
vided by adding together the total reported hours of attendance for each
month of the reporting period; and

(B) Divide the total computed in (A) by the approved staffing ratio to
compute the annual number of direct service hours required to maintain
the approved staffing ratio.

(d) Determine the annual number of direct service hours actually pro-
vided by direct care staff by adding together the reported number of direct
service hours for each month of the reporting period.

(e) The annual number of direct service hours actually provided by di-
rect care staff, as computed in (d), shall be compared with the annual
number of direct service hours allowed, based on the approved staffing
ratio, as computed in (b)(1) or (2), and with the annual number of direct
service hours required, based on the approved staffing ratio, as computed
in (c)(1) or (2).

( 1 ) If the amount computed in (d) exceeds the amount computed in
(b)( 1 ) or (2), then the number of direct service hours provided exceeds
the number of direct service hours allowed, and the Department shall de-
crease the total salary and wage and fringe benefit costs, reported pur-
suant to sections 57434 (e)( 1 )(A) and (a)(2), by the cost of the excess di-
rect service hours, as follows:

(A) Determine the excess direct service hours by subtracting the
amount computed in (b)(1) or (2) from the amount computed in (d);

(B) Multiply the amount computed in (A) by the average hourly salary
and wage and fringe benefit costs reported pursuant to section 57434
(a)(1)(B); and

(C) Subtract the amount computed in (B) from the total salary and
wage and fringe benefit costs reported pursuant to sections 57434
(a)(1)(A) and (a)(2). This amount shall then be used in step two, section
57511(a)(2).

(2) If the amount computed in (d) is less than the amount computed in
(c)( 1) or (2), then the number of direct service hours provided is less than
the number of direct service hours, required, and the Department shall ex-
clude the vendor's costs in determining the mean and allowable range of
rates pursuant to step three, section 57512 (a)(1)(B).

(3) If the amount computed in (d) is equal to or exceeds the amount
computed in (c)(1) or (2), but does not exceed the amount computed in
(b)( 1 ) or (2), then the number of direct service hours provided is within
the number of direct service hours allowed and required to maintain the
approved staffing ratio, and the Department shall make no adjustment to
the total salary and wage and fringe benefit costs reported pursuant to
sections 57434 (a)( 1 )(A) and (a)(2), except for non-allowable costs iden-
tified in section 57436.

Note: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency: operative 7 1-90 (Kceistcr 90.
No. 36). A Cenificate ofCompliance must be transmitted to OAL by 10 29 90
or emeraency language will be repealed by operation of law on the tbllDw ine
day.

2. Certificate ofCompliance as to 6-26-90 order transmitted to OAL 9 28 90 and
filed 10-29-90 (Register 90. No. 46).

3. Change without regulatory effect amending subsections (a), (b). (b)( 1 )( A), (c)
and(e){2)filed 1-17-97 pursuant to section 100, title l.Califomia Code of Reg-
ulations (Register 97, No. 3).

Subchapter 9. Rate-Setting Methodology
for Community-Based Day Programs

Article 1. Permanent Payment Rates

§ 57500. General Provisions.

(a) The methodology for computing permanent payment rates is based
on program, cost, vendor income, and as applicable, regional center pay-
ment information submitted by all vendors receiving permanent payment
rates. The Department shall use each vendor's program, cost, vendor in-
come, and as applicable, regional center payment information to estab-
lish that vendor's permanent payment rate pursuant to this methodology.
NOTE: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 469 !..'>, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate ofCompliance must be transmitted to OAL by 1 0 29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate ofCompliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate ofCompliance must be transmitted to OAL 3^-92 or
emergency language will be repealed by operation of law on the following day.

4. Amendment retlled 3-4-92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2 92 or
emergency language will be repealed b\ operation of law on the following day.

5. Certificate ofCompliance as to 3-4-92 order transmitted to OAL 6-25 92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate ofCompliance as to 6-1 7-93 order transmitted to OAL 6-20 94 and
filed 8-2-94 (Register 94, No 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100. title 1, California Code of Regulations (Register 97, No. 3;.

§ 57510. Step One: Grouping of Like Program Vendors.

(a) Step one in the process of determining a permanent payment rate
is the grouping of like program vendors. Each vendor shall be grouped
with like program vendors, according to their service code and staffing
ratio approved by the Department pursuant to Section 56756 or 56772.
Note: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate ofCompliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate ofCompliance as to 6-26-90 order transmitted to OAL 9-28 90 and
filed 10-29-90 (Register 90, No. 46).

3. Editorial correction inserting inadvertently omitted section 57510 (Register
2000, No. 18).

§ 5751 1 . Step Two: Computing an Amount Using

Allowable Costs and Consumer Attendance.

(a) Step two in the process of determining a permanent payment rate
is to compute an amount or amounts, as applicable, for each vendor with-
in the group of like programs, based on allowable costs and consumer at-
tendance as follows;

(1) For each vendor, the Department shall compute an amount by:
(A) Determining the total allowable costs as follows:
1 . Add together the total costs reported by the vendor identified in Sec-
tion 57434;

Page 292.39

§ 57512

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

2. Subtract from the amount computed in 1 . the amount of any non-al-
lowable costs specified in Section 57436. which were identified by the
Department or vendoring regional center during their review of the infor-
mation submitted by the vendor; and

3. For vendors who agreed to a negotiated level of payment, as speci-
fied in Section 5730()(d), and whose temporary payment rate is being
converted to a permanent payment rate, or whose permanent payment
rate is being established, the Department shall increase the amount com-
puted in 2. by:

a. Subtract the total amount of the actual regional center payments
which the vendor received for services provided, as reported pursuant to
Section 57439(a)(1), from the maximum amount of the regional center
payment which the vendor would have received, as reported pursuant to
Section 57439(a)(2): and

b. Adding the amount computed in a. or the total amount of cost reduc-
tions reported pursuant to Section 57439(b), whichever is less, to the
amount computed in 2.

(B) Dividing the total allowable costs computed in (A) by the vendor's
actual hours or days of consumer attendance, identified in Section
57433(b)(2)(B) or (3)(D); and

(C) Increasing or decreasing, if applicable, the amount computed in
(B) for any of the following that has occurred from July I through Sep-
tember 30 following the reported period, and which have not been in-
cluded in the total allowable costs reported by the vendor:

1 . Increase the amount computed in (B) by the amount of any COLA
authorized in the Budget Act for the fiscal year following the reporting
period;

2. Increase the amount computed in (B) by the amount of any rate in-
crease granted by the Department, as a result of a rate adjustment pur-
suant to Sections 57920 through 57924, and/or audit adjustment pursuant
to Section 57930, and/or rate appeal pursuant to Sections 57940 through
57948; and/or

3. Decrease the amount computed in (B ) by the amount of any rate de-
crease issued by the Department, as a result of a rate adjustment pursuant
to Sections 57920 through 57924. and/or audit adjustment pursuant to
Section 57930, and/or rate appeal pursuant to Sections 57940 through
57948.

(2) For each vendor included in (a)(1), whose annual number of direct
service hours results in excess direct service hours, as determined pur-
suant to Section 57444(e)( 1 ), the Department shall compute an addition-
al amount using that vendor's allowable costs and consumer attendance
and the steps specified in (a)(1). except the Department shall reduce the
total allowable costs determined in (a)(l )( A) by the costs of the excess
direct service hours computed in Section 57444(e)(1). This additional
amount shall only be used in the computation of the mean and allowable
range of rates, for those vendors with excess direct service hours.
NOTE: Authority cited: Chapter 722, Statutes of 1992. Section 147; and Sections
4691, 4691.5 and 479 l(i). Welfare and Institutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)( 1 )(A) 1-2 and new subsection (a)( 1 )(A)3-b and
amendment of Notk filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Reg-
ister 92, No. 21). A Certificate of Compliance must be transmitted to OAL
3-4-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

4. Amendment of subsections (a)( I )(A)]-2 and new subsection (a)( l)(A)3-b and
amendment of Note refiled 3-4-92 as an emergency; operafive 3-4-92 (Regis-
ter 92, No. 25). A Certificate of Compliance must be transmitted to OAL
7-2-92 or emergency language will be repealed by operation of law on the fol-
lowing day.

5. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tions (a)( 1 )( A)3 and (a)( 1 )( A)3b transmitted to OAL 6-25-92 and filed 8-6-92
(Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

8. Change without regulatory effect amending section heading and subsections
(a).(a)(l)(B)and(a)(2)filed 1-17-97 pursuant to section 1 00 Jitle 1, California
Code of Regulations (Register 97, No. 3).

§ 57512. Step Three: Computing the Mean for Each Like
Program.

(a) Step three in the process of determining a permanent payment rate
is the computation of the mean for all like programs. In making this com-
putation, the Department shall:

( 1 ) Use the amount computed for each vendor in step two, section
57511 (a)(1), except that:

(A) For each vendor with excess direct service hours, the Department
shall substitute the amount computed in section 57511 (a)(1) with the
amount computed in section 5751 1 (a)(2); and

(B) For each vendor whose direct service hours are less than required,
as identified in section 57444 (e)(2), the Department shall exclude that
vendor's allowable costs, as determined in step two, in the computation
of the mean.

(2) Add together the amount specified in (1) for each vendor within
each like program; and

(3) Divide the sum computed in (2) by the number of vendors included
in calculating the sum.

NOTE: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Secfions 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 57513. Step Four: Determination of the Allowable Range
of Rates for Each Like Program.

(a) Step four in the process of determining a permanent payment rate
is the computation of an allowable range of rates for each like program.
The Department shall determine the upper and lower limits of the allow-
able range of rates as follows:

(1) For Fiscal Year 1997-98, and each alternate fiscal year thereafter:

(A) Multiply the mean computed in section 57512 for Fiscal Year
1993-94, by 50 percent to determine the range;

(B) Subtract the lower limit from the upper limit of the allowable range
of rates established for Fiscal Year 1991-92. and adjusted for any COLA
for Fiscal Year 1992-93, to determine the existing range;

(D) The lesser of the two ranges compared in (C) shall be divided by
two;

(E) The upper limit shall be determined by adding the amount com-
puted in (D) to the mean computed pursuant to section 575 12 for Fiscal
Year 1997-98, and each alternate fiscal year thereafter; and

(F) The lower limit shall be determined by subtracting the amount
computed in (D) from the mean computed pursuant to section 575 1 2 for
Fiscal Year 1997-98, and each alternate fiscal year thereafter.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (b)-(b)(3) and amendment of Note filed 6-20-94 as an emer-
gency; operative 6-20-94. Submitted to OAL for prinfing only pursuant to
Chapter 722, Statutes of 1992, Secfion 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6-20-94 order, including amendment of subsec-
tion (b), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 1 3).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, fitle 1, California Code of Regulations (Register 97. No. 3).

Page 292.40

Title 17

Health and Welfare Agency — Department of Developmental Services

§57517

§ 57514. Step Five: Adjusting the Amount Computed in
Step Two for Gap Funding.

(a) Step five in the process of determining a permanent payment rate
is to adjust tlie amount computed in step two. section 5751 1 (a)(1). for
any money appropriated pursuant to the Budget Act. to fund the gap com-
puted in Section 57820. The Department shall:

(1) Convert the vendor's current permanent payment rate into an
amount as follows:

(A) Add back any vendor income subtracted out when the Department
computed the vendor's current permanent payment rate. The increased
rate shall become the amount for use in this step;

(B) If no vendor income was used in computing the vendor's current
permanent payment rate, that rate shall become the amount for use in this
step.

(2) If the amount computed in ( 1 ):

(A) Is below, or within the allowable range of rates, the gap adjustment
combined with the amount computed in (1) shall not exceed the upper
limit of the allowable range of rates; or

(B) Exceeds the upper limit of the allowable range of rates, the vendor
shall not be eligible for a gap adjustment.

(3) For those vendors eligible for a gap adjustment pursuant to (2)(A).
the Department shall:

(A) Increase to the upper limit, the difference between the amount
computed in (1) and the amount computed in step two. Section 5751 1
(a)( 1). if the appropriation in the Budget Act is sufficient to fully cover
the statewide fiscal impact of the gap computed in Section 57820; or

(B) Increase the amount computed in (1) up to the upper limit, based
upon the percentage of available funds, if the appropriation in the Budget
Act is insufficient to fully cover the statewide fiscal impact of the gap
computed in Section 57820. The Department shall, for those eligible ven-
dors:

1. Determine the percentage of available funds by dividing the state-
wide fiscal impact of the gap computed in Section 57820. by the amount
appropriated in the Budget Act;

2. Determine the difference between each vendor's amount as com-
puted in Step two, section 5751 1 (a)(1), and their amount as computed
in(l);

3. Multiply the difference computed in 2. by the percentage of avail-
able funds computed in 1 .; and

4. Increase the amount computed in (1 ) by the amount computed in 3.
NOTH: Authority cited: Sections 469 1 and 469 1.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title I, California Code of Regulations (Register 97, No. 3).

§ 57515. Step Six: Adjusting the Amount Computed in

Step Five by the Upper and Lower Limit of the
Allowable Range of Rates.

(a) Step six in the process of determining a permanent payment rate is
to adjust the amount computed in step five, section 57514, by the upper
and lower limit of the allowable range of rates:

( 1 ) For Fiscal Year 1997-98. and each alternate fiscal year thereafter,
the upper and lower limit adjustment shall be computed as follows:

(A) For vendors whose amount, as determined in step five, is within
the allowable range of rates, the Department shall make no change to that
amount;

(B) For vendors whose amount, as determined in step five, is above the
upper limit of the allowable range of rates, the Department shall reduce
that amount to the upper limit;

(C) For vendors whose amount, as determined in step five, is below the
lower limit of the allowable range of rates, the Department shall increase

the amount to the lower limit, based upon available funds pursuant to
(a)(l)(C)l. through 3.

1 . The amount of available funds to increase amounts computed in step
five shall be determined as follows:

a. Multiply each vendor's reduction computed pursuant to ( 1 )(H) by
their consumer attendance identified in section 57433 (b)(2)(B) or
(3)(D);

b. Add the amount computed in a. for each vendor to determine the to-
tal available funds from the upper limit reduction pursuant to ( 1 )( B ); and

c. Add to the amount determined in b. any gap funding appropriated
pursuant to the Budget Act, for those vendors specified in section 57810
(a)(1)(A) and (B). ^

2. The amount of funds needed to increase amounts computed in step
five to the lower limit, shall be determined as follows:

a. Determine the difference between, the lower limit and each vendor's
amount as computed in step five;

b. Multiply the difference computed in a. by consumer attendance
identified in section 57433 (b)(2)(B) or (3)(D); and

c. Add the amounts computed in b. to determine the total amount of
needed funds.

3. The total amountof available funds, as determined in (C)l.. shall be
compared to the total amount of funds needed, as determined in (C)2.

a. If there are sufficient funds to fully fund the lower limit increase, the
Department shall increase amounts computed in step five to the lower
limit.

b. If there are insufficient funds to fully fund the lower limit increase,
the Department shall adjust the difference computed in (C)2.a. by the per-
centage of available funds. The Department shall:

(1 .) Calculate the percentage of available funds, by dividing the total
amount of available funds computed in (C)l.c. by the total amount of
funds needed computed in (C)2.c.;

(2.) Mulfiply the percentage of available funds, by the difference com-
puted in (C)2.a. for each vendor; and

(3.) Increase amounts computed in step five by the amount computed
in (C)3.b.(2.).

NOTIi: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1 . New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 57517. Step Seven: Adjusting the Amount Computed in
Step Six by Vendor Income.

(a) Step seven in the process of determining a permanent payment rate
is to adjust the amount computed in step six. section 575 1 5, if applicable,
by the amount of any vendor income reported by the vendor pursuant to
section 57438 as follows. The Department shall:

( 1 ) Divide vendor income by the vendor' s actual consumer attendance
identified in secdon 57433 (b)(2)(B) or (3)(D); and

(2) Subtract the amount computed in (1) from the amount computed
in step six.

NOTE: Authority cited: Sections 4691 and 469 1.5. Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Weltare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL b} l()-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9 28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a)(1) filed L 17 97
pursuant to section 1 00, title 1 , CaUforniu Code of Regulations ( Register 97 .No.
3).

Page 292.41

§57518

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

§ 57518. Step Eight: Adjusting the Amount Computed in
Step Seven for Budget Act Adjustment.

(a) Step eight in the process of determining a permanent payment rate
is to adjust the amount computed in step seven, section 575 17, if applica-
ble, for the following that will occur in the fiscal year for which the per-
manent payment rate is established:

( 1 ) COLA authorized in the Budget Act: and/or

(2) Legislative adjustment, for any item of cost(s), specified in the
Budget Act.

NOTH: Authority cited: Sections 4691 and 4691 .5. Welfare and Institutions Code.
Reference: Sections 4691 and 4691..'i. Welfare and In.stitutions Code.

History

1. New .section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 57519. Adjusting the Rate Methodology for COLAs.

(a) For each fiscal year in which a COLA is granted in the Budget Act,
the Department shall increase the mean, computed in step three, section
57512, and upper and lower limits of the existing allowable range of
rates, computed in step four, section 57513, by the percentage of the
COLA.

(b) If the COLA is granted in a fiscal year in which the Department
does not calculate a mean and an allowable range of rates, the COLA
shall be applied to the mean and allowable range of rates calculated in the
previous fiscal year.

(c) The effective date of the adjustment to the mean and allowable
range of rates for a COLA pursuant to (a) or (b), shall be the effective date
of the COLA as specified in the Budget Act.

NOTI-; Authority cited: Secnons4691 and 469 1.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5. Welfare and Institufions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

Article 2. Temporary Payment Rate

§ 57520. General Provisions.

(a) The methodology for computing temporary payment rates is based
on program, cost, vendor income, and as applicable, regional center pay-
ment information submitted by all vendors receiving permanent payment
rates. The Department shall use each vendor's program information to
establish that vendor's temporary payment rate pursuant to this method-
ology.

NOTE: Authority cited: Sections 4691 and 469L5, Welfare and Insfitutions Code.
Reference: Secfions 4691 and 4691.5, Welfare and InsfituUons Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

4. Amendment refiled 3^^92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed 6-17-93 as an emergency; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 57522. Establishment of the Temporary Payment Rate.

(a) The temporary payment rate is determined using the same informa-
tion and steps specified in sections 57510, 5751 1, 57512 and 57519 for
establishing a perinanent payment rate.

NOTli; Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691, 4691.5 and 479 l(i). Welfare and Institutions Code. Reference: Sections
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. New subsections (b)-(b)(3) and amendment of Noth filed 6-20-94 as an emer-
gency; operative 6-20-94. Submitted to OAL for printing only pursuant to
Chapter 722, Statutes of 1992, Section 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6-20-94 order, including amendment of subsec-
fion (b), transmitted to OAL 2-20-96 and filed 3-29-96 (Register 96, No. 1 3).

5. Change without regulatory effect repealing subsecfions (b)-(b)(3) filed
1-1 7-97 pursuant to section 1 00, title 1 , California Code of Reeulations (Regis-
ter 97, No. 3).

Article 3. Non-Mobile Supplemental Rate

§ 57530. Supplemental Rate for Community-Based Day
Programs Serving Non-Mobile Consumers.

(a) Vendors of activity centers, adult development centers, behavior
management programs and social recreation programs, may supplement
their direct care staffing ratios for non-mobile consumers as specified in
section 56756 (b).

(b) For vendors specified in (a), effective July 1, 2000, the maximum
rate of reimbursement shall not exceed $.76 per consumer per hour, or
one-tenth of the prevailing minimum wage, as mandated by State and
Federal laws, plus fringe benefits at 20% of the prevailing minimum
wage, whichever is greater. This rate shall be in addition to the vendor's
permanent or temporary payment rate.

(1) The per-consumer, per-hour rate, as specified in (b), is based on
a 1 : 10 staff-to-consumer ratio for a maximum of six hours per day.

(2) The Department shall authorize regional centers to pay up to six
hours per-day, per-consumer in the amount established in (b).

(3) The amount in (b) shall be increased by any COLA included in the
Budget Act for that purpose.

(4) If there is an increase in the prevailing minimum wage, the Depart-
ment shall only, if applicable, increase the existing hourly supplemental
rate up to the amount of the new prevailing minimum wage.

NOTE: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691 .5, Welfare and Institutions Code; Budget Act
of 2000-01, Item 4300-101-0001.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and subsections
(a), (b)(1) and (b)(2) filed 1-17-97 pursuant to section 100, title 1, CaUfornia
Code of Regulations (Register 97, No. 3).

4. Amendment of subsections (b)-(b)(3) and amendment of Note filed
3-14-2001 as an emergency; operafive 3-14-2001 (Register 2001, No. 11). A
Certificate of Compliance must be transmitted to OAL by 7-12-2001 or emer-
gency language will be repealed by operation of law on the following day.

5. Amendment of subsections (b)-(b)(3) and amendment of Note refiled
7-12-2001 as an emergency; operative 7-12-2001 (Register 2001, No. 28). A
Certificate of Compliance must be transmitted to OAL by 1 1-9-2001 or emer-
gency language will be repealed by operation of law on the following day.

6. Reinstatement of section as it existed prior to 7-12-2001 emergency amend-
ment by operation of Government Code section 1 1346. 1(0 (Register 2001, No.
47).

7. Amendment of subsections (b)-(b)(3) and amendment of Note filed
11-19-2001 as an emergency; operative 11-19-2001 (Register2001,No. 47).
A Certificate of Compliance must be transmitted to OAL by 3-19-2002 or
emergency language will be repealed by operafion of law on the following day.

8. Certificate of Compliance as to 11-19-2001 order transmitted to OAL
3-15-2002 and filed 3-27-2002 (Register 2002, No. 13).

Page 292.42

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57540

§ 57532. Effective Date.

(a) The effective date for funding of staff wlio provide a 1 : 10 staff-to-
consumer ratio for non-mobile consumers shall be the date the commu-
nity-based day program began incurring the additional cost.
NOTI;; Authority cited: Sections 469 1 and 469 1 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section tiled 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 57534. Written Notification of the Supplemental Rate
Established for Community-Based Day
Programs Serving Non-Mobile Consumers.

(a) For vendors receiving a supplemental rate established in section
57530 (b). the Department shall notify the regional center in writing of
the supplemental rate. The regional center shall notify each vendor eligi-
ble for this supplemental rate.

NOTE: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institufions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading filed 1-17-97 pur-
suant to section 1(X), fitle 1, California Code of Regulations (Register 97, No.
3).

Article 4. Service Contracts

§ 57540. Service Contracts Between the Regional Center
and Community-Based Day Program Vendors.

(a) Once the Department has established a rate of reimbursement for
community-based day program vendors pursuant to Sections 57500
through 57519 for vendors whose temporary payment rate is being con-
verted to a permanent payment rate and vendors whose permanent pay-
ment rate is being established or reestablished, or pursuant to Sections
57520 through 57522, for vendors who are requesting a temporary pay-
ment rate, a regional center and a vendor may negotiate a service contract
for provisions of the vendored service.

(b) The service contract shall commence on the date agreed to by the
regional center and vendor, and shall terminate on the expiration date
specified by the Department in its written notification to the vendor of the
established rate, or earlier, if an earlier termination date has been mutual-
ly agreed to by the regional center and vendor.

( 1 ) If the service contract terminates on the expiration date specified
in the Department" s written notification to the vendor of the established
rate, the Department shall:

(A) For those vendors whose established rate is a temporary payment
rate, establish a permanent payment rate, as applicable, pursuant to Sec-
tion 57642 or 57652; or

(B) For those vendors whose established rate is a permanent payment
rate:

1. Reestablish the permanent payment rate during Fiscal Year
1996-97, and each alternate fiscal year thereafter, as specified in Section
57640; or

2. Establish a permanent payment rate during Fiscal Year 1997-98,
and each alternate fiscal year thereafter, as specified in Section 57650.

(2) If the service contract terminates prior to the expiration date speci-
fied in the Department's written notification to the vendor of the estab-
lished rate, the vendor shall be reimbursed at the rate established by the
Department until the expiration of the estabJished rate.

(1 ) Level of payment;

(2) Effective date for commencing and terminating payment as deter-
mined by the regional center and vendor pursuant to (b) above;

(3) Units of service which the vendor shall use to charge and invoice
the regional center for services provided to consumers. The units of ser-
vice shall include the minimum and inaximum number of units of service
to be provided during the period specified. Units of service for contracts
reimbursed other than a daily or houriy rate shall also be maintained pur-
suant to Secdon 50604(d)(3)(A) through (F), as applicable.

(d) The level of payment agreed to under the service contract inay be
less than but shall not exceed the maximum reiinbursement possible dur-
ing the contract period, using the rate established by the Department and
the units of service actually provided by the vendor as the basis for deter-
mining the maximum reimbursement possible.

(e) In addition to the items specified in (a) through (d) above, service
contracts negoUated pursuant to the provisions of this section shall in-
clude;

(1) The provisions specified in Sections 50607 through 5061 1; and

(2) A statement that the vendor shall agree to maintain service and pro-
gram information in accordance with the provisions of Section
50604(d)(1) through (3)(F), as applicable, and Section 57433(b)(1), (2),
and (3).

(3) A provision requiring the vendor to submit to the regional center
with their billings/invoices the information specified in Section
50604(d)(3)(A) through (F), as applicable, for the billing period.
NOTE: Authority cited: Chapter 157, Statutes of 2003; Sections 4648(a), 4691 and
4691.5, Welfare and Insdtutions Code. Reference: Sections 4648(a), 4691 and
4691.5, Welfai-e and Insdtutions Code.

History

1. New section filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3^-92 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 3-4-92 as an emergency; operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operafion of law on the following day.

3. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tions (c)(3)(A) and (B) transmitted to OAL 6-25-92 and filed 8-6-92 (Register
92, No. 33).

4. Editorial correcdon of prindng ertor inserting article heading (Register 92, No.
34).

5. Amendment of secdon filed as an emergency 6-17-93; operadve 6-17-93.
Submitted to OAL for prindng only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

7. Amendment of section heading, secdon and Note filed 8-28-95 as an emergen-
cy; operative 8-28-95 (Register 95, No. 35). This amendment is deemed an
emergency, is not subject to OAL review, and shall remain in effect until revised
or repealed by the Department pursuant to Stats. 1992, ch. 722, sec. 147.

8. Certificate of Compliance as to 8-28-95 order transmitted to OAL 5-16-96 and
filed 6-28-96 (Register 96, No. 26).

9. Change without regulatory effect amending subsecdons (b)(l)(A)-(b)(l )(B)2.
and (c)(3) filed 1-17-97 pursuant to section 100, tide 1, California Code of Reg-
ulations (Register 97, No. 3).

10. Amendment of subsecdons (c)(3) and (e)(2), new subsection (e)(3) and
amendment of Note filed 10-9-2003 as an emergency; operative 10-9-2003
(Register 2003, No. 41). A Certificate of Compliance must be transmitted to
OAL by 2-6-2004 or emergency language will be repealed by operation of law
on the following day.

11. Amendment of subsections (c)(3) and (e)(2), new subsection (e)(3) and
amendment of Note refiled 2-3-2004 as an emergency; operative 2-3-2004
(Register 2004, No. 6). A Certificate of Compliance must be transmitted to OAL
by 6-2-2004 or emergency language will be repealed by operation of law on
the following day.

12. Amendment of subsecdons (c)(3) and (e)(2), new subsecdon (e)(3) and
amendment of Note refiled 6-1-2004 as an emergency; operative 6-1-2004
(Register 2004, No. 23). A Certificate of Compliance must be transmitted to
OAL by 9-29-2004 or emergency language will be repealed by operation of
law on the following day.

13. Certificate of Compliance as to 6-1-2004 order, including amendment of sub-
secdons (c)(3), (e)(2) and (e)(3), transmitted to OAL 9-15-2004 and filed
10-28-2004 (Register 2004, No. 44).

Page 292.43

§ 57600

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Subchapter 10. Schedule of Payment Rates
for Community-Based Day Programs

Article 1. General Provisions

§ 57600. General Provisions for Schedule of Payment
Rates for All Fiscal Years.

(a) Each fiscal year, the Department shall establish a payment rate for
each vendor.

(b) The appropriate like program for each vendor shall be determined
based upon their service code and the staffing ratio approved by the De-
partment pursuant to Section 56756 or 56772.

(c) Each vendor shall submit information, as applicable, pursuant to
Sections 57433 through 57439. The vendoring regional center and the
Department shall review the information pursuant to Sections 57440 and
57442.

NOTE: Authority cited: Sections 4691 and 4691 ,5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (c) and Note filed 1 1-5-91 as an emergency; opera-
tive 1 1-5-91 (Register92, No. 21). A Certificate of Compliance must be trans-
mitted to OAL 3-4-92 or emergency language will be repealed by operation of
law on the following day.

4. Amendment of subsection (c) and Note refiled 3-4-92 as an emergency; opera-
tive 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be trans-
mitted to OAL 7-2-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3^^92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

Article 2.

Schedule of Payment Rates for
Fiscal Year 1990-91

§ 57620. Vendors Receiving Permanent Rates.

NOTE: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Insfitutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed IO-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 2 (secdons 57620-57624)
and section filed 1-17-97 pursuant to section 100, title 1, California Code of
Regulations (Register 97, No. 3).

§ 57622. Vendors Receiving Provisional Rates.

NOTE: Authority cited: Secfions 4691 and 469 1 .5. Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, tide 1, California Code of Regulations (Register 97, No. 3).

§ 57624. New Vendors.

NOTE: Authority cited: Sections 4691 and 469 1 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 3.

Schedule of Payment Rates for
Fiscal Year 1991-92

§ 57630. Vendors Receiving Permanent Rates.

NOTE: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 3 (sections 57630-57636)
and section filed 1-17-97 pursuant to section 100, title I, California Code of
Regulations (Register 97, No. 3).

§ 57632. Vendors Receiving Temporary Payment Rates.

NOTE: Authority cited: Sections 4691 and 4691 .5. Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (b) and (d)( 1 ) and Note filed 1 1-5-9 1 as an emer-
gency; operative 11-5-91 (Register 92, No. 21). A Certificate of Compliance
must be transmitted to OAL 3-4-92 or emergency language will be repealed by
operation of law on the following day.

4. Amendment of subsections (b) and (d)(1) and Note refiled 3-^1-92 as an emer-
gency; operative 3-4-92 (Register 92, No. 25). A Certificate of CompUance
must be transmitted to OAL 7-2-92 or emergency language will be repealed by
operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 57634. Vendors Receiving Provisional Rates.

Note: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 57636. New Vendors.

NOTE: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

Page 292.44

Title 17 Health and Welfare Agency — Department of Developmental Services § 57636

History 2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-2K "JO and

1 . New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90, filed 10-29-90 (Register 90, No. 46).

No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90 3. Change without regulatory effect repealing section filed 1-1 7-97 pursuant to

or emergency language will be repealed by operation of law on the following section 100, title 1. California Code of Regulations (Register 97, No. 3).
day.

•

[The next page is 292.45.]

•

Page 292.44(a) Register 2004, No. 44; 10-29-2004

•

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57652

Article 4. Schedule of Payment Rates for

Fiscal Year 1996-97 and Each Alternate

Fiscal Year Thereafter

§ 57640. Vendors Receiving Permanent Payment Rates.

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter,
the Department shall reestablish permanent payment rates that were es-
tablished the previous fiscal year by adjusting those rates pursuant to sec-
tions 57515 and 57518.

(b) The effective date of the reestablished permanent payment rate
shall be September 1, 1996, for Fiscal Year 1996-97, and September 1
for each alternate fiscal year thereafter.

(c) The expiration date of the reestablished permanent payment rate
shall be August 31, 1997, for Fiscal Year 1996-97. and August 31 for
each alternate fiscal year thereafter.

Note: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending article heading and section filed
1-17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

§ 57642. Vendors Receiving Temporary Payment Rates.

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter,
the temporary payment rate established the previous fiscal year shall con-
tinue until the Department converts it to a permanent payment rate pur-
suant to Section 57652(b) through (e).

(b) If the mean is adjusted for a COLA pursuant to section 575 19 (b),
the Department shall adjust the temporary payment rate established tlie
previous fiscal year, by the amount of the COLA.

(c) The effective date of the adjustment of the temporary payment rate,
as specified in (b), shall be the effective date of the COLA as specified
in section 57519 (c).

NoTE: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a) filed 1-17-97 pur-
suant to section 100, dtle 1, California Code of Regulations (Register 97, No.
3).

§ 57644. New Vendors.

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter,
new vendors requesting a rate shall receive the temporary payment rate
established the previous fiscal year, adjusted for a COLA, if applicable,
pursuant to section 57519. The Department shall use the program infor-
mation specified in section 57433, submitted by each new vendor by the
date specified in section 57432(a)(3), to establish the vendor' s temporary
payment rate.

(b) The temporary payment rate shall be effective on the date the ven-
dor begins providing services to consumers.

( 1 ) The Department converts the temporary payment rate to a perma-
nent payment rate pursuant to Section 57652; or

(2) It expires, which shall be twenty-one months from the date it be-
came effective.

NOTE: Authority cited: Sections 469 1 and 469 1 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL h\ 1 0 29 90
or emergency language will be repealed by operation of law on the follow ing
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28 90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 5. Schedule of Payment Rates for

Fiscal Year 1997-98 and Each Alternate

Fiscal Year Thereafter

§ 57650. Vendors Receiving Permanent Payment Rates.

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter,
the Department shall establish permanent payment rates pursuant to Sec-
tions 57500 through 575 1 9, based upon the program, cost and vendor in-
come information specified in Sections 57433 through 57438, and as
applicable, the regional center payment information specified in Section
57439, submitted by vendors receiving permanent payment rates, by the
date specified in Section 57432(a)(2) for the reporting period specified
in Section 57431(a)(2).

(b) The effective date of the established permanent payment rate shall
be September 1, 1997, for Fiscal Year 1997-98, and September 1 for
each alternate fiscal year thereafter.

(c) The expiration date of the established permanent payment rate shall
be August 31, 1998, for Fiscal Year 1997-98, and August 3 1 for each al-
ternate fiscal year thereafter.

Note: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Noxi- filed 1 1-5-91 as an emergency; opera-
tiv.e 1 1-5-91 (Register 92, No. 21 ). A Certificate of Compliance must be trans-
mitted to OAL 3--4-92 or emergency language will be repealed by operation of
law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending article heading and section filed
1-17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

§ 57652. Vendors Receiving Temporary Payment Rates.

(a) The temporary payment rate shall continue until the Department
converts it to a permanent payment rate pursuant to (b) through (e).

(b) All vendors converting from a temporary payment rate to a perma-
nent payment rate shall submit the program, cost and vendor income in-
formation specified in Sections 57433 through 57438, and as applicable,
the regional center payment information specified in Section 57439 by
the dates specified in Section 57432(a)(1) for the reporting period speci-
fied in Section 57431(a)(1).

(c) The Department shall convert the temporary payment rate to a per-
manent payment rate pursuant to Sections 57500 through 575 1 9, with the
following exceptions:

(1) The amount computed in Step five, Section 575 14, shall not be ad-
justed for gap funding;

(2) The permanent payment rate shall not exceed the upper limit: and

(3) If the amount computed in Step five is below the lower limit of the
allowable range of rates, the Department shall increase that amount to the

Page 292.45

§ 57654

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

lower limit based upon available funds from the upper limit reduction
process for vendors with a permanent payment rate pursuant to Section
57515.

(d) The effective date of the conversion of the temporary payment rate
to a permanent payment rate shall be:

( 1 ) Thirty days from the date the Department receives the program,
cost and vendor income information that complies with Sections 57422,
and 57433 through 57438, and as applicable, the regional center payment
information specified in Section 57439; or

(2) No later than 21 months from the date the temporary payment rate
was initially established, if the vendor did not receive an extension of the
temporary payment rale pursuant to Section 57431(a)(1).

(e) Temporary payment rates which are converted to a permanent pay-
ment rate shall expire August 31, following the effective date.

NOTIi: Authority cited: Sections 4691 and 469 1 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing and adding new section filed
1-1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

4. Amendment of subsection (d)(2) filed 4-25-2000; operative 5-25-2000 (Reg-
ister 2000, No. 17).

§ 57654. New Vendors.

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter,
new vendors requesting a rate shall receive a temporary payment rate es-
tablished pursuant to sections 57520 and 57522, using the program infor-
mation specified in section 57433 submitted by each new vendor by the
date specified in section 57432(a)(3). The temporary payment rate shall
be based upon the program, cost and vendor income information sub-
mitted by vendors receiving permanent payment rates pursuant to section
57650(a).

(b) The temporary payment rate shall be effective on the date specified
in Section 57644(b).

(c) Once the temporary payment rate is established, the vendor shall
continue to receive that rate until it is converted or it expires as specified
in Section 57644(c).

NOTE: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 6. Timelines for Rate Establishment
and Written Notification

§ 57660. Timelines for Continuation of the Permanent Rate
and Written Notification.

NOTE: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 57662. Timelines for Extension of the Provisional Rate
and Written Notification.

NOTE: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatoi7 effect repealing section filed 1-17-97 pursuant to
section 100, title 1, CaUfornia Code of Regulations (Register 97, No. 3).

§ 57664. Timelines for Establishment of the Permanent
Payment Rate and Written Notification.

(a) For vendors receiving a permanent payment rate, the Department
shall, upon receipt of the information which complies with Sections
57422, and 57433 through 57439, and by September 1 , of each year, es-
tablish or reestablish the permanent payment rate and notify, in writing,
each vendor, the vendoring regional center, and utilizing regional cen-
ter(s), if any, of the following:

( 1 ) The permanent payment rate;

(2) The effective date and expiration date of the permanent payment
rate;

(3) The service code and staffing ratio used to determine the perma-
nent payment rate;

(4) Any Budget Act adjustments;

(5) The next required reporting period, and submission date pursuant
to Sections 5743 1 (a)(2) and 57432(a)(2) for the program, cost, vendor in-
come, and as applicable, regional center payment information;

(6) That payment of the permanent payment rate shall be suspended
pursuant to Section 57432(c)(1)(B) if the required information specified
in (a)(5) is not submitted; and

(7) The vendor's right to appeal the permanent payment rate pursuant
to Sections 57940 through 57948.

(b) For vendors converting their temporary payment rates to a perma-
nent payment rate, the Department shall establish the permanent pay-
ment rate and provide the notification specified in (a) within 30 days of
receipt of program, cost and vendor income information that complies
with Sections 57422, and 57433 through 57438, and as applicable, the
regional center payment information specified in Section 57439 for ven-
dors with a temporary payment rate that is converted to a permanent pay-
ment rate.

Note: Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institudons Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsecfions (a), (a)(5), and (b)(3) and Note filed 1 1-5-91 as an
emergency; operadve 11-5-91 (Register 92, No. 21). A Certificate of Com-
pliance must be transmitted to OAL 3-4-92 or emergency language will be re-
pealed by operafion of law on the following day.

4. Amendment of subsections (a), (a)(5), and (b)(3) and Note refiled 3-4-92 as
an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending secfion filed I-I7-97 pursuant to
section 100, fitle 1, Califomia Code of Regulafions (Register 97, No. 3).

§ 57666. Timelines for Establishment of the Temporary
Payment Rate and Written Notification.

(a) For vendors requesting a temporary payment rate, the Department
shall within 30 days from receipt of program information that complies

Page 292.46

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57910

with section 57433, establish a temporary payment rate and notify, in
writing, each vendor, the vendoring regional center, and utilizing region-
al center(s), if any, of the following:

( 1 ) The temporary payment rate;

(2) The effective date and expiration date of the temporary payment
rale;

(3) The service code and staffing ratio used to determine the temporary
payment rate;

(4) Any cost-of-living adjustment;

(5) The next required reporting period, and submission date pursuant
to sections 5743 1 (a)( 1 ) and 57432(a)( 1) for the program, cost and vendor
income information;

(6) Tliat payment of the temporary payment rate shall be suspended
pursuant to section 57432(c)(1)(A) if the required information specified
in (a)(5) is not submitted;. and

(7) The vendor's right to appeal the temporary payment rate pursuant
to sections 57940 through 57948.

Note-. Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)(5) and (a)(6) filed
1 - 1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

Subchapter 11. Reporting Requirements
for Community-Based Day Programs

Article 1. Annual Report to the Legislature

§ 57810. The Department's Annual Report to the
Legislature.

(a) By April 15, 1997, for Fiscal Year 1997-98, and by April 15 for
each alternate fiscal year thereafter, the Department shall report the fol-
lowing to the Legislature:

(1) The amount needed to fund the statewide fiscal impact of the gap
including identification of the amount attributed to vendors who are:

(A) Not eligible for a gap adjustment pursuant to section 57514
(a)(2)(B); or

(B) Eligible only for a partial gap adjustment pursuant to section
57514 (a)(2)(A).

(2) Any other known pertinent costs or rate information which the De-
partment deems necessary, in order to show cost-of-living increases to
an allowable cost item that affects all vendors, and which has not been:

(A) Funded in the current fiscal year's Budget Act; nor

(B) Included in the next fiscal year's Governor's Budget.

(b) By April 15, 1998, for Fiscal Year 1998-99, and by April 15 for
each alternate fiscal year thereafter, the Department shall report:

( 1 ) The amount determined in (a)( 1 ) that was unfunded in the previous
year; and

(2) The information specified in (a)(2).

NOTE; Authority cited: Sections 4691 and 4691 .5, Welfare and Institutions Code.
Reference: Sections 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a) and (b) filed
1-17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

§ 57812. The Joint Report to the Legislature for Fiscal Year
1996-97.

NOTE: Authority cited: Sections 4691 and 4691 .5. Welfare and Institutions Code.
Reference: Secdons 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, tide 1, California Code of Reeulations (Register 97, No. 3).

Article 2. Calculation of the Statewide
Fiscal Impact of the Gap

§ 57820. Determination of the Statewide Fiscal Impact of
the Gap for Fiscal Year 1997-98, and Each
Alternate Fiscal Year Thereafter.

(a) For vendors with a permanent payment rate whose amount com-
puted in step two, section 575 1 1 (a)( 1 ), is below the upper limit of the al-
lowable range of rates computed in section 575 13 the Department shall:

( 1 ) For each vendor, calculate the difference between step two, section
5751 1(a)(1) and step five, section 57514(a)(1);

(2) Multiply the amount computed in ( 1 ) for each vendor by each ven-
dor's actual consumer attendance identified in section 57433(b)(2)(B) or
(3)(D); and

(3) Add the amounts computed in (2) to determine the statewide gap.
Note: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and subsections (a)
and (a)(2) filed 1-1 7-97 pursuant to section 1 00, title 1 , California Code of Reg-
ulations (Register 97, No. 3).

§ 57822. Determination of the Statewide Fiscal Impact of
the Gap for Fiscal Year 1993-94, and Each
Alternate Fiscal Year Thereafter.

NOTE: Authority cited: Sections 4691 and 4691.5, Welfare and Institutions Code.
Reference: Secdons 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, dtle 1, California Code of Regulations (Register 97, No. 3).

Subchapter 12. Rate Adjustments, Audit
Adjustments and Rate Appeals for
Community-Based Day Programs

Article 1 . General Provisions

§57910. General Provisions.

(a) A permanent payment rate may be adjusted pursuant to this article,
by the Department, only for the following:

(1) A rate adjustment pursuant to section 57920(b) and (c); and/or

(2) An audit adjustment pursuant to section 57930(a)(1)(A); and/or

Page 292.47

§ 57910 BARCLAYS CALIFORNIA CODE OF REGULATIONS Title 17

(3) A rate appeal pursuant to sections 57940 through 57948. (c) The Department shall not adjust any rate to exceed the upper limit

(b) A temporary payment rale may be adjusted pursuant to this article, of the allowable range of rates,

by the Department, only for the following: Note; Authority cited: Section 4691, Welfare and Institutions Code. Reference:

( 1 ) A rate adjustment pursuant to section 57920(b)( 1 ); and/or Section 4691, Welfare and Institutions Code.

(2) An audit adjustment pursuant to section 57930(a)(1)(B); and/or History

/T> . , "i „ .^ .- tzncAPLtu u cnoAo 1. New section filed 6-26-90 as an emergency; Operative 7-1-90 (Register 90,

(3) A rate appeal pursuant to sections 57940 through 57948. ^^ 3^^ ^ Certificate of Compliance must be transmitted to OAL by 10-29-90

Page 292.48 Register 2003, No. 41; 10-10-2003

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57924

or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a), repealing subsec-
tions (cMc)(3) and relettering remaining subsection tiled 1-17-97 pursuant to
section 100, title 1 , California Code of Regulations (Register 97, No. 3).

Article 2. Rate Adjustments

§ 57920. General Provisions.

(a) Once a payment rate for each community-based day program has
been established by the Department, adjustments to that rate shall be con-
sidered by the Department, for either anticipated or unanticipated pro-
gram changes, in accordance with (b) and (c).

(b) Anticipated program changes are service modifications which the
vendor and/or the vendoring regional center can plan for and expect to
occur in the next fiscal year. Anticipated program changes shall be sub-
mitted to the Department and the vendoring regional center prior to De-
cember 1 of the year previous to the fiscal year in which the changes are
expected to occur. Any requests submitted after December 1 shall not be
considered by the Department. Anticipated program changes shall be
limited to the following:

( 1 ) A modification in the program design pursuant to section 567 1 2 or
56762 which results in a change in the approved existing staffing ratio
or approved service code. Changes in the approved existing staffing ratio
or approved service code shall be based upon the characteristics and
needs of the consumers served and/or the program curriculum as speci-
fied in section 56756 or 56772;

(2) Relocation of the service due to expiration of the vendor's facility
lease or tenancy arrangement; and/or

(3) A loss or gain of any vendor income used to compute the vendor's
rate.

(c) Unanticipated program changes shall be submitted by the vendor
to the Department and the vendoring regional center no later than 60 days
from the date the change has occurred. Unanticipated program changes
received after the 60 days shall not be considered by the Department. Un-
anticipated program changes shall be limited to the following:

(1) Mandated service adjustments due to changes in, or additions to,
existing statutes, laws, regulations or court decisions; and/or

(2) Emergency relocations as required to protect the health and safety
of the consumers.

(d) Anticipated program changes shall be funded by the Department
only if there are funds made available in the Budget Act appropriation to
the Department for that purpose.

(e) Unanticipated program changes shall be funded effective the date
the Department approves them pursuant to section 57924.

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (b)( 1 ), repealing subsec-
tions (b)(2)-(b)(2)(B), renumbering subsections, and amending subsection
(c)(2) filed 1-17-97 pursuant to section 100, tide 1, California Code of Regula-
tions (Register 97, No. 3).

§ 57922. Submission Requirements for Rate Adjustments.

(a) Any community-based day program vendor requesting a rate ad-
justment due to anticipated or unanticipated program changes pursuant
to the requirements of section 57920 shall submit the following informa-
tion in writing to the Department with a copy to the vendoring regional
center:

(1) Vendor program information specified in section 57433(a)(1)
through (4);

(2) The specific reason for the adjustment request;

(3) All supporting documentation and any other information necessary
to substantiate and/or justify the request;

(4) Program, cost and vendor income information for only those items
relatingto the rate adjustment request; and

(5) The date the additional cost was incurred or is expected to be in-
curred.

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 57924. Review Procedures for Rate Adjustments.

(a) Within five days of receipt of the rate adjustment request from the
vendor, the Departinenl shall send a written notification to the vendoring
regional center which shall indicate that the Department has received the
rate adjustment request from the vendor.

(b) Within 30 days from the date of the Department's written notifica-
tion pursuant to (a), the vendoring regional center shall:

( 1 ) Review all information submitted by the vendor to determine if it
complete and complies with the requirements of sections 57920 and
57922; and

(2) Notify the Department in writing, with a copy to the vendor, of the
vendoring regional center's recommendation, including supporting ra-
tionale for their recommendation. The vendoring regional center's sup-
porting rationale shall include:

(A) The specific regulatory basis for the request;

(B) A statement that the circumstances necessitating the request have
been verified by the regional center; and

(c) If the vendoring regional center does not notify the Department of
the results of its review and recommendation pursuant to (b), the Depart-
ment shall proceed with its review procedures pursuant to (d) through (g).

(d) Within 50 days of receipt of the rate adjustment request from the
vendor, the Department shall review the request to determine if it is com-
plete and complies with the requirements of sections 57920 and 57922.

(1) If the vendor's rate adjustment request is complete and complies
with the requirements of sections 57920 and 57922, the Department shall
approve the vendor's rate adjustment request within 60 days of receipt
of the request. However, requests for anticipated program changes shall
only be approved contingent upon funds being available pursuant to sec-
tion 57920(d).

(2) If the vendor's rate adjustment request is not complete or does not
comply with the requirements of sections 57920 and 57922, the Depart-
ment shall make a written request to the vendor for additional informa-
tion, as required, and send a copy of the request to the vendoring regional
center. The vendor shall submit the required additional information to the
Department within 15 days from receipt of the written request.

(A) If the vendor fails to submit the required additional information
within 15 days, the Department shall deny the vendor's rate adjustment
request.

(B) If the vendor submits the required additional information within
the 15 days and it is complete and complies with the requirements of sec-
tions 57920 and 57922, the Department shall approve the vendor's rate
adjustment request within 60 days of receipt of the required additional
information. However, requests for anticipated program changes shall
only be approved contingent upon funds being available pursuant to sec-
tion 57920(d).

(C) If the vendor submits the required additional information within
15 days and it is not complete and does not comply with the requirements
of sections 57920 and, 57922, the Department shall deny the vendor's
rate adjustment request.

(e) The Department shall notify, in writing, the vendor, the vendoring
regional center, and utiUzing regional center(s), if any, of the following:

Page 292.49

§ 57930

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(1 ) The decision to approve or deny the vendor's rate adjustment re-
quest pursuant to (d). Notification shall be as follows:

(A) Within.the time specified in (d)(1) if the vendor's rate adjustment
request, when initially received by the Department, is complete and com-
plies with sections 57920 and 57922;

(B) Within 15 days from the date any required additional information
from the vendor is due, if the vendor fails to submit the required addition-
al information within the time specified in (d)(2)(A);

(C) Within the time specified in (d)(2)(B) if the vendor submits the re-
quired additional information within 1 5 days and it is complete and com-
plies with sections 57920 and 57922; or

(D) Within 60 days of receipt of any required additional information
which is not complete and does not comply with sections 57920 and
57922. as specified in (d)(2)(C).

(2) The availability of funds in the Budget Act, to fund previously ap-
proved anticipated program changes pursuant to section 57920(d). The
notification shall be by September 1 .

(0 The effective date for all approved rate adjustments due to antici-
pated program changes, pursuant to section 57920(b), shall be Septem-
ber 1 of the subsequent fiscal year, or later, depending upon when the cost
relating to the change actually occurs.

(g) The effective date for all approved rate adjustments due to unantic-
ipated program changes pursuant to section 57920(c) shall be the date the
community-based day program began incurring the additional cost.
NoTE; Authority cited: Section 4691. Welfare and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

Article 3. Audit Adjustments

§ 57930. Rate Adjustments Resulting From Audit Findings.

(a) If the Department or regional center conducts an audit of the ven-
dor, and an adjustment to the rate is required as a result of the audit, the
Department shall adjust the vendor's rate as follows:

( 1 ) The audit report shall be utilized by the Department in determining
whether an adjustment to the vendor's rate is required. This determina-
tion shall be made prior to issuance of the audit report.

(A) For vendors reimbursed at a permanent payment rate, the vendor's
rate shall be adjusted if the program, cost, vendor income, and as applica-
ble, regional center payment information, used as a basis for determining
the rate, does not substantiate or support the rate established by the De-
partment.

(B) For vendors reimbursed at a temporary payment rate, the vendor's
rate shall be adjusted if any of the program information used as a basis
for determining the rate, does not substantiate or support the rate estab-
lished by the Department.

(2) The revised rate and the effective date of the revised rate shall be
determined as follows:

(A) For vendors reimbursed at a permanent payment rate, the vendor's
program, cost, vendor income, and as applicable, regional center pay-
ment information used as a basis for determining the vendor's rate, ad-
justed for any findings in the final audit report, shall be used to determine
the revised rate and its effecdve date.

(B) For vendors reimbursed at a temporary payment rate, the vendor's
program information used as a basis for determining the vendor's rate,
adjusted for any findings in the final audit report, shall be used to deter-
mine the revised rate and its effective date.

(b) If an adjustment to the vendor's rate was made pursuant to (a), the
Department shall include, with the final audit report released to the ven-
dor, written notification of the following:

(1) The revised rate and its effective date;

(2) The vendor's right to defer implementation of the revised rate and/
or its effective date, pending the results of an audit appeal, if the vendor
appeals the audit pursuant to Title 17, Sections 50700 through 50767;

(3) That if the vendor appeals the audit, the results of the audit appeal
shall be used by the Department in accordance with (a) to determine the
revised rate and its effective date; and

(4) The vendor's right to appeal errors by the Department in calculat-
ing its revised rate and/or the effective date of the revised rate pursuant
to Sections 57940 through 57948.

(c) Vendors shall not appeal issues pertaining to the audit through the
rate appeal process specified in Sections 57940 through 57948.

(d) A copy of the written notification and final audit report specified
in (b) shall be sent to the vendoring regional center, and utilizing regional
center(s). if any, at the same time the original notice and audit report are
sent to the vendor. The Department shall provide the vendor, the vendor-
ing regional center, and the utilizing regional center(s), if any, with writ-
ten nofification of the results of any audit appeal and revisions, if any, in
the vendor's rate and its effective date.

NOTE: Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of subsections (a)(1)(A) and (a)(2)(A) and Note filed 1 1-5-91 as
an emergency; operative 1 1-5-91 (Register 92, No. 21). A Certificate of Com-
pliance must be transmitted to OAL 3-4-92 or emergency language will be re-
pealed by operation of law on the following day.

4. Amendment of subsections (a)(1)(A) and (a)(2)(A) and NoTErefiled 3-4-92 as
an emergency; operative 3-4-92 (Register 92, No. 25). A Certificate of Com-
pliance must be transmitted to OAL 7-2-92 or emergency language will be re-
pealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order transmitted to OAL 6-25-92 and
filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100. title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Rate Appeals

§ 57940. General Provisions.

(a) A vendor may appeal the following to the Department's Deputy Di-
rector who has the responsibility for setting rates:

( 1 ) Errors in program and/or cost and/or vendor income and/or, as
applicable, regional center payment information submitted by the vendor
which was udlized by the Department to establish the vendor's rate;

(2) Errors by the Department in calculating the vendor's rate, includ-
ing revised rates based on a final audit report or the results of an appeal
of a final audit report;

(3) The effective date of the rate, including revised rates based on a fi-
nal audit report or the results of an appeal of a final audit report; and/or

(4) A rate adjustment request denied by the Department pursuant to
Secfions 57920 through 57924, except anticipated program changes that
were not approved because funding was not appropriated for that pur-
pose.

(b) The vendor shall file the appeal with the Deputy Director within
12 months after the receipt of written notificafion from the Department
of the vendor's rate.

(c) If an appeal is not filed within the time specified, it shall be denied
unless good cause pursuant to Secdon 57946 is established for the late
submission. Good cause shall be determined by the Deputy Director in
accordance with Section 57946. If good cause for late submission is es-
tablished, the Deputy Director shall proceed to decide the appeal in ac-
cordance with Section 57941.

Page 292.50

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57944

NoTH: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691 and
4791, Welfare and Institutions Code.

History

2. Ceilificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
fded 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)( 1 ) and NoTi: filed 1 1-5-91 as an emergency; op-
erative 1 1-5-91 (Register 92. No. 21 ). A Certificate of Compliance must be
transmitted to OAL 3-4-92 or emergency language will be repealed by opera-
tion of law on the following day.

4. Amendment of subsection (a)( 1 ) and Note refiled 3—4-92 as an emergency; op-
erative 3-4-92 (Register 92, No. 25). A Certificate of Compliance must be
transmitted to OAL 7-2-92 or emergency language will be repealed by opera-
tion of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including repealer of forms trans-
mitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 57941. Contents of Appeal and Decision.

(a) The appeal filed pursuant to section 57940 shall be in writing and
shall include the following:

(1) Vendor program information specified in section 57433(a)(1)
through (4);

(2) Identification of the rate error or effective date being appealed;

(3) The specific basis of the appeal; and

(4) All suppoiting documentation and any other information necessary
to substantiate and/or justify the appeal including the specific regulation
used as the basis for the appeal.

(b) At the time the vendor files the appeal with the Deputy Director,
a copy shall be mailed to the vendoring regional center, and utilizing re-
gional center(s), if any.

(c) Within 15 days after receipt of the appeal, the Deputy Director shall
review the appeal to determine whether it complies with sections 57940
and 57941(a).

( 1 ) If all required information has been submitted, the Deputy Director
shall render a decision pursuant to (d);

(2) If all required information has not been submitted and/or additional
information is needed, the Deputy Director shall request the additional
information, in writing, from the appellant within 15 days after receipt
of the appeal. The appellant shall submit the additional information with-
in 15 days after receipt of the request.

(A) If the information is not submitted within the tiine specified, the
appeal shall be deemed withdrawn and no further action shall be taken
unless the appellant establishes good cause pursuant to section 57946, for
the late submission. Good cause shall be determined by the Deputy Di-
rector, in accordance with section 57946. If good cause for late submis-
sion is established and the information is submitted, the Deputy Director
shall proceed with the appeal and render a decision pursuant to (d);

(B) If the information is submitted but does not comply with the re-
quest, the appeal shall be deemed withdrawn and no further action shall
be taken.

(d) The Deputy Director shall render a decision on the appeal within
60 days after receipt of all required and/or requested information. The de-
cision .shall:

( 1 ) Identify the specific issue(s) in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling; and

(4) Identify the statutes and regulations upon which each ruling is
based.

(e) A written copy of the decision shall be mailed to the appellant, the
vendoring regional center, and utilizing regional center(s). if an} . within
15 days after the decision is rendered.

(f) If the appellant does not appeal the decision to the Director, pur-
suant to secfion 57942, it shall be deemed final.

NOTI:: Authority cited: Section 4691, Wel*are and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance mu>t be transmitted to OAL by 1 0-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9 28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 57942. Appeal of Deputy Director's Decision.

(a) The appellant may appeal the Deputy Director's decision to the Di-
rector within 15 days after receipt of the written decision. The appeal
shall be in writing and shall include the following:

(1) All information submitted to the Deputy Director pursuant to sec-
tion 57941(a);

(2) A copy of the Deputy Director's decision; and

(3) A statement of the issue(s), facts, documentation, and supporting
authority identifying why the appellant believes the decision of the
Deputy Director should be reversed by the Director.

(b) Within 30 days after receipt of the appeal, the Director or the Chief
Deputy Director shall review the appeal and determine whether addition-
al information upon which to base a decision is needed from the appellant
utilizing the process specified in section 57941(c).

(c) Within 60 days of receipt of all required and/or requested informa-
tion, the Director or the Chief Deputy Director shall render a decision uti-
lizing to the process specified in section 57941(d).

(d) A written copy of the decision shall be sent to the appellant, the
vendoring regional center, and udlizing regional center(s), if any, within
15 days after the decision is rendered.

(e) An appeal filed with the Director is the final level of appeal. The
decision rendered by the Director or the Chief Deputy Director shall be
deemed final.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147 and Sections
4691 and 4791(i), Welfare and Institutions Code. Reference: Sections 4691 and
4791, Welfare and Insdtutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9 28 -90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 57944. Effective Date of Decision.

The effecdve date of the decision rendered pursuant to Sections 57941
and 57942 shall be stated in the decision. The effective date shall be the
date the Department received the appeal pursuant to Section 57940 or the
date the costs are incurred, whichever is later.

Note; Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691 and 4791(1), Welfare and Institutions Code. Reference: Sections 4691 and
4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergencj; operative 7- 1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by fO-29 90
or emergency language will be repealed by operation of law on the follow ing
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28 90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6 17 93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Regi-ster 93, No. 26).

Page 292.50(a)

§ 57946

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 57946. Good Cause.

(a) For the purposes of sections 57940 through 57944, good cause tor
a failure to act is limited to:

(1 ) A violent act of nature, including, but not limited to. flood, earth-
quake, blizzard or fire; and/or

(2) Arson, vandalism and/or theft of records and/or property, by indi-
viduals other than the appellant, which preclude the appellant from filing
a timely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days
after the vendor has notice of the incident giving rise to its claim of good
cause, submit to the Deputy Director or the Director, as appropriate, the
basis for its claim of good cause and all supporting documents or other
evidence to substantiate its claim. The Deputy Director. Director or Chief
Deputy Director, whichever is appropriate, shall, within 30 days of re-
ceipt of, the claim and supporting documentation, review the information
and render a decision regarding whether good cause has been estab-
lished.

(c) The Deputy Director. Director or Chief Deputy Director, as appro-
priate, shall notify the appellant in writing of the good cause determina-
tion, and shall specify what action shall be taken, if any. pursuant to sec-
tions 57941 through 57944.

NOTK: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4691 and 4791{i), Welfare and Institutions Code. Reference: Sections 4691 and
4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

§ 57948. Review of Documents Only.

An appeal made pursuant to sections 57940 through 57946 shall be de-
cided only on the documents submitted. Tliere shall be no oral testimony
or argument.

NOTE; Authority cited: Section 4691, Welfare and Institutions Code. Reference:
Section 4691, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of forms filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of forms filed as an emergency 6-17-93; operative 6-17-93. Sub-
mitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of
1992) Section 147(a) (Register 93, No. 26).

5. Amendment of form DS1897 Instructions filed 6-20-94 as an emergency; op-
erative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722.
Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

7. Editorial correction of form (Register 96, No. 13).

8. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

Page 292.50(b)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57948

•

Appendix B to Subchapter 12

State of California — Health and Welfare Agency

Department of Developmental Services

COMMUNITY-BASED DAY PROGRAMS COST STATEMENT

DS 1897(12/92)

Reporting Period .

J9_

throu.eh

Page

2. Vendor Name

3. Vendor Number

Service Code

Subcode

4. Business Address

Street

City

State

Zip

5. Mailing Address

Street

City

State

Zip

6. Management Organization Name (if applicable)

7. Service Director

Telephone Number
( )

PROGRAM INFORMATION

8. Name of Vendoring Regional Center:

9. Name of User Regional Centers:

Temporary payment rate applicants only
10. Date service began or will begin:

, 19.

TEMPORARY PAYMENT RATE APPLICANTS STOP HERE AND SIGN LINE 21

PERMANENT PAYMENT RATE APPLICANTS COMPLETE REMAINDER OF PAGE

1 1 . Actual cHent days

12. Actual client hours

VENDOR COSTS

13. Salaries and Wages

lt>

13a. Average Salary and Wage and fringe benefit

14. Fringe Benefits

15. Operating Expenses (/rem /7fi(ge 4, /me 7 7J

16. Management Organization Costs (from page 5, line 2)

17. Negotiated Level of Payment Adjustment (from page 6, line 4)

18. TOTAL COST $

19. VENDOR INCOME (from page 5, line 5) ( )

20. NET COST $

21 . I hereby certify to the best of my knowledge and belief that this cost statement is true and correct, and complies with the requirements of Til
Sections 57422 through 57439.

Signature

Date

[The next page is 292.51.]

Page 292.50(c)

Title 17

Health and Welfare Agency — Department of Developmental Services

{} 57948

State of California — Health and Welfare Agency
DS 1X97(12/92)

Department of Developmental Services

Paue 2

UNITS OF SERVICE AND STAFFING

FOR ACTIVITY CENTERS, ADULT DEVELOPMENT CENTERS
AND BEHAVIOR MANAGEMENT PROGRAMS ONLY

Vendor Name:

Vendor Number:
Service Code: _

.Subcode:

Number of direct service hours operated per day:

Month

Year

Staff Hours for
Direct Senice

Senice
Days

3
Clients Enrolled

Client Days
of Attendance

JANUARY

FEBRUARY

MARCH

APRIL

MAY

JUNE

JULY

AUGUST

SEPTEMBER

OCTOBER

NOVEMBER

DECEMBER

Page 292.51

§ 57948

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

State of California — Health and Welfare Agency
DS 1897(12/92)

Department of Developmental Services

Page 3

UNITS OF SERVICE AND STAFFING

FOR SOCIAL RECREATION, INDEPENDENT LIVING
AND INFANT DEVELOPMENT PROGRAMS ONLY

Vendor Name:

Vendor Number:
Service Code: _

.Subcode:

Month

Year

Staff Hours

for

Direct Ser\'ice

Authorized
Direct Ser\'ice
Hours

Authorized

Number of

Clients

Number of

Clients Receiving

Sen'ice

Actual

Hours of

Attendance

JANUARY

FEBRUARY

MARCH

APRIL

MAY

JUNE

JULY

AUGUST

SEPTEMBER

OCTOBER

NOVEMBER

DECEMBER

Page 292.52

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57948

State of California — Health and Welfare Agency
DS 1897(12/92)

Vendor Name: _
Vendor Number:
Service Code: _

Department of Developmental Services

Page 4

.Subcode:

OPERATING EXPENSE SHEET

1 . Accounting fees

2. Bank service fees

3. Communication costs

4. Contractual/consultant fees

5. Depreciation costs

6. General expenses

7. Insurance costs

8. Janitorial fees

9. Legal fees

10. Maintenance costs

1 1 . Office and program supplies

12. Rental and lease costs

13. Staff training costs

1 4. Travel costs

15. Utility costs

1 6. Vehicle depreciation

1 7. TOTAL OPERATING COSTS (to page 1, line 75)

Page 292.53

§ 57948

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

State of California — Health and Welfare Agency
DS 1897(12/92)

Vendor Name:

Vendor Number:
Service Code:

Department of Developmental Services

Page 5

Subcode:

MANAGEMENT ORGANIZATION COST

1 . Total allowed cost

2, Amount allocated to this service
(to page ], line 16)

3 Method for allocating cost (check one)

LJ Hours of attendance

LJ Days of attendance

L-J Total cost for each service

VENDOR INCOME

4. Name of Vendor
Income Source

Duration of Funding

Total Income

5. Total (to page 1, line 19)

Page 292.54

Title 17 Health and Welfare Agency — Department of Developmental Services § 57948

Slate of California — Health and Welfare Agency Department of Developmental Services

])S 1897(12/92) Page 6

APPLICABLE ONLY TO VENDORS WHO NEGOTIATED A LOWER LEVEL OF PAYMENT

Vendor Name:

Vendor Number:

Service Code: Subcode:

REGIONAL CENTER PAYMENT INFORMATION

A BCD

Total Amount of Actual Maximum Amount of

Name of Regional Center Regional Center Payment Regional Center Payment Difference

Total

3. Total amount of cost reductions
implemented as a result of the
negotiated level of payment.

4. Enter the lesser of line 2D or line 3.

(to page 1, line 17)

Page 292,55 Register 96, No. 13; 3-29-96

§ 57948

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

INSTRUCTIONS

Form DS 1897 (6/94) — Page 1
Line

1 . Enter the reporting period of this cost statement.

2. Enter vendor name.

3. Enter the vendor number, service code, and subcode.

4. Enter the address where the vendored service is located.

5. Enter the mailing address for the vendored service.

6. Enter the name of the management organization, if the service is affiliated with a management
organization.

7. Enter the name of the service director and telephone number for the vendored service.

8. Enter the name of the vendoring regional center.

9. Excluding the vendoring regional center, enter the names of all regional centers for which you
provide services.

10. If you are applying for a temporary payment rate, enter the date you began or intend to begin
providing services.

Reference
57431

57433 (a)(1)

57433(a)(1)

57433 (a)(2)

57433(a)(1)

57433 (a)(3)
57433 (a)(2)

57433 (a)(4)

57433(c)(1)

VENDORS REQUESTING A TEMPORARY PAYMENT RATE. GO TO LINE 21
VENDORS REQUESTING A PERMANENT PAYMENT RATE. COMPLETE LINES 11 THROUGH 21

11 & 12. Enter the total actual number of client days or hours of attendance during this reporting period, 57422 (a)(2)(A) or (B)
from page 2, column 4 or page 3, column 5.

13. Enter the total gross salaries and wages, including overtime, and staff relief time for the vendored 57434 (a)(1)(A)
service.

13a. Add the total salary and wage and fringe benefits for the direct service function. Divide this total by 57434 (a)(1)(B)
the total hours of employment for the direct service function. Enter this amount.

14. Enter the total allowable fringe benefits associated with the salaries and wages on line 13 above. 57434 (a)(2)

15. Enter the total allowable operating expenses from page 4. line 17. 57434 (a)(3)

16. Enter the total allowable management organization costs from page 5, line 2. 57434 (a)(4)

17. Enter the amount from page 6, line 4 57439 (b)

18. Enter the total of lines 13, 14, 15, 16, and 17.

19. Enter the total allowable vendor income from page 5, line 5. 57438

20. Subtract line 19 from line 18.

21. Sign and date Statement of Certification. 57430 (a)

TEMPORARY PAYMENT RATE VENDORS: INCLUDE WITH THE 57433 (a)(5)

SIGNED COST STATEMENT, A COPY OF THE PROGRAM 57433 (c)(2)

DESIGN AND VENDOR APPROVAL LETTER.

PERMANENT PAYMENT RATE VENDORS: INCLUDE WITH THE 57433 (a)(5)

SIGNED COST STATEMENT, A COPY OF THE PROGRAM DESIGN.

Page 292.56

Title 17 Health and Welfare Agency — Department of Developmental Services § 57948

INSTRUCTIONS

Page 2 — UNITS OF SERVICE AND STAFFING

Page 2 applies to Activity Centers, Adult Development Centers and Behavior Management Programs only.

For Social Recreation, Independent Living and Infant Development Programs proceed to page 3.

This page is to report monthly data on the amount of staff hours used to perform the direct service function and the units of service
provided. Unlike subsequent pages, data on this page is not transferred to page 1 but is used to verify the vendors annual staffing
ratio per Section 57444.

Column Reference

1 . Enter the number of direct service hours actually provided to clients each month. Direct 57433 (b)( 1 )
service hours are defined as the number of hours during which direct services were 57210 (a)(3)
provided to clients by direct care staff and, for vendors reimbursed for absences, the number

of direct service hours for which the vendor received reimbursement.

2. Enter the number of days in which the service was actually provided to clients each month, which shall 57433 (b)(2)(C)
include the number of days for which reimbursement for absences was received.

3. Enter the maximum number of clients enrolled each month. 57433 (b)(2)(A)

4. Enter the actual number of days of attendance each month for all clients, which shall include the 57433 (b)(2)(B)
the actual number of client days for which reimbursement for absences was received.

Page 292.57 Register 96, No. 13; 3-29-96

§ 57948 BARCLAYS CALIFORNIA CODE OF REGULATIONS Title 17

INSTRUCTIONS

Page 3 — UNITS OF SERVICE AND STAFFING

Page 3 applies lo Social Recreation. Independent Living, and Infant Development Programs only.

Column Reference

1 . Enter the number of direct service hours actually provided to clients. Direct service hours are 57433 (b)(1)
defined as the number of hours during which direct services were provided to clients by 57210 (a)(3)
direct care staff and, for vendors reimbursed for absences, the number of direct service

hours for which the vendor received reimbursement.

2. Enter the authorized number of direct service hours each month for all clients. 57433 (b)(3)(A)

3. Enter the number of clients scheduled to receive services each month within the hours identified 57433 (b)(3)(B)
in column 2.

4. Enter the number of clients who actually received services each month within the hours 57433 (b)(3)(C)
identified in column 2, which shall include the number of clients for whom reimbursement

for absences was received.

5. Enter the actual number of hours of attendance each month for all clients, which shall 57433 (b)(3)(D)
include the actual number of hours for which reimbursement for absences was received.

Page 292.58 Register 96, No. 13; 3-29-96

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57948

INSTRUCTIONS

Page 4 — OPERATING EXPENSE DETAIL SHEET

Line Reference

1 . Enter the cost for accounting fees. 57434 (a)(3)(A)

2. Enter the cost for bank service fees. 57434(a)(3)(B)

3. Enter the communication costs including telephone, telegraph, teletype, centrex, telepak, 57434 (a)(3)(C)
postage, message service, facsimiles, and TDD.

4. Enter the cost for contractual/consultant fees that do not have a specific cost category. 57434 (a)(3)(D)

5. Enter the depreciation cost excluding vehicle depreciation which is reported on line 16. 57434 (a)(3)(E)

6. Enter the cost for general expenses. See section referenced for items allowable under 57434 (a)(3)(F)
general expense.

7. Enter the insurance costs. 57434 (a)(3)(G)

8. Enter the janitorial costs. 57434 (a)(3)(H)

9. Enter the cost for legal fees. 57434 (a)(3)(I)

10. Enter the maintenance costs. See section referenced for items allowable under maintenance costs. 57434 (a)(3)(J)

1 1 . Enter the office and program supplies costs. See section referenced for allowable office and supplies 57434 (a)(3)(K)
costs.

12. Enter the rental and lease costs. See section referenced for items allowable under rental and lease costs. 57434 (a)(3)(L)

1 3. Enter the staff training costs. 57434 (a)(3)(M)

14. Enter the travel costs. 57434 (a)(3)(N)

15. Enter the utilities costs. 57434 (a)(3)(0)

16. Enter the vehicle depreciation costs. See referenced section regarding depreciation 57434 (a)(3)(P)
methodology and useful life.

17. Enter the total of lines 1 through 16 here and on page 1, line 15.

Page 292.59

§ 57948 BARCLAYS CALIFORNIA CODE OF REGULATIONS Title 17

INSTRUCTIONS

Page 5 — MANAGEMENT ORGANIZATION COST AND VENDOR INCOME DETAIL SHEET

MANAGEMENT ORGANIZATION COST

Line Reference

1 . Enter the total allowed cost of the management organization. 57434 (a)(4)(C)2.

2. Enter the amount of management organization costs allocated to this service here and on 57434 (a)(4)(C)
page 1, line 16.

3. Check the method of allocation used. 57434 (a)(4)(C)l .a.

57434 (a)(4)(C) Lb.
VENDOR INCOME

4. Enter the name of each source of vendor income, duration of funding, and total income. 57438 (a)

5. Enter the total of all vendor income here and on page 1, Hne 19, 57438 (a)

Page 292.60 Register 96, No. 13; 3-29-96

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 57948

INSTRUCTIONS

Page 6 — REGIONAL CENTER PAYMENT INFORMATION DETAIL SHEET

APPLICABLE ONLY TO VENDORS WHO NEGOTIATED A LOWER LEVEL OF PAYMENT

Regional Center Payment Information

Line

1 . Enter the name of each regional center, total amount of the actual regional center payment
received from the regional center, and maximum amount of the regional center payment which
you would have received from the regional center based upon the established rate and the units
of service actually provided, and the difference between the two amounts.

2. Enter the total amount of all actual regional center payments received and the total of all maximum
amounts of regional center payments, and the total difference between the two amounts.

3. Enter the total amount of cost reductions implemented as a result of the negotiated level of payment.

4. Enter the lesser of the amounts entered on line 2D or line 3 here and on page 1. line 17.

Reference

57439 (a)( 1 )
57439 (a)(2)

57439(a)(1)
57439 (a)(2)

57439 (b)

Page 292.61

§ 58000

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Subchapter 13. Rate-Setting Procedures

for In-Home Respite Services Agency

Vendors

Article 1. Definitions

§ 58000. Terms Defined In Other Subchapters.

(a) As used in Sections 58020 through , the following words and
phrases have the meanings specified in Sections 54302 and 57210:

(1) Authorized Consumer Representative

(2) Consumer

(3) Cost-of-Living Adjustment or COLA

(4) Days

(5) Department

(6) Director

(7) Family Member

(8) Fiscal Year

(9) Generic Agency

(10) In-Home Respite Services

(11) Level of Payment

(12) Like Programs

(13) Management Organizations

(14) Profit or Surplus

(15) Public Agency

(16) Regional Center

(17) Regional Center Payments

(18) Service Code

(19) Straight-Hne Depreciation

(20) Subcode

(21) User Regional Center or Utilizing Regional Center

(22) Vendor ^

(23) Vendor Identification Number

(24) Vendoring Regional Center

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Section 4690.2, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)('7) and (a)(ll) and subsection renumbering and amend-
ment of Nori: filed 11-5-91 as an emergency; operative 11-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

4. New subsections (a)(7) and (a)(ll) and subsection renumbering and amend-
ment of Note refiled 3-4-92 as an emergency; operative 3^4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

5. Certificate of Compliance as to 3-4-92 order including adoption of subsecfion
(a)(17) and subsection renumbering transmitted to OAL 6-25-92 and filed
8-6-92 (Register 92, No. 33).

6. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

7. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

8. Change without regulatory effect amending subsecdons (a)(1) and (a)(2) filed
1-17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

§ 58010. Additional Terms Defined.

(a) As used in sections 58020 through 58448. the following words and
phrases have the following meanings:

( 1 ) "Allowable Range" means the distance from the lower limit to the
upper limit in a distribution of amounts among like programs determined
pursuant to step four, section 581 13;

(2) "Direct Service Hours" means the number of hours during which
a respite worker provides care to a consumer in the consumer's place of
residence and, for vendors reimbursed for absences pursuant to Section
54326(a)(12), the number of direct service hours for which reimburse-
ment was received shall also be included;

(3) "Gap" means the difference between the amount determined for
each vendor in step five, section 58 1 14 (a)( 1 ) and the amount determined
for each vendor in step two, section 581 1 1 based upon allowable cost and
direct consumer service hours reported to the Department;

(4) "Gap Funding" means an amount of funds appropriated in the Bud-
get Act pursuant to Section 58320:

(5) "Lower Limit" means the lowest amount allowed in the distribu-
tion of amounts among like programs, without an increase in the amount
pursuant to step six, section 581 15;

(6) "Permanent Payment Rate" means a rate established by the Depart-
ment subsequent to the effective date of sections 58000 through 58448,
which is based upon each vendor's service, allowable cost, direct service
hours, vendor income, and as applicable, regional center payment infor-
mation;

(7) "Temporary Payment Rate" means a rate established by the De-
partment subsequent to the effective date of sections 58000 through
58448, for vendors who do not have an actual cost history which the De-
partment can use to establish a permanent payment rate;

(8) "Upper limit" means the highest amount allowed in the distribution
of amounts among like programs, without a decrease in the amount pur-
suant to step six, section 581 15; and

(9) "Vendor Income" means all income received from any public
agency, with the exception of the Department or regional centers, for ser-
vices to consumers pursuant to section 58038.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(6) and Note filed 8-6-92; operative 8-6-92
(Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operafive 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsection (a)(2) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsections (a)(2)-(a)(4), repealing
subsections (a)(7) and (a)(8), renumbering subsections, and amending newly
designated subsection (a)( 1 1 ) filed 1 - 1 7-97 pursuant to section 1 00, dtle 1 , Cal-
ifornia Code of Regulations (Register 97, No. 3).

Article 2. General Provisions

§ 58020. General Requirements.

(a) If a vendor serves both consumers and persons other than consum-
ers, the vendor shall:

(1) Report only the service, cost and vendor income information re-
lated to services to consumers; and

(2) Allocate its costs and vendor income to consumers and to other per-
sons served by the vendor based upon the total actual number of direct
service hours.

(b) If a vendor operates more than one service and the services share
costs and/or vendor income, the vendor shall allocate these costs and/or

Page 292.62

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58033

vendor income based upon each service's representative share of the cost
and/or vendor income.

Nt)TK: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Section 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New .section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by fO-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
tiled 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)-(a)(2) filed
1-17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

Article 3.

Submission of Required
Information

§ 58030. Submission of Information.

(a) Each in-home respite services agency vendor shall submit the ser-
vice, cost and vendor income information specified in Sections 58033
through 58038, and as applicable, the regional center payment informa-
tion specified in Section 58039, on Form DS 1 897B, dated 1 2/92, entitled
In-Home Respite Services Agency: Service, Cost and Vendor Income
Statement, for each service for which the vendor is requesting that a rate
be established. The vendor shall sign and date Form DS 1 897B which in-
cludes a certification that the information is true, correct and complies
with Sections 58020 through 58039. The vendor shall submit the original
document to the Department with a copy of this document submitted to
the vendoring regional center at the same time the original document is
submitted to the Department.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690.2 and 479 l(i). Welfare and Institutions Code. Reference: Sections 4690.2,
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language wiU be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsecfion (a) and Note filed 8-6-92; operafive 8-6-92 (Regis-
ter 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prinfing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Ceitificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 58031 . Reporting Periods for Submission of Information.

(a) Information submitted pursuant to sections 58033 through 58039
shall cover the following reporting periods:

( 1 ) For vendors receiving a temporary payment rate and whose tempo-
rary payment rate will be converted to a permanent payment rate, the re-
porting period shall be 12 consecutive months of representative actual al-
lowable cost information, incurred within 18 months from the date the
temporary payment rate became effective. The Department may grant an
extension of the temporary payment rate for a period of up to six months
if the vendor is unable to submit the required cost information due to
delayed consumer enrollment into the program; and

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690.2 and 4791, Welfare and Institutions Code. Reference: Sections 4690.2,
4691, 4691. .5 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language wi]J be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and NOTi; filed 8-6-92; operative 8-6-92 (Regis-
ter 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1. California Code of Regulations (Register 97, No. 3).

7. Amendment of subsection (a)(1) filed 4-25-2000; operative 5-25-2000 (Reg-
ister 2000, No. 17).

§ 58032. Required Due Dates for Submission of
Information.

(a) The required dates for submission are as follows:

(2) Prior to expiration of the temporary payment rate for those vendors
who received an extension pursuant to Section 58031(a)(1);

(4) At the time the vendor requests establishment of a temporary pay-
ment rate, for vendors requesting a temporary payment rate.

(b) If the information is received by the dates specified in (a), the ven-
doring regional center and the Department shall review the information
pursuant to Sections 58040 and 58042.

(c) If the information is not received by the dates specified in (a), the
Department shall within 15 days, notify in writing, the vendor, the ven-
doring regional center, and utilizing regional center(s), if any, as follows:

(1) For the following vendors that payment of the vendor's rate was
suspended, the effective date of the suspension and that payment .shall re-
main suspended until the information is received:

(A) For vendors required to submit information pursuant to (a)( 1 ), sus-
pension is effective at the end of 1 8 months, unless an extension has been
granted pursuant to Section 58031(a)(1); and

(B) For vendors who have received an extension of their temporary
payment rate pursuant to Secfion 58031(a)(1), suspension is effective
upon termination of the extension;

(C) For vendors required to submit information pursuant to (a)(3), sus-
pension is effective on September 30, 1996, and each alternate Septem-
ber 30 thereafter.

(2) This provision does not apply to vendors requesUng a temporary
payment rate since the Department cannot initiate any action until the
vendor submits its request for establishment of a temporary payment rate.

(d) If the information is submitted after the dates specified in (a) when
payment of the vendor's rate has been suspended, the vendoring regional
center and the Department shall review the information pursuant to Sec-
tions 58040 and58042 and the Department shall authorize the vendoring
regional center and utihzing regional center(s), if any, to reinstate pay-
ment of the vendor's rate as of the date payment was suspended.
NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of CompHance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28 90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
secfion 100, title 1, California Code of Regulations (Register 97, No. 3).

4. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000. No. 17).

§ 58033. Required Service Information.

(a) In order for the Department to establish a temporary payment rate
or permanent payment rate, the vendor shall submit the following service
information:

(1) Vendor name, and name of the management organization, if any,
vendor identification number, service code and subcode;

(2) Office telephone number, business and mailing addresses;

Page 292.63

§ 58034

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(3) Name of the service director;

(4) Name of the vendoring regional center and utihzing regional cen-
ter(s), if any; and

(5) A copy of the service design which was submitted to the vendoring
regional center pursuant to section 54310(a)(10)(F).

(b) In addition to the information in (a), vendors requesting a perma-
nent payment rate shall also submit the total actual number of direct ser-
vice hours for all consumers and, for vendors reimbursed for absences
pursuant to Section 54326(a)( 1 1 ), the number of direct service hours for
which reimbursement was received shall also be included.

( 1 ) The date that the vendor began, or intends to begin, providing ser-
vices to consumers; and

(2) A copy of the vendorization approval letter specified in section
54322(d).

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4690.2,
4691, 4691..'S and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsections (a)(5) and (c)(2) filed 8-6-92; operative 8-6-92
(Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsection (b) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsections (b), (c)(1) and (c)(2)
filed 1-17-97 pursuant to section 100, title 1, California Code of Regulations
(Register 97, No. 3).

9. Change without regulatory effect amending subsection (b) filed 1-14-2003 pur-
suant to section 100, title 1, California Code of Regulations (Register 2003, No.
3).

§ 58034. Required Cost Information.

(a) In order for the Department to establish a permanent payment rate,
the vendor shall submit information for the following allowable costs if
they are incurred by the vendor and are necessary for the vendored ser-
vice.

( 1 ) Total gross salary and wages including overtime for the staff func-
tions specified in Section 56792.

(2) Fringe benefit costs associated with the salary and wage costs for
the staff functions identified in (1) which shall be limited to the follow-
ing:

(A) Old Age Security Disability Insurance (OASDI) or Federal Insur-
ance Compensation Act (FICA);

(B) Workers' compensation;

(D) Life insurance;

(E) Health insurance;

(F) Dental insurance;

(G) Retirement;

(H) Vision insurance;

(I) Employee Training Tax as specified in the California State Unem-
ployment Insurance Code Section 976.6; and
(J) Long-term disability insurance.

(3) Operating expenses which shall not duplicate other allowable costs
and shall be limited to the following cost categories:

(A) Accounting fees of the vendor for the establishment and mainte-
nance of accounting records and other information systems required for
the fiscal management of the vendored service;

(B) Bank service fees of the vendor;

(C) Communication costs for services including telephone, telegraph,
teletype, centrex, telepak, postage, message services, facsimiles and
TDD;

(D) Contractual/consultant fees for service operation that do not have
a specific cost category;

1 . Buildings which have been purchased by the vendor;

2. Furniture and equipment which has been purchased by the vendor
and has a unit acquisition cost of at least $500 and a normal useful life
of at least four years; and

3. Capital improvements that add to the value or useful life of the build-
ing or equipment. Capital improvements shall be treated as a permanent
investment to be added to the cost basis of the building or equipment and
charged to depreciation.

(F) General expense costs for the following items only:

1 . Furniture and equipment which do not meet the criteria specified in
(E)2;

2. Interest on loans attributable to the vendored service;

3. Subscriptions for periodicals which are used in the operation of the
vendored service or for the purpose of staff development;

4. Staff recruitment costs; staff screening costs, such as fingerprinting
prospective employees; and staff hiring costs which shall include the
costs for physical examinations or other health and safety costs that may
be required prior to employment;

5. Fees for licenses, certifications, registrations or permits, if neces-
sary for vendorization or the continued operation of the service subse-
quent to vendorization;

6. Accreditation fees;

7. Association dues or fees;

8. Costs for providing or preparing information related to the vendored
service which is used as general information to the consumers or to the
authorized consumer representatives;

9. Local business fees or taxes;

10. Costs related to inoculations or clinical tests of an employee, for
the employee's or consumer's health and safety; and

1 1 . Fuel and oil.

(G) Insurance costs;
(H) Janitorial fees;
(I) Legal fees;

(J) Maintenance costs for repair and upkeep of furniture and equip-
ment, vehicles, buildings and grounds which neither adds to the perma-
nent value nor prolongs its useful life, but maintains it in an efficient op-
erating condition;

(K) Office supply costs;

1 . Furniture and equipment;

2. Vehicles; and

3. Buildings.

(M) Staff training costs for in-service training and employee develop-
ment which meet the requirements specified in Section 56794;

(N) Staff travel costs which are specifically related to the administra-
tion of the vendored service.

(O) Utility costs such as gas, electricity, water, garbage, sewer fees or
other utility expenses which occur at the vendored service site;

(P) Vehicle depreciation cost for owned vehicles shall be calculated
by using the straight-ling depreciation method and the minimum normal
service life which is allowed by the Urban Mass Transportation Adminis-
tration. The minimum normal service life for vehicles such as regular and
specialized vans and cars is at least four years for service or an accumula-
tion of at least 100,000 total miles on the vehicle.

Page 292.64

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58039

(4) Management organization costs which:

(A) Shall include for staff functions of the management organization,
the allowable costs specified in (a)(1) through (3) of this section.

(B) Shall not include:

1 . More than 1 00 percent of the allocated costs of the management or-
ganization;

2. Costs applicable to or claimed by other services operated by the ven-
dor.

3. Any non-allowable costs pursuant to Section 58036; and

4. Costs for respite worker staff.

(C) Shall be allocated on a basis consistent with the administrative
support provided to each separate service, and each vendor shall:

1 . Indicate whether the methodolgy used to allocate the costs of the
management organization is based upon.

a. Direct service hours; or

b. Tlie total costs of each service.

2. Include the total allowed costs of the management organization for
the reporting period.

(b) Cost information submitted pursuant to (a) shall not include respite
worker travel costs. These costs shall be reimbursed pursuant to Sections
58130 and 58132.

Note.- Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order tiansmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)(3)(F)8. and
(a)(3)(F)10. filed 1-17-97 pursuant to section 100, title 1, California Code of
Regulations (Register 97, No. 3).

4. Amendment of subsections (a)( I ), (a)(2)(I), (a)(3)(F)2., (a)(3)(F)9., (a)(4)(B)3.
and (b) filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§ 58036. Costs Not to Be Reported.

(a) Non-allowable costs shall not be reported, and are limited to the
following:

(1) Camperships, student aid funds and scholarships;

(2) Consumer entertainment and admission fees;

(3) Consumer moving expenses;

(4) Contractual/consultant fees for individual services which can be
obtained through a generic agency and which the generic agency is legal-
ly responsible to provide;

(5) Depreciation costs for furniture, equipment, buildings or vehicles
that are donated, secured or purchased through government grants;

(6) Depreciation costs for owned land;

(7) Donated services, buildings, furniture, equipment or vehicles;

(8) Donations to other agencies;

(9) Employee bonuses and commissions;

(10) Office furniture, equipment, or vehicle rental or lease costs asso-
ciated with items which are owned by a management organization, its af-
fiUates or a commonly owned entity; and are leased or rented back to the
management organization, its affiliates or a commonly owned entity, or
the services it operates, when submission of such costs would result in
the vendor being reimbursed twice for the same costs;

(11) Federal/state income tax and penalties or fees associated with
payment of federal or state income taxes;

(12) Fund raising costs;

(13) Gifts for consumers or employees;

(14) Legal fees directly related to a consumer, or expenses for the
prosecution of claims against the regional center or state agencies;

(15) Management organization costs pursuant to Section 58034
(a)(4)(B);

(16) Payroll tax penalties;

(17) Profit;

(18) Public relations costs;

(19) Refundable deposits;

(20) Supplements to consumers for their daily living needs;

(21) Surplus as defined in Section 57210(a)(l 1); and

(22) Travel costs associated with transporting consumers to or from
the vendored service site except for emergencies when the consumer' s
health and safety is at risk.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency: operative 7-1-90 (Register 90.
No. 36), A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a)(20) filed 8-6-92; operative 8-6-92 (Register 92,
No. 33).

4. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulafions (Register 97, No. 3).

5. Amendment of subsection (a)(I5), new subsection (a)(16), subsection renum-
bering and amendment of newly designated subsection (a)(21) filed
4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

§ 58038. Required Vendor Income Information.

(a) In order for the Department to establish a permanent payment rate,
the vendor shall submit the following vendor income information:

( 1 ) The name of each vendor income source;

(2) The total amount of vendor income received from each source; and

(3) The duration of funding provided by each vendor income source.

(b) Vendor income shall not include income:

(1) Received from private sources;

(2) Used for non-allowable costs or for persons other than consumers;
and

(3) Received from the Department or regional centers.

NOTE: Authority cited: Section 4690.2, Welfare and InsUtutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2 . Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (b)(2) filed I-I7-97
pursuant to secfion 1 00, title I , California Code of Regulations (Register 97, No.
3).

§ 58039. Required Regional Center Payment and Vendor
Cost Reduction Information.

(a) In order for the Department to establish a permanent payment rate
for vendors whose temporary payment rate is being converted to a per-
manent payment rate, or for vendors whose permanent payment rate is
being established, each vendor who agreed, pursuant to Section 57300(d)
or Section 58140, to a negotiated level of payment shall submit regional
center payment information for each regional center with whom the ven-
dor agreed to a negotiated level of payment as follows:

( 1 ) The total amount of the actual regional center payments which the
vendor received for services provided to consumers during the reporting
period; and

(2) The maximum amount of the regional center payment which the
vendor would have received during the reporting period, had the vendor
not agreed to a negotiated level of payment. The maximum amount of the
regional center payment shall be computed by multiplying the vendor's
estabhshed temporary payment rate or permanent payment rate for the
reporting period, by the actual number of direct service hours which the
vendor charged and invoiced the regional center for services provided to
consumers.

(b) In addition to the information specified in (a) above, each \endor
who agreed, pursuant to Section 57300(d) or Section 58140, to a nego-
tiated level of payment shall submit the total amount of cost reductions
implemented as a result of the agreed upon lower level of payment.

(c) The provisions of this section shall not apply to respite services pro-
vided to family members as a result of a voucher as specified in Section
57310(a)(3), (a)(12), (b)(3) and (b)(12).

Page 292.65

§ 58040

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTH: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4690.2,
4691. 4691.5 and 4791, Welfare and Institutions Code.

History

1. New section filed 8-6-92: operative 8-6-92 (Register 92, No. 33).

2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

3. Amendment of subsection (c)(1) filed 6-20-94 as an emergency; operative
6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, Statutes
of 1992, Section 147 (Register 94, No. 25).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

5. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

6. Change without regulatory effect amending subsections (a)( 1 ), (a)(2) and (b)(2)
filed 1-17-97 pursuant to secdon 100, Utfe 1, California Code of Regulations
(Register 97, No. 3).

7. Amendment filed 4-25-2000; operative 5-25-2000 (Register 2000, No. 17).

Article 4. Review Requirements

§ 58040. Vendoring Regional Center Review Procedures.

(a) Vendoring regional center review procedures shall apply only to
the establishment of permanent payment rates, including conversion of
temporary payment rates to a permanent payment rate.

(b) Within 30 days from the date of the Department's written notifica-
tion pursuant to section 58042 (a)(1)(A), the vendoring regional center
shall:

(1) Review the information submitted by the vendor to determine the
following:

(A) That services being provided are consistent with the service de-
sign, pursuant to section 56780;

(B) That the information submitted by the vendor is complete and
complies with sections 58020, and 58033 though 58038; and

(C) Any known inconsistencies in the vendor's reporting of cost and/
or vendor income and/or, as applicable, regional center payment infor-
mation.

(2) Forward a written copy of the review results to the Department and
the vendor.

(c) If the regional center does not notify the Department of the results
of its review pursuant to (b), the Department shall proceed with its review
procedures pursuant to section 58042.

NOTE: Authority cited: Section 4690.2, Welfare and Institudons Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (b)(1)(C) and Note filed 8-6-92; operative 8-6-92
(Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending subsection (a) filed 1-17-97 pur-
suant to section 100, title 1, California Code of Regulations (Register 97, No.
3).

§ 58042. Department Review Procedures.

(a) Department review procedures are as follows:

(1) For vendors whose temporary payment rates are being converted
to permanent payment rates, and for vendors whose permanent payment
rate is being established, the Department shall:

(B) Upon receipt of the information required from the vendoring re-
gional center pursuant to section 58040, or within 50 days of receipt of
the information required from the vendor, review the information to de-

termine if it is coinplete and complies with the requirements of sections
58020, and 58033 through 58039.

(b) If the information is complete and complies with the requirements
of:

(1) Sections 58020, and 58033 through 58039, the Department shall,
for those vendors identified in (a)( 1 ), establish a perinanent payment rate
pursuant to sections 58100 through 581 19; or

(2) SecUon 58033, the Department shall, for those vendors identified
in (a)(2), establish a temporary payment rate pursuant to sections 58120
and 58122.

(c) If the informafion is not complete or does not comply with the re-
quirements of sections 58020, and 58033 through 58039, for establish-
ment of a permanent payment rate, or section 58033, for establishment
of a temporary payment rate,

(1) The Department shall, within the time specified in (a)(1)(B) or
(a)(2):

(A) Make a written request to the vendor for any additional or clarify-
ing information; and

(B) Send a copy of the request to the vendoring regional center and uti-
lizing regional center(s). if any.

(2) The vendor shall submit the required information to the Depart-
ment with a copy to the vendoring and utilizing regional centers, if any,
within 15 days from receipt of the Department's written request:

(A) If the vendor submits the required information within the time spe-
cified, and it is complete and complies with the requirements of:

1. Sections 58020, and 58033 through 58039, the Department shall,
for those vendors idenfified in (a)( 1 ), establish a permanent payment rate
pursuant to sections 58100 through 581 19; or

2. Section 58033, the Department shall, for vendors identified in
(a)(2), establish a temporary payment rate pursuant to sections 58 1 20 and
58122.

1. For those vendors identified in (a)(1):

a. That unless their rate has expired, payment of their rate shall be sus-
pended within 15 days from the date of the Department's written notifica-
tion; and

b. That payment shall remain suspended until the required information
is received.

2. For those vendors identified in (a)(2), that the Department shall take
no further action on their rate request until all required information has
been received.

1. Sections 58020, and 58033 through 58039, the Department shall,
for those vendors identified in (a)(1):

a. Establish a permanent payment rate pursuant to sections 58100
through 581 19; and

b. Authorize the vendoring regional center and utilizing regional cen-
ter(s), if any, to reinstate payment of the vendor' s rate as of the date pay-
ment was suspended. The reinstated rate shall be effective until the new
permanent payment rate is effective.

2. Section 58033, the Department shall, for those vendors identified
in (a)(2), establish a temporary payment rate pursuant to sections 58120
and 58122.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institufions Code.

History
1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90

Page 292.66

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58113

or cnlcrecnc^ languanc will be repealed by operation of law on the following

da\.
2. Ceilifieate of Coniplianee as to 6-26-90 order transmitted to GAL 9-28-90 and

filed 10-29 -90 (Register 90, No. 46).
.\ Amendment of text and NoTi. filed 8-6-92; operative 8-6-92 (Register 92, No.

3.-^).

4. Amendment of seetion filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printinc only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Regrster93, No. 26).

5. Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-^94 (Register 94, No. 31).

6. Change without regulatory effect amending subsection (a)(1) filed 1-17-97
pursuant to section 1 00, title 1 , California Code of Regulations ( Register 97. No.
3).

Subchapter 14. Rate-Setting Methodology

for In-Home Respite Services Agency

Vendors

Article 1 . Permanent Payment Rates

§58100. General Provisions.

(a) The methodology for computing permanent payment rates is based
on service, cost, vendor income, and as applicable, regional center pay-
ment information submitted by all vendors receiving permanent payment
rates. The Department shall use each vendor's service, cost, vendor in-
come, and as applicable, regional center payment information to estab-
lish that vendor's permanent payment rate pursuant to this methodology.
NOTE: Authority cited: Section 4690.2. Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Nori' filed 8-6-92; operative 8-6-92 (Regis-
ter 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 581 1 1 . Step Two: Computing an Amount Using

Allowable Costs and Direct Service Hours.

(a) Step two in the process of determining a permanent payment rate
is to compute an amount for each vendor within the group of like pro-
grams, based on allowable costs and direct service hours. For each ven-
dor, the Department shall compute an amount by:

(1) Determining the total allowable costs as follows:

(A) Add together the total costs reported by the vendor pursuant to sec-
tion 58034;

(B) Subtract from the amount computed in (A) the amount of any non-
allowable costs specified in section 38036, which were identified by the
Department or vendoring regional center during their review of the infor-
mation submitted by the vendor; and

(C) For vendors who agreed to a negotiated level of payment . as speci-
fied in Section 57300(d), and whose temporary payment rate is being
converted to a permanent payment rate, or whose permanent payment
rate is being established, the Department shall increase the amount com-
puted in (B) by:

1 . Subtracting the total amount of the actual regional center payments
which the vendor received for services provided during the reporting pe-
riod, as reported pursuant to Section 58039(a)(1), from the maximum
amount of the regional center payment which the vendor would have re-
ceived during the reporting period, as reported pursuant to Section
58039(a)(2); and

2. Adding the amount computed in 1 . or the total amount of cost reduc-
tions reported pursuant to Section 58039(b), whichever is less, to the
amount computed in (B).

(2) Dividing the total allowable costs coinputed in (1) by the vendor's
actual direct service hours pursuant to section 58033 (b) .

(3) Increasing or decreasing, if applicable, the amount computed in (2)
for any of the following that has occurred from July 1 through September
30 following the reporting period, and which have not been included in
the total allowable costs reported by the vendor:

(A) Increase the amount computed in (2) by the amount of any COLA
authorized in the Budget Act for the fiscal year following the reporting
period;

(B) Increase the amount coinputed in (2) by the amount of any rate in-
crease granted by the Department, as a result of a rate adjustment pur-
suant to sections 58420 through 58424, and/or audit adjustment pursuant
to section 58430, and/or rate appeal pursuant to sections 58440 through
58448; and/or

(C) Decrease the amount computed in (2) by the amount of any rate
decrease issued by the Department, as a result of a rate adjustment pur-
suant to sections 58420 through 58424, and/or audit adjustment pursuant
to section 58430, and/or rate appeal pursuant to sections 58440 through
58448.

NOTE: Authority cited: Chapter 722, Statutes of 1992. Section 147; and Sections
4690.2 and 479 l(i). Welfare and Institutions Code. Reference: Sections 4690.2.
4691. 4691.5 and 4791, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency: operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. New subsections (a)(l)(C)-(C)2. and amendment of subsections (a)( 1 )(A)- (B)
and Note filed 8-6-92; operative 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6 20-94 and
filed 8-2-94 (Register 94, No. 31).

§ 581 1 2. step Three: Computing the Mean.

(a) Step three in the process of determining a permanent payment rate
is the computation of the mean using the amount determined in step two,
section 58111:

( 1 ) Add together the amount computed in step two for each vendor;
and

(2) Divide the sum computed in ( 1 ) by the number of vendors included
in calculating the sum.

NOTE; Authority cited: Section 4690.2. Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

HfSTORY

1. New section filed 6-26-90 as an emergency; operative 7 1 -90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 58113. Step Four: Determination of the Allowable Range
of Rates.

(a) Step four in the process of determining a permanent payment rate
is the computation of an allowable range of rates. The Department shall
determine the upper and lower limits of the allowable range of rates as
follows:

(1) For Fiscal Year 1997-98 and each alternate fiscal year thereafter;

(A) Multiply the mean computed in section 58112 for Fiscal Year
1993-94, by 50 percent to determine the range;

(B) Subtract the lower limit from the upper limit of the allow able range
of rates established for Fiscal Year 1991-92, and adjusted for any COLA
for Fiscal Year 1992-93, to determine the existing range;

Page 292.67

§58114

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(D) The lesser of the two ranges compared in (C) shall be divided by
two;

(E) The upper limit shall be determined by adding the amount com-
puted in (D) to the mean computed pursuant to section 581 12 for Fiscal
Year 1997-98. and each alternate fiscal year thereafter; and

(F) The lower limit shall be determined by subtracting the amount
computed in (D) from the mean computed pursuant to section 581 12 for
Fiscal Year 1997-98, and each alternate fiscal year thereafter.

NOTH: Authoritv cited: Section 4690.2, Welfare and histitutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency: operative 7-1-90 (Register 90,
No. ."^6). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending .section filed 1-17-97 pursuant to
section 100, title I, California Code of Regulations (Regi.ster 97, No. 3).

§ 5811 4. Step Five: Adjusting the Amount Computed in
Step Two for Gap Funding.

(a) Step five in the process of determining a permanent payment rate
is to adjust the amount computed in step two, section 581 1 1, for any
money appropriated pursuant to the Budget Act, to fund the gap com-
puted in Section 58320. The Department shall:

(1) Convert the vendor's current permanent payment rate into an
amount as follows:

(A) Add back any vendor income subtracted out when the Department
computed the vendor's current permanent payment rate. The increased
rate shall become the amount for use in this step;

(B) If no vendor income was used in computing the vendor's current
permanent payment rate, that rate shall become the amount for use in this
step.

(2) If the amount computed in (1):

(A) Is below, or within the allowable range of rates, the gap adjustment
combined with the amount computed in ( 1 ) shall not exceed the upper
limit of the allowable range of rates; or

(B) Exceeds the upper limit of the allowable range of rates, the vendor
shall not be eligible for a gap adjustment.

(3) For those vendors eligible for a gap adjustment pursuant to (2)(A),
the Department shall:

(A) Increase to the upper limit, the difference between the amount
computed in ( 1 ) and the amount computed in step two, section 581 1 1 if
the appropriation in the Budget Act is sufficient to fully cover the state-
wide fiscal impact of the gap computed in Section 58320; or

(B) Increase the amount computed in ( 1 ) up to the upper limit, based
upon the percentage of available funds, if the appropriation in the Budget
Act is insufficient to fully cover the statewide fiscal impact of the gap
computed in Section 58320. The Department shall, for those eligible ven-
dors:

1 . Determine the percentage of available funds by dividing the state-
wide fiscal impact of the gap computed in Section 58320, by the amount
appropriated in the Budget Act;

2. Determine the difference between each vendor's amount as com-
puted in step two, section 581 1 1, and their amount as computed in (1);

3. Multiply the difference computed in 2. by the percentage of avail-
able funds computed in 1.; and

4. Increase the amount computed in (1) by the amount computed in 3.
NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History
1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a)-(a)(I)(B) and
(a)(3)(A)-(a)(3)(B)l. filed 1-17-97 pursuant to section 100, title 1. California
Code of Regulations (Register 97, No. 3).

§ 58115. Step Six: Adjusting the Amount Computed in

Step Five by the Upper and Lower Limit of the
Allowable Range of Rates.

(a) Step six in the process of determining a permanent payment rate is
to adjust the amount computed in step five, section 581 14, by the upper
and lower limit of the allowable range of rates:

( 1 ) For Fiscal Year 1 997-98, and each alternate fiscal year thereafter,
the upper and lower limit adjustment shall be computed as follows:

(A) For vendors whose amount, as determined in step five, is within
the allowable range of rates, the Department shall make no change to that
amount;

(B) For vendors whose amount, as deterinined in step five, is above the
upper limit of the allowable range of rates, the Department shall reduce
that amount to the upper limit;

(C) For vendors whose amount, as determined in step five, is below the
lower hmit of the allowable range of rates, the Department shall increase
the amountto the lower limit, based upon available funds pursuant to
(a)(l)(C)l. through 3.

1 . The amount of available funds to increase the amounts computed in
step five shall be determined as follows:

a. Multiply each vendor's reduction computed pursuant to (1)(B) by
their direct service hours identified in section 58033 (b);

b. Add the amount computed in a. for each vendor to determine the to-
tal available funds from the upper limit reduction pursuant to ( 1 ) (B); and

c. Add to the amount determined in b. any gap funding appropriated
pursuant to the Budget Act, for those vendors specified in section 583 1 0
(a)(1)(A) and (B).

2. The amount of funds needed to increase amounts computed in step
five to the lower limit, shall be determined as follows:

a. Determine the difference between the lower limit and each vendor's
amount as computed in step five;

b. Multiply the difference computed in a. by each vendor's direct ser-
vice hours identified in section 58033 (b); and

c. Add the amounts computed in b. to determine the total amount of
needed funds.

3. The total amount of available funds, as determined in (C) 1., shall
be compared to the total amount of funds needed, as determined in (C)2.

a. If there are sufficient funds to fully fund the lower limit increase, the
Department shall, increase amounts as determined in step five to the low-
er limit.

b. If there are insufficient funds to fully fund the lower limit increase,
the Department shall adjust the difference computed in (C)2.a. by the per-
centage of available funds. The Department shall:

(1.) Calculate the percentage of available funds by dividing the total
amount of available funds, computed in (C)l.c. by the total amount of
funds needed computed in (C)2.c.;

(2.) Multiply the percentage of available funds, by the difference com-
puted in (C)2.a. for each vendor; and

(3.) Increase amounts computed in step five by the amount computed
in (C)3.b.(2).

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

Page 292.68

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58132

3. Change v\ ithoul regulatory effect amending subsections (a)(1) and (a)( 1 )(B) and
repealing subsections (a)( 1 )(C)4.-(a)(2)(B) filed 1-17-97 pursuant to section
100, title 1. California Code of Regulations (Register 97, No. 3).

5j 58117. Step Seven: Adjusting the Amount Computed in
Step Six by Vendor Income.

(a) Step seven in the process of determining a permanent payment rate
is to adjust the amount computed in step six, section 58 11 5, if applicable,
by the amount of any vendor incoine reported by the vendor pursuant to
section 58038 as follows. The Department shall:

(1) Divide vendor income by the vendor's actual direct service hours
identified in section 58033 (b); and

(2) Subtract the amount computed in (1) from the amount computed
in step six.

NoTE; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 58118. Step Eight: Adjusting the Amount Computed in
Step Seven for Budget Act Adjustment.

(a) Step eight in the process of determining a permanent payment rate
is to adjust the amount computed in step seven, section 58 1 1 7, if applica-
ble, for the following that will occur in the fiscal year for which the per-
manent payment rate is established:

( 1 ) COLA authorized in the Budget Act; and/or

(2) Legislative adjustment, for any item of cost(s), specified in the

Budget Act.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 58119. Adjusting the Rate Methodology for COLAs.

(a) For each fiscal year in which a COLA is granted in the Budget Act,
the Department shall increase the mean, computed in step three, section
58112, and upper and lower limits of the existing allowable range of
rates, computed in step four, section 58113. by the percentage of the
COLA.

(c) The effective date of the adjustment to the mean and allowable
range of rates for a COLA pursuant to (a) or (b), shall be the effective date
oi" the COLA specified in the Budget Act.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History
1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,

No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90

or emergency language will be repealed by operation of law on the following

day.
2 Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and

filed 10-29-90 (Register 90, No. 46).

Article 2. Temporary Payment Rate

§ 58120, General Provisions.

(a) The methodology for computing temporary payment rates is based
on service, cost, vendor income, and as applicable, regional center pay-

ment information submitted by all vendors receiving perinanent payment
rates. The Department shall use each vendor's service information to es-
tablish that vendor's temporary payment rate pursuant to this methodolo-
gy-

NOTti: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7 1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0 29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9 28 90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsection (a) and Noti- filed 8-6 92; operative 8- 6 -92 (Regis-
ter 92. No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6 17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6 20-94 and
filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100. title I. California Code of Regulations (Register 97. No. 3).

§ 58122. Establishment of the Temporary Payment Rate.

(a) The temporary payment rate is determined using the same informa-
tion and steps specified in sections 581 10, 581 1 1, 581 12, and 581 19 for
establishing a permanent payment rate.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 10 29 90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9 -28 90 and
filed 10-29-90 (Register 90. No. 46).

Article 3. Supplemental Rate for Respite
Worker Travel Costs

§ 58130. Supplemental Rate for Respite Worker Travel
Costs.

(a) Regional centers shall reimburse the in-home respite service
agency for respite worker travel costs for private vehicle travel or public
transportation which is required in order for the respite worker to travel
to and from and between respite sites. Travel costs shall also include costs
for consumer travel which is necessary in order for the respite worker to
carry out assigned functions.

(b) Respite worker travel costs shall be authorized pursuant to mini-
mum state of California travel reimbursement rates for state employees
pursuant to Welfare and Institutions Code, section 4690.2 (b)(5).
NOTE: Authority cited; Chapter 722. Statutes of 1992. Section 147; and Sections
4690.2 and 4791(i). Welfare and Institutions Code. Reference: Sections 4690.2,
4691. 4691.5 and 4791. Welfare and Institutions Code.

History

1. New secfion filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 (>-29-9()
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6 17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Secfion 147(a) (Register 93. No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20 94 and
filed 8-2-94 (Register 94, No. 31).

5. Change without regulatory effect amending subsection (a) filed 1-17-97 pur-
suant to section 100, fitle 1, California Code of Reeulations (Register 97. .No.
3).

§ 58132. Written Notification of the Supplemental Rate for
Respite Worker Travel Costs.

(a) For vendors receiving a supplemental rate for respite worker tra\ el
cost pursuant to section 58130, the Department shall notify the regional
center in writing of the reimbursement rate. The regional center shall
notify each vendor eligible for this supplemental rate.

Page 292.69

§ 58140

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

NOTI-:; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

Article 4. Negotiating the Level of Payment
When Serving More than One Consumer

§ 58140. Negotiating the Level of Payment When Serving
More Than One Consumer.

(a) Once the Department has established a rate of reimbursement pur-
suant to Sections 58100 through 581 19, for vendors whose temporary
payment rate is being converted to a permanent payment rate and vendors
whose permanent payment rate is being established or reestablished, or
wSections 58120 through 58122 for vendors who are requesting a tempo-
rary payment rate, a regional center, or its designee, and a vendor may
negotiate the level of payment when a family member has more than one
consumer residing with them who has been authorized by the regional
center to receive in-home respite services. The amount of the level of
payment may be less than but shall not exceed the per-consumer per-
hour rate established by the Department and shall only apply to the addi-
tional consumer(s) receiving services.

(b) Each regional center and vendor shall mutually agree in writing
upon the level of payment and the effective date for commencing and ter-
minating payment at the agreed upon amount.

(c) The level of payment negotiated by a regional center and vendor
shall commence on the date agreed to by the regional center and vendor,
and shall terminate on the expiration date specified by the Department in
its written notification to the vendor of the established rate, or earlier, if
an earlier termination date has been mutually agreed to by the regional
center and vendor.

( 1 ) If the level of payment agreed to by the regional center and vendor
terminates on the expiration date specified in the Department's written
notification to the vendor of the established rate, the Department shall:

(A) For those vendors whose established rate is a temporary payment
rate, establish a permanent payment rate, as applicable, pursuant to Sec-
tion 58242 or 58252; or

(B) For those vendors whose established rate is a permanent payment
rate:

1. Reestablish the permanent payment rate during Fiscal Year
1996-97, and each alternate fiscal year thereafter, as specified in Section
58240; or

2. Establish the permanent payment rate during Fiscal Year 1997-98,
and each alternate fiscal year thereafter, as specified in Section 58250.

(2) If the level of payment agreed to by the regional center and vendor
terminates prior to the expiration date specified in the Department's writ-
ten notification to the vendor of the established rate, the vendor shall be
reimbursed at the rate established by the Department until the expiration
of the established rate.

(d) Within the limitations specified in this section, the level of payment
negotiated by a regional center and a vendor may be renegotiated.

(e) Each regional center shall provide the Department and vendor with
a copy of the written agreement specifying the terms of the level of pay-
ment.

NOTE; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1 . New section filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 3-4-92 as an emergency; operative 3^-92 (Register 92.
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-4-92 order including amendment of subsec-
tion (a) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printine onlv pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Regrster 93, No. 26).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

6. Change without regulatory effect amending ailicle heading, section heading,
and subsections (a)4c)(l )(A) and (c)( 1 ){B)L and 2. filed 1-17-97 pursuant to
section 100, title 1. California Code of Regulations (Register 97, No. 3).

Article 5. Payment Rates for Existing
In-Home Respite Services Agency Vendors

§ 58150. Payment Rates for Existing In-Home Respite
Services Agency Vendors.

(a) Existing in-home respite services agency vendors requesting a
payment rate to provide new in-home respite services at an additional
business address shall receive:

( 1 ) A temporary payment rate as specified in Section 58236, 58244 or
58254 if separate vendorization of the additional business address was
not waived pursuant to Section 54342(a)(37); or

(2) The permanent payment rate established for the existing in-home
respite services agency if separate vendorization of the additional busi-
ness address was waived pursuant to Section 54342(a)(37).

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147: and Sections
4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4690.2
and 4791, Welfare and Institutions Code.

History

1. New section filed 1 1-5-91 as an emergency; operative 1 1-5-91 (Register 92,
No. 21). A Certificate of Compliance must be transmitted to OAL 3-4-92 or
emergency language will be repealed by operation of law on the following day.

2. New section refiled 3^-92 as an emergency: operative 3-4-92 (Register 92,
No. 25). A Certificate of Compliance must be transmitted to OAL 7-2-92 or
emergency language will be repealed by operation of law on the following day.

3. Certificate of Compliance as to 3-4—92 order including amendment of subsec-
tions (a)( 1 )-(2) transmitted to OAL 6-25-92 and filed 8-6-92 (Register 92. No.
33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Amendment of subsections (a)( 1 )-(2) and Noti-: filed 6-20-94 as an emergen-
cy; operative 6-20-94. Submitted to OAL for printing only pursuant to Chapter
722, Statutes of 1992, Section 147 (Register 94, No. 25).

6. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31).

7 . Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
filed 3-29-96 (Register 96, No. 13).

8. Change without regulatory effect amending subsections (a)(1) and (a)(2) filed
1 - 1 7-97 pursuant to section 1 00, title 1 , California Code of Regulations ( Regis-
ter 97, No. 3).

Subchapter 15. Schedule of Payment Rates

for In-Home Respite Services Agency

Vendors

Article 1. General Provisions

§ 58210. General Provisions for Schedule of Payment
Rates for All Fiscal Years.

(a) Each fiscal year, the Department shall establish a payment rate for
each vendor.

(b) The appropriate like program for each vendor shall be determined
based upon their service code.

(c) Each vendor shall submit information, as applicable, pursuant to
sections 58033 through 58039. The vendoring regional center and the

Page 292.70

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58240

Department shall review the information pursuant to sections 58040 and
5S()42.

N( vn:: Aiithoritv cited: Section 4690.2, Welfai-e and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5. Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. ."^6). A Ceilificate of Compliance must be transmitted loOAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10 29-yO (Register 90, No. 46).

?. Amendment of subsection (c) and NoTi. filed 8-6-92; operative 8-6-92 (Regis-
ter 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing onlv pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Regfster 93, No. 26).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8 2-94 (Register 94, No. 31).

Article 2.

Schedule of Payment Rates for
Fiscal Year 1990-91

§ 58220. Vendors Receiving Permanent Rates.

Note: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 2 (sections 58220-58224)
and section filed 1-17-97 pursuant to section 100, title 1, California Code of
Regulations (Register 97, No. 3).

§ 58222. Vendors Receiving Provisional Rates.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmiUed to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Comphance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 58224. New Vendors.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title I, California Code of Regulations (Register 97, No. 3).

Article 3.

Schedule of Payment Rates for
Fiscal Year 1991-92

§ 58230. Vendors Receiving Permanent Rates.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5. Welfai-e and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 10-29-90
or emergency lunguage will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing article 3 (sections 58230-58236)
and section filed 1-17-97 pursuant to section 100. title 1, California Code of
Regulations (Register 97. No. 3).

§ 58232. Vendors Receiving Temporary Payment Rates.

NoiE: Authority cited: Section 4690.2. Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28- 90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of subsections (b) and (d)(1) and NOTH filed 8-6-92; operative
8-6-92 (Register 92. No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17 93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93. No. 26).

5. Certificate of Compliance asto6-17-93 order transmitted toOAL6-20 94 and
filed 8-2-94 (Register 94, No. 31 ).

6. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100. ntle I, California Code of Regulations (Register 97. No. 3).

§ 58234. Vendors Receiving Provisional Rates.

NOTE: Authority cited: Section 4690.2. Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5. Welfaic and Institutions Code.

History

1. New section filed 6-26-90 as an einergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by I(>-29-9()
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100. title 1, Cahfornia Code of Regulations (Register 97. No. 3).

§ 58236. New Vendors.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of CompUance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 4. Schedule of Payment Rates for

Fiscal Year 1996-97 and Each Alternate

Fiscal Year Thereafter

§ 58240. Vendors Receiving Permanent Payment Rates.

(b) The effective date of the reestablished permanent payment rate
shall be September 1, 1996, for Fiscal Year 1996-97, and September 1
for each alternate fiscal year thereafter.

(c) The expiration date of the reestablished permanent payment rate
shall be August 31, 1997, for Fiscal Year 1996-97. and August 31 for
each alternate fiscal year thereafter.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

Page 292.71

5} 58242

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

3. Change without regulatory efteet amending artiele heading and seetion filed
1-1 7-97 pursuant to seetion 100. title 1 , California Code of Regulations (Regis-
ter 97. No. 3).

§ 58242. Vendors Receiving Temporary Payment Rates.

(b) If the mean is adjusted for a COLA pursuant to section 581 19 (b),
the Department shall adjust the temporary payment rate established the
previous fiscal year, by the amount of the COLA.

(c) The effective date of the adjustment to the temporary payment rate,
as specified in (h), shall be the effective date of the COLA as specified
in section 581 19(c).

NOTf-;: Authority eited: Seetion 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5. Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a) filed 1-17-97 pur-
suant to section 100, title 1. California Code of Regulations (Reaister 97, No.
3).

§ 58244. New Vendors.

(a) For Fiscal Year 1996-97, and each alternate fiscal year thereafter,
new vendors requesting a rate shall receive the temporary payment rate
established the previous fiscal year, adjusted for a COLA, if applicable,
pursuant to section 58119. The Department shall use the service informa-
tion specified in section 58033, submitted by each new vendor by the date
specified in Secfion 58032(a)(3), to establish the vendor's temporary
payment rate.

(b) The temporary payment rate shall be effective on the date the ven-
dor begins providing services to consumers.

( 1 ) The Department converts the temporary payment rate to a perma-
nent payment rate pursuant to Secdon 58252; or

(2) It expires, which shall be twenty-one months from the date it be-
came effective.

NOTE; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 5. Schedule of Payment Rates for

Fiscal Year 1997-98 and Each Alternate

Fiscal Year Thereafter

§ 58250. Vendors Receiving Permanent Payment Rates.

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter,
the Department shall establish permanent payment rates pursuant to sec-
fions 58100 through 58 11 9, based upon the service, cost and vendor in-
come information specified in secUons 58033 through 58038, and as
applicable, the regional center payment information specified in Section
58039, submitted by vendors receiving permanent payment rates by the
date specified in Section 58032(a)(2) for the reporting period specified
in Section 58031(a)(2).

(b) The effective date of the established permanent payment rate shall
be September 1, 1997, for Fiscal Year 1997-98, and September 1 for
each alternate fiscal year thereafter.

(c ) The expiration date of the established permanent payment rate shall
be August 31,1 998, for Fiscal Year 1 997-98, and August 3 1 for each al-
ternate fiscal year thereafter.

NOTt:: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5. Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL by r0-29-9()
or emergency language will be repealed by operation of law on the following
day.

2 . Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of subsection (a) and Noth filed 8-6-92; operative 8-6-92 (Regis-
ter 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printine only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93. No. 26).

5. Certificate of Compliance as to 6- 1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

6. Change without regulatory effect amending article heading and section filed
1-17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97. No. 3).

§ 58252. Vendors Receiving Temporary Payment Rates.

(a) The temporary payment rate shall confinue until the Department
converts it to a permanent payment rate pursuant to (b) through (e).

(b) All vendors converting from a temporary payment rate to a perma-
nent payment rate shall submit the service, cost and vendor income infor-
maUon specified in Secfions 58033 through 58038. and as applicable, the
regional center payment informafion specified in Section 58039 by the
dates specified in Section 58032(a)( 1 ) for the reporting period specified
in Section 58031(a)(1).

(c) The Department shall convert the temporary payment rate to a per-
manent payment rate pursuant to Sections 58 1 00 through 58119, with the
following exceptions:

( 1 ) The amount computed in Step five. Section 58 11 4 shall not be ad-
justed for gap funding;

(2) The permanent payment rate shall not exceed the upper limit; and

(3) If the amount computed in Step five is below the lower limit of the
allowable range of rates, the Department shall increase that amount to the
lower limit based upon available funds from the upper limit reduction
process for vendors with a permanent payment rate pursuant to Section
58115.

(d) The effective date of the conversion of the temporary payment rate
to a permanent payment rate shall be:

( 1 ) Thirty days from the date the Department receives the service, cost
and vendor income information that complies with Sections 58020 and
58033 through 58038, and as applicable, the regional center payment in-
formation specified in Section 58039; or

(2) No later than 21 months from the date the temporary payment rate
was inidally established.

(e) Temporary payment rates which are converted to a permanent pay-
ment rate shall expire August 3 1 , following the effective date.

NOTE: Authority cited: Section 4690.2. Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2 . Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing and adding new section filed
1-17-97 pursuant to section 100, title 1 , California Code of Regulations (Regis-
ter 97, No. 3).

§ 58254. New Vendors.

(a) For Fiscal Year 1997-98, and each alternate fiscal year thereafter,
new vendors requesting a rate shall receive a temporary payment rate es-
tablished pursuant to secdons 58 1 20 through 58 1 22, using the service in-

Page 292.72

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58310

formation specified in section 58033 submitted by each new vendor by
llic date specified in Section 58032(a)(3). The temporary payment rate
shall be based upon the service, cost and vendor income information sub-
mitted by vendors receiving permanent payment rates-pursuant to sec-
tion 58250 (a).

(h) The temporary payment rate shall be effective on the date specified
in Section 58244(b).

(c) Once the temporary payment rate is established, the vendor shall
continue to receive that rate until it is converted, or it expires, as specified
in Section 58244(c).

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending secfion filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 6. Timelines for Rate Establishment
and Written Notification

§ 58260. Timelines for Continuation of the Permanent Rate
and Written Notification.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 58262. Timelines for Extension of the Provisional Rate
and Written Notification.

Note: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Insfitudons Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

§ 58264. Timelines for Establishment of the Permanent
Payment Rate and Written Notification.

(a) For vendors receiving a permanent payment rate, the Department
shall, upon receipt of the information which complies with sections
58020, and 58033 through 58039, and by September 1, of each year, es-
tablish or reestablish a permanent payment rate and notify, in writing,
each vendor, the vendoring regional center, and utilizing regional cen-
tcr(s), if any, of the following:

(1) The permanent payment rate;

(2) The effective date and expiration date of the permanent payment
rate;

(3) The service code used to determine the permanent payment rate;

(4) Any Budget Act adjustments;

(5) The next required reporting period, and submission date pursuant
to Section 58031(a)(2) and 58032(a)(2) for the service, cost, vendor in-
coine, and as applicable, regional center payment information;

(6) That payment of the permanent payment rate shall be suspended
pursuant to section 58032 (c)(1)(B) if the required information specified
in (a)(5) is not submitted; and

(7) The vendor's right to appeal the permanent payment rate pursuant
to sections 58440 through 58448.

(b) For vendors converting their temporary payment rates to a perma-
nent payment rate, the Department shall establish the permanent pay-
ment rate and provide the notification specified in (a) within 30 days of
receipt of the service, cost and vendor income information that complies
with sections 58022, and 58033 through 58038, and as applicable, the re-
gional center payment information specified in Section 58039 for ven-
dors with a temporary payment rate that is converted to a permanent pay-
ment rate.

Note; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5. Welfare and In.stilutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsecfions (a), (a)(5) and (b)(3) and Note filed 8-6-92; opera-
tive 8-6-92 (Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Change without regulatory effect amending section filed 1-17-97 pursuant to
section 100, fitle 1, California Code of Regulations (Register 97, No. 3).

§ 58266. Timelines for Establishment of the Temporary
Payment Rate and Written Notification.

(a) For vendors requesting a temporary payment rate, the Department
shall, within 30 days from receipt of the service information, that com-
plies with section 58033, establish a temporary payment rate and notify,
in writing, each vendor, the vendoring regional center, and utilizing re-
gional center(s), if any, of the following:

(1) The temporary payment rate;

(2) The effective date and expiration date of the temporary payment
rate;

(3) The service code used to determine the temporary payment rate;

(4) Any cost-of-living adjustment;

(5) The next required reporting period, and submission date, pursuant
to Sections 58031(a)(1) and 58032(a)(1) for the service, cost and vendor
income information;

(6) That payment of the temporary payment rate shall be suspended
pursuant to Section 58032(c)(1)(A) if the required information specified
in (a)(5) is not submitted; and

(7) The vendor's right to appeal the temporary payment rate pursuant
to sections 58440 through 58448.

Note: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New secfion filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Change without regulatory effect amending subsections (a)(5) and (a)(6) filed
1-17-97 pursuant to section 100, title 1 . California Code of Regulations (Regis-
ter 97, No. 3).

Subchapter 16. Reporting Requirements

for In-Home Respite Services Agency

Vendors

Article 1 . Annual Report to the Legislature

§ 58310. The Department's Annual Report to the
Legislature.

(a) By April 15, 1997, for Fiscal Year 1997-98, and by April 15 for
each alternate fiscal year thereafter, the Department shall report the fol-
lowing to the Legislature:

Page 292.73

§ 58312

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

( 1 ) The amount needed to fund the statewide fiscal impact of the gap
including identification of the amount attributed to the vendors who are:

(A) Not eligible for a gap adjustment pursuant to section 58114
(a)(2)(B); or

(B) Eligible only for a partial gap adjustment pursuant to section
581I4(a)(^2)(A).

(A) Funded in the current fiscal year's Budget Act; nor

(B) Included in the next fiscal year's Governor's Budget.

(b) By April 15, 1998, for Fiscal Year 1998-99. and by April 15 for
each alternate fiscal year thereafter, the Department shall report:

( 1 ) The amount determined in (a)( 1 ) that was unfunded in the previous
year; and

(2) The information specified in (a)(2).

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsections (a) and (b) filed
1-17-97 pursuant to section 100, title 1, California Code of Regulations (Regis-
ter 97, No. 3).

§ 58312. The Joint Report to the Legislature for Fiscal Year
1996-97.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmiued to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, tide 1 , California Code of Regulauons (Register 97, No. 3).

Article 2. Calculation of the Statewide
Fiscal Impact of the Gap

§ 58320. Determination of the Statewide Fiscal Impact of
the Gap for Fiscal Year 1997-98, and Each
Alternate Fiscal Year Thereafter.

(a) For vendors with a permanent payment rate whose amount com-
puted in step two, section 58 1 1 1 , is below the upper limit of the allowable
range of rates computed in section 581 13, the Department shall:

( 1 ) For each vendor, calculate the difference between step two, section
5811 1 and step five, section 58114 (a)(1);

(2) Multiply the amount computed in ( 1 ) for each vendor by each ven-
dor's actual direct consumer service hours identified in section 58033
(b); and

(3) Add the amounts computed in (2) to determine the statewide gap.
Note: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending section heading and subsections (a)
and (a)(2) filed 1-1 7-97 pursuant to secfion 100, title 1 , California Code of Reg-
ulations (Register 97, No. 3).

§ 58322. Determination of the Statewide Fiscal Impact of
the Gap for Fiscal Year 1993-94, and Each
Alternate Fiscal Year Thereafter.

Note: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5. Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Change without regulatory effect repealing section filed 1-17-97 pursuant to
section 100, title 1, California Code of Reguladons (Register 97, No. 3).

Subchapter 17. Rate Adjustments, Audit

Adjustments and Rate Appeals for In-Home

Respite Services Agency Vendors

Article 1. General Provisions

§58410. General Provisions,

(a) A permanent payment rate may be adjusted pursuant, to this article,
by the Department, only for the following:

(1) A rate adjusttnent pursuant to section 58420 (b) and (c); and/or

(2) An audit adjustment pursuant to section 58430 (a)(1)(A); and/or

(3) A rate appeal pursuant to sections 58440 through 58448.

(b) A temporary payment rate may be adjusted pursuant to this article,
by the Department, only for the following:

(1) An audit adjustment pursuant to section 58430 (a)(1)(B); and/or

(2) A rate appeal pursuant to sections 58440 through 58448.

NOTE; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institufions Code.

History

1. New section filed 6-26-90 as an emergency; operafive 7-1-90 (Register 90,
No. 36). A Certificate of CompHance must be transmitted to OAL by 10-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Change without regulatory effect amending subsection (a), repealing subsec-
tions (c)-(c)(3) and relettering remaining subsection filed 1-17-97 pursuant to
section 100, title 1, California Code of Regulations (Register 97, No. 3).

Article 2. Rate Adjustments

§ 58420. General Provisions.

(a) Once a payment rate for each in-home respite services agency ven-
dor has been established by the Department, adjustments to that rate shall
be considered by the Department, for either anticipated or unanticipated
changes, in accordance with (b) and (c).

(b) Anticipated changes are service modifications which the vendor
and/or the vendoring regional center can plan for and expect to occur in
the next fiscal year. Anticipated changes shall be submitted to the Depart-
ment and the vendoring regional center prior to December 1 of the year
previous to the fiscal year in which the changes are expected to occur.
Any requests submitted after December 1 shall not be considered by the
Department. Anticipated changes shall be limited to the following:

( 1 ) Relocation of the vendor' s office due to expiration of the vendor' s
office lease or tenancy arrangement; and/or

(2) A loss or gain of any vendor income used to compute the vendor's
rate;

(3) An increase or decrease in the units of service purchased by region-
al centers, where such change equals 25% or more annually from the

•

Page 292.74

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58424

•

units of service used in the cost statement upon which their rate was
based.

(c) Unanticipated changes shall be submitted by the vendor to the De-
partment and the vendoring regional center no later than 60 days from the
date the change has occurred. Unanticipated changes received after the
60 days shall not be considered by the Department. Unanticipated
changes shall include mandated service adjustments due to changes in,
or additions to, existing statutes, laws or regulations or court decisions.

(d) Anticipated changes shall be funded by the Department only if
there are funds made available in the Budget Act appropriation to the De-
partment for that purpose.

(e) Unanticipated changes shall be funded effective the date the De-
partment approves them pursuant to section 58424.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and histitutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment filed 8-30-2001 as an emergency; operative 8-30-2001 (Register

2001, No. 35). A Certificate of Compliance must be transmitted to OAL by
12-28-2001 or emergency language will be repealed by operation of law on the
following day.

4. Reinstatement of section as it existed prior to 8-30-2001 emergency amend-
ment by operation of Government Code section 1 1 346. 1 (f) (Register 2002, No.
15).

5. Amendment filed 4-1 1-2002 as an emergency; operative 4-1 1-2002 (Register

2002, No. 15). A Certificate of Compliance must be transmitted to OAL by
8-9-2002 or emergency language will be repealed by operation of law on the
following day.

6. Amendment refiled 8-8-2002 as an emergency; operative 8-8-2002 (Register

2002, No. 32). A Certificate of Compliance must be transmitted to OAL by
12-6-2002 or emergency language will be repealed by operafion of law on the
following day.

7. Amendment refiled 12-5-2002 as an emergency; operative 12-5-2002 (Regis-
ter 2002, No. 49). A Certificate of CompHance must be transmitted to OAL by
4-4-2003 or emergency language will be repealed by operation of law on the
following day.

8. Certificate of Compliance as to 1 2-5-2002 order transmitted to OAL 4-4-2003,
and withdrawn from OAL review on 5-15-2003.

9. Amendment filed 5-15-2003 as an emergency; operative 5-15-2003 (Register

2003, No. 20). A Certificate of Compliance must be transmitted to OAL by
9-12-2003 or emergency language will be repealed by operation of law on the
following day.

10. Certificate of Compliance as to 5-15-2003 order transmitted to OAL
6-23-2003 and filed 7-28-2003 (Register 2003, No. 31).

§ 58422. Submission Requirements for Rate Adjustments.

(a) Any in-home respite services agency vendor requesting a rate ad-
justment due to anticipated or unanticipated program changes pursuant
to the requirements of section 58420 shall submit the following informa-
tion in writing to the Department with a copy to the vendoring regional
center:

(1) Vendor service information specified in section 58033 (a)(1)
through (4);

(2) The specific reason for the adjustment request;

(3) All supporting documentation and any other information necessary
to substantiate and/or justify the request;

(4) Service, cost and vendor income information for only those items
relating to the rate adjustment request; and

(5) The date the additional cost was incurred or is expected to be in-
curred.

NOTti; Authority cited: Section 4690.2, Welfare and Institufions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Insfitutions Code,

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 58424. Review Procedures for Rate Adjustments.

(a) Within five days of receipt of the rate adjustment request from the
vendor, the Department shall send a written notification to the vendoring
regional center which shall indicate that the Department has received the
rate adjustment request from the vendor.

(b) Within 30 days from the date of the Department's written notifica-
tion pursuant to (a), the vendoring regional center shall:

( 1 ) Review all information submitted by the vendor to determine if it
complies with the requirements of sections 58420 and 58422; and

(2) Notify the Department, in writing, with a copy to the vendor, of the
regional center's recommendation, including supporting rationale for
their recommendation. The regional center's supporting rationale shall
include:

(A) The specific regulatory basis for the request;

(B) A statement that the circumstances necessitating the request have
been verified by the regional center; and

(c) If the regional center does not notify the Department of the results
of its review and recommendation pursuant to (b), the Department shall
proceed with its review procedures pursuant to (d) through (g).

(d) Within 50 days of the receipt of the rate adjustment request from
the vendor, the Department shall review the request to determine if it is
complete and complies with the requirements of sections 58420 and
58422.

(1) If the vendor's rate adjustment request is complete and complies
with the requirements of sections 58420 and 58422, the Department shall
approve the vendor's rate adjustment request within 60 days of receipt
of the request. However, requests for anticipated program changes shall
only be approved contingent upon funds being available pursuant to sec-
tion 58420 (d).

(2) If the vendor's rate adjustment request is not complete or does not
comply with the requirements of sections 58420 and 58422, the Depart-
ment shall make a written request to the vendor for additional informa-
tion, as required, and send a copy of the request to the vendoring regional
center. The vendor shall submit the required additional information to the
Department within 15 days from receipt of the written request.

(A) If the vendor fails to submit the required additional information
within 15 days, the Department shall deny the vendor's rate adjustment
request.

(B) If the vendor submits the required additional information within
the 15 days and it is complete and complies with the requirements of sec-
tions 58420 and 58422, the Department shall approve the vendor's rate
adjustment request within 60 days of receipt of the required additional
information. However, requests for anticipated program changes shall
only be approved contingent upon funds being available pursuant to sec-
tion 58420 (d).

(C) If the vendor submits the required additional information within
15 days and it is not complete and does not comply with the requirements
of sections 58420 and 58422, the Department shall deny the vendor' s rate
adjustment request.

(e) The Department shall notify, in writing, the vendor, the vendoring
regional center, and utiUzing regional center(s), if any, of the following:

(1) The decision to approve or deny the vendor's rate adjustment re-
quest pursuant to (d). Notification shall be as follows:

(A) Within the time specified in (d)(1) if the vendor's rate adjustment
request, when initially received by the Department, is complete and com-
plies with sections 58420 and 58422;

(B) Within 15 days from the date any required additional information
from the vendor is due, if the vendor fails to submit the required addition-
al informafion within the time specified in (d)(2)(A);

(C) Within the time specified in (d)(2)(B) if the vendor submits the re-
quired additional informafion within 1 5 days and it is complete and com-
plies with sections 58420 and 58422; or

(D) Within 60 days of receipt of any required additional information
which is not complete and does not comply with sections 58420 and
58422, as specified in (d)(2)(C).

Page 292.74(a)

§ 58430

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

(2) The availability of funds in the Budget Act, to fund previously ap-
proved anticipated program changes pursuant to section 58420 (d). The
notification shall be by September 1 .

(f) The effective date for all approved rate adjustments due to antici-
pated program changes pursuant to section 58420 (b) shall be September
1 of the subsequent fiscal year, or later, depending upon when the cost
relating to the change actually occurs.

(g) The effective date for all approved rate adjustments due to unantic-
ipated program changes pursuant to sectitm 58420 (c) shall be the date
the service began incurring the additional cost.

Note-. Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2. 4691 and 4691.5, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

Article 3. Audit Adjustments

§ 58430. Rate Adjustments Resulting from Audit Findings.

(A) For vendors reimbursed at a permanent payment rate, the vendor's
rate shall be adjusted if the service, cost, vendor income, and as applica-
ble, regional center payment information, used as a basis for determining
the rate, does not substantiate or support the rate established by the De-
partment.

(B) For vendors reimbursed at a temporary payment rate, the vendor's
rate shall be adjusted if any of the service information used as a basis for
determining the rate, does not substantiate or support the rate established
by the Department.

(2) The revised rate and the effective date of the revised rate shall be
determined as follows:

(A) For vendors reimbursed at a permanent payment rate, the vendor' s
service, cost, vendor income, and as applicable, regional center payment
information used as a basis for determining the vendor's rate, adjusted
for any findings in the final audit report, shall be used to determine the
revised rate and its effective date.

(B) For vendors reimbursed at a temporary payment rate, the vendor's
service information used as a basis for determining the vendor's rate, ad-
justed for any findings in the final audit report, shall be used to determine
the revised rate and its effective date.

(b) If an adjustment to the vendor's rate was made pursuant to (a), the
Department shall include, with the final audit report released to the ven-
dor, written notification of the following:

(1) The revised rate and its effective date;

(2) The vendor's right to defer implementation of the revised rate and/
or its effective date, pending the results of an audit appeal, if the vendor
appeals the audit pursuant to title 17, section 50700 through 50767;

(3) That if the vendor appeals the audit, the results of the audit appeal
shall be used by the Department in accordance with (a) to determine the
revised rate and its effective date; and

(4) The vendor's right to appeal errors by the Department in calculat-
ing its revised rate and/or the effective date of the revised rate pursuant
to sections 58440 through 58448.

(c) Vendors shall not appeal issues pertaining to the audit through the
rate appeal process specified in sections 58440 through 58448.

(d) A copy of the written notification and final audit report specified
in (b) shall be sent to the vendoring regional center, and utilizing regional
center(s), if any, at the same time the original notice and audit report are
sent to the vendor. The Department shall provide the vendor, the vendor-
ing regional center, and utilizing regional center(s), if any, with written

notification of the results of any audit appeal and revisions, if any, in the
vendor's rate and its effective date.

NOTE: Authority cited: Section 4690.2, Welfare and histitutionsCode. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order n^ansmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90. No. 46).

3. Amendment of subsections (a)( 1 )( A) and (a)(2)(A) and NoTK filed 8-6-92; op-
erative 8-6-92 (Register 92. No. 33).

4. Amendment of secfion filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to 8648-5 (Chapter 722. Statutes
of 1992) Section 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94. No. 31 ).

6. Change without regulatory effect amending subsecfions (a)(l)(A)-(B) and
(a)(2)(A)-(B) filed r-17-97 pursuant to section 100, title 1, California Code of
Regulations (Register 97, No. 3).

Article 4. Rate Appeals

§ 58440. General Provisions.

(a) A vendor may appeal the following to the Department's Deputy Di-
rector who has the responsibility for setting rates:

( 1 ) Errors in service and/or cost and/or vendor income and/or, as appli-
cable, regional center payment information submitted by the vendor
which was utilized by the Department to establish the vendor's rate;

(2) Errors by the Department in calculating the vendor's rate, includ-
ing revised rates based on a final audit report or the results of an appeal
of a final audit report;

(3) The effective date of the rate, including revised rates based on a fi-
nal audit report or the results of an appeal of a final audit report; and/or

(4) A rate adjustment request denied by the Department pursuant to
secdons 58420 through 58424, except anticipated program changes that
were not approved because funding was not appropriated for that pur-
pose.

(b) The vendor shall file the appeal with the Deputy Director within
12 months after the receipt of written notification from the Department
of the vendor's rate.

(c) If an appeal is not filed within the time specified, it shall be denied
unless good cause pursuant to section 58446 is estabUshed for the late
submission. Good cause shall be determined by the Deputy Director in
accordance with section 58446. If good cause for late submission is es-
tablished, the Deputy Director shall proceed to decide the appeal in ac-
cordance with section 58441.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of subsecfion (a)(1) and Note filed 8-6-92; operative 8-6-92
(Register 92, No. 33).

4. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for prinfinc only pursuant to SB485 (Chapter 722, Statutes
of 1992) Secfion 147(a) (Register 93, No. 26).

5. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

§ 58441 . Contents of Appeal and Decision.

(a) The appeal filed pursuant to secfion 58440 shall be in wrifing and
shall include the following:

(1) Vendor service information specified in secfion 58033 (a)(1)
through (4);

(2) Idenfificafion of the rate error or effecfive date being appealed;

(3) The specific basis of the appeal; and

(4) All supporfing documentafion and any other information necessary
to substantiate and/or justify the appeal, including the specific regulation
used as the basis for the appeal.

•

Page 292.74(b)

Title 17 Health and Welfare Agency — Department of Developmental Services ^ 5S441

(b) At the time the vendor files the appeal with the Deputy Director, ( I ) If all required information has been submitted, the Deputy Director
a copy shall be mailed to the vendoring regional center, and utilizing re- shall render a decision pursuant to (d);

gional center(s). if any. (2) If all required information has not been submitted, and/or addition-

(c) Within 13 days after receipt of the appeal, the Deputy Director shall al information is needed, the Deputy Director shall request the additional
i-evie\v the appeal to determine whether it complies with sections 58440

and 58441 (a).

[The next page is 292.74(e).

Page 292.74(C) Register 2003, No. 31; 8-1-2003

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58448

information, in writing, from the appellant within L'^ days after receipt
of the appeal. The appellant shall submit the additional information with-
in 15 days after receipt of the request.

(A) If the information is not submitted within the time specified, the
appeal shall he deemed withdrawn, and no further action shall be taken
unless the appellant establishes good cause, pursuant to section 58446,
for the late submission. Good cause shall be determined by the Deputy
Director, in accordance with section 58446. If good cau.se for late sub-
mission is established, and the information is submitted, the Deputy Di-
rector shall proceed with the appeal and render a decision pursuant to (d);

(B) If the information, is submitted but does not comply with the re-
quest, the appeal shall be deemed withdrawn and no further action shall
be taken.

(d) The Deputy Director shall render a decision on the appeal within
60 days after receipt of all required and/or requested information. The de-
cision shall:

(1) Identify the specific issue(s) in dispute;

(2) Rule on each issue identified;

(3) State the facts supporting each ruling; and

(4) Identify the statutes and regulations upon which each ruling is
based.

(e) A written copy of the decision shall be mailed to the appellant, the
vendoring regional center, and utilizing regional center(s), if any, within
15 days after the decision is rendered.

(f) If the appellant does not appeal the decision to the Director, pur-
suant to section 58442, it shall be deemed final.

NOTH; Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

§ 58442. Appeal of Deputy Director's Decision.

(a) The appellant may appeal the Deputy Director's decision to the Di-
rector within 15 days after receipt of the written decision. The appeal
shall be in writing and shall include the following:

( 1 ) All information submitted to the Deputy Director pursuant to sec-
tion 58441(a);

(2) A copy of the Deputy Director's decision; and

(3) A statement of the issue(s), facts, documentation, and supporting
authority identifying why the appellant believes the decision of the
Deputy Director should be reversed by the Director.

(c) Within 60 days of receipt of all required and/or requested informa-
tion, the Director or the Chief Deputy Director shall render a decision uti-
lizing the process specified in section 58441 (d).

(d) A written copy of the decision shall be sent to the appellant, the
vendoring regional center and utilizing regional center(s), if any, within
1 5 days after the decision is rendered.

(c) An appeal filed with the Director is the final level of appeal. The
decision rendered by the Director or the Chief Deputy Director shall be
deemed final.

NOTt-:: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690.2 and 4791 (i). Welfare and In.stitutions Code. Reference: Sections 4690.2,
4691, 4691.5 and 4791, Welfare and Institutions Code.

History

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6 17-93; operative 6 17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

§ 58444. Effective Date of Decision.

The effective date of the decision rendered pursuant to Sections 5844 1
and 58442 shall be stated in the decision. The effective date shall be the
date the Department received the appeal pursuant to Section 58440 or the
date the costs are incurred, whichever is later.

NOTE: Authority cited: Chapter 722. Statutes of 1992, Section 147; and Sections
4690.2 and 479 l(i). Welfare and Institutions Code. Reference: Sections 4690.2,
469 1 , 469 1 .5 and 479 1 , Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20-94 and
filed 8-2-94 (Register 94, No. 31 ).

§ 58446. Good Cause.

(a) For the purposes of sections 58440 through 58444, good cause for
a failure to act is limited to:

(1) A violent act of nature, including, but not limited to, fiood. earth-
quake, blizzard or fire; and/or

(2) Arson, vandalism, and/or theft of records and/or property, by indi-
viduals other than the appellant, which preclude the appellant from filing
a timely appeal.

(b) The appellant shall, within a reasonable time, not to exceed 60 days
after the vendor has notice of the incident giving rise to its claim of good
cause, submit to the Deputy Director, or the Director, as appropriate, the
basis for its claim of good cause and all supporting documents or other
evidence to substantiate its claim. The Deputy Director, Director, Chief
Deputy Director, as appropriate, shall, within 30 days of receipt of the
claim and supporting documentation, review the information and render
a decision regarding whether good cau.se has been established.

(c) The Deputy Director, Director or Chief Deputy Director, as appro-
priate, shall notify the appellant in writing of the good cause determina-
tion, and shall specify what action will be taken, if any, pursuant to sec-
tions 58441 through 58444.

NOTE: Authority cited: Chapter 722, Statutes of 1992, Section 147; and Sections
4690.2 and 4791(i), Welfare and Institutions Code. Reference: Sections 4690.2,
4691, 4691.5 and 4791, Welfare and Institufions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90,
No. 36). A Certificate of Compliance must be transmitted to OAL by 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-90 order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of section filed as an emergency 6-17-93; operative 6-17-93.
Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes
of 1992) Section 147(a) (Register 93, No. 26).

4. Certificate of Compliance as to 6-1 7-93 order transmitted to OAL 6-20 -94 and
filed 8-2-94 (Register 94, No. 31).

§ 58448. Review of Documents Only.

An appeal made pursuant to sections 58440 through 58446 shall be de-
cided only on the documents submitted. There shall be no oral testimony
or argument.

NOTE: Authority cited: Section 4690.2, Welfare and Institutions Code. Reference:
Sections 4690.2, 4691 and 4691.5, Welfare and Institutions Code.

History

1. New section filed 6-26-90 as an emergency; operative 7-1-90 (Register 90.
No. 36). A Certificate of Compliance must be transmitted to OAL b\ 1 0-29-90
or emergency language will be repealed by operation of law on the following
day.

2. Certificate of Compliance as to 6-26-9U order transmitted to OAL 9-28-90 and
filed 10-29-90 (Register 90, No. 46).

3. Amendment of forms filed 8-6-92; operadve 8 6 92 (Register 92, No, 33).

Page 292.74(e)

§ 58448

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

4. Aincndmcnt of forms filed as an emergency 6-17-93; operative 6-17-93. Sub- Statutes of 1992, Section 147 (Register 94, No. 23).
mitted to OAL for printing onlv pursuant to SB485 (Chapter 722. Statutes of ^ ,,■ ■ , .• /•<• ,t^ • ,^^ k, .-,.
1992) Section 147(a) (Register"93, No. 26). 6- ^^'"'t""^' 'correction of form (Register 96. No. 13).

5. Amendment of form DS 1 897B Instructions filed 6-20-94 as an emergency; op- 7. Certificate of Compliance as to 6-20-94 order transmitted to OAL 2-20-96 and
erative 6-20-94. Submitted to OAL for printing only pursuant to Chapter 722, filed 3-29-96 (Register 96, No. 13).

Appendix C to Subchapter 17

State of California — Health and Welfare Agency

IN-HOME RESPITE COST STATEMENT
DS 18978(12/92)

Department of Developmental Services

Paee

1 . Reporting Period

19 through

, 19_

Vendor Name

Vendor Number

Service Code

Subcode

Business Address

Street

City

"State

Zip

Mailing Address

Street

City

State

Zip

6. Management Organization Name (if applicable)

7. Service Director

Telephone Number

PROGRAM INFORMATION

8. Name of Vendoring Regional Center:

9. Name of User Regional Centers:

Temporary payment rate applicants only
10. Date service began or will begin:

, 19_

TEMPORARY PAYMENT RATE APPLICANTS STOP HERE AND SIGN LINE 20

PERMANENT PAYMENT RATE APPLICANTS COMPLETE REMAINDER OF PAGE

Direct Service Hours

VENDOR COSTS

12. Salaries and Wages

13. Fringe Benefits

14. Operating Expenses (from page 2, line 17)

15. Management Organization Costs (from page 3, line 2)

1 6. Negotiated Level of Payment Adjustment (from page 4, line 4)

17. TOTAL COST

18. VENDOR INCOME (from page 3, line 5)

19. NET COST $

20. I hereby certify to the best of my knowledge and belief that this cost statement is true and correct, and complies with the requirements of
Title 17, Sections 58020 through 58039.

(

Signature

Date

Page 292.74(f)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58448

Slate of Calilbmia — Health and Welfare Agency
1)S 18978(12/92)

Vendor Name:

Vendor Number: .
Service Code:

Department of Developmental Services

Page 2

Subcode:

OPERATING EXPENSE SHEET

8.
9.
10.

11.
12.

13.
14.
15.
16.
17.

Accounting fees

Bank service fees ,

Communication costs

Contractual/consultant fees

Depreciation costs

General expenses

Insurance costs

Janitorial fees

Legal fees

Maintenance costs

Office supplies

Rental and lease costs

Staff training costs

Staff travel costs

Utility costs

Vehicle depreciation

TOTAL OPERATING COSTS (to page 1, line 14)

Page 292.74(g)

§ 58448

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

State of California — Health and Welfare Agency

DS 1897B (12/92)

Vendor Name:

Vendor Number:.
Service Code:

Department of Developmental Services

Page 3

Subcode:

MANAGEMENT ORGANIZATION COST
1 . Total Cost

2. Amount allocated to this service
(to page I, line 15)

3. Method for allocating cost (check one)
n Hours of attendance

n Total cost for each service

VENDOR INCOME

4. Name of Vendor
Income Source

Duration
of Funding

Total
Income

5. Total (to page J, line 18)

Page 292.74(h)

Title 17 Health and Welfare Agency — Department of Developmental Services § 58448

Slate of California — Health and Welfare Agency Department of Developmental Services

DS 1897B (12/92) Page 4

APPLICABLE ONLY TO VENDORS WHO NEGOTIATED A LOWER LEVEL OF PAYMENT

Vendor Name:
Vendor Number:

Service Code: Subcode:

REGIONAL CENTER PAYMENT INFORMATION

A BCD

Total Amount of Actual Maximum Amount of

Name of Regional Center Regional Center Payment Regional Center Payment Difference

Total

?i. Total amount of cost reductions
implemented as a result of the
negotiated level of payment.

4. Enter the lesser of line 2D or line 3.

(to page L line 16)

Page 292.74(h)(1) Register 96, No. 13; 3-29-%

§ 58448

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

INSTRUCTIONS

Form DS 1897B (6/94) — Page 1
Line

1 . Enter the reporting period of tliis cost statement.

2. Enter vendor name.

3. Enter vendor number, service code, and subcode.

4. Enter the address where the vendored service is located.

5. Enter the maihng address for the vendored service.

6. Enter the name of the management organization, if the service is affiliated with a management
organization.

7. Enter the name of the service director and telephone number for the vendored service.

8. Enter the name of the vendoring regional center.

9. Excluding the vendoring regional center, enter the names of all regional centers for which you
provide services.

10. If you are applying for a temporary payment rate, enter the date you began or intend to begin
providing services.

Reference
58031

58033 (a)( I )

58033(a)(1)

58033 (a)(2)

58033 (a)( 1 )

58033 (a)(3)
58033 (a)(2)

58033 (a)(4)

58033(c)(1)

VENDORS REQUESTING A TEMPORARY PAYMENT RATE, GO TO LINE 20
VENDORS REQUESTING A PERMANENT PAYMENT RATE, COMPLETE LINES 11 THROUGH 20

11. Enter the total actual number of direct service hours provided to clients during this reporting period, 58033 (b)
and, for vendors reimbursed for absences, the number of direct service hours for which reimbursement

was received.

12. Enter the total gross salaries and wages, including overtime, for the vendored service. 58034 (a)(1)

1 3. Enter the cost of allowable fringe benefits associated with the salaries and wages on line 12 above. 58034 (a)(2)

14. Enter the total allowable operating expenses from page 2, line 17. 58034 (a)(3)

15. Enter the total allowable management organization costs from page 3, line 2. 58034 (a)(4)

16. Enter the amount from page 4, line 4. 58039(b)

17. Enter the total of lines 12, 13, 14, 15, and 16.

18. Enter the total allowable vendor income from page 3, line 4. 58038

19. Subtract hne 18 from line 17.

20. Sign and date Statement of Certification. 58030(a)

TEMPORARY PAYMENT RATE VENDORS: INCLUDE WITH THE 58033 (a)(5)

SIGNED COST STATEMENT, A COPY OF THE SERVICE 58033 (c)(2)

DESIGN AND VENDOR APPROVAL LETTER.

PERMANENT PAYMENT RATE VENDORS: INCLUDE WITH THE 58033 (a)(5)

SIGNED COST STATEMENT, A COPY OF THE SERVICE DESIGN.

Page 292.74(h)(2)

Title 17

Health and Welfare Agency — Department of Developmental Services

§ 58448

INSTRUCTIONS

Page 2 — OPERATING EXPENSE DETAIL SHEET

•

Liiw

1 . Enter the cost for accounting fees.

2. Enter the cost for bank service fee.

3. Enter the communication costs including telephone, telegraph, teletype, centrex, telepak,
postage, message service, facsimiles and TDD.

4. Enter the cost for contractual/consultant fees that do not have a specific cost category.

5. Enter the depreciation cost excluding vehicle depreciation which is reported on line 16.

6. Enter the cost for general expenses. See section referenced for items allowable under
general expense.

7. Enter the insurance costs.

8. Enter the janitorial costs.

9. Enter the cost for legal fees.

1 0. Enter the maintenance costs. See section referenced for items allowable under maintenance costs.

11. Enter the office supplies costs. See section referenced for allowable office supplies costs.

12. Enter the rental and lease costs. See section referenced for items allowable under rental and lease costs.

13. Enter the staff training costs.

14. Enter the costs for staff travel.

15. Enter the utilities costs.

1 6. Enter the vehicle depreciation costs. See referenced section regarding depreciation
methodology and useful life.

17. Enter total of lines 1 through 16 here and on page 1, line 14.

Reference

58034 (a

(3){A)

58034 (a

(3)(B)

58034 (a

(3)(C)

58034 (a

(3)(D)

58034 (a

(3)(E)

58034 (a

)(3)(F)

58034 (a

)(3)(G)

58034 (a

)(3)(H)

58034 (a

)(3)(I)

58034 (a

)(3)(J)

58034 (a

(3)(K)

58034 (a

(3)(L)

58034 (a

(3){M)

58034 (a

(3)(N)

58034 (a

(3)(0)

58034 (a

(3)(P)

Page 292.74(h)(3)

§ 58448 BARCLAYS CALIFORNIA CODE OF REGULATIONS Title 17

INSTRUCTIONS

Page 3 — MANAGEMENT ORGANIZATION COST

AND VENDOR INCOME DETAIL SHEET

MANAGEMENT ORGANIZATION COST

Line Reference

1 . Enter the total allowed cost of the management organization. 58034 (a)(4)(C)2.

2. Enter the amount of management organization costs allocated to this service here and on 58034 (a)(4)(C)
page 1, line 15.

3. Check the method of allocation used. 58034 (a)(4)(C) 1 .a.

58034 (a)(4)(C) l.b.

VENDOR INCOME

Line Reference

4. Enter name of each source of vendor income, duration of funding and total income. 58038 (a)

5. Enter the total of all vendor income here and on page 1. line 18. 58038 (a)

Page 292.74(ll) (4) Register 96, No. 13; 3-29-96

•

Title 17 Health and Welfare Agency — Department of Developmental Services § 58448

INSTRUCTIONS

Page 4 — REGIONAL CENTER PAYMENT INFORMATION DETAIL SHEET

APPLICABLE ONLY TO VENDORS WHO NEGOTIATED A LOWER LEVEL OF

PAYMENT

Regional Center Payment Information

Line Reference

1 . Enter the name of eacli regional center, total amount of the actual regional center payment
received from the regional center, and maximum amount of the regional center payment which

you would have received from the regional center based upon the established rate and the actual units 58039 (a)(l )

of service provided, and the difference between the two amounts. 58039 {a)(2)

2. Enter the total amount of all actual regional center payments received, the total of all maximum 58039 (a)( 1 )
amounts of regional center payments, and the total difference between the two amounts. 58039 (a)(2)

3. Enter the total amount of cost reductions implemented as a result of the negotiated level of payment. 58039 (b)

4. Enter the lesser of the amounts entered on line 2D or line 3 here and on page 1 , line 1 6.

•

Page 292.74(h) (5) Register 2004, No. 44; 10-29-2(KJ4

§ 58500

BARCLAYS CALIFORNIA CODE OF REGULATIONS

Title 17

Subchapter 18. Transportation Service

Article 1. Definitions

§ 58500. Meaning of Words.

Words shall have their usual meaning unless the context or a definition
clearly indicates a different meaning. Words used in their present tense
include the future tense. Words used in the singular form include the plu-
ral form. Use of the word "shall" denotes mandatory conduct and "may"
denotes permissive conduct.

NOTH: Authority cited: Sections 4405 and 4631, Welfare and Institutions Code;
and Section 11152, Government Code. Reference: Sections 4690 and 4690.1,
Welfare and Institutions Code.

History
1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code

section 11346.2(d) (Register 92, No. 10).

§58501. Definitions.

(a) The following definitions shall apply to the regulations contained
in this subchapter:

( 1 ) "Basis for Payment" means the method used to calculate and deter-
mine the rate of payment;

(2) "Bid" means all the documents submitted by the bidder to the re-
gional center in response to a Request for Proposal (RFP);

(3) "Bidder" means an individual or entity who submits a bid to the re-
gional center in response to an RFP;

(4) "Bidders" Conference" means a meeting held by the regional cen-
ter after an RFP is issued to respond to questions from potential bidders;

(5) "Bid Form" means that part of the bid which contains the bid price
and all supporting cost information;

(6) "Cost Effective" means obtaining the optimum results for the ex-
penditure;

(7) "Rate of Payment" means the price charged to a regional center by
a vendor for each unit of service;

(8) "Route Miles" means the number of miles driven, while consumers
are in the vehicle, during the provision of transportation service;

(9) "Submit" means the postmarking or hand delivery of the item re-
quired;

(10) "Transportation Aide" means a person who assists and monitors
regional center consumers while the consumers are receiving transporta-
tion service;

(11) "Transportation Service" means the conveyance of a consumer
including boarding and exiting the vehicle.

Note: Authority cited: Sections 4405, 463 1 , 4690 and 4690. 1 , Welfare and Insti-
tutions Code; and Section 11 152, Government Code. Reference: Sections 4631,
4690 and 4690.1, Welfare and Institutions Code.

History

1. New section filed 9-26-91; operative 9-26-91 pursuant to Government Code
section 1 1346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsections (a)(8), (a)(10) and
(a)(ll) filed 1-17-97 pursuant to section 100, title 1 , California Code of Regu-
lations (Register 97, No. 3).

§ 58502. Terms Defined in Other Subchapters.

(a) As used in this subchapter, the following words and phrases have
the meanings specified in Subchapter 2, Section 54302.

(1) Authorized Consumer Representative

(2) Community-based Day Programs

(3) Consumer

(4) Department

(5) Individual Program Plan (IPP)

(6) Interdisciplinary (ID) Team

(7) Management Organization

(8) Regional Center

(9) Service Code

(10) Special Incident Report

(11) Subcode

(12) Unit of Service

(13) Vendor

(14) Vendor Identification Number

(15) Vendoring Regional Center

(b) As used in this subchapter, the following words and phrases have
the meanings specified in Subchapter 7, Section 57210:

(1) Straight-line Depreciation

(2) Vendor Income

NOTE: Authority cited: Sections 4405, 463 1 , 4690 and 4690. 1 . Welfare and Insti-
tutions Code; and Section 1 1 152. Government Code. Reference: Sections 4631,
4690 and 4690.1, Welfare and Institutions Code.

History

1 . New section filed 9-26-91 : operative 9-26-91 pursuant to Government Code
section 11346.2(d) (Register 92, No. 10).

2. Change without regulatory effect amending subsection (a)( 1 ), repealing subsec-
tion (a)(2), renumbering subsections, and adding new subsection (a)(3) filed
1-1 7-97 pursuant to .section 100, title 1, California Code ofRegulations (Regis-
ter 97, No. 3).

•

Article 2. General Provisions

§ 58510. General Requirements Applicable to Regional
Centers.

(a) The regional center shall purchase transportation service only
when:

(1) The transportation service is included in the consumer's IPP;

(2) The vendor has a rate approved by the Department or the regional
center;

(3) Provision of the transportation service is not the responsibility of
any public agency which receives public funds for providing the trans-
portation service;

(4) Provision of the transportation service is not part of the consumer's
community-based day program; and

(b) The regional center shall purchase transportation service by using,
at its discretion, any of the following processes:

(1) Competitive procurement utilizing a Request for Proposal (RFP)
pursuant to Sections 58530 through 58535;

(2) Noncompetitive procurement, which is limited to:

(A) Negotiated rate, pursuant to Section 58540;

(B) Cost statement, pursuant to Sections 58550 through 58555;

(D) Standardized rates pursuant to Section 58542; and

(E) Standard Rate Schedule pursuant to Section 58543.

( 1 ) Establish the level of liability insurance coverage to be obtained by
each vendor, for damages for bodily injuries or death and for damages to
or destruction of property;

(2) Provide monthly records of services provided to each consumer,
including the date, city or county where service was provided, and the
number of miles driven, or number of trips provided, by vendor. Units of
service for contracts reimbursed other than a per mile, per day. or per trip
rate shall also be maintained and reported as specified above. The above
information must be submitted to the Department on a monthly basis, and
no later than 30 days after the end of the previous month;

(3) At least annually inform the local transportation planning agency
designated pursuant to Government Code Section 29532 of the transpor-
tation needs of its consumers; and

(4) Determine the necessity for transportation assistant and transp

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